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The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
October 15, 2008
08-41
___________________________________
PRODUCT
Publix Vanilla Wafers in 12oz. paperboard box; UPC 4415-00609, Recall # F-001-9
CODE
030409A
RECALLING FIRM/MANUFACTURER
Toufayan Bakery of Plant City, Plant City, FL, by e-mail on August, 14th, 2008 and by press release on August 15, 2008. Firm initiated recall is complete.
REASON
Vanilla wafers contain undeclared soy lecithin.
VOLUME OF PRODUCT IN COMMERCE
309 cases/12 packages per case
DISTRIBUTION
FL, GA, SC, AL, and TN
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Source Plasma, Recall # B-0035-09
CODE
Units: KP101203, KP101459, 06MTNA3176, and 06MTNA2955
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by facsimile on December 5, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had a tattoo applied within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA, FL
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0036-09;
b) Platelets Pooled Leukocytes Reduced, Recall # B-0037-09;
c) Fresh Frozen Plasma, Recall # B-0038-09
CODE
a) and c) Unit 6829803; b) Unit 1006583
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by letter on October 29, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0040-09
CODE
Units: 5807908, 4070622, 4051130, 4004265
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by facsimile and letter on July 20, 2006. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
LA and MI
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0041-09;
b) Platelets Pooled Leukocytes Reduced, Recall # B-0042-09
CODE
a) Unit: 0605860;
b) Unit: 1006908
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by letter dated November 16, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Source Plasma, Recall # B-0045-09
CODE
Unit: 363017769
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Fort Worth, TX, by facsimile on September 22, 2006. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who did not have a complete annual physical exam, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma, Recall # B-0047-09
CODE
Units: 363017557, 363017312, 363016769, 363016547, 363015954, 363015705, 363015149, 363014879, 363012291, and 363009637
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Fort Worth, TX, by facsimile on September 26, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0062-09
CODE
Unit: FC61111
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by telephone on June 17, 2008 and letter on June 27, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0064-09
CODE
Unit: 29GS76956
RECALLING FIRM/MANUFACTURER
American National Red Cross, Mid Atlantic Region, Norfolk, VA, by letter on October 1, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from donors whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0065-09
CODE
Unit: 035GC82741
RECALLING FIRM/MANUFACTURER
American National Red Cross Blood Services, Roanoke, VA, by telephone on September 30, 2006 and by letter dated October 30, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0101-09;
b) Fresh Frozen Plasma, Recall # B-0103-09;
c) Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0104-09;
d) Fresh Frozen Plasma (Apheresis), Recall # B-0105-09;
e) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0106-09;
f) Plasma Frozen, Recall # B-0107-09;
g) Platelets Pheresis Leukocytes Reduced, Recall # B-0108-09;
CODE
a) Units: FE26631 FE26638 FE26641 FE26644 FE26649 FE26652 FE26659 FE27395 FE27399 FE27402 FE27405 FE27411 FE28372 FE28375 FE28378 FE28380 FE28382 FE28387 FE28392 FE28393 FE29229 FE29232 FE29234 FE29237 FE29239 FE29242 FE29245 FE29246 FK15820 FK15821 FK15822 FK15823 FK15824 FK15825 FK15826 FK15832 FK16463 FK16464 FK16465 FK16466 FK16467 FK16468 FK16469 FK16470 FK16471 FK16472 FK16473 FK16474 FK16475 FK16476 FK16477 FK16793 FK16795 FK16796 FK16797 FK16798 FK16799 FK16800 FK16802 FP05891 FP05893 FP05896 FP05899 FP05901 FP05902 FP05904 FP06066 FP06068 FP06069 FP06070 FP06071 FP06072 FP06074 FP06075 FP06076 FP06077 FP06078 FP06080 FY11402 FY11405 FY11406 FY11473 FY11474 FY11476 FY11477 FY11478 FY11479 FY11481 FY11482 FY11484 FY11485 FY11487 FY11506 FY11507 FY11508 FY11509 FY11511 FY11512 FY11514 FY11518 FY11519 FY11520 FY11521 FY11522 FY11524 FY11541 FY11542 FY11543 FY11544 FY11546 FY11548 FY11549 FY11550 FY11551 FY11576 FY11577 FY11578 FY11580 FY11581 FY11582 FY11583 FY11584 FY11585 FY11586 FY11587 FY11588 FY11589 FY11590 FY11591 FY11592 FY11593 FY11594 FY11595 FY11596 FY11597 FY11598 FY11599 FY11601 FY11602 FY11603 FY11604 FY11605 FY11606 FY11607 FY11608 FY11644 FY11645 FY11646 FY11647 FY11648 FY11650 FY11651 FY11652 FY11653 FY11654 FY11655 FY11656 FY11657 FY11658 FY11659 FY11660 FY11661 FY11662 FY11663 FY11666 FY11667 FY11668 FY11967 FY11968 FY11969 FY11970 FY11972 FY11973 FY11974 FY11976 FY11977 FY11978 FY11979 FY11980 FY11981 FY11983 FY11984 FY11986 FY11987 FY11988 FY11989 FY11990 FY11991 FY11999 FY12000 FY12001 FY12008 FY12009 FY12010 FY12011 FY12014 FY12017 FY12018 FY12019 FY12020 FY12021 FY12022 FY12023 FY12024 FY12025 FY12026 FY12027 FY12028 FY12029 FY12030 FY12031 FY12032 FY12033 FY12034 FY12035 FY12036 FY12037 FY12038 FY12039 FY12040 FY12041 FY12042 FY12071 FY12072 FY12073 FY12076 FY12078 FY12079 FY12080 FY12081 FY12083 FY12084 FY12086 FY12087 FY12088 FY12089 FY12090 FY12091 FY12092 FY12093 FY12094 FY12095 FY12096 FY12097 FY12098 FY12101 FY12102 FY12111 FY12112 FY12113 FY12114 FY12115 FY12116 FY12118 FY12119 FY12121 FY12122 FY12123 FY12124 FY12125 FY12126 FY12127 FY12128 FY12129 FY12130 FY12131 FY12133 FY12144 FY12145 FY12146 FY12147 FY12148 FY12149 FY12150 FY12151 FY12152 FY12153 FY12154 FY12155 FY12156 FY12158 FY12159 FY12160 FY12161 FY12162 FY12163 FY12164 FY12165 FY12166 FY12167 FY12168 FY12169 FY12186 FY12187 FY12188 FY12189 FY12190 FY12192 FY12193 FY12194 FY12195 FY12196 FY12223 FY12225 FY12226 FY12227 FY12228 FY12229 FY12230 FY12232 FY12233 FY12234 FY12235 FY12236 FY12247 FY12248 FY12249 FY12250 FY12251 FY12252 FY12253 FY12254 FY12255 FY12256 FY12257 FY12258 FY12259 FY12260 FY12261 FY12262 FY12263 FY12265 FY12266 FY12268 FY12284 FY12285 FY12286 FY12287 FY12288 FY12289 FY12290 FY12291 FY12292 FY12293 FY12294 FY12295 FY12296 FY12297 FY12298 FY12311 FY12312 FY12314 FY12315 FY12316 FY12317 FY12318 FY12323 FY12324 FY12370 FY12371 FY12372 FY12373 FY12374 FY12375 FY12377 FY12378 FY12379 FY12383 FY12384 FY12385 FY12387 FY12389 FY12390 FY12391 FY12392 FY12393 FY12394 FY12395 FY12396 FY12397 FY12398 FY12399 FY12400 FY12401 FY12402 FY12404 FY12405 FY12406 FY12407 FY12408 FY12409 FY12410 FY12411 FY12412 FY12413 FY12443 FY12444 FY12445 FY12446 FY12447 FY12448 FY12449 FY12450 FY12452 FY12453 FY12454 FY12467 FY12469 FY12471 FY12472 FY12473 FY12474 FY12475 FY12476 FY12477 FY12478 FY12479 FY12481 FY12482 FY12483 FY12496 FY12497 FY12498 FY12499 FY12500 FY12501 FY12502 FY12503 FY12504 FY12505 FY12506 FY12507 FY12508 FY12510 FY12511 FY12512 FY12513 FY12514 FY12515 FY12516 FY12517 FY12518 FY12519 FY12520 FY12521 FY12522 FY12523 FY12541 FY12542 FY12543 FY12544 FY12545 FY12546 FY12547 FY12548 FY12549 FY12550 FY12551 FY12552 FY12553 FY12554 FY12555 FY12556 FY12566 FY12567 FY12568 FY12569 FY12570 FY12571 FY12572 FY12573 FY12574 FY12575 FY12576 FY12577 FY12578 FY12579 FY12581 FY12582 FY12583 FY12585 FY12586 FY12587 FY12589 FY12590 FY12591 FY12615 FY12616 FY12617 FY12618 FY12619 FY12620 FY12621 FY12622 FY12623 FY12624 FY12625 FY12626 FY12641 FY12642 FY12643 FY12644 FY12645 FY12646 FY12647 FY12649 FY12650 FY12651 FY12652 FY12653 FY12654 FY12655 FY12656 FY12657 FY12658 FY12659 FY12669 FY12670 FY12671 FY12673 FY12674 FY12675 FY12676 FY12677 FY12691 FY12692 FY12693 FY12694 GG11191 GG11200 GG11207 GG11217 GG11222 GG11225 GG11235 GG11246 GG11257 GG11267 GG11270 GG11361 GG11370 GG11379 GG11383 GG11396 GG11406 GG11431 GG11436 GG11444 GG11448 GG11455 GG11463 GG11547 GG11552 GG11561 GG11567 GG11574 GG11578 GG11582 GG11594 GG11600 GG11607 GG13374 GG13378 GG13388 GG13395 GG13398 GG13401 GG13404 GG13407 GG13409 GG13456 GG13458 GG13462 GG13465 GG13470 GG13472 GG13476 GG13482 GG17586 GG17590 GG17593 GG17600 GG17604 GG17609 GG17615 GG17621 GG17622 GG17624 GG17627 GG17629 GG17633 GG17638 GG17648 LC68413 LC68432 LC68436 LC68439 LC68443 LC68446 LC68643 LC68645 LC68646 LC68647 LC68653 LC68654 LC68669 LC68671 LC68672 LC68989 LC68997 LC69000 LC69009 LC69014 LC69043 LC69046 LC69048 LC69049 LC69051 LC69053 LC69065 LC69067 LC69070 LC69075 LC69079 LC69081 LC69083 LC69084 LC69085 LC69173 LC69177 LC69180 LC69182 LC69185 LC69188 LC69238 LC69242 LC69244 LC69251 LC69271 LC69292 LC69295 LC69296 LC69309 LC69312 LC69314 LC69316 LC69319 LC69320 LC69451 LC69452 LC69516 LC69520 LC69525 LC69535 LC69573 LC69583 LC69592 LC72836 LC72839 LC72840 LC72846 LC72848 LC72849 LC73053 LC73059 LC73062 LC73065 LC73069 LC73080 LC73085 LC73086 LC73096 LC73300 LC73301 LC73305 LC73307 LC73309 LC73313 LC73319 LC73322 LC74676 LC74679 LC74680 LC74682 LC74685 LC74688 LH88814 LH88819 LH88823 LH88827 LH88838 LH88839 LH88844 LH88855 LH88856 LH88860 LH88862 LH88867 LH88872 LH88875 LH88952 LH88956 LH88964 LH88966 LH92337 LH92341 LH92346 LH92357 LH92363 LH92366 LH92387 LH92391 LH92403 LH92409 LH92412 LH92423 LH92427 LH92432 LH92437 LH92442 LH92806 LH92814 LH93018 LH93021 LH93025 LH93030 LH93034 LH93040 LH93042 LH93046 LH93048 LH93051 LH93057 LH93060 LH93063 LH93186 LH93188 LH93193 LH93257 LH93259 LH93262 LH93265 LH93269 LH93277 LH93279 LH93281 LH93284 LH93289 LH93290 LH93294 LH93297 LH94860 LH94873 LH94877 LH94881 LH94885 LH94929 LH94949 LJ69916 LJ69923 LJ69927 LJ69940 LJ69942 LJ69945 LJ69949 LJ69955 LJ69965 LJ69966 LJ69969 LJ70206 LJ70217 LJ70219 LJ70223 LJ70225 LJ70235 LJ70242 LJ70251 LJ70255 LJ70281 LJ70609 LJ70613 LJ70616 LJ70618 LJ70620 LJ70622 LJ70626 LJ70628 LJ70632 LJ70634 LJ70638 LJ70643 LJ70647 LJ70669 LJ70670 LJ70671 LX20707 LX20710 LX20714 LX20716 LX20718 LX20720 LX20723 LX20725 W 52829 W 52831 W 52833 W 52835 W 52837 W 52839 W 52844 W 52848 W 52850 W 52854 W 52855 W 53301 W 53302 W 53303 W 53306 W 53307 W 53309 W 53311;
b) Units: FE27402 FE27411 FE28392 FE28396 FE29232 FP05894 FP05904 FP06069
FY11473 FY11474 FY11475 FY11476 FY11477 FY11478 FY11481 FY11482
FY11484 FY11485 FY11487 FY11518 FY11519 FY11520 FY11521 FY11524
FY11576 FY11577 FY11578 FY11580 FY11581 FY11582 FY11583 FY11584
FY11585 FY11586 FY11587 FY11588 FY11589 FY11590 FY12018 FY12021
FY12041 FY12074 FY12076 FY12080 FY12096 FY12097 FY12098 FY12099
FY12100 FY12101 FY12112 FY12113 FY12114 FY12115 FY12116 FY12117
FY12118 FY12119 FY12120 FY12150 FY12259 FY12260 FY12261 FY12262
FY12263 FY12264 FY12265 FY12266 FY12268 FY12311 FY12312 FY12320
FY12467 FY12468 FY12474 FY12476 FY12477 FY12481 FY12482 FY12502
FY12544 FY12545 FY12546 FY12547 FY12548 FY12549 FY12551 FY12554
FY12555 FY12556 FY12568 FY12569 FY12570 FY12571 FY12572 FY12573
FY12577 FY12579 FY12581 FY12582 FY12583 FY12585 FY12586 FY12587
FY12589 FY12590 FY12591 FY12657 GG13458 GG13470 GG13472 LC69043
LC69048 LC69177 LC69180 LC69182 LC69185 LC69238 LC69242 LC69271
LC69292 LC69295 LC69296 LC69308 LC69309 LC69312 LC69314 LC69316
LC69319 LC69320 LC69518 LC69525 LC69535 LC69592 LC73300 LC73301
LC73305 LC73307 LC73309 LC73313 LC73319 LC73322 LC74679 LC74680
LC74685 LH88872 LH88956 LH92357 LH92376 LH92387 LH92419 LH92423
LH92442 LH92814 LH93179 LH93186 LH93193 LH94929 LH94949 LJ69965
LJ70647 LX20725 W 53306 W 53309 W 53311;
c) FE26655 FK16792 FP06073 FY11486 FY11513 FY11547 FY11664 FY11982
FY11985 FY12007 FY12012 FY12013 FY12015 FY12016 FY12074 FY12075
FY12085 FY12099 FY12100 FY12117 FY12120 FY12191 FY12320 FY12376
FY12386 FY12468 FY12648 FY12672 GG17617 LC68434 LC68667 LC69012
LC69172 LC69308 LC72834 LC72843 LC73071 LC73090 LH88812 LH92351
LH92371 LH92419 LH93179 LH94850 LJ69911 LJ70202 LJ70211 LJ70229
LJ70238 LX20712 LX20722 LX20727 W 52843 W 52852 W 53312;
d) Unit: P 80264;
e) Units: P 80226 P 80256 P 80257 P 80264 P 82582;
f) Units: FY12157 LH88844 LH93046 LJ69940;
g) Units: P 80137 P 80221 P 80221 P 80223 P 80223 P 80224 P 80224 P 80225 P 80225
P 80226 P 80227 P 80228 P 80228 P 80229 P 80229 P 80230 P 80256 P 80257
P 82575 P 82582
RECALLING FIRM/MANUFACTURER
American National Red Cross Blood Services, Wichita, KA, by telephone on June 2, 2007 and later by fax. Firm initiated recall is complete.
REASON
Donor Screening/Donor record incomplete or incorrect.
VOLUME OF PRODUCT IN COMMERCE
1,769 units (including Recall # B-0102-09 – Class III)
DISTRIBUTION
AL, KS, OK, TX, TN, MO, PR, AR, IL, CA, MI and Switzerland
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III ___________________________________
PRODUCT
Source Plasma, Recall # B-0039-09
CODE
Unit: 06MTNA2590
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Memphis, TN, by facsimile on August 8, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from donors who did not have a complete medical history interview, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
a) Red Blood Cells, Recall # B-0043-09;
b) Platelets Pooled Leukocytes Reduced, Recall # B-0044-09
CODE
a) Unit: 0126589;
b) Unit: 1004595
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by facsimile on April 2, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from donors who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0061-09
CODE
Units: 9732481 (split unit); 9916720 Part 2; 9916252; 9913969; 9913970 (triple unit); 9916251; 9732480 (split unit); 9732482 (split unit)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on December 5, 2007. Firm initiated recall is complete.
REASON
Blood products, labeled with incorrect expiration date and product code, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
FL, MD, D.C., SC
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0063-09
CODE
Unit: 29GS76956
RECALLING FIRM/MANUFACTURER
American National Red Cross, Mid Atlantic Region, Norfolk, VA, by letter on October 1, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from donors whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0102-09
CODE
Units: FE26631 FE26638 FE26641 FE26644 FE26649 FE26652 FE26655 FE26659 FE26665 FE27395 FE27399 FE27405 FE28372 FE28375 FE28378 FE28380 FE28382 FE28387 FE28393 FE28396 (Red Cells); FE29229 FE29234 FE29237 FE29239 FE29245 FE29246 FK15820 FK15821 FK15822 FK15823 FK15824 FK15825 FK15826 FK15832 FK16463 FK16464 FK16465 FK16466 FK16467 FK16468 FK16469 FK16470 FK16471 FK16472 FK16473 FK16474 FK16475 FK16476 FK16477 FK16792 FK16793 FK16795 FK16797 FK16798 FK16799 FK16800 FK16802 FP05891 FP05893 FP05894 (Red Cells); FP05896 FP05899 FP05901 FP05902 FP06066 FP06068 FP06070 FP06071 FP06072 FP06073 FP06074 FP06075 FP06076 FP06077 FP06078 FP06080 FY11402 FY11405 FY11406 FY11475 (Red Cells); FY11479 FY11486 FY11504 (Red Cells); FY11504 FY11505 (Red Cells); FY11505 FY11506 FY11507 FY11508 FY11509 FY11510 (Red Cells); FY11510 FY11511 FY11512 FY11513 FY11514 FY11515 (Red Cells); FY11515 FY11516 (Red Cells); FY11516 FY11517 (Red Cells); FY11517 FY11522 FY11541 FY11542 FY11543 FY11544 FY11546 FY11547 FY11548 FY11549 FY11550 FY11551 FY11591 FY11592 FY11593 FY11594 FY11595 FY11596 FY11597 FY11598 FY11599 FY11600 (Red Cells); FY11600 FY11601 FY11602 FY11603 FY11604 FY11605 FY11606 FY11607 FY11608 FY11644 FY11645 FY11646 FY11647 FY11648 FY11649 (Red Cells); FY11649 FY11650 FY11651 FY11652 FY11653 FY11654 FY11655 FY11656 FY11657 FY11658 FY11659 FY11660 FY11661 FY11662 FY11663 FY11664 FY11666 FY11667 FY11668 FY11967 FY11968 FY11969 FY11970 FY11972 FY11973 FY11974 FY11976 FY11977 FY11978 FY11979 FY11980 FY11981 FY11982 FY11983 FY11984 FY11985 FY11986 FY11987 FY11988 FY11989 FY11990 FY11991 FY11992 (Red Cells); FY11992 FY11999 FY12000 FY12001 FY12007 FY12008 FY12009 FY12010 FY12011 FY12012 FY12013 FY12014 FY12015 FY12016 FY12017 FY12019 FY12020 FY12022 FY12023 FY12024 FY12025 FY12026 FY12027 FY12028 FY12029 FY12030 FY12031 FY12032 FY12033 FY12034 FY12035 FY12036 FY12037 FY12038 FY12039 FY12040 FY12042 FY12071 FY12072 FY12073 FY12075 FY12077 FY12078 FY12079 FY12081 FY12083 FY12084 FY12085 FY12086 FY12087 FY12088 FY12089 FY12090 FY12091 FY12092 FY12093 FY12094 FY12095 FY12102 FY12111 FY12121 FY12122 FY12123 FY12124 FY12125 FY12126 FY12127 FY12128 FY12129 FY12130 FY12131 FY12133 FY12144 FY12145 FY12146 FY12147 FY12148 FY12149 FY12151 FY12152 FY12153 FY12154 FY12155 FY12156 FY12157 (Red Cells); FY12158 FY12159 FY12160 FY12161 FY12162 FY12163 FY12164 FY12165 FY12166 FY12167 FY12168 FY12169 FY12186 FY12187 FY12188 FY12189 FY12190 FY12191 FY12192 FY12193 FY12194 FY12195 FY12196 FY12223 FY12224 (Red Cells); FY12225 FY12226 FY12227 FY12228 FY12229 FY12230 FY12232 FY12233 FY12234 FY12235 FY12236 FY12247 FY12248 FY12249 FY12250 FY12251 FY12252 FY12253 FY12254 FY12255 FY12256 FY12257 FY12258 FY12264 (Red Cells); FY12267 (Red Cells); FY12267 FY12284 FY12285 FY12286 FY12287 FY12288 FY12289 FY12290 FY12291 FY12292 FY12293 FY12294 FY12295 FY12296 FY12297 FY12298 FY12314 FY12315 FY12316 FY12317 FY12318 FY12319 FY12322 FY12323 FY12324 FY12370 FY12371 FY12372 FY12373 FY12374 FY12375 FY12376 FY12377 FY12378 FY12379 FY12383 FY12384 FY12385 FY12386 FY12387 FY12389 FY12390 FY12391 FY12392 FY12393 FY12394 FY12395 FY12396 FY12397 FY12398 FY12399 FY12400 FY12401 FY12402 FY12404 FY12405 FY12406 FY12407 FY12408 FY12409 FY12410 FY12411 FY12412 FY12413 FY12443 FY12444 FY12445 FY12446 FY12447 FY12448 FY12449 FY12450 FY12452 FY12453 FY12454 FY12469 FY12471 FY12472 FY12473 FY12475 FY12478 FY12479 FY12483 FY12496 FY12497 FY12498 FY12499 FY12500 FY12501 FY12503 FY12504 FY12505 FY12506 FY12507 FY12508 FY12510 FY12511 FY12512 FY12513 FY12514 FY12515 FY12516 FY12517 FY12518 FY12519 FY12520 FY12521 FY12522 FY12523 FY12541 FY12542 FY12543 FY12552 FY12553 FY12565 FY12566 FY12567 FY12574 FY12575 FY12576 FY12578 FY12615 FY12616 FY12617 FY12618 FY12619 FY12620 FY12621 FY12622 FY12623 FY12624 FY12625 FY12626 FY12641 FY12643 FY12644 FY12645 FY12646 FY12647 FY12648 FY12649 FY12650 FY12651 FY12652 FY12653 FY12654 FY12655 FY12658 FY12659 FY12669 FY12670 FY12671 FY12672 FY12673 FY12674 FY12675 FY12676 FY12677 FY12691 FY12692 FY12693 FY12694 GG11191 GG11200 GG11207 GG11217 GG11222 GG11225 GG11235 GG11246 GG11257 GG11267 GG11270 GG11361 GG11370 GG11379 GG11383 GG11396 GG11406 GG11431 GG11436 GG11444 GG11448 GG11455 GG11463 GG11547 GG11552 GG11561 GG11567 GG11574 GG11578 GG11582 GG11594 GG11600 GG11607 GG13374 GG13378 GG13382 GG13388 GG13395 GG13398 GG13401 GG13404 GG13407 GG13409 GG13456 GG13462 GG13465 GG13476 GG13482 GG17586 GG17590 GG17593 GG17600 GG17604 GG17609 GG17615 GG17617 GG17621 GG17622 GG17624 GG17627 GG17629 GG17633 GG17638 GG17648 LC68413 LC68432 LC68434 LC68436 LC68439 LC68443 LC68446 LC68643 LC68645 LC68646 LC68647 LC68653 LC68654 LC68662 (Red Cells); LC68662 LC68667 LC68669 LC68671 LC68672 LC68989 LC68997 LC69000 LC69009 LC69012 LC69014 LC69046 LC69049 LC69051 LC69053 LC69065 LC69067 LC69070 LC69075 LC69079 LC69081 LC69083 LC69084 LC69085 LC69172 LC69173 LC69188 LC69244 LC69251 LC69451 LC69452 LC69516 LC69520 LC69573 LC69583 LC72834 LC72836 LC72839 LC72840 LC72843 LC72846 LC72848 LC72849 LC73053 LC73059 LC73062 LC73065 LC73069 LC73071 LC73080 LC73085 LC73086 LC73090 LC73096 LC74688 LH88812 LH88814 LH88819 LH88823 LH88827 LH88838 LH88839 LH88855 LH88856 LH88860 LH88862 LH88867 LH88875 LH88952 LH88964 LH88966 LH92337 LH92341 LH92346 LH92351 LH92363 LH92366 LH92371 LH92376 (Red Cells); LH92391 LH92403 LH92409 LH92412 LH92427 LH92432 LH92437 LH92806 LH93018 LH93021 LH93025 LH93030 LH93034 LH93040 LH93042 LH93048 LH93051 LH93057 LH93060 LH93063 LH93188 LH93257 LH93259 LH93262 LH93265 LH93269 LH93277 LH93279 LH93281 LH93284 LH93289 LH93290 LH93294 LH93297 LH94850 LH94860 LH94873 LH94877 LH94881 LH94885 LJ69911 LJ69916 LJ69923 LJ69927 LJ69942 LJ69945 LJ69949 LJ69955 LJ69966 LJ69969 LJ70202 LJ70206 LJ70211 LJ70217 LJ70219 LJ70223 LJ70225 LJ70229 LJ70235 LJ70238 LJ70242 LJ70251 LJ70253 LJ70255 LJ70281 LJ70609 LJ70613 LJ70616 LJ70618 LJ70620 LJ70622 LJ70626 LJ70628 LJ70632 LJ70634 LJ70638 LJ70643 LJ70669 LJ70670 LJ70671 LX20707 LX20710 LX20712 LX20714 LX20716 LX20718 LX20720 LX20722 LX20723 LX20727 W 52829 W 52831 W 52833 W 52835 W 52837 W 52839 W 52843 W 52844 W 52848 W 52850 W 52852 W 52854 W 52855 W 53301 W 53302 W 53303 W 53307 W 53312
RECALLING FIRM/MANUFACTURER
American National Red Cross Blood Services, Wichita, KA, by telephone on June 2, 2007 and later by fax. Firm initiated recall is complete.
REASON
Donor Screening/Donor record incomplete or incorrect.
VOLUME OF PRODUCT IN COMMERCE
1,769 units (including Recall #’s: B-0101-09, B-0103-09 thru B-0108-09 – Class II)
DISTRIBUTION
AL, KS, OK, TX, TN, MO, PR, AR, IL, CA, MI and Switzerland
___________________________________
PRODUCT
Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215) Used with: Nova Biomedical StatStrip Glucose Hospital Meter (P/N 42224) and Nova Biomedical StatSensor Creatinine Hospital Meter and EZ CHEM Creatinine Meter (P/N 9600). Statstrip Meter an In vitro diagnostic for use by health care professionals in the quantitative determination of glucose (GLU) in whole blood. EZ Chem In vitro diagnostic for the quantitative measurement of creatinine in capillary, venous or arterial blood. The Nova Biomedical products that contain the lithium batteries include the following part numbers: Part # 41772 - Battery Assy, Part # 42215 - Battery Replacement pack, Part # 42224 - Kit Meter, Part # 43735 - Kit Meter EZ CHEM, Part # 43773 - Kit Meter, Part # 43811 - Battery Replacement Pack EZ CHEM, Part # 44013 - Kit Meter, Part # 44014 - Kit Meter and Part # 44251 - Kit Meter, Recall # Z-1472-2008
CODE
Batteries coded: XX07 and earlier
RECALLING FIRM/MANUFACTURER
Nova Biomedical Corporation, Waltham, MA, by telephone and letters dated February 21, 2008 and March 17, 2008. Firm initiated recall is ongoing.
REASON
Lithium batteries may fail if the glucose or creatinine meters have been dropped.
VOLUME OF PRODUCT IN COMMERCE
4, 432 batteries
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Product Description : GE Healthcare Innova 3100 Digital Fluoroscopic Imaging
(Cardiovascular Imaging System), Recall # Z-1521-2008;
b) GE Healthcare Innova 4100 Digital Fluoroscopic Imaging, Recall # Z-1522-2008
CODE
a) Systems Id: 8613100, 0910163013, 4103323100, 4103623100, 5034353100,
7083333100, 7278253100, 8019643100, 82416040010, 082416040016,
082416040017, 082416050002, 082416070004, 082416100008, 82416120005,
082416120006, 082416130013, 0002581738X, 06074VAS01, 201541LAB2,
214324INNOVA2, 24516572980IN, 309691P3100, 310423INNOVA1, 313593IC1,
313593IC2, 314525SACL2, 314768SMCL3, 318448INNOVA2, 318449INNOVA2,
409899LAB3, 413447CATH, 413540IN1, 417269SCLD, 502587LAB4,
518525LAB1, 540953INNOVA, 561266IN31, 563421CATHLAB8, 573815BCR1,
600130VA01, 601553CL3, 602239LAB4, 602239LAB6, 602266LAB2, 603778ECL1,
608524NOVA, 615338CV2, 615769SKYCV2, 619340VA8, 619482INNOVA1,
619541INNOVA31, 619552INNOVA1, 702616INNOVA, 7028803100A,
713794LAB7, 713794LAB9, 714966INNOVA, 718283INNOVA3, 724773C1,
731422CV1, 732294INOV, 765453INNOVA1, 770991CL3, 773792CL3100,
773NORWG3100, 803329CL31, 808547QCV2A, 812238LIB1, 812283IN31,
812482INNOVA, 815599FHN3100, 817433HSW3100, 83INNOVA1188379,
850678IN3100, 904202CATH3, 908522LAB1, 928779INNOVA1, 936266CL1,
956389INN31, 956698INN31, 956994INN1, 956994INN2, 973971LAB3, A5108239,
A5203215, BPINNOVA2, BPINNOVA3R, DK1066VA01, FHORLCL1,
H1420VAS04, HC1536XR04, IQ1083VA01, IR1747VA01, LB1160XR07,
LV4012VA01, M2848425, M2970614, PL1622VA01, RU1156VA01, RU1482VA02,
RU1550VA01, RU2457VA01, TT-2586581-CO, YV0022, YV0026, YV0036;
b) Systems id: 77573841, 80158241, 910063039, 3018774100, 4103374100,
4438494100, 5134754100, 5138534100, 6029234100, 8159374100, 8595724100,
9408984100, 82406010011, 082416130011, 82416130012, 00095VAS07,
205759CL2, 216844INNOVA, 229228INNOV41V, 229434INNOV, 239436CATH1,
251435ICV5, 304255INNOVA, 304347INNOVA, 315448RM4, 315448RM5,
319338VA4100, 325670CATH, 337981INNOVA, 352333VASC, 352376SP,
352401CATH, 352401VASC, 407518SP2, 407518SP3, 407SPECIALS,
414961INN4100, 478633INOV, 508856OR41, 515263IL4100, 516562INNOVA4,
573632CRA, 573761SMA, 574535IN41, 600050VA01, 6012884100SP1,
606833INNOVA, 609652CATH3, 614293LIBERTY1, 614293LIBERTY2,
704487CR41, 706802FINN, 715369INN4100, 717763INNOVA41, 717763OR4100,
718518CVL1, 724656ANG, 727725SPEC1, 727819SPSC, 740592INNOVA,
757398INNOVA, 757736INNOVA, 803329CL41, 804320CATH2B, 804594CATH,
812279INNOVA1, 813972INTV, 816276SP1, 817255NH4100, 828696IN41,
865541CCL5, 865693CCL3, 901726SP2, 903CSM4100, 904276SP, 906485ANGIO,
918307SHIN4, 941483INNOVA41, 956632INN4100, A5630803, B5801711,
BE5005VA01, BY4020VA01, RU1018VA03, SA1188VA03, SLIN4100, YV0003
RECALLING FIRM/MANUFACTURER
Recalling Firm: Datex - Ohmeda, Inc., Madison, WI, by letter, dated June 2008.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
REASON
GE Healthcare has become aware of a potential condition that may impact operator or patient safety. One customer has reported that inability to terminate X-ray exposure after releasing the hand switch control (located in the control room).
VOLUME OF PRODUCT IN COMMERCE
194 systems
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Deltec® 3000 Large Volume Infusion Pump, CE 0473, RX Only. Made in UK.
Reorder numbers 21-5301-01 & 21-5306-01. The product is used for general drug
delivery infusion therapies. The product is only intended to be used by trained
clinicians, Recall # Number : Z-1604-2008;
b) Deltec® Micro 3100 Large Volume Infusion Pump, CE 0473, RX Only. Made in the
UK. Reorder number 21-5311-01. The product is used for general drug delivery
infusion therapies. The product is only intended to be used by trained clinicians,
Recall # Z-1605-2008
CODE
All serial numbered devices
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smiths Medical MD, Inc., Saint Paul MN, by letter dated February 5, 2008.
Manufacturer: Smiths Medical International Ltd., Watford, UK. Firm initiated recall is ongoing.
REASON
The Deltec, Graseby, and 3M, Large Volume Infusion Pump - Models 3000 and 3100, may deliver an unintended bolus if the pump door is opened and then immediately closed. This problem is due to a timing delay when the pumping mechanism resets itself.
VOLUME OF PRODUCT IN COMMERCE
2,303 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) GE Precision 500D, model 2288798, 2289299, 2290479, 2305472, 2305473, 2305495,
2336900, 2345243, 2401181, 2403790, 2403791, 2404103, 2407276, 2407576,
5179385, 2289299-2, 2290479-2, 2345260-12, 2345260-3, 2403790-3, and
2403791-3, GE Medical Systems - Americas: Milwaukee, USA. The device is used
to perform fluoroscopic examination of human anatomy, Recall # Z-1610-2008;
b) Advantx Legacy Radiographic and Fluoroscopic systems, model 2102424, 2118104,
2157009, 2183000, 2206038, 2206048, 2206056, 2224559, 2258627, 2268730,
2330340, 2333974, 2118104-2, 2118104-3, 2118104-4, 2118104-5, 2118104-6,
2118104-7, 2118104-8, 2139574-2, 2147592-13, 2171204-2, 46-262751G6, 46-
262751G7, 46-262751G8, 46-275382G58, and 46-302056G1. GE Medical Systems –
Americas: Milwaukee, USA. The device is used to perform fluoroscopic examination
of human anatomy, Recall # Z-1611-2008;
CODE
a) Serial numbers: 00000004108GQ7, 00000004874GQ4, 00000006742GQ1, 00000007111GQ8, 00000008717GQ1, 00000008892GP2, 00000010136GQ0, 00000012808GP2, 00000013547GP5, 00000013737GP2, 00000013844GP6, 00000985953WK9, 00000987224WK3, 00000987333WK2, 00000989376WK9, 00012966GP8000, 00000000BRBGDM, 00000000BRBGDR, 00000000BRBUF8, 00000000BRD138, 00000000BRF490, 00000000BRF49B, 00000000BRBBXV, 00000000BRBL7V, 00000000BRETRE, 00000986515WK5, 00000097958WK2, 000000980212WK, 00000098186WK0, 00000098235WK4, 00000098734WK5, 00000970756WK3, 00000971704WK2, 00000972504WK5, 00000972505WK2, 00000972772WK8, 00000973070WK6, 00000973500WK2, 00000973502WK8, 00000973616WK6, 00000973617WK4, 00000973618WK2, 00000973624WK0, 00000973883WK2, 00000973884WK0, 00000973885WK7, 00000974085WK3, 00000974087WK9, 00000974410WK3, 00000974411WK1, 00000974412WK9, 00000974445WK9, 00000974446WK7, 00000974447WK5, 00000974676WK9, 00000974677WK7, 00000974678WK5, 00000975166WK0, 00000975167WK8, 00000975169WK4, 00000975171WK0, 00000975172WK8, 00000975626WK3, 00000975627WK1, 00000975628WK9, 00000975629WK7, 00000975630WK5, 00000975631WK3, 00000975632WK1, 00000975946WK5, 00000975947WK3, 00000975948WK1, 00000975949WK9, 00000975958WK0, 00000975959WK8, 00000975960WK6, 00000975961WK4, 00000975962WK2, 00000975964WK8, 00000977046WK2, 00000977047WK0, 00000977048WK8, 00000977049WK6, 00000977050WK4, 00000977051WK2, 00000977052WK0, 00000977053WK8, 00000977054WK6, 00000977055WK3, 00000977233WK6, 00000977234WK4, 00000977236WK9, 00000977238WK5, 00000977239WK3, 00000977853WK1, 00000977854WK9, 00000977855WK6, 00000977857WK2, 00000977858WK0, 00000977859WK8, 00000977860WK6, 00000977861WK4, 00000978079WK2, 00000978080WK0, 00000978082WK6, 00000978083WK4, 00000978084WK2, 00000978085WK9, 00000978086WK7, 00000978485WK1, 00000978486WK9, 00000978487WK7, 00000978488WK5, 00000978489WK3, 00000978490WK1, 00000978491WK9, 00000978492WK7, 00000978493WK5, 00000978494WK3, 00000978715WK1, 00000978716WK9, 00000978826WK6, 00000978827WK4, 00000979056WK9, 00000979057WK7, 00000979083WK3, 00000979084WK1, 00000979097WK3, 00000979125WK2, 00000979126WK0, 00000979150WK0, 00000979151WK8, 00000979206WK0, 00000979207WK8, 00000979227WK6, 00000979228WK4, 00000979256WK5, 00000979257WK3, 00000979380WK3, 00000979381WK1, 00000979388WK6, 00000979389WK4, 00000979390WK2, 00000979391WK0, 00000979448WK8, 00000979449WK6, 00000979450WK4, 00000979466WK0, 00000979467WK8, 00000979468WK6, 00000979469WK4, 00000979516WK2, 00000979517WK0, 00000979518WK8, 00000979584WK0, 00000979638WK4, 00000979639WK2, 00000979640WK0, 00000979641WK8, 00000979691WK3, 00000979692WK1, 00000979693WK9, 00000979827WK3, 00000979828WK1, 00000979894WK3, 00000979895WK0, 00000979896WK8, 00000979897WK6, 00000979898WK4, 00000979941WK2, 00000979942WK0, 00000979944WK6, 00000979945WK3, 00000980041WK8, 00000980042WK6, 00000980043WK4, 00000980044WK2, 00000980045WK9, 00000980183WK8, 00000980213WK3, 00000980317WK2, 00000980318WK0, 00000980319WK8, 00000980321WK4, 0000098032OWK6, 00000980423WK8, 00000980424WK6, 00000980425WK3, 00000980426WK1, 00000980427WK9, 00000980612WK6, 00000980613WK4, 00000980614WK2, 00000980615WK9, 00000980616WK7, 00000980695WK1, 00000980696WK9, 00000980746WK2, 00000980747WK0, 00000980748WK8, 00000980845WK2, 00000980846WK0, 00000980847WK8, 00000980848WK6, 00000980849WK4, 00000980937WK7, 00000980938WK5, 00000980939WK3, 00000980941WK9, 00000980942WK7, 00000980943WK5, 00000980944WK3, 00000980945WK0, 00000980946WK8, 00000981214WK0, 00000981215WK7, 00000981216WK5, 00000981217WK3, 00000981218WK1, 00000981354WK4, 00000981355WK1, 00000981361WK9, 00000981362WK7, 00000981363WK5, 00000981364WK3, 00000981368WK4, 00000981369WK2, 00000981370WK0, 00000981371WK8, 00000981372WK6, 00000981520WK0, 00000981521WK8, 00000981523WK4, 00000981524WK2, 00000981717WK2, 00000981718WK0, 00000981719WK8, 00000981720WK6, 00000981721WK4, 00000981722WK2, 00000981723WK0, 00000981724WK8, 00000981725WK5, 00000981726WK3, 00000981861WK8, 00000981862WK6, 00000981863WK4, 00000981864WK2, 00000981865WK9, 00000981866WK7, 00000981867WK5, 00000981868WK3, 00000981869WK1, 00000982053WK1, 00000982054WK9, 00000982055WK6, 00000982056WK4, 00000982058WK0, 00000982059WK8, 00000982061WK4, 00000982062WK2, 00000982159WK6, 00000982160WK4, 00000982161WK2, 00000982162WK0, 00000982163WK8, 00000982164WK6, 00000982165WK3, 00000982166WK1, 00000982167WK9, 00000982359WK2, 00000982360WK0, 00000982361WK8, 00000982362WK6, 00000982363WK4, 00000982364WK2, 00000982365WK9, 00000982366WK7, 00000982367WK5, 00000982521WK7, 00000982522WK5, 00000982523WK3, 00000982524WK1, 00000982525WK8, 00000982631WK4, 00000982632WK2, 00000982633WK0, 00000982634WK8, 00000982635WK5, 00000982636WK3, 00000982637WK1, 00000982638WK9, 00000982840WK1, 00000982841WK9, 00000982842WK7, 00000982843WK5, 00000982845WK0, 00000982846WK8, 00000982847WK6, 00000982848WK4, 00000982849WK2, 00000983022WK5, 00000983023WK3, 00000983024WK1, 00000983025WK8, 00000983026WK6, 00000983027WK4, 00000983028WK2, 00000983030WK8, 00000983031WK6, 00000983317WK9, 00000983318WK7, 00000983319WK5, 00000983320WK3, 00000983321WK1, 00000983322WK9, 00000983323WK7, 00000983324WK5, 00000983325WK2, 00000983326WK0, 00000983629WK7, 00000983734WK5, 00000983735WK2, 00000983799WK8, 00000983800WK4, 00000983801WK2, 00000983802WK0, 00000984048WK9, 00000984049WK7, 00000984050WK5, 00000984051WK3, 00000984052WK1, 00000984053WK9, 00000984054WK7, 00000984055WK4, 00000984056WK2, 00000984057WK0, 00000984347WK5, 00000984348WK3, 00000984349WK1, 00000984350WK9, 00000984351WK7, 00000984352WK5, 00000984355WK8, 00000984356WK6, 00000984769WK0, 00000984770WK8, 00000984771WK6, 00000985469WK6, 00000985471WK2, 00000985472WK0, 00000985473WK8, 00000986121WK2, 00000986122WK0, 00000986123WK8, 00000986124WK6, 00000986166WK7, 00000986167WK5, 00000986168WK3, 00000986169WK1, 00000986306WK9, 00000986307WK7, 00000986308WK5, 00000986309WK3, 00000986310WK1, 00000986438WK0, 00000986439WK8, 00000986440WK6, 00000986441WK4, 00000986447WK1, 00000986448WK9, 00000986449WK7, 00000986450WK5, 00000986451WK3, 00000986564WK3, 00000986565WK0, 00000986566WK8, 00000987038WK7, 00000987039WK5, 00000987041WK1, 00000987042WK9, 00000987043WK7, 00000987044WK5, 00000987045WK2, 00000987046WK0, 00000987047WK8, 00000987639WK2, 00000987640WK0, 00000987641WK8, 00000987642WK6, 00000987643WK4, 00000987961WK0, 00000987962WK8, 00000987963WK6, 00000987964WK4, 00000987965WK1, 00000988158WK2, 00000988159WK0, 00000988160WK8, 00000988161WK6, 00000988162WK4, 00000988616WK9, 00000988617WK7, 00000988618WK5, 00000988619WK3, 00000988620WK1, 00000988621WK9, 00000988622WK7, 00000988623WK5, 00000988983WK3, 00000988984WK1, 00000988985WK8, 00000988986WK6, 00000988987WK4, 00000988988WK2, 00000988989WK0, 00000989175WK5, 00000989568WK1, 00000989569WK9, 00000989570WK7, 00000989571WK5, 00000989572WK3, 00000989573WK1, 00000989574WK9, 00000989575WK6, 00000989576WK4, 00000989577WK2, 00000989801WK6, 00000989802WK4, 00000989803WK2, 00000989804WK0, 00000989805WK7, 00000989887WK5, 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00001008140WK4, 00001008141WK2, 00001008142WK0, 00001008143WK8, 00001008509WK0, 00001008734WK4, 00001008735WK1, 00001008736WK9, 00001008737WK7, 00001008739WK3, 00001008740WK1, 00001008741WK9, 00001008742WK7, 00001008743WK5, 00001008879WK7, 00001008881WK3, 00001008882WK1, 00001008883WK9, 00001008908WK4, 00001008909WK2, 00001008911WK8, 00001008912WK6, 00001008913WK4, 00001008914WK2, 00001008915WK9, 00001008990WK2, 00001008991WK0, 00001008992WK8, 00001008993WK6, 00001008994WK4, 00001009079WK3, 00001009080WK1, 00001009081WK9, 00001009082WK7, 00001009083WK5, 00001009084WK3, 00001009085WK0, 00001009086WK8, 00001009236WK9, 00001009238WK5, 00001009239WK3, 00001009274WK0, 00001009301WK1, 00001009331WK8, 00001009332WK6, 00001009334WK2, 00001009335WK9, 00001009337WK5, 00001009338WK3, 00001009539WK6, 00001009540WK4, 00001009541WK2, 00001009542WK0, 00001009543WK8, 00001009577WK6, 00001009578WK4, 00001009639WK4, 00001009640WK2, 00001009641WK0, 00001009642WK8, 00001009643WK6, 00001009644WK4, 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RECALLING FIRM/MANUFACTURER
GE Healthcare, Waukesha, WI, by letter dated January 9, 2008. Firm initiated recall is ongoing.
REASON
GE Healthcare was notified that 2 recently installed Precision 500D systems were not in compliance with portions of the Performance Standard for Diagnostic X-ray Equipment. X-ray production was possible from the fluoroscopic X-ray tube when the Primary Protective Barrier was not in position to intercept the X-ray beam. Users are recommended to follow good clinical standards to ensure the Image Intensifier carriage assembly is in the forward and locked position over the table top prior to initiating a fluoroscopic X-ray procedure. A GE Healthcare Field Engineer will schedule a field visit to inspect and replace the park latch switch, as needed.
VOLUME OF PRODUCT IN COMMERCE
2,863 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
Ultraview Digital Telemetry Transmitter, Model 90478 The Spacelabs Medical Digital Telemetry system provides continuous electrocardiographic (ECG) monitoring to detect ST segment changes, abnormal cardiac rhythms, including asystole, ventricular fibrillation and ventricular tachycardia, Recall # Z-1652-2008
CODE
Serial Numbers 478-111508, 478-111509, 478-111510, 478-111511, 478-111962, 478-111963, 478-111964, 478-111965, , 478-114831, 478-117016, 478-117395, 478-117602, 478-122332, 478-122333, 478-122535, 478-124039, 478-124040, 478-124042, 478-124055, 478-108923, 478-108924, 478-108925, 478-108926, 478-108927, 478-108928, 478-108929, 478-108930, 478-112419, 478-112420, 478-112421, 478-112422, 478-114943, 478-114944, 478-114945, 478-114946, 478-114947, 478-114948, 478-114949, 478-114950, 478-114951, 478-114952, 478-122698, 478-122704, 478-122711, 478-137602, 478-137603, 478-144927, , 478-122680, 478-122680, 478-122680, 478-122680, 478-128481, 478-128483, 478-128515, 478-128525, 478-112052, 478-113089, 478-113097, 478-113704, 470-110122, 478-110126, 478-110939, 478-110940, 478-113098, 478-113099, 478-113101, 478-120415, 478-122158, 478-122159, 478-122163, 478-124049, 478-124057, 478-124058, 478-124570, 478-124571, 478-124994, 478-124996, 478-113527, 478-113528, 478-113529, 478-113530, 478-113531, 478-113532, 478-113533, 478-113761, 478-111405, 478-111803, 478-111827, 478-111828, 478-111829, 478-111836, 478-111837, 478-111838, 478-111839, 478-111840, 478-111841, 478-111842, 478-111843, 478-111844, 478-111845, 478-111846, 478-111847, 478-111848, 478-111849, 478-111850, 478-111851, 478-111852, 478-111853, 478-111854, 478-111887, 478-111888, 478-111996, 478-112013, 478-112014, 478-112016, 478-118020, 478-118367, 478-119474, 478-119475, 478-122679, 478-122685, 478-122687, 478-122688, 478-122691, 478-122692, 478-124272, 478-124274, 478-124723, 478-124724, 478-124725, 478-124726, 478-124732, 478-124733, 478-124734, 478-124735, 478-124736, 478-124739, 478-124740, 478-124741, 478-124742, 478-124743, 478-124748, 478-124750, 478-124751, 478-124762, 478-127124, 478-127129, 478-127155, 478-127473, 478-127997, 478-128063, 478-128067, 478-128528, 478-114841, 478-114866, 478-114868, 478-114869, 478-114870, 478-114871, 478-114872, 478-114873, 478-105101, 478-105145, 478-105269, 478-105481, 478-105531, 478-105617, 478-105634, 478-106017, 478-110011, 478-110012, 478-110013, 478-110024, 478-110025, 478-111180, 478-115421, 478-113006, 478-113007, 478-113008, 478-113010, 478-115358, 478-117023, 478-117034, 478-117074, 478-118351, 478-118352, 478-122327, 478-122329, 478-123849, 478-123854, 478-123941, 478-123949, 478-128001, , 478-129153, , 478-120034, 478-120040, 478-120041, 478-120047, 478-106809, 478-106810, 478-105975, 478-110117, 478-110123, 478-115390, 478-115426, 478-116810, 478-116817, 478-116824, 478-117122, 478-117126, 478-117127, 478-118041, 478-118256, 478-124126, 478-124127, 478-124128, 478-124331, 478-125680, 478-125681, 478-125682, 478-128661, 478-128662, 478-128665, 478-128667, 478-129167, 478-129684, 478-129687, 478-129691, , 478-129949, , 478-132784, 478-132785, 478-127983, 478-127985, 478-127990, 478-127991, 478-127993, 478-127994, 478-127995, 478-128020, 478-107614, 478-107615, 478-107616, 478-107617, 478-107618, 478-107613, 478-100222, 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478-132710, 478-132711, 478-132712, 478-132713, 478-132715, 478-132716, 478-132717, 478-132718, 478-132719, 478-132720, 478-132721, 478-132722, 478-132723, 478-132724, 478-132725, 478-132726, 478-132727, 478-132728, 478-132729, 478-133278, 478-133279, 478-133280, 478-133281, 478-133282, 478-133283, 478-133331, 478-133335, 478-133370, 478-133371, 478-133914, 478-133915, 478-133916, 478-133918, 478-133919, 478-133920, 478-133921, 478-133922, 478-133923, 478-133924, 478-133925, 478-133926, 478-133927, 478-133928, 478-133929, 478-133930, 478-133931, 478-133932, 478-133933, 478-133934, 478-133935, 478-133936, 478-133937, 478-133938, 478-133939, 478-133940, 478-133941, 478-133942, 478-133943, 478-133944, 478-133945, 478-133946, 478-133947, 478-133949, 478-134006, 478-134007, 478-134254, 478-134255, 478-130756, 478-130757, 478-130762, 478-130763, 478-130764, 478-133332, 478-133333, 478-133334, 478-133917, 478-133978, 478-133979, 478-133980, 478-133982, 478-130229, 478-130515, 478-130516, 478-130517, 478-130519, 478-132787, 478-132788, 478-132789, 478-139434, 478-132280, 478-132281, 478-132284, 478-132286, 478-132362, 478-132365, 478-132367, 478-132369, 478-132410, 478-132411, 478-132413, 478-132416, 478-132931, 478-132933, 478-132999, 478-133000, 478-133001, 478-133002, 478-133003, 478-133004, 478-133005, 478-133006, 478-133013, 478-133023, 478-133328, 478-133329, 478-133330, 478-134234, 478-134235, 478-134236, 478-134237, 478-134239, 478-134240, 478-134295, 478-134296, 478-134297, 478-134298, 478-134299, 478-134300, 478-134301, 478-134302, 478-134585, 478-134586, 478-134595, 478-134596, 478-134597, 478-134602, 478-134603, 478-134606, 478-136373, 478-136374, 478-136375, 478-136376, 478-136377, 478-136378, 478-136379, 478-136380, 478-136388, 478-136389, 478-136390, 478-136391, 478-136392, 478-136393, 478-136395, 478-136396, 478-136401, 478-136402, 478-136403, 478-136404, 478-136405, 478-136406, 478-136407, 478-136408, 478-136633, 478-136634, 478-136637, 478-136638, 478-109950, 478-124986, 478-124989, 478-125008, 478-125631, 478-125632, 478-141804, 478-141805, 478-141806, 478-141807, 478-141808, 478-141809, 478-141810, 478-141811, 478-141812, 478-141813, 478-141814, 478-141816, 478-143399, 478-143400, 478-143401, 478-143402, 478-146839, 478-146840, 478-146841, 478-146842, 478-146844, 478-146845, 478-146846, 478-146847, 478-146848, 478-146849, 478-146850, 478-146851, , 478-110624, 478-110968, 478-113052, 478-113053, 478-113090, 478-113091, 478-113092, 478-113093, 478-113094, 478-113111, 478-113112, 478-115377, 478-115395, 478-115397, 478-115400, 478-115402, 478-115404, 478-115405, 478-115417, 478-115418, 478-115419, 478-115420, 478-115422, , 478-113599, 478-113600, 478-117388, 478-117391, 478-118780, 478-118781, 478-118784, 478-118785, 478-122162, 478-122164, , 478-108544, 478-108545, 478-111549, 478-111550, 478-111552, 478-111555, 478-111557, 478-111558, 478-111559, 478-111560, 478-144585, , 478-117158, 478-117804, 478-117805, 478-117806, 478-117807, 478-117808, 478-117809, 478-117810, 478-117811, 478-122542, 478-122543, , 478-130293, , 478-111709, 478-111858, 478-111859, 478-111860, 478-111861, 478-111862, 478-115005, 478-115334, 478-116340, 478-117533, 478-117534, 478-117535, 478-117536, 478-117537, 478-117538, 478-117764, , 478-117134, 478-118259, 478-118260, 478-119686, 478-122224, 478-122225, 478-122226, 478-122231, , 478-125078, 478-128335, 478-128340, , 478-130301, 478-130882, 478-132238, 478-132248, 478-132268, 478-132282, 478-132285, , 478-109902, 478-109904, 478-109905, 478-109906, 478-109935, 478-109936, 478-110120, 478-110121, 478-110318, 478-110319, 478-111042, 478-111043, , 478-129946, 478-129947, 478-129951, 478-130520, , 478-128333, 478-128545, 478-128546, 478-128547, 478-129165, 478-129168, 478-129169, 478-129172, , 478-108772, 478-108777, 478-108789, 478-108931, 478-108932, 478-108933, 478-108935, 478-108936, 478-108937, 478-108938, 478-108939, 478-111823, 478-111824, 478-111825, 478-111826, 478-115437, 478-115438, 478-111894, 478-111895, 478-111896, 478-111897, 478-142240, 478-142241, 478-142242, 478-142243, 478-143973, 478-143978, 478-146906, 478-146907, 478-146908, 478-146910, , 478-106050, 478-106063, , 478-110203, 478-110450, 478-110458, 478-110598, 478-115844, 478-116162, 478-116163, 478-116271, 478-122862, 478-122873, 478-122875, 478-122876, 478-136422, 478-136423, 478-136424, 478-136425, 478-136426, 478-136427, 478-136428, 478-136431, 478-145278, 478-145322, 478-145323, 478-145552, 478-146101, 478-146167, 478-146952, 478-147043, 478-147070, 478-147153, 478-147164, 478-147165, , 478-112023, 478-113451, 478-113452, 478-113453, 478-113455, 478-113456, 478-113457, 478-113458, 478-113459, 478-119358, 478-119359, 478-122700, 478-122701, , 478-128338, 478-128339, 478-128341, 478-128342, , 478-112793, 478-112794, 478-116378, 478-124853, 478-126549, 478-126551, 478-126553, 478-126556, 478-126557, 478-126856, 478-126862, 478-126870, 478-126894, , 478-115231, 478-115234, 478-115287, 478-115293, 478-115294, 478-115295, 478-115296, 478-115351, 478-117720, 478-132714, 478-132732, 478-133975, 478-133976, , 478-125684, 478-125687, , 478-116797, 478-116798, , 478-145297, 478-145298, 478-145299, 478-145300, 478-145301, , 478-110493, 478-112048, 478-113096, 478-114216, 478-121458, 478-121459, 478-122161, 478-122165, 478-132730, 478-132731, 478-132733, 478-132734, 478-133326, 478-133327, , 478-141815, 478-142590, 478-142602, , 478-113727, 478-113795, 478-113796, 478-113798, 478-129381, 478-129796, 478-129797, 478-129883, 478-129884, 478-129885, 478-129886, 478-129887, 478-129888, 478-129889, 478-129890, 478-129892, 478-129355, 478-129444, 478-105999, 478-130223, 478-109741, 478-109763, 478-109773, 478-109774, 478-109775, 478-109776, 478-109777, 478-109778, 478-111498, 478-111612, 478-111613, 478-111614, 478-111615, 478-111617, 478-111657, 478-111702, 478-111705, 478-111733, 478-112260, 478-112262, 478-113287, 478-113535, 478-113536, 478-113537, 478-113538, 478-113539, 478-113540, 478-113541, 478-113542, 478-113543, 478-113544, 478-113545, 478-113546, 478-113547, 478-113549, 478-113550, 478-113551, 478-113552, 478-113553, 478-113554, 478-113555, 478-113556, 478-113557, 478-113558, 478-113559, 478-113560, 478-113561, 478-113562, 478-113563, 478-113564, 478-113565, 478-113566, 478-113567, 478-113568, 478-113569, 478-113570, 478-113571, 478-113572, 478-115448, 478-115471, 478-115473, 478-115474, 478-115475, 478-115476, 478-115477, 478-115478, 478-115479, 478-115480, 478-115481, 478-115482, 478-115484, 478-115485, 478-115486, 478-115487, 478-116892, 478-117203, 478-117204, 478-117205, 478-117264, 478-117306, 478-117307, 478-117308, 478-117309, 478-117542, 478-117913, 478-117914, 478-117915, 478-117916, 478-117917, 478-117918, 478-117919, 478-117920, 478-118563, 478-118564, 478-118565, 478-118566, 478-118567, 478-118568, 478-118569, 478-118570, 478-118571, 478-118572, 478-118573, 478-118574, 478-118575, 478-118576, 478-118577, 478-118578, 478-118579, 478-118580, 478-118581, 478-118582, 478-118855, 478-118948, 478-118949, 478-118950, 478-118951, 478-119098, 478-119317, 478-119335, 478-119336, 478-119341, 478-119342, 478-119355, 478-120247, 478-120248, 478-120249, 478-120279, 478-120512, 478-120515, 478-120516, 478-120517, 478-120518, 478-120519, 478-120521, 478-120522, 478-120523, 478-120524, 478-120606, 478-120673, 478-120676, 478-120739, 478-120740, 478-120741, 478-120745, 478-120806, 478-120840, 478-120861, 478-120879, 478-120883, 478-120904, 478-120905, 478-120921, 478-122061, 478-122117, 478-122308, 478-122557, 478-122569, 478-126539, 478-126543, 478-126545, 478-126602, 478-126608, 478-126619, 478-126635, 478-126642, 478-126655, 478-126659, 478-126844, 478-126886, 478-126945, 478-127025, 478-127096, 478-127111, 478-127112, 478-127120, 478-127136, 478-127432, 478-127442, 478-127486, 478-127487, 478-127488, 478-127489, 478-127490, 478-127492, 478-127493, 478-127494, 478-127495, 478-127496, 478-127497, 478-132775, 478-132776, 478-132777, 478-132778, 478-132792, 478-132793, 478-132794, 478-133203, 478-133204, 478-133205, 478-133206, 478-133207, 478-133208, 478-133209, 478-133210, 478-133211, 478-133212, 478-133213, 478-133214, 478-133215, 478-133948, 478-134001, 478-134002, 478-134005, 478-134256, 478-134257, 478-134258, 478-134259, 478-134261, 478-134262, 478-135146, 478-135147, 478-135148, 478-135182, 478-135183, 478-135184, 478-135191, 478-135192, 478-135213, 478-135214, 478-136965, 478-136966, 478-136967, 478-136968, 478-136969, 478-137544, 478-137548, 478-137556, 478-137557, 478-137558, 478-137559, 478-137560, 478-137630, 478-138697, 478-138698, 478-138699, 478-138700, 478-140092, 478-140110, 478-140122, 478-140123, 478-140124, 478-140125, 478-140126, 478-140127, 478-140128, 478-140129, 478-140132, 478-140133, 478-140134, 478-140135, 478-140137, 478-140138, 478-140139, 478-140140, 478-140141, 478-140142, 478-140143, 478-140144, 478-140145, 478-140146, 478-140540, 478-140541, 478-140542, 478-140543, 478-140544, 478-140545, 478-140546, 478-140547, 478-140548, 478-140549, 478-140550, 478-140551, 478-143935, 478-144477, 478-144583, 478-144584, 478-144586, 478-144587, 478-144588, 478-144592, 478-144596, 478-144609, 478-144616, 478-144617, 478-144618, 478-144619, 478-144620, 478-144621, 478-144622, 478-144624, 478-144625, 478-144626, 478-144627, 478-144629, 478-144630, 478-144631, 478-144632, 478-144633, 478-144634, 478-144635, 478-144636, 478-144637, 478-144638, 478-144639, 478-144640, 478-144641, 478-144642, 478-144643, 478-144644, 478-144645, 478-144646, 478-144647, 478-144648, 478-144649, 478-144650, 478-144671, 478-144672, 478-144673, 478-144674, 478-144675, 478-144676, 478-144677, 478-144678, 478-144679, 478-144680, 478-144681, 478-144682, 478-144683, 478-144684, 478-144685, 478-144686, 478-144687, 478-144688, 478-144689, 478-144690, 478-144691, 478-144692, 478-144693, 478-144695, 478-144709, 478-144710, 478-144711, 478-144712, 478-144832, 478-144843, 478-144844, 478-144845, 478-144846, 478-144847, 478-144848, 478-144849, 478-146254, 478-146255, 478-146888, 478-146889, 478-146890, 478-146891, 478-146892, 478-146893, 478-146894, 478-146895, 478-146896, 478-146897, 478-146898, 478-146899, 478-146900, 478-146901, 478-147191, 478-147192, 478-147197, 478-147198, 478-147212, 478-147261, 478-147262, 478-147265, 478-147266, 478-147267, 478-147268, 478-147269, 478-147270, 478-147271, , 478-112404, , 478-129943, 478-129944, 478-129945, 478-129948, 478-129952, 478-130231, 478-130513, 478-130518, , 478-145035, 478-145363, 478-145616, 478-145617, 478-146203, , 478-106144, 478-110402, 478-110403, 478-110404, 478-110405, 478-112022, 478-112025, 478-112491, , 478-110920, 478-110921, 478-110975, 478-110977, 478-110978, 478-110979, 478-110983, 478-111004, 478-113700, 478-113701, 478-113702, 478-113703, 478-115398, 478-115399, 478-115401, 478-115407, 478-115408, 478-115409, 478-115410, 478-115411, 478-115412, 478-115413, 478-115414, 478-115415, 478-115416, 478-124997, 478-124998, 478-125001, 478-125004, 478-143367, 478-143368, 478-143369, 478-143370, , 478-110494, 478-110934, 478-110935, 478-127065, , 478-136878, 478-136879, 478-136880, 478-136881, 478-137222, 478-137223, 478-137224, 478-137561, 478-137562, 478-137563, 478-137564, 478-137565, 478-137566, 478-137567, 478-137568, 478-137569, 478-137570, 478-137571, 478-137572, 478-137573, 478-137574, 478-137575, 478-138415, 478-138717, 478-138718, 478-138719, 478-139025, 478-139026, 478-139901, 478-139902, 478-140272, 478-140285, 478-140288, 478-140289, 478-140290, 478-140291, 478-140292, 478-140293, 478-140294, 478-140295, 478-140296, 478-140297, 478-140298, 478-140299, 478-140300, 478-140301, 478-140302, 478-140303, 478-140304, 478-140305, 478-140306, 478-140307, 478-140308, 478-140309, 478-140310, 478-140311, 478-140349, 478-140350, 478-140351, 478-140352, 478-140353, 478-140355, 478-140358, 478-140359, 478-140360, 478-140361, 478-140362, 478-140363, 478-140364, 478-140410, 478-140414, 478-140418, 478-140432, 478-140460, 478-140464, 478-140469, 478-140471, 478-140476, 478-140477, 478-140478, 478-140479, 478-140480, 478-140482, 478-140483, 478-140484, 478-140485, 478-140486, 478-140488, 478-140489, 478-140490, 478-140492, 478-140493, 478-140494, 478-140495, 478-140709, 478-142624, 478-142659, 478-142747, 478-143259, 478-143260, 478-143261, 478-143262, 478-143263, 478-143264, 478-143265, 478-143266, 478-143267, 478-143268, 478-143269, 478-143270, 478-143685, 478-143686, 478-143930, 478-143931, 478-143932, 478-143933, 478-143934, 478-144262, 478-144472, 478-144666, 478-144667, 478-144970, 478-144994, 478-144995, 478-144996, 478-144997, 478-144998, 478-144999, 478-145000, 478-145001, 478-145002, 478-145003, 478-145004, 478-145048, 478-145207, 478-145357, 478-145358, 478-145359, 478-145364, 478-145365, 478-145366, 478-145367, 478-145368, 478-145369, 478-145370, 478-145533, 478-145534, 478-145535, 478-145536, 478-145538, 478-145539, 478-145540, 478-145541, 478-147188, 478-147189, , 478-146936, , 478-118777, 478-118778, 478-118900, 478-118903, 478-118904, 478-118905, 478-118906, 478-118907, , 478-108843, , 478-127071, 478-127466, , 478-122541, 478-122669, 478-122670, 478-123084, 478-123086, 478-123088, 478-123846, 478-123850, 478-123851, 478-123852, 478-123853, 478-123943, , 478-129143, 478-129144, 478-129145, 478-129146, 478-129148, 478-129149, 478-129155, 478-129156, 478-129158, 478-129162, 478-130567, 478-130570, 478-130571, 478-130572, , 478-126528, , 478-128769, 478-128770, 478-128771, 478-128772, , 478-130566, , 478-105175, 478-107427, 478-107428, 478-107429, 478-107430, 478-109603, 478-109604, 478-110336, 478-110347, 478-110348, , 478-145321, 478-145360, 478-145361, 478-145362, , 478-142405, , 478-125627, 478-125628, 478-125629, 478-125630, , 478-129548, 478-129550, , 478-147585, 478-147586, 478-147587, 478-147588, , 478-120422, 478-124054, 478-124121, 478-124122, 478-124123, 478-124124, 478-124125, 478-124332, 478-124333, 478-124334, 478-124470, 478-124471, 478-124472, 478-124473, 478-124474, 478-124476, 478-124563, 478-124567, 478-124569, 478-128550, 478-128553, 478-128554, , 478-111119, , 478-100466, 478-107417, 478-107418, 478-107420, 478-107426, 478-107790, 478-107791, 478-107792, 478-107793, 478-107843, 478-108790, 478-108794, 478-108799, 478-108814, 478-108815, 478-108840, 478-108841, 478-108876, 478-108877, 478-108878, 478-119096, 478-119333, 478-120423, 478-121450, 478-121454, 478-122166, 478-124475, 478-124477, 478-124479, 478-124565, 478-124566, 478-128024, 478-128334, 478-129689, , 478-130759, 478-140374, 478-140710, 478-140731, 478-140732, 478-141143, 478-141144, 478-141145, 478-141146, 478-141578, 478-141579, 478-141580, 478-141581, 478-141582, 478-141583, 478-141584, 478-141585, 478-143624, 478-143625, 478-143626, 478-143627, 478-143628, 478-143629, 478-143630, 478-143631, 478-143632, 478-143633, 478-145637, 478-145638, 478-145639, 478-145640, 478-145641, 478-145642, 478-145643, 478-145644, 478-145645, 478-145646, 478-146919, 478-146920, 478-146921, 478-146922, 478-146923, 478-146924, 478-146925, 478-146926, 478-146927, 478-146928, , 478-111041, 478-125079, 478-125083, 478-125084, 478-125666, 478-125683, 478-125685, 478-125686, 478-125688, 478-125689, 478-126674, 478-126675, 478-126678, 478-128549, 478-128658, 478-128659, 478-128660, 478-128663, 478-128664, 478-129163, 478-129164, 478-129166, 478-129170, 478-129171, 478-129683, 478-129685, 478-129686, 478-129688, 478-129690, 478-129692, , 478-122109, 478-126251, 478-126262, 478-126270, 478-126271, 478-126275, 478-126280, 478-126282, 478-126284, 478-126285, , 478-128768, 478-129147, 478-129150, 478-129151, , 478-130224, 478-130225, , 478-144421, 478-144422, 478-145026, 478-145028, 478-145029, 478-145030, 478-145031, 478-145032, 478-145033, 478-145034, 478-145036, 478-145037, 478-145038, 478-145039, 478-145040, , 478-125011, 478-125012, 478-125013, 478-125014, 478-128873, 478-128874, 478-128875, 478-128876, 478-128877, 478-128878, 478-128879, 478-128880, 478-128881, 478-128882, 478-128883, 478-128884, 478-128885, 478-128886, 478-128887, 478-128888, 478-128889, 478-128890, 478-128891, 478-128892, 478-129314, 478-129679, 478-129814, 478-129821, 478-133989, 478-133990, 478-133991, 478-133992, 478-133993, 478-133994, 478-133995, 478-133996, 478-133997, 478-133998, 478-133999, 478-134000, 478-138407, 478-138408, 478-138409, 478-138410, 478-138411, 478-138412, 478-138413, 478-138414, 478-139033, 478-139035, 478-139037, 478-139038, 478-139039, 478-139040, 478-139041, 478-139042, 478-139056, 478-139057, 478-139157, 478-139158, 478-139160, 478-139161, 478-139162, 478-139163, 478-139165, 478-139166, 478-139167, 478-139168, 478-139169, 478-139170, 478-139171, 478-139172, 478-139173, 478-139174, 478-139175, 478-139176, 478-139178, 478-139179, 478-139180, 478-139181, 478-139190, 478-139191, 478-139192, 478-139193, 478-139194, 478-139195, 478-139196, 478-139197, 478-139198, 478-139199, 478-139200, 478-139201, 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478-111315, 478-111316, 478-111317, 478-111318, 478-111319, 478-111320, 478-111321, 478-111322, 478-111323, 478-111324, 478-111325, 478-111326, 478-111327, 478-111328, 478-111329, 478-111330, 478-111331, 478-111332, 478-111333, 478-111334, 478-111335, 478-111336, 478-111337, 478-111338, 478-113001, 478-113002, 478-113003, 478-113004, 478-113005, 478-113009, 478-113011, 478-113012, 478-113013, 478-113014, 478-113015, 478-113016, 478-113017, 478-113018, 478-113019, 478-113020, 478-113021, 478-113022, 478-113023, 478-113024, 478-113025, 478-113026, 478-113027, 478-113028, 478-113029, 478-113030, 478-113601, 478-113602, 478-113603, 478-113801, 478-113802, 478-113803, 478-113804, 478-113805, 478-113862, 478-113863, 478-113864, 478-113865, 478-113866, 478-113867, 478-113868, 478-113869, 478-113870, 478-113871, 478-113872, 478-113873, 478-113874, 478-113875, 478-113876, 478-113877, 478-113878, 478-113879, 478-115352, 478-115353, 478-115354, 478-115355, 478-115356, 478-115357, 478-115359, 478-115360, 478-115361, 478-115362, 478-115363, 478-115364, 478-115365, 478-115366, 478-115367, 478-115368, 478-115369, 478-115370, 478-115371, 478-115372, 478-115373, 478-115374, 478-115375, 478-115376, 478-116445, 478-116451, 478-116452, 478-116453, 478-117049, 478-117146, 478-117147, 478-117148, 478-117149, 478-117150, 478-117151, 478-117152, 478-117153, 478-117154, 478-117155, 478-117156, 478-117157, 478-117159, 478-117160, 478-117161, 478-117162, 478-117163, 478-117164, 478-117165, 478-117166, 478-117167, 478-117168, 478-117169, 478-117170, 478-118273, 478-118274, 478-118333, 478-118334, 478-118335, 478-118336, 478-118337, 478-118338, 478-118339, 478-118340, 478-118341, 478-118342, 478-118343, 478-118344, 478-118345, 478-118346, 478-118347, 478-118348, 478-118349, 478-118350, 478-118749, 478-118750, 478-118751, 478-118752, 478-118753, 478-118754, 478-118755, 478-118756, 478-118757, 478-118758, 478-118759, 478-118760, 478-118762, 478-118763, 478-118765, 478-118766, 478-118767, 478-118768, 478-118769, 478-118770, 478-118771, 478-118772, 478-118773, 478-118901, 478-118902, 478-118908, 478-118909, 478-122328, 478-122534, 478-122536, 478-122671, 478-122673, 478-122674, 478-122675, 478-122676, 478-122677, 478-122907, 478-122908, 478-122910, 478-122911, 478-122912, 478-123845, 478-123942, 478-124041, 478-124043, 478-124044, 478-124045, 478-124046, 478-124047, 478-124048, 478-134655, 478-134656, 478-134657, 478-134658, 478-134659, 478-134660, 478-134661, 478-134662, 478-141217, 478-141218, 478-141219, 478-141220, 478-141221, 478-141222, 478-141223, 478-141224, 478-141983, 478-141984, 478-142223, 478-142224, 478-142225, 478-142226, 478-142227, 478-142649, 478-142650, 478-142651, 478-143278, 478-143279, 478-143280, 478-143281, 478-143447, 478-143448, 478-143449, 478-143450, 478-143687, 478-143688, 478-143689, 478-143690, 478-143927, 478-143928, 478-143929, 478-143970, 478-143971, 478-143972, 478-143974, 478-143975, 478-143976, 478-143977, 478-143979, 478-147294, 478-147295, , 478-106825, 478-133977, 478-133981, 478-133983, 478-133984, 478-133985, 478-133986, 478-133987, 478-133988, 478-137692, 478-139189, 478-139614, 478-139615, 478-139616, 478-139617, 478-139618, 478-139619, 478-139620, 478-139621, 478-139622, 478-139623, 478-140408, 478-140552, 478-140733, 478-141450, 478-141451, 478-141452, 478-141453, 478-141454, 478-141455, 478-141557, 478-142565, 478-142566, 478-142567, 478-142568, 478-142569, 478-143691, 478-143692, 478-144928, 478-144929, 478-144930, 478-144931, 478-144932, 478-144933, 478-144934, 478-144935, 478-144936, 478-145112, 478-145113, 478-146515, 478-146516, 478-146517, 478-146518, 478-146519, 478-146520, 478-146719, 478-146720, 478-146721, 478-146929, 478-146930, 478-146931, 478-146932, 478-146933, 478-146934, , 478-105988, 478-105989, 478-105990, 478-105991, 478-106006, 478-106007, 478-106506, 478-106997, 478-106998, 478-107421, 478-107934, 478-108222, 478-108223, 478-108224, 478-108225, 478-108226, 478-109068, 478-109155, 478-109156, 478-109157, 478-109158, 478-109334, 478-109335, 478-109336, 478-109337, 478-109338, 478-109339, 478-109340, 478-109341, 478-109665, 478-109666, 478-109667, 478-109668, 478-110125, 478-110999, 478-111181, 478-111182, 478-112026, 478-112028, 478-112029, 478-112030, 478-112031, 478-112032, 478-112033, 478-112034, 478-112035, 478-112038, 478-112042, 478-112043, 478-112045, 478-112051, 478-112476, 478-112480, 478-112481, 478-112482, 478-112483, 478-112484, 478-112485, 478-112486, 478-112487, 478-112488, 478-112489, 478-112496, 478-112497, 478-112499, 478-113031, 478-113033, 478-113037, 478-113038, 478-113039, 478-113040, 478-113041, 478-113042, 478-113043, 478-113044, 478-113045, 478-113049, 478-113100, 478-113104, 478-113105, 478-113106, 478-113107, 478-113108, 478-113110, 478-113113, 478-114222, 478-115387, 478-115392, 478-115394, 478-115396, 478-116789, 478-116791, 478-116792, 478-116793, 478-116794, 478-116795, 478-116796, 478-116807, 478-116809, 478-116826, 478-116829, 478-117119, 478-117120, 478-117121, 478-117125, 478-117128, 478-117133, 478-117135, 478-117137, 478-117138, 478-117139, 478-117140, 478-117141, 478-117142, 478-117143, 478-119325, 478-119680, 478-119681, 478-119682, 478-119683, 478-119684, 478-119685, 478-119687, 478-119688, 478-119689, 478-120416, 478-120417, 478-120418, 478-120419, 478-120420, 478-120421, 478-120424, 478-121451, 478-121452, 478-121453, 478-121455, 478-121456, 478-121457, 478-124053, 478-124129, 478-124130, 478-124325, 478-124326, 478-124327, 478-124328, 478-124329, 478-124330, 478-124564, 478-124981, 478-124982, 478-124983, 478-124991, 478-124993, 478-124995, 478-125002, 478-125003, 478-125005, 478-125006, 478-125007, 478-125009, 478-125010, 478-125065, 478-125066, 478-125067, 478-125068, 478-125080, 478-126676, 478-126677, 478-128023, 478-128025, 478-128026, 478-128027, 478-129950, 478-130226, 478-130227, 478-130228, 478-130230, 478-130232, 478-130514, 478-130521, 478-130522, 478-130754, 478-130755, 478-130765, 478-131979, 478-132780, 478-132781, 478-132782, 478-140375, 478-140376, 478-140531, 478-140532, 478-140533, 478-140534, 478-140535, 478-140536, 478-140537, 478-140538, 478-140899, 478-140900, 478-141076, 478-141077, 478-141108, 478-141109, 478-141110, 478-141111, 478-141112, 478-141113, 478-141114, 478-141115, 478-141116, 478-141117, 478-141118, 478-141119, 478-141120, 478-141121, 478-141122, 478-143034, 478-143035, 478-143036, 478-143037, 478-143038, 478-143039, 478-143040, 478-143041, 478-143051, 478-143052, 478-143563, 478-143564, 478-143565, 478-143566, 478-144177, 478-144178, 478-144179, 478-144180, 478-144181, 478-144182, 478-144183, 478-144184, 478-144186, 478-144187, 478-144188, 478-144189, 478-144190, 478-144191, 478-144192, 478-144193, 478-144194, 478-144195, 478-144196, 478-144197, 478-144198, 478-144199, 478-144201, 478-144202, 478-144203, 478-144204, 478-144206, 478-144207, 478-144208, 478-144209, 478-144210, 478-144211, 478-144212, 478-144213, 478-144214, 478-144215, 478-144216, 478-144217, 478-144218, 478-144219, 478-144220, 478-144221, 478-144222, 478-144223, 478-144225, 478-144226, 478-144227, 478-144228, 478-144229, 478-144230, 478-144231, 478-144232, 478-144233, 478-144234, 478-144235, 478-144236, 478-144237, 478-144238, 478-144239, 478-144240, 478-144241, 478-144242, 478-144243, 478-144244, 478-144245, 478-144246, 478-144247, 478-144248, 478-144249, 478-144250, 478-144264, 478-145553, 478-145554, 478-145615, 478-145647, 478-145924, 478-146053, 478-146054, 478-146055, 478-146056, 478-146057, 478-146107, 478-146129, 478-146130, 478-146131, 478-146132, 478-146204, 478-146205, 478-146206, 478-146265, 478-146283, 478-146397, 478-146403, 478-146426, 478-146453, 478-146462, 478-1466911, 478-1466912, 478-1466913, 478-1466914, 478-1466915, 478-1466916, 478-146917, 478-146918, 478-100075, 478-100250, 478-111102, 478-111103, 478-112071, 478-112847, 478-112848, 478-112849, 478-112850, 478-112851, 478-112852, 478-112853, 478-112854, 478-112855, 478-112894, 478-112895, 478-112896, 478-112897, 478-112898, 478-112899, 478-112900, 478-112901, 478-112902, 478-112903, 478-112904, 478-112905, 478-112906, 478-112907, 478-114666, 478-116219, 478-122727, 478-125119, , 478-109954, 478-109955, 478-109956, 478-109957, 478-109958, 478-109959, 478-112631, 470-112426, 478-100366, 478-101160, 478-101556, 478-105117, 478-105237, 478-106022, 478-106031, 478-106090, 478-106097, 478-106194, 478-106263, 478-106422, 478-106426, 478-106583, 478-106593, 478-106602, 478-106614, 478-106615, 478-106622, 478-106624, 478-106625, 478-106630, 478-106634, 478-107101, 478-107103, 478-107469, 478-107470, 478-107471, 478-107472, 478-108020, 478-108021, 478-108022, 478-108023, 478-108024, 478-108025, 478-108958, 478-108959, 478-108960, 478-108967, 478-109027, 478-109934, 478-110041, 478-110042, 478-110043, 478-110044, 478-110045, 478-110046, 478-110047, 478-110048, 478-110049, 478-110050, 478-110051, 478-110576, 478-111071, 478-111121, 478-111122, 478-111123, 478-111124, 478-111125, 478-111127, 478-111129, 478-111711, 478-112015, 478-112147, 478-112427, 478-112559, 478-112569, 478-112570, 478-112571, 478-112572, 478-112611, 478-112612, 478-112613, 478-112621, 478-112622, 478-112623, 478-112638, 478-112639, 478-112756, 478-112757, 478-112758, 478-112759, 478-112760, 478-112761, 478-112762, 478-112763, 478-112765, 478-112766, 478-112767, 478-112781, 478-112782, 478-112783, 478-112784, 478-112785, 478-112786, 478-112787, 478-112788, 478-112789, 478-112790, 478-112791, 478-112792, 478-112797, 478-112798, 478-112799, 478-112800, 478-112808, 478-112826, 478-112827, 478-112828, 478-112845, 478-112846, 478-113210, 478-113211, 478-113582, 478-113669, 478-113762, 478-113763, 478-113765, 478-113766, 478-113767, 478-113768, 478-113769, 478-113770, 478-113771, 478-113779, 478-113785, 478-113788, 478-113790, 478-114023, 478-114025, 478-114134, 478-114135, 478-114220, 478-114364, 478-114365, 478-114366, 478-114368, 478-114369, 478-114370, 478-114371, 478-114372, 478-114373, 478-114374, 478-114375, 478-114399, 478-114400, 478-114401, 478-114402, 478-114443, 478-114506, 478-114507, 478-114508, 478-114509, 478-114585, 478-114587, 478-114588, 478-114595, 478-114628, 478-114633, 478-114635, 478-114664, 478-114686, 478-114687, 478-114688, 478-114689, 478-114691, 478-115083, 478-115084, 478-115085, 478-115086, 478-116335, 478-116790, 478-116799, 478-116800, 478-116801, 478-116802, 478-116803, 478-116804, 478-116805, 478-116806, 478-116808, 478-116811, 478-116812, 478-116813, 478-116814, 478-116815, 478-116816, 478-116818, 478-116819, 478-116820, 478-116821, 478-116822, 478-116823, 478-116825, 478-117123, 478-117124, 478-117129, 478-117130, 478-117131, 478-117132, 478-117136, 478-117310, 478-117316, 478-118037, 478-118038, 478-118039, 478-118043, 478-118044, 478-118045, 478-118046, 478-118251, 478-118252, 478-118253, 478-118254, 478-118255, 478-118257, 478-118258, 478-118858, 478-119982, 478-120449, 478-120468, 478-120478, 478-120479, 478-122118, 478-122119, 478-122309, 478-122690, 478-122707, 478-122708, 478-122709, 478-122743, 478-124305, 478-124313, 478-124314, 478-124317, 478-124319, 478-124324, 478-127066, 478-128472, 478-128485, 478-128501, 478-128503, 478-128511, 478-128512, 478-128541, 478-129459, 478-129603, 478-129616, 478-129619, 478-129642, 478-129643, 478-130688, 478-130748, 478-125081, 478-125082, 478-109079, 478-110974, 478-112046, 478-113034, 478-113035, 478-113046, 478-113047, 478-113048, 478-113054, 478-113055, 478-113095, 478-113102, 478-113103, 478-114219, 478-114223, 478-114225, 478-115378, 478-115379, 478-115380, 478-115382, 478-115389, 478-116827, 478-116828, 478-116830, 478-116831, 478-118042, 478-122160, 478-122167, 478-124050, 478-124051, 478-124052, 478-124056, 478-124478, 478-124572, 478-124984, 478-124985, 478-124987, 478-124990, 478-124992, 478-124999, 478-125000, 478-125073, 478-125074, 478-125075, 478-125076, 478-106175, 478-106181, 478-106183, 478-128524, 478-129152, 478-127063, 478-127078, 478-128745, 478-130071, 478-130304, 478-130305, 478-130359, 478-146058, 478-146059, 478-130564, 478-130565, 478-130568, 478-130569, 478-120326, 478-120470, 478-120471, 478-120472, 478-120475, 478-120486, 478-120490, 478-120493, 478-120495, 478-122689, 478-118544, 478-119360, 478-122342, 478-124306, 478-124307, 478-124308, 478-124309, 478-124315, 478-124316, 478-124318, 478-124321, 478-124322, 478-124323, 478-126427, 478-126431, 478-126434, 478-126660, 478-127449, 478-127757, 478-127758, 478-127855, 478-128298, 478-128469, 478-128543, 478-128544, 478-109114, 478-116014, 478-116015, 478-116676, 478-118332, 478-122296, 478-122297, 478-122299, 478-122300, 478-122301, 478-122302, 478-122303, 478-122311, 478-122376, 478-122378, 478-128354, 478-128400, 478-128426, 478-128475, 478-127579, 478-128266, 478-110558, 478-122295, 478-122316, 478-130366, 478-132101, 478-132102, 478-132103, 478-132104, 478-127072, , 478-111194, 478-111211, 478-111266, 478-111267, 478-105379, , 478-108390, 478-108391, 478-110666, 478-110668, 478-110678, 478-110681, 478-110683, 478-110717, 478-110722, 478-110724, 478-110730, 478-110733, 478-110738, 478-110967, 478-111012, , 478-100055, 478-100377, 478-100437, 478-101115, 478-101144, 478-106394, 478-108846, 478-108856, 478-108857, 478-108869, 478-108870, 478-108874, 478-108875, 478-108879, 478-108882, 478-108885, 478-108891, 478-108892, 478-108893, 478-108895, 478-108921, 478-108922, 478-108941, 478-108942, 478-108944, 478-108946, 478-108947, 478-108955, 478-108956, 478-108957, 478-119332, 478-119349, 478-131047, 478-131073, 478-131074, 478-131098, 478-131102, 478-131118, 478-133446, 478-133447, 478-133448, 478-133449, 478-133450, 478-133451, 478-133452, 478-133453, 478-133454, 478-133455, 478-133456, 478-133457, 478-133458, 478-133459, 478-133460, 478-133479, 478-133480, 478-133481, 478-133482, 478-133483, 478-133484, 478-133485, 478-133486, 478-133487, 478-133488, 478-133489, 478-133490, 478-133491, 478-133492, 478-133493, 478-133494, 478-133495, 478-133496, 478-133497, 478-133498, 478-133499, 478-133500, 478-133501, 478-133503, 478-133504, 478-140502, 478-140503, 478-140504, 478-140505, 478-140506, 478-140507, 478-140508, 478-140509, 478-140510, 478-140511, 478-143339, 478-143340, 478-143341, 478-143342, 478-144082, 478-144089, 478-144090, 478-144091, 478-144092, 478-144093, 478-144094, 478-144095, 478-144097, 478-144099, , 478-117513, 478-117516, 478-117529, 478-117530, 478-117531, 478-117532, 478-117768, 478-117769, 478-117771, 478-117774, 478-117778, 478-117779, , 478-107858, 478-111152, 478-111339, 478-111340, 478-111351, 478-111353, 478-111354, 478-111355, 478-118463, 478-118464, 478-118465, 478-118472, 478-118473, 478-118475, 478-118476, 478-118477, 478-118481, 478-118482, , 478-110227, 478-110228, 478-110390, 478-118731, 478-118896, 478-118930, 478-119528, 478-119529, 478-121488, 478-121526, 478-121527, 478-121530, 478-121531, 478-121541, 478-121930, 478-121931, 478-121932, 478-137038, 478-137073, 478-137126, 478-137134, 478-137185, 478-137197, 478-137198, 478-137199, 478-137200, 478-137201, 478-137202, 478-137203, 478-137204, 478-137205, 478-137206, 478-137207, 478-137208, 478-137211, 478-137212, 478-137213, 478-137214, 478-137215, 478-137216, 478-137217, 478-137218, 478-137219, 478-137220, 478-137221, 478-137225, and 478-137226
RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare, Inc., Issaquah, WA, by letter dated July 16, 2008. Firm initiated recall is ongoing.
REASON
Telemetry Modules are failing to alarm for low heart rate and asystole.
VOLUME OF PRODUCT IN COMMERCE
37,590 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Kendall Calf Garment - Reprocessed Sterile device used to cover calf while
conducting sterile procedures. Catalog No. 5329, Recall # Z-1661-2008;
b) Zimmer, 34" Tourniquet Cuff Single Port Single Bladder Luer Lock Connector
Brown Trim, Latex Free - Reprocessed Sterile device -- Pneumatic tourniquet.
Cataloge No 60-7075-006, Recall # Z-1662-2008;
c) Neonatal/Adult 02 Transducer, (Nellcor), Latex Free. - Reprocessed Sterile device –
Pulse Oximeter. Catalog No. MAX-N, Recall # Z-1663-2008;
d) Adult 02 Transducer (Nellcor) - Reprocessed Sterile device -- Pulse Oximeter.
Catalog No. MAX-A, Recall # Z-1664-2008;
e) Hill-Rom Foot Garment - Reprocessed Sterile device -- Compressible limb
sleeve. Catalog No. P3808, Recall # Z-1665-2008;
f) Huntleigh Healthcare, Calf Garment - Regular. -- Reprocessed Sterile device –
Compressible limb sleeve. Catalog No DVT-10, Recall # Z-1666-2008;
g) Mitek 3.5 mm Side Effect Electrode - - Reprocessed Sterile device -- Orthopedic
Arthroscope. Catalog No 225301, Recall # Z-1667-2008;
h) Arthrocare 3.6 mm Right Angle - Reprocessed Sterile device -- Orthopedic
Arthroscope. Catalog No A1336-01, Recall # Z-1668-2008;
i) Turbovac Suction Wand - Reprocessed Sterile device -- Orthopedic Arthroscope.
Catalog No AS1335-01, Recall # Z-1669-2008;
j) Mitek Angled Side Effect Electrode - Reprocessed Sterile device -- Orthopedic
Arthroscope. Catalog No 225302, Recall # Z-1670-2008;
k) Huntleigh Healthcare Thigh Garment. - Reprocessed Sterile device -- Compressible
limb sleeve. Catalog No DVT-30, Recall # Z-1671-2008;
l) VasoPress Foot Garment. - Reprocessed Sterile device -- Compressible limb sleeve.
Catalog VP 520, Recall # Z-1672-2008;
m)Tourniquet Cuff Single Port Single Bladder - Reprocessed Sterile device -- Pneumatic
tourniquet. Catalog No 60-7075-003, Recall # Z-1673-2008;
n) Inlet Medical Suture Passer - Reprocessed Sterile device -- Endoscope and accessories.
Catalog No CTI-512N, Recall # Z-1674-2008;
o) Biomet Stablecut Saw Blade - Reprocessed Sterile device -- Powered Saw and
Accessories. Catalog No 506090, Recall # Z-1675-2008;
p) Kendall Thigh Garment - Reprocessed Sterile device -- Compressible limb sleeve.
Catalog No 9530, Recall # Z-1676-2008;
q) Stryker Oscillating & Sagittal Blade - Reprocessed Sterile device -- Powered Saw and
Accessories. Catalog No 2296-3-105, Recall # Z-1677-2008;
r) Color Cuff II, Double Port Single Bladder - Reprocessed Sterile device -- Pneumatic
tourniquet. Catalog No DT-7034-02-QC, Recall # Z-1678-2008;
s) Zimmer Tourniquet Cuff - Reprocessed Sterile device -- Pneumatic tourniquet. Catalogue No 60-7070-106, Recall # Z-1679-2008;
t) Turbovac Suction Wand - Reprocessed Sterile device -- Orthopedic Arthroscope.
Catalog No AS1337-01, Recall # Z-1680-2008;
u) Mitek Angled Side Effect Electrode - Reprocessed Sterile device -- Orthopedic
Arthroscope. Catalog No 225304, Recall # Z-1681-2008;
v) Stryker Oscillating & Sagittal Blade - Reprocessed Sterile device -- Powered Saw
and Accessories. Catalog No 2296-3-114, Recall # Z-1682-2008;
w) Infant 02 Transducer (Nellcor) - Reprocessed Sterile device -- Pulse Oximeter.
Catalog No I-20, Recall # Z-1683-2008
CODE
a) Lot # 135736;
b) Lot # 115010;
c) Lot # 118141, 139207, and 135902;
d) Lot # 118668, 140345, 144466, 148710, 149790, and 149925;
e) Lot # 130849;
f) Lot # 135657, 135889, 136197, and 136402;
g) Lot # 135978;
h) Lot # 135982;
i) Lot # 135992;
j) Lot #136025;
k) Lot # 136178;
l) Lot # 136357;
m) Lot # 136548;
n) Lot #137656;
o) Lot #145046;
p) Lot #147056;
q) Lot #152838;
r) Lot #135905;
s) Lot #114986;
t) Lot #136023;
u) Lot #136027;
v) Lot #152840;
w) Lot #135254
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ascent Healthcare Solutions, Inc., Lakeland, FL, by letter on March 11, 2008.
Manufacturer: Venice International, Orlando, FL. Firm initiated recall is ongoing.
REASON
Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety products.
VOLUME OF PRODUCT IN COMMERCE
8,306 devices
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
GE Healthcare Proteus XR/a Eclipse Collimator model # 2379827, Recall # Z-1713-2008
CODE
Units: 42948HL0, 42949HL8, 43054HL6, 43055HL3, 43056HL1, 43057HL9, 43132HL0, 43133HL8, 43134HL6, 43135HL3, 43201HL3, 43202HL1, 43203HL9, 44605HL4, 44606HL2, 44607HL0, 44608HL8, 44609HL6, 44610HL4, 44681HL5, 45046HL0, 45047HL8, 45048HL6, 45128HL6, 45129HL4, 45130HL2, 45131HL0, 48119HL2, 48120HL0, 48121HL8, 48122HL6, 48123HL4, 48124HL2, 48125HL9, 48126HL7, 48127HL5, 48128HL3, 48164HL8, 48181HL2, 48274HL5, 48276HL0, 48277HL8, 48278HL6, 48680HL3, 48682HL9, 48683HL7, 48684HL5, 48685HL2, 48686HL0, 48687HL8, 48688HL6, 48689HL4, 48876HL7, 48877HL5, 48878HL3, 48995HL3, 48997HL1, 48998HL9, 49000HL3, 49208HL2, 49209HL0, 49210HL8, 49211HL6, 49391HL6, 49392HL4, 49393HL2, 49395HL7, 49494HL8, 49496HL3, 49497HL1, 49498HL9, 49499HL7, 49500HL2, 49501HL0, 49502HL8, 49503HL6, 49681HL0, 49682HL8, 49683HL6, 49684HL4, 49685HL1, 49686HL9, 49687HL7, 49688HL5, 49850HL1, 49851HL9, 49852HL7, 49853HL5, 49855HL0, 49856HL8, 49857HL6, 50027HL2, 50028HL0, 50029HL8, 50030HL6, 50031HL4, 50177HL5, 50178HL3, 50179HL1, 50180HL9, 50321HL9, 50322HL7, 50323HL5, 50324HL3, 50444HL9, 50445HL6, 50446HL4, 50447HL2, 50448HL0, 50449HL8, 50450HL6, 50451HL4, 50452HL2, 50453HL0, 50790HL5, 50791HL3, 50792HL1, 50793HL9, 50794HL9, 50795HL4, 50797HL0, 50798HL8, 50801HL0, 51143HL6, 51144HL4, 51145HL1, 51147HL7, 51486HL9, 51487HL7, 51488HL5, 52014HL8, and 70RD05001
RECALLING FIRM/MANUFACTURER
GE Healthcare, Waukesha, WI, by visit beginning March 29, 2007. Firm initiated recall is complete.
REASON
The actual average illuminance for the collimators are approximately 140-lux. This does not meet the 160-lux requirement. GE will be correcting the units by replacing all collimators.
VOLUME OF PRODUCT IN COMMERCE
132 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
GE Datex-Ohmeda Engstrom Carestation. The Carestation consists of three main components: a display, a ventilator unit, and an optional module bay. The display allows the user to interface with the system and control settings. The ventilator unit controls electrical power, nebulization, and pneumatic gas flow to and from the patient. The module bay allows the integration of various patient monitoring modules with the ventilator. This issue affects all of the Engström Carestations shipped between 12/4/2006 and 9/4/2007, encompassed by serial numbers CBCK00464 through CBCL01134, Recall # Z-1829-2008
CODE
Serial Number CBCL01134 CBCL01133 CBCL01128 CBCL01089 CBCL01087 CBCL01084 CBCL01075 CBCL01072 CBCL01070 CBCL01068 CBCL01067 CBCL01051 CBCL01050 CBCL01022 CBCL01021- CBCL01019 CBCL01018 CBCL01015 CBCL01012 CBCL01011 CBCL01010 CBCL01009 CBCL01008 CBCL01007 CBCL01000 CBCL00998 CBCL00997 CBCL00996 CBCL00995 CBCL00994 CBCL00993 CBCL00985 CBCL00984 CBCL00983 CBCL00978 CBCL00975 CBCL00974 CBCL00973 CBCL00972 CBCL00971 CBCL00968 CBCL00967 CBCL00966 CBCL00965 CBCL00964 CBCL00963 CBCL00962 CBCL00959 CBCL00958 CBCL00957 CBCL00956 CBCL00955 CBCL00954 CBCL00953 CBCL00952 CBCL00951 CBCL00950 CBCL00949 CBCL00948 CBCL00947 CBCL00946 CBCL00945 CBCL00944 CBCL00943 CBCL00942 CBCL00941 CBCL00940 CBCL00939 CBCL00938 CBCL00937 CBCL00936 CBCL00935 CBCL00934 CBCL00933 CBCL00932 CBCL00931 CBCL00930 CBCL00929 CBCL00928 CBCL00927 CBCL00926 CBCL00925 CBCL00924 CBCL00923 CBCL00922 CBCL00916 CBCL00915 CBCL00914 CBCL00913 CBCL00912 CBCL00911 CBCL00910 CBCL00909 CBCL00908 CBCL00907 CBCL00906 CBCL00905 CBCL00904 CBCL00903 CBCL00902 CBCL00901 CBCL00900 CBCL00899 CBCL00898 CBCL00897 CBCL00896 CBCL00895 CBCL00894 CBCL00893 CBCL00892 CBCL00891 CBCL00890 CBCL00889 CBCL00888 CBCL00887 CBCL00886 CBCL00885 CBCL00884 CBCL00883 CBCL00882 CBCL00881 CBCL00880 CBCL00879 CBCL00878 CBCL00877 CBCL00876 CBCL00875 CBCL00874 CBCL00873 CBCL00872 CBCL00871 CBCL00870 CBCL00869 CBCL00868 CBCL00867 CBCL00866 CBCL00865 CBCL00864 CBCL00863 CBCL00862 CBCL00861 CBCL00860 CBCL00859 CBCL00858 CBCL00857 CBCL00856 CBCL00855 CBCL00854 CBCL00853 CBCL00852 CBCL00851 CBCL00850 CBCL00849 CBCL00848 CBCL00847 CBCL00846 CBCL00845 CBCL00844 CBCL00843 CBCL00841 CBCL00840 CBCL00839 CBCL00837 CBCL00836 CBCL00835 CBCL00833 CBCL00832 CBCL00831 CBCL00830 CBCL00829 CBCL00828 CBCL00827 CBCL00826 CBCL00825 CBCL00824 CBCL00823 CBCL00821 CBCL00820 CBCL00818 CBCL00817 CBCL00816 CBCL00815 CBCL00814 CBCL00813 CBCL00812 CBCL00811 CBCL00810 CBCL00809 CBCL00808 CBCL00807 CBCL00806 CBCL00805 CBCL00804 CBCL00803 CBCL00802 CBCL00801 CBCL00800 CBCL00799 CBCL00798 CBCL00797 CBCL00796 CBCL00795 CBCL00794 CBCL00793 CBCL00792 CBCL00791 CBCL00790 CBCL00789 CBCL00788 CBCL00787 CBCL00786 CBCL00785 CBCL00784 CBCL00783 CBCL00782 CBCL00781 CBCL00780 CBCL00779 CBCL00778 CBCL00777 CBCL00776 CBCL00775 CBCL00774 CBCL00773 CBCL00772 CBCL00771 CBCL00770 CBCL00769 CBCL00768 CBCL00767 CBCL00766 CBCL00765 CBCL00764 CBCL00759 CBCL00758 CBCL00757 CBCL00756 CBCL00755 CBCL00754 CBCL00753 CBCL00752 CBCL00751 CBCL00750 CBCL00749 CBCL00748 CBCL00747 CBCL00746 CBCL00745 CBCL00744 CBCL00743 CBCL00742 CBCL00741 CBCL00740 CBCL00739 CBCL00738 CBCL00737 CBCL00736 CBCL00735 CBCL00734 CBCL00733 CBCL00732 CBCL00731 CBCL00730 CBCL00729 CBCL00728 CBCL00727 CBCL00726 CBCL00725 CBCL00724 CBCL00723 CBCL00722 CBCL00721 CBCL00720 CBCL00719 CBCL00718 CBCL00717 CBCL00716 CBCL00715 CBCL00714 CBCL00713 CBCL00712 CBCL00711 CBCL00710 CBCL00709 CBCL00708 CBCL00707 CBCL00706 CBCL00705 CBCL00704 CBCL00703 CBCL00702 CBCL00701 CBCL00700 CBCL00699 CBCL00698 CBCL00697 CBCL00696 CBCL00695 CBCL00694 CBCL00693 CBCL00692 CBCL00691 CBCL00690 CBCL00689 CBCL00688 CBCL00687 CBCL00684 CBCL00683 CBCL00682 CBCL00681 CBCL00680 CBCL00679 CBCL00678 CBCL00677 CBCL00676 CBCL00675 CBCL00674 CBCL00673 CBCL00672 CBCL00671 CBCL00670 CBCL00669 CBCL00668 CBCL00667 CBCL00666 CBCL00665 CBCL00664 CBCL00663 CBCL00662 CBCL00661 CBCL00660 CBCL00659 CBCL00658 CBCL00657 CBCL00656 CBCL00655 CBCL00654 CBCL00653 CBCL00652 CBCL00651 CBCL00650 CBCL00649 CBCL00648 CBCL00647 CBCL00646 CBCL00645 CBCL00644 CBCL00643 CBCL00642 CBCL00641 CBCL00640 CBCL00639 CBCL00638 CBCL00637 CBCL00636 CBCL00635 CBCL00634 CBCL00633 CBCL00632 CBCL00631* CBCL00630* CBCL00629* CBCL00628* CBCL00627* CBCL00626* CBCL00625* CBCL00624* CBCL00623 CBCL00622 CBCL00621 CBCL00620 CBCL00619 CBCL00618 CBCL00617 CBCL00616 CBCL00615 CBCL00614 CBCL00613 CBCL00612 CBCL00611 CBCL00610 CBCL00609 CBCL00608 CBCL00607 CBCL00606 CBCL00605 CBCL00604 CBCL00603 CBCL00602 CBCL00600 CBCL00599 CBCL00598 CBCL00597 CBCL00596 CBCL00595 CBCL00594 CBCL00593 CBCL00592 CBCL00591 CBCL00590 CBCL00589 CBCL00588 CBCL00587 CBCL00586 CBCL00585 CBCL00584 CBCL00583 CBCL00582 CBCL00581 CBCL00580 CBCL00579 CBCL00578 CBCL00577 CBCL00576 CBCL00575 CBCL00574 CBCL00573 CBCL00572 CBCL00571 CBCL00570 CBCL00569 CBCL00568 CBCL00567 CBCL00566 CBCL00565 CBCL00564 CBCL00563 CBCL00562 CBCL00561 CBCL00560 CBCL00559 CBCL00558 CBCL00557 CBCL00556 CBCL00555 CBCL00554 CBCL00553 CBCL00552 CBCL00551 CBCL00550 CBCL00549 CBCL00548 CBCL00547 CBCL00546 CBCL00545 CBCL00544 CBCL00543 CBCL00542 CBCL00541 CBCL00540 CBCL00539 CBCL00538 CBCL00537 CBCL00536 CBCL00535 CBCL00534 CBCL00533 CBCL00532 CBCL00531 CBCL00530 CBCL00529 CBCL00528 CBCL00527 CBCL00526 CBCL00525 CBCL00524 CBCL00523 CBCL00522 CBCL00521 CBCL00520 CBCL00519 CBCL00518 CBCL00517 CBCL00516 CBCL00515 CBCL00514 CBCL00513 CBCL00511 CBCL00510 CBCL00509 CBCL00508 CBCL00507 CBCL00506 CBCL00505 CBCL00503 CBCL00501 CBCL00500 CBCL00499 CBCL00498 CBCL00497 CBCL00496 CBCL00495 CBCL00494 CBCL00493 CBCL00492 CBCL00491 CBCL00490 CBCL00489 CBCL00488 CBCL00487 CBCL00486 CBCL00485 CBCL00484 CBCL00483 CBCL00482 CBCL00481 CBCL00480 CBCL00479 CBCL00478 CBCL00477 CBCL00476 CBCL00475 CBCL00474 CBCL00473 CBCL00472 CBCL00471 CBCL00470 CBCL00469 CBCL00468 CBCL00467 CBCL00466 CBCL00465 CBCL00464 CBCL00463 CBCL00462 CBCL00461 CBCL00460 CBCL00459 CBCL00458 CBCL00457 CBCL00456 CBCL00455 CBCL00454 CBCL00453 CBCL00452 CBCL00451 CBCL00450 CBCL00449 CBCL00448 CBCL00447 CBCL00446 CBCL00445 CBCL00444 CBCL00443 CBCL00442 CBCL00441 CBCL00440 CBCL00439 CBCL00438 CBCL00437 CBCL00436 CBCL00435 CBCL00434 CBCL00433 CBCL00432 CBCL00431 CBCL00430 CBCL00429 CBCL00428 CBCL00427 CBCL00426 CBCL00425 CBCL00424 CBCL00423 CBCL00422 CBCL00421 CBCL00420 CBCL00419 CBCL00418 CBCL00417 CBCL00416 CBCL00415 CBCL00414 CBCL00413 CBCL00412 CBCL00411 CBCL00410 CBCL00409 CBCL00408 CBCL00407 CBCL00406 CBCL00405 CBCL00404 CBCL00403 CBCL00402 CBCL00401 CBCL00400 CBCL00399 CBCL00398 CBCL00397 CBCL00396 CBCL00395 CBCL00394 CBCL00393 CBCL00392 CBCL00391 CBCL00390 CBCL00389- CBCL00388 CBCL00387- CBCL00386- CBCL00385 CBCL00384 CBCL00383 CBCL00382 CBCL00381 CBCL00380 CBCL00379 CBCL00378 CBCL00377 CBCL00376 CBCL00375 CBCL00374 CBCL00373 CBCL00372 CBCL00371 CBCL00370 CBCL00369 CBCL00368 CBCL00367 CBCL00366 CBCL00365 CBCL00364 CBCL00363 CBCL00362 CBCL00361 CBCL00360 CBCL00359 CBCL00358 CBCL00357 CBCL00356 CBCL00355 CBCL00354 CBCL00353 CBCL00352 CBCL00351 CBCL00350 CBCL00349 CBCL00348 CBCL00347 CBCL00346 CBCL00345 CBCL00344 CBCL00343 CBCL00342 CBCL00341 CBCL00340 CBCL00339 CBCL00338 CBCL00337 CBCL00336 CBCL00335 CBCL00334 CBCL00333 CBCL00332 CBCL00331 CBCL00330 CBCL00329 CBCL00328 CBCL00327 CBCL00326 CBCL00325 CBCL00324 CBCL00323 CBCL00322 CBCL00321 CBCL00320 CBCL00319 CBCL00318 CBCL00317 CBCL00316 CBCL00315 CBCL00314 CBCL00313 CBCL00312 CBCL00311 CBCL00310 CBCL00309 CBCL00308 CBCL00307 CBCL00306 CBCL00305 CBCL00304 CBCL00303 CBCL00302 CBCL00301 CBCL00300 CBCL00299 CBCL00298 CBCL00297 CBCL00296 CBCL00295 CBCL00294 CBCL00293 CBCL00292 CBCL00291 CBCL00290 CBCL00289 CBCL00288 CBCL00287 CBCL00286 CBCL00285 CBCL00284 CBCL00283 CBCL00282 CBCL00281 CBCL00280 CBCL00279 CBCL00278 CBCL00277 CBCL00276 CBCL00275 CBCL00274 CBCL00273 CBCL00272 CBCL00271 CBCL00270 CBCL00269 CBCL00268 CBCL00267 CBCL00266 CBCL00265 CBCL00264 CBCL00263 CBCL00262 CBCL00261 CBCL00260 CBCL00259 CBCL00258 CBCL00257 CBCL00256 CBCL00255 CBCL00253 CBCL00252 CBCL00251 CBCL00250 CBCL00249 CBCL00248 CBCL00247 CBCL00246 CBCL00245 CBCL00244 CBCL00243 CBCL00242 CBCL00241 CBCL00240 CBCL00239 CBCL00238 CBCL00237 CBCL00236 CBCL00235 CBCL00234 CBCL00233 CBCL00232 CBCL00231 CBCL00230 CBCL00229 CBCL00228 CBCL00227 CBCL00226 CBCL00225 CBCL00224 CBCL00223 CBCL00222 CBCL00221 CBCL00220 CBCL00219 CBCL00218 CBCL00217 CBCL00216 CBCL00215 CBCL00214 CBCL00213 CBCL00212 CBCL00211 CBCL00210 CBCL00209 CBCL00208 CBCL00207 CBCL00206 CBCL00205 CBCL00204 CBCL00203 CBCL00202 CBCL00201 CBCL00200 CBCL00199 CBCL00198 CBCL00197 CBCL00196 CBCL00195 CBCL00194 CBCL00193 CBCL00192 CBCL00191 CBCL00190 CBCL00189 CBCL00188 CBCL00187 CBCL00186 CBCL00185 CBCL00184 CBCL00183 CBCL00182 CBCL00181 CBCL00180 CBCL00179 CBCL00178 CBCL00177 CBCL00175 CBCL00174 CBCL00172 CBCL00171 CBCL00170 CBCL00169 CBCL00168 CBCL00167 CBCL00166 CBCL00164 CBCL00163 CBCL00162 CBCL00161 CBCL00160 CBCL00159 CBCL00158 CBCL00157 CBCL00156 CBCL00155 CBCL00154 CBCL00153 CBCL00152 CBCL00151 CBCL00150 CBCL00149 CBCL00148 CBCL00147 CBCL00146 CBCL00145 CBCL00144 CBCL00143 CBCL00142 CBCL00141 CBCL00140 CBCL00139 CBCL00138 CBCL00137 CBCL00136 CBCL00135 CBCL00133 CBCL00132 CBCL00131 CBCL00130 CBCL00129 CBCL00128 CBCL00127 CBCL00126 CBCL00125 CBCL00124 CBCL00123 CBCL00122 CBCL00121 CBCL00120 CBCL00119 CBCL00118 CBCL00117 CBCL00116 CBCL00115 CBCL00114 CBCL00113 CBCL00112 CBCL00111 CBCL00110 CBCL00108 CBCL00107 CBCL00106 CBCL00105 CBCL00104 CBCL00103 CBCL00102 CBCL00101 CBCL00100 CBCK00883 CBCK00882 CBCK00881 CBCK00880 CBCK00879 CBCK00878 CBCK00877 CBCK00876 CBCK00875 CBCK00874 CBCK00873 CBCK00872 CBCK00871 CBCK00870 CBCK00869 CBCK00868 CBCK00867 CBCK00866 CBCK00865 CBCK00864 CBCK00863 CBCK00862 CBCK00861 CBCK00860 CBCK00859 CBCK00858 CBCK00857 CBCK00856 CBCK00855 CBCK00854 CBCK00853 CBCK00852 CBCK00851 CBCK00850 CBCK00849 CBCK00848 CBCK00847 CBCK00846 CBCK00845 CBCK00844 CBCK00843 CBCK00842 CBCK00841 CBCK00840 CBCK00839 CBCK00838 CBCK00837 CBCK00836 CBCK00835 CBCK00834 CBCK00833 CBCK00832 CBCK00831 CBCK00830 CBCK00829 CBCK00828 CBCK00827 CBCK00826 CBCK00825 CBCK00824 CBCK00823 CBCK00822 CBCK00821 CBCK00820 CBCK00819 CBCK00818 CBCK00817 CBCK00816 CBCK00815 CBCK00814 CBCK00813 CBCK00812 CBCK00811 CBCK00810 CBCK00809 CBCK00808 CBCK00807 CBCK00806 CBCK00805 CBCK00803 CBCK00802 CBCK00801 CBCK00800 CBCK00799 CBCK00798 CBCK00797 CBCK00796 CBCK00795 CBCK00794 CBCK00793 CBCK00792 CBCK00791 CBCK00790 CBCK00789 CBCK00788 CBCK00787 CBCK00786 CBCK00785 CBCK00784 CBCK00783 CBCK00782 CBCK00781 CBCK00780 CBCK00779 CBCK00778 CBCK00777 CBCK00776 CBCK00775 CBCK00774 CBCK00773 CBCK00772 CBCK00771 CBCK00770 CBCK00769 CBCK00768 CBCK00767 CBCK00766 CBCK00765 CBCK00764 CBCK00763 CBCK00762 CBCK00761 CBCK00760 CBCK00759 CBCK00758 CBCK00757 CBCK00756 CBCK00755 CBCK00754 CBCK00753 CBCK00752 CBCK00751 CBCK00750 CBCK00749 CBCK00745 CBCK00744 CBCK00743 CBCK00742 CBCK00741 CBCK00740 CBCK00739 CBCK00738* CBCK00737 CBCK00736 CBCK00735 CBCK00734 CBCK00733 CBCK00732 CBCK00730 CBCK00729* CBCK00728 CBCK00727 CBCK00725 CBCK00724 CBCK00723 CBCK00722 CBCK00721 CBCK00720 CBCK00719 CBCK00718 CBCK00717 CBCK00716 CBCK00715 CBCK00714 CBCK00713 CBCK00712 CBCK00711 CBCK00710 CBCK00709 CBCK00708 CBCK00707 CBCK00706 CBCK00705 CBCK00704 CBCK00703 CBCK00702 CBCK00701 CBCK00700 CBCK00699 CBCK00698 CBCK00697 CBCK00696 CBCK00695 CBCK00694 CBCK00693 CBCK00692 CBCK00691 CBCK00690 CBCK00689 CBCK00688 CBCK00687 CBCK00686 CBCK00685 CBCK00684 CBCK00683 CBCK00682 CBCK00681 CBCK00680 CBCK00679 CBCK00678 CBCK00677 CBCK00676 CBCK00675 CBCK00674 CBCK00673 CBCK00672 CBCK00671 CBCK00670 CBCK00669 CBCK00668 CBCK00666 CBCK00665 CBCK00664 CBCK00663 CBCK00662 CBCK00661 CBCK00660 CBCK00659 CBCK00658 CBCK00657 CBCK00656 CBCK00655 CBCK00654 CBCK00653 CBCK00652 CBCK00651 CBCK00650 CBCK00649 CBCK00648 CBCK00647 CBCK00642 CBCK00626 CBCK00614 CBCK00613 CBCK00612 CBCK00611 CBCK00560 CBCK00559 CBCK00558 CBCK00557 CBCK00556 CBCK00555 CBCK00554 CBCK00552 CBCK00551 CBCK00550 CBCK00469 and CBCK00464
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI, by letter on May 12, 2008.
Manufacturer: Datex – Ohmeda, Inc., Madison, WI. Firm initiated recall is ongoing.
REASON
There is a correction associated with Engstrom Carestation with an integrated Aerogen Professional Nebulizer System. There is an issue relating to the removal of the nebulizer cable from nebulizer connection port, which, when done while the nebulizer is active, may result in the discontinuance of mechanical ventilation.
VOLUME OF PRODUCT IN COMMERCE
1,130 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Gambro Cartridge Blood Set, 003410-510, is intended for single use in a hemodialysis
treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems, Z-1860-
2008;
b) Gambro Cartridge Blood Set, 0141080XXXC, is intended for single use in a
hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery
Systems, Recall # Z-1861-2008
CODE
a) Serial numbers: 04P158215 and below, 03P158XXX (all lots);
b) Serial numbers: 0XP15XXXX (all lots)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gambro Renal Products, Inc., Lakewood, CO, by letter on May 2, 2008 and May 27, 2008.
Manufacturer: Gambro Renal Products S.A. de C.V., Tijuana, B.C. Mexico. Firm initiated recall is ongoing.
REASON
Dialysis tubing sets may have occlusions restricting blood flow.
VOLUME OF PRODUCT IN COMMERCE
1,500,000 sets
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Hawkins III Breast Localization Needle. Product # 243075. The product is used in the marking of non-palpable lesions, Recall # Z-1878-2008
CODE
Lot # 80281L5V
RECALLING FIRM/MANUFACTURER
Medical Device Technologies, Inc., Gainesville, FL, by letter on May 6, 2008. Firm initiated recall is ongoing.
REASON
The sterility of the product cannot be guaranteed.
VOLUME OF PRODUCT IN COMMERCE
490 units
DISTRIBUTION
Nationwide and Mexico
___________________________________
PRODUCT
GE Healthcare Definium 8000 Digital Radiographic System, model number 5135678. The intended use of this product is to generate tomographic images of human anatomy, Recall # Z-1883-2008
CODE
Serial numbers: 0000000002772E, 00000001191M36, 00000001561M30, 00000001895M32, 00000002041M32, 00000002047M39, 00000002051M31, 00000002052M39, 00000002065M31, 00000002364M38, 00000002439M38, 00000002441M34, 00000002650M30, 00000002767EN2, 00000002771M34, 00000002965M32, 00000002968M36, 00000003468M36, 00000003505M35, 00000003506M33, 00000003806M37, 00000004101M32, 00000004105M33, 00000004199M36, 00000004442M30, 00000004547M36, 00000005052M36, 00000005487M34, 00000096383DP5, 00000096401DP5, 00000096986DP%, 00000097412DP1, 00000097656DP3, 00000097918DP7, 00000100740WK6, 00000114134VE0, 00000114148VE0, 00000114297VE5, 00000114452VE6, 00000TA41711-6, 00000TA41732-3, 00000TA41827-4, 00000TA41867-8, 00000TA41882-7, 00000TA41896Ë4, 00000TA41972-3, 00000TA41984-4, 00000TA41984-6, 00000TA41995-7, 00000TA42004Ë5, 00000TA42007-4, 00000TA42020-3, 00000TA42025Ë4, 00000TA42184-1, 00000TA42274-8, 00000TA42869-6, 00001003925WK3, 00001003974WK1, 00001004022WK8, 00001004138WK2, 00001004163WK0, 00001004319WK8, 00001004330WK5, 00001004331WK3, 00001004332WK1, 00001004504WK5, 00001004505WK2, 00001004507WK8, 00001004508WK6, 00001004509WK4, 00001004510WK2, 00001004512WK8, 00001004513WK6, 00001004763WK7, 00001004764WK5, 00001004765WK2, 00001004766WK0, 00001004767WK8, 00001004768WK6, 00001004769WK4, 00001004770WK2, 00001004771WK0, 00001004772WK8, 00001005016WK9, 00001005017WK7, 00001005018WK5, 00001005019WK3, 00001005020WK1, 00001005021WK9, 00001005022WK7, 00001005023WK5, 00001005024WK3, 00001005025WK0, 00001005026WK8, 00001005027WK6, 00001005029WK2, 00001005030WK0, 00001005031WK8, 00001005032WK6, 00001005033WK4, 00001005034WK2, 00001005035WK9, 00001005179WK5, 00001005180WK3, 00001005181WK1, 00001005182WK9, 00001005183WK7, 00001005184WK5, 00001005185WK2, 00001005186WK0, 00001005187WK8, 00001005188WK6, 00001005260WK3, 00001005319WK7, 00001005339WK5, 00001005669WK5, 00001005698WK4, 00001005699WK2, 00001005700WK8, 00001005701WK6, 00001005702WK4, 00001005705WK7, 00001005706WK5, 00001005707WK3, 00001005755WK2, 00001005757WK8, 00001005758WK6, 00001005759WK4, 00001005760WK2, 00001005761WK0, 00001005762WK8, 00001005763WK6, 00001005764WK4, 00001005841WK0, 00001005911WK1, 00001005912WK9, 00001005913WK7, 00001005914WK5, 00001005915WK2, 00001006015WK0, 00001006040WK8, 00001006041WK6, 00001006042WK4, 00001006043WK2, 00001006044WK0, 00001006177WK8, 00001006178WK6, 00001006179WK4, 00001006469WK9, 00001006470WK7, 00001006471WK5, 00001006474WK9, 00001006475WK6, 00001006476WK4, 00001006477WK2, 00001006478WK0, 00001006631WK4, 00001006633WK0, 00001006634WK8, 00001006635WK5, 00001006636WK3, 00001006637WK1, 00001006638WK9, 00001006664WK5, 00001006665WK2, 00001006666WK0, 00001006667WK8, 00001006668WK6, 00001006822WK9, 00001006833WK6, 00001006834WK4, 00001006871WK6, 00001006872WK4, 00001006873WK2, 00001006874WK0, 00001006875WK7, 00001006876WK5, 00001006877WK3, 00001006878WK1, 00001006880WK7, 00001007160WK3, 00001007161WK1, 00001007162WK9, 00001007163WK7, 00001007164WK5, 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RECALLING FIRM/MANUFACTURER
GE Healthcare, Waukesha, WI, by visit beginning January 1, 2008. Firm initiated recall is ongoing.
REASON
Not properly labeling the manual switch for disabling positive beam limitation (PBL) located on the overhead tube support user interface as required.
VOLUME OF PRODUCT IN COMMERCE
668 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) GE OEC 9800 Fluoroscopic X-Ray System. The intended use of this device is to
perform mobile fluoroscopic examination of human anatomy, Recall # Z-1884-2008;
b) GE OEC 9900 Elite Fluoroscopic X-Ray System. The intended use of this device is to
perform mobile fluoroscopic examination of human anatomy, Recall # Z-1885-2008
CODE
a) Serial Numbers: 82-2965, 82-3366, 82-3403, 82-3563, 82-3570, 82-3614, 82-3634, 82-3815, 82-3839, 82-3851, 82-3882, 82-3884, 82-3887, 82-3888, 82-3890, 82-3894, 82-3895, 82-3896, 82-3898, 82-3899, 82-3901, 82-3903, 82-3904, 82-3910, 82-3911, 82-3912, 82-3913, 82-3914, 82-3915, 82-3917, 82-3919, 82-3920, 82-3921, 82-3922, 82-3923, 82-3925, 82-3928, 82-3929, 82-3930, 82-3931, 82-3933, 82-3934, 82-3935, 82-3936, 82-3937, 82-3938, 82-3939, 82-3941, 82-3942, 82-3943, 82-7154-CMH, 82-7189-MH, 82-7190-MH, 82-7191-MH, 82-7197-MH, 82-7200, 82-7206, 89-3211, 89-3355, 89-3420, 89-3461, 89-3479, 89-3483, 89-3488, 89-3490, 89-3494, 89-3495, 89-3499, 89-3501, 89-3504, 89-3508, 89-3509, 89-3511, 89-3512, 89-3513, 89-3514, 89-3515, 89-3519, 89-3520, 89-3522, 89-3524, 89-3527, 89-3529, 89-3530, 89-3533, 89-3537, 89-3538, 89-3539, 89-3543, 89-3544, 89-3545, 89-3546, 89-3547, 89-89-3549, 89-3551, 89-3552, 89-3553, 89-3554, 89-3555, 89-3556, 89-3557, 89-3558, 89-3559, 89-3560, 89-3561, 89-3562, 89-3563, 89-3564, 89-3565, 89-3567, 89-3568, 89-3569, 89-3570, 89-3571, 89-3572, 89-3573, 89-3574, 89-3578, 89-3579, 8S-1474-C, 8S-2329, 8S-2462, 8S-2532, 8S-2985, 8S-3111, 8S-3112, 8S-3179, 8S-3183, 8S-3197, 8S-3205, 8S-3207, 8S-3211-CH, 8S-3216, 8S-3222, 8S-3231, 8S-3233, 8S-3243, 8S-3245, 8S-3246, 8S-3247, 8S-3248, 8S-3249, 8S-3253, 8S-3254, 8S-3255, 8S-3256, 8S-3257, 8S-3258, 8S-3259, 8S-3260, 8S-3261, 8S-3262, 8S-3263, 8S-3264, 8S-3265, 8S-3266, 8S-3267, 8S-3268, 8S-3269-H, 8S-3270-H, 8S-3271-H, 8S-3272-H, 8S-3273-CH, 8S-3274-CH, 8S-3275, 8S-3276, 8S-3278, 8S-3279, 8S-3280, 8S-3281, 8S-3282, 8S-3283, 8S-3285, 8S-3286, 8S-3287, 8S-3288-H, 8S-3289-H, 8S-3291, 8S-3292, 8S-3296, 8S-3299, 8S-3301-H, 8S-3302, 8S-3305, 8S-3306, 8S-3307, 8S-3308, 8S-3309, 8S-3310-H, 8S-3311, 8S-3315, 8S-7094-CMH, 8S-7228-CMH, 8S-7229-CMH, 8S-7230-CMH, 8S-7231-MH, 8S-7232-MH, and 8S-7233-MH;
b) Serial Numbers: E2-0001, E2-0015, E2-0026, E2-0028, E2-0084, E2-0108, E2-0111, E2-0117, E2-0120, E2-0122, E2-0130, E2-0143, E2-0148, E2-0151, E2-0152, E2-0153, E2-0154, E2-0155, E2-0156, E2-0157, E2-0158, E2-0159, E2-0160, E2-0161, E2-0162, E2-0163, E2-0164, E2-0165, E2-0167, E2-0168, E2-0169, E2-0171, E2-0172, E2-0173, E2-0174, E2-0175, E2-0176, E2-0177, E2-0178, E2-0179, E2-0180, E2-0181, E2-0182, E2-0183, E2-0184, E2-0185, E2-0186, E2-0187, E2-0188, E2-0189, E2-0190, E2-0191, E2-0192, E2-0193, E2-0194, E2-0195, E2-0196, E2-0197, E2-0198, E2-0199, E2-0200, E2-0201, E2-0202, E2-0203, E2-0204, E2-0205, E2-0206, E2-0207, E2-0208, E2-0209, E2-0210, E2-0211, E2-0212, E2-0213, E2-0215, E2-0217, E2-0222, E2-0224, E2-0225, E2-0230, E2-0231, E2-0232, E2-0233, E2-0234, E2-0235-C, E2-0237, E2-0238, E2-0239, E2-0240, E2-0241, E2-0242, E2-0243, E2-0244, E2-0245, E2-0246, E2-0247, E2-0248, E2-0250, E2-0251, E2-0252, E2-0253, E2-0254, E2-0255, E2-0256, E2-0257, E2-0258, E2-0259, E2-0260, E2-0261, E2-0262, E2-0263, E2-0264, E2-0265, E2-0266, E2-0267, E2-0268, E2-0269, E2-0270, E2-0271, E2-0272, E2-0273, E2-0274, E2-0275, E2-7014-MH, E2-7020-MH, E2-7048-MH, E2-7050-MH, E2-7051-MH, E2-7057-MH, E2-7058-MH, E2-7059-MH, E2-7060-MH, E2-7061-MH, E2-7062-MH, E2-7063-MH, E2-7064-MH, E2-7065-MH, E2-7066-MH, E2-7067-MH, E2-7068-MH, E2-7069-CMH, E2-7070-MH, E2-7071-MH, E2-7072-MH, E2-7074-MH, E2-7075-MH, E2-7076-MH, E2-7077-CMH, E2-7078-MH, E2-7079-MH, E9-0025, E9-0031, E9-0037, E9-0050, E9-0083, E9-0085, E9-0086, E9-0088, E9-0089-G, E9-0090, E9-0091, E9-0092, E9-0093, E9-0094, E9-0095, E9-0098, E9-0099, E9-0100, E9-0101, E9-0102, E9-0103, E9-0108, E9-0109, E9-0110, E9-0111, E9-0112, E9-0113, E9-0114, E9-0115, E9-0116, E9-0118, E9-0119, E9-0120, E9-0121, E9-0122, E9-0123, E9-0124, E9-0125, E9-0126, E9-0127, E9-0128, E9-0129, E9-0130, E9-0139, E9-0141, E9-0142, E9-0143, E9-0144, E9-0145, E9-0146, E9-0147, E9-0148, E9-0149, E9-0150, E9-0151, E9-0152, E9-0153, E9-0155, E9-0157, E9-0158, E9-0159, E9-0162, E9-0163, E9-0164, E9-0165, E9-0166, E9-0169, E9-0170, E9-0171, E9-0172, E9-0173, E9-0177, E9-0178, E9-0179, E9-0180, E9-0181, E9-0183, E9-0184, E9-0185, E9-0188, E9-0249, E9-0253, ES-0005, ES-0006, ES-0007-C, ES-0022-CH, ES-0029-CH, ES-0056, ES-0069, ES-0071, ES-0072, ES-0078, ES-0084-G, ES-0086-G, ES-0087, ES-0088, ES-0089, ES-0090, ES-0091-H, ES-0092-CH, ES-0096, ES-0097, ES-0098, ES-0099-CH, ES-0101-CH, ES-0102-CH, ES-0103, ES-0104, ES-0105, ES-0106, ES-0107, ES-0108, ES-0109, ES-0110, ES-0111, ES-0112, ES-0113, ES-0114, ES-0115, ES-0116, ES-0117, ES-0118, ES-0119, ES-0120, ES-0121, ES-0122, ES-0123, ES-0124, ES-0125, ES-0126, ES-0127, ES-0128, ES-0129, ES-0130, ES-0131-H, ES-0132, ES-0133, ES-0134, ES-0135, ES-0136, ES-0138, ES-0139, ES-0140, ES-0141, ES-0142, ES-0147, ES-0155-H, ES-0156, ES-0158, ES-0159, ES-0160, ES-0163-G, ES-0169-CH, ES-0170, ES-0171, ES-0172, ES-0176, ES-0178, ES-0180, ES-0181, ES-0182, ES-0184-CH, ES-0185-H, ES-0186-H, ES-0187-H, ES-0190-CH, ES-0191-H, ES-0192-H, ES-7010-CMH, ES-7015-MH, ES-7018-MH, ES-7021-MH, ES-7028-CMH, ES-7029-MH, ES-7030-CMH, ES-7031-CMH, ES-7033-CMH, ES-7034-CMH, ES-7035-CMH, ES-7036-CMH, ES-7037-CMH, and ES-7039-MH
RECALLING FIRM/MANUFACTURER
OEC Medical Systems, Inc., Salt Lake City, UT, by letter on August 12, 2008. Firm initiated recall is ongoing.
REASON
Beam limitation may be non-compliant on some X-ray units.
VOLUME OF PRODUCT IN COMMERCE
536 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Model 2000 CMS/ Model 2000 Plus Ambulatory Infusion Pump, Model Number:
340-1001, Recall # Z-1896-2008;
b) Model 4000 Plus Ambulatory Infusion Pump, Model Number: 350-1001, Recall # Z-
1897-2008;
c) Model 4000 CMS Ambulatory Infusion Pump, Model Number: 350-1101, Recall # Z-
1898-2008;
d) Model 6000 CMS, CMS IOD, or Plus Ambulatory Infusion Pump, Model Number:
360-1101, Recall # Z-1899-2008;
e) PainSmart, PainSmart IOD Ambulatory Infusion System, Model Number: 360-1301;
Recall # Z-1900-2008
CODE
Serial Numbers for all affected units: 100074 to 210458
RECALLING FIRM/MANUFACTURER
Curlin Medical Llc, Huntington Beach, CA, by letter on May 30, 2008. Firm initiated recall is ongoing.
REASON
Over-delivery/free-flow involving Curlin ambulatory peristaltic multi-therapy infusion pumps where the pumping chamber door (platen) had become deformed in a manner that permitted gravity flow.
VOLUME OF PRODUCT IN COMMERCE
39,366 units
DISTRIBUTION
Nationwide, Australia, Croatia, Germany, Italy, New Zealand, and South Africa
___________________________________
PRODUCT
1) Margron DTC Hip Replacement System; Margron hip - Femoral neck Y, sterile;
REF 1-746-000. Product is used for Orthopedic surgery, Recall # Z-1931-2008;
2) Margron DTC Hip Replacement System; Margron hip - Femoral neck Z, sterile;
REF 1-747-000. Product is used for Orthopedic surgery, Recall # Z-1932-2008;
3) Margron DTC Hip Replacement System; Margron hip - Femoral neck AZ, sterile;
REF 1-750-000. Product is used for Orthopedic surgery, Recall # Z-1933-2008;
4) Margron DTC Hip Replacement System; Margron hip - Femoral neck A, sterile;
REF 1-654-000. Product is used for Orthopedic surgery, Recall # Z-1934-2008;
5) Margron DTC Hip Replacement System; Margron hip - Femoral neck B, sterile;
REF 1-656-000. Product is used for Orthopedic surgery, Recall # Z-1935-2008;
6) Margron DTC Hip Replacement System; Margron hip - Femoral neck C, sterile;
REF 1-658-000. Product is used for Orthopedic surgery, Recall # Z-1936-2008;
7) Margron DTC Hip Replacement System; Margron hip - Femoral neck CB+6, sterile;
REF 1-685-000. Product is used for Orthopedic surgery, Recall # Z-1937-2008;
8) Margron DTC Hip Replacement System; Margron hip - Femoral neck B-A, sterile;
REF 1-686-000. Product is used for Orthopedic surgery, Recall # Z-1938-2008;
9) Margron DTC Hip Replacement System; Margron hip - Femoral neck C-A, sterile;
REF 1-687-000. Product is used for Orthopedic surgery, Recall # Z-1939-2008;
10) Margron DTC Hip Replacement System; Margron hip - Femoral neck C-B, sterile;
REF 1-688-000. Product is used for Orthopedic surgery, Recall # Z-1940-2008;
11) Margron DTC Hip Replacement System; Margron hip - Femoral neck B+4, sterile;
REF 1-689-000. Product is used for Orthopedic surgery, Recall # Z-1941-2008;
12) Margron DTC Hip Replacement System; Margron hip - Femoral neck C+6, sterile;
REF 1-690-000. Product is used for Orthopedic surgery, Recall # Z-1942-2008;
13) Margron DTC Hip Replacement System; Margron hip - Femoral stem Y+0, sterile;
REF 1-726-000. Product is used for Orthopedic surgery, Recall # Z-1943-2008;
14) Margron DTC Hip Replacement System; Margron hip - Femoral stem Z+0, sterile;
REF 1-727-000. Product is used for Orthopedic surgery, Recall # Z-1944-2008;
15) Margron DTC Hip Replacement System; Margron hip - Femoral stem 1+0, sterile;
REF 1-647-000. Product is used for Orthopedic surgery, Recall # Z-1945-2008;
16) Margron DTC Hip Replacement System; Margron hip - Femoral stem 2+0, sterile;
REF 1-648-000. Product is used for Orthopedic surgery, Recall # Z-1946-2008;
17) Margron DTC Hip Replacement System; Margron hip - Femoral stem 3+0, sterile;
REF 1-649-000. Product is used for Orthopedic surgery, Recall # Z-1947-2008;
18) Margron DTC Hip Replacement System; Margron hip - Femoral stem 4+0, sterile;
REF 1-650-000. Product is used for Orthopedic surgery, Recall # Z-1948-2008;
19) Margron DTC Hip Replacement System; Margron hip - Femoral stem 5+0, sterile;
REF 1-651-000. Product is used for Orthopedic surgery, Recall # Z-1949-2008;
20) Margron DTC Hip Replacement System; Margron hip - Femoral stem 6+0, sterile;
REF 1-652-000. Product is used for Orthopedic surgery, Recall # Z-1950-2008;
21) Margron DTC Hip Replacement System; Margron hip - Femoral stem Y+1, sterile;
REF 1-730-061. Product is used for Orthopedic surgery, Recall # Z-1951-2008;
22) Margron DTC Hip Replacement System; Margron hip - Femoral stem Y+2, sterile;
REF 1-730-062. Product is used for Orthopedic surgery, Recall # Z-1952-2008;
23) Margron DTC Hip Replacement System; Margron hip - Femoral stem Z+1, sterile;
REF 1-730-071. Product is used for Orthopedic surgery, Recall # Z-1953-2008;
24) Margron DTC Hip Replacement System; Margron hip - Femoral stem Z+2, sterile;
REF 1-730-072. Product is used for Orthopedic surgery, Recall # Z-1954-2008;
25) Margron DTC Hip Replacement System; Margron hip - Femoral stem 1+1, sterile;
REF 2-662-011. Product is used for Orthopedic surgery, Recall # Z-1955-2008;
26) Margron DTC Hip Replacement System; Margron hip - Femoral stem 1+2, sterile,
REF 2-662-012. Product is used for Orthopedic surgery, Recall # Z-1956-2008;
27) Margron DTC Hip Replacement System; Margron hip - Femoral stem 2+1, sterile;
REF 2-662-021. Product is used for Orthopedic surgery, Recall # Z-1957-2008;
28) Margron DTC Hip Replacement System; Margron hip - Femoral stem 2+2, sterile,
REF 2-662-022. Product is used for Orthopedic surgery, Recall # Z-1958-2008;
29) Margron DTC Hip Replacement System; Margron hip - Femoral stem 3+1, sterile;
REF 2-662-031. Product is used for Orthopedic surgery, Recall # Z-1959-2008;
30) Margron DTC Hip Replacement System; Margron hip - Femoral stem 3+2, sterile;
REF 2-662-032. Product is used for Orthopedic surgery, Recall # Z-1960-2008;
31) Margron DTC Hip Replacement System; Margron hip - Femoral stem 4+1, sterile;
REF 2-662-041. Product is used for Orthopedic surgery, Recall # Z-1961-2008;
32) Margron DTC Hip Replacement System; Margron hip - Femoral stem 4+2, sterile;
REF 2-662-042. Product is used for Orthopedic surgery, Recall # Z-1962-2008;
33) Margron DTC Hip Replacement System; Margron hip - Femoral stem 5+1, sterile;
REF 2-662-051. Product is used for Orthopedic surgery, Recall # Z-1963-2008;
34) Margron DTC Hip Replacement System; Margron hip - Femoral stem 5+2, sterile;
REF 2-662-052. Product is used for Orthopedic surgery, Recall # Z-1964-2008;
35) Margron DTC Hip Replacement System; Margron hip - Femoral stem 6+1, sterile;
REF 2-662-061. Product is used for Orthopedic surgery, Recall # Z-1965-2008;
36) Margron DTC Hip Replacement System; Margron hip - Femoral stem 6+2, sterile;
REF 2-662-062. Product is used for Orthopedic surgery, Recall # Z-1966-2008;
37) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture
holes Y+3, sterile; REF 1-730-963. Product is used for Orthopedic surgery,
Recall # Z-1967-2008;
38) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture
holes Y+4, sterile; REF 1-730-964. Product is used for Orthopedic surgery,
Recall # Z-1968-2008;
39) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture
holes Y+5, sterile; REF 1-730-965. Product is used for Orthopedic surgery,
Recall # Z-1969-2008;
40) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture
holes Z+3, sterile; REF 1-730-973. Product is used for Orthopedic surgery,
Recall # Z-1970-2008;
41) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture
holes Z+4, sterile; REF 1-730-974. Product is used for Orthopedic surgery,
Recall # Z-1971-2008;
42) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture
holes Z+5, sterile; REF 1-730-975. Product is used for Orthopedic surgery,
Recall # Z-1972-2008;
43) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture
holes 1+3, sterile; REF 2-662-913. Product is used for Orthopedic surgery, Recall
# Z-1973-2008;
44) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture
holes 1+4, sterile; REF 2-662-914. Product is used for Orthopedic surgery,
Recall # Z-1974-2008;
45) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture
holes 1+5, sterile; REF 2-662-915. Product is used for Orthopedic surgery, Recall
# Z-1975-2008;
46) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture
holes 2+3, sterile; REF 2-662-923. Product is used for Orthopedic surgery, Recall
# Z-1976-2008;
47) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture
holes 2+4, sterile; REF 2-662-924. Product is used for Orthopedic surgery, Recall
# Z-1977-2008;
48) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture
holes 2+5, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-925.
Product is used for Orthopedic surgery, Recall # Z-1978-2008;
49) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture
holes 3+3, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-933.
Product is used for Orthopedic surgery, Recall # Z-1979-2008;
50) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture
holes 3+4, sterile, Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-934.
Product is used for Orthopedic surgery, Recall # Z-1980-2008
51) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture
holes 3+5, sterile; REF 2-662-935. Product is used for Orthopedic surgery, Recall
# Z-1981-2008;
52) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture
holes 4+3, sterile; REF 2-662-943. Product is used for Orthopedic surgery, Recall #
Z-1982-2008;
53) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture
holes 4+4, sterile; REF 2-662-944. Product is used for Orthopedic surgery, Recall #
Z-1983-2008;
54) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture
holes 4+5, sterile; REF 2-662-945. Product is used for Orthopedic surgery, Recall #
Z-1984-2008;
55) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture
holes 5+3, sterile; REF 2-662-953. Product is used for Orthopedic surgery, Recall #
Z-1985-2008;
56) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture
holes 5+4, sterile; REF 2-662-954. Product is used for Orthopedic surgery, Recall #
Z-1986-2008;
57) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture
holes 5+5, sterile; REF 2-662-955. Product is used for Orthopedic surgery, Recall #
Z-1987-2008;
58) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture
holes 5+6, sterile; REF 2-662-956. Product is used for Orthopedic surgery, Recall #
Z-1988-2008;
59) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes
6+3, sterile; REF 2-662-963. Product is used for Orthopedic surgery, Recall #
Z-1989-2008;
60) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes
6+4, sterile; REF 2-662-964. Product is used for Orthopedic surgery, Recall #
Z-1990-2008;
61) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes
6+5, sterile; REF 2-662-965, Recall # Z-1991-2008;
62) Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes
6+6, sterile; REF 2-662-966, Recall # Z-1992-2008;
63) Margron DTC Hip Replacement System; Margron hip extension module AA6,
sterile; REF 2-662-201. Product is used for Orthopedic surgery, Recall #
Z-1993-2008;
64) Margron DTC Hip Replacement System; Margron hip extension module AA7,
sterile; REF 2-662-202. Product is used for Orthopedic surgery, Recall #
Z-1994-2008;
65) Margron DTC Hip Replacement System; Margron hip extension module BB6,
sterile, REF 2-662-203. Product is used for Orthopedic surgery, Recall #
Z-1995-2008;
66) Margron DTC Hip Replacement System; Margron hip extension module BB7,
sterile; REF 2-662-204. Product is used for Orthopedic surgery, Recall #
Z-1996-2008;
67) Margron DTC Hip Replacement System; Margron hip extension module CC7,
sterile; REF 2-662-205. Product is used for Orthopedic surgery, Recall #
Z-1997-2008;
68) Margron DTC Hip Replacement System; Margron hip extension module YY6,
sterile; REF 2-731-005. Product is used for Orthopedic surgery, Recall #
Z-1998-2008;
69) Margron DTC Hip Replacement System; Margron hip extension module YY7,
sterile; REF 2-731-006. Product is used for Orthopedic surgery, Recall #
Z-1999-2008;
70) Margron DTC Hip Replacement System; Margron hip extension module ZZ6,
sterile; REF 2-731-007. Product is used for Orthopedic surgery, Recall #
Z-2000-2008;
71) Margron DTC Hip Replacement System; Margron hip extension module ZZ7,
sterile; REF 2-731-008. Product is used for Orthopedic surgery, Recall #
Z-2001-2008
CODE
All lots
RECALLING FIRM/MANUFACTURER
Portland Orthopaedics Pty, Ltd., Saint George Hospital, Kogarah, Australia, by letters dated June 20, 2008. Firm initiated recall is ongoing.
REASON
Australian data indicates the product is associated with a higher than average rate of hip replacement revision surgery.
VOLUME OF PRODUCT IN COMMERCE
2,403 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
6.5 Cancellous Bone Screw 25 mm; Made in USA; Catalog Number: 2030-6525-1 The Omnifit bone screws are intended to augment the fixation of compatible acetabular cups, Recall # Z-2007-2008
CODE
Lot # 35323605
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on December 20, 2005. Firm initiated recall is ongoing.
REASON
One lot of 6.5 Cancellous Bone Screws 25 mm was packaged and labeled as 25 mm in length when it maybe 20 mm in length.
VOLUME OF PRODUCT IN COMMERCE
29 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) 5 Hole Locking 1st Tarsometatarsal Plate. REF 70-0007-S, Recall # Z-2108-2008;
2) 4 Hole Locking 1st Tarsometatarsal Plate. REF 70-0008-S, Recall # Z-2109-2008;
3) 4 Hole Locking 2nd and 3rd Tarsometatarsal Plate. REF 70-0009-S, Recall # Z-2110-
2008;
4) Left Locking Proximal Metatarsal Wedge Plate. REF 70-0010-S, Recall # Z-2111-
2008;
5) Right Locking Proximal Metatarsal Wedge Plate. REF 70-0011-S, Recall #
Z-2112-2008;
6) Left Locking Dorsal 1st MTP Fusion Plate. REF 70-0012-S, Recall # Z-2113-2008;
7) Left Locking 1st MTP Revision Fusion Plate. REF 70-0018-S, Recall # Z-2114-2008;
8) Right Locking 1st MTP Revision Fusion Plate. REF 70-0019-S, Recall # Z-2115-
2008;
9) Left Locking 2nd MTP/MPJ Combo Fusion Plate. REF 70-0036-S, Recall # Z-2116-
2008;
10) Right Locking 1st MTP/MPJ Combo Fusion Plate, REF 70-0037-S, Recall # Z-
2117-2008;
11) 6mm Bone Graft Drill. Product labeled in part, Size: 6mm Bone Graft Drill...
REF BG-8006-S, Recall # Z-2118-2008;
12) 10mm Bone Graft Drill. Product labeled in part, Size: 10mm Bone Graft Drill... REF
BG-8020-S, Recall # Z-2119-2008;
13) Locking Clavicle Plate, 10 Holes Large Left. Product labeled in part, REF PL-
CL10LL-S, Recall # Z-2120-2008;
14) Locking Clavicle Plate, 10 Holes Large Right. Product labeled in part, REF PL-
CL10LR-S, Recall # Z-2121-2008;
15) Locking Clavicle Plate, 6 Holes Small Left. REF PL-CL6SL-S, Recall # Z-2122-
2008;
16) Locking Clavicle Plate, 6 Holes Small Right. REF PL-CL6SR-S, Recall # Z-2123-
2008;
17) Locking Clavicle Plate, 8 Holes, J-Plate Left., REF PL-CL8JL-S, Recall # Z-2124-
2008;
18) Locking Clavicle Plate, 8 Holes, J-Plate Right. REF PL-CL8JR-S, Recall # Z-2125-
2008;
19) Locking Clavicle Plate, 8 Holes Large Left. REF PL-CL8LL-S, Recall # Z-2126-
2008;
20) Locking Clavicle Plate, 8 Holes Large Right. REF PL-CL8LR-S, Recall # Z-2127-
2008;
21) Locking Clavicle Plate, 8 Holes Medium Left. REF PL-CL8ML-S, Recall # Z-2128-
2008;
22) Locking Clavicle Plate, 8 Holes Medium Right. REF PL-CL8MR-S, Recall #
Z-2129-2008;
23) Locking Clavicle Plate, 8 Holes Small Right. REF PL-CL8SR-S, Recall #
Z-2130-2008;
24) Locking Clavicle Plate, 9 Holes, J-Plate Left. REF PL-CL9JL-S, Recall # Z-2131-
2008;
25) Locking Clavicle Plate, 9 Holes, J-Plate Right. REF PL-CL9JR-S, Recall # Z-2132-
2008
CODE
1) Work order number/Lot: W58115 (W=work order, ###=sequential number);
Expiration date: 2014-11 (Year/Month);
2) Work order number/Lot: W58116 (W=work order, ###=sequential number);
Expiration date: 2014-11 (Year/Month);
3) Work order number/Lot: W58117 (W=work order, ###=sequential number);
Expiration date: 2014-11 (Year/Month);
4) Work order number/Lot: W58118 (W=work order, ###=sequential number);
Expiration date: 2014-11 (Year/Month);
5) Work order number/Lot: W58119 (W=work order, ###=sequential number);
Expiration date: 2014-11 (Year/Month);
6) Work order number/Lot: W58120 (W=work order, ###=sequential number);
Expiration date: 2014-11 (Year/Month);
7) Work order number/Lot: W58121 (W=work order, ###=sequential number);
Expiration date: 2014-11 (Year/Month);
8) Work order number/Lot: W58122 (W=work order, ###=sequential number);
Expiration date: 2014-11 (Year/Month);
9) Work order number/Lot: W58123 (W=work order, ###=sequential number);
Expiration date: 2014-11 (Year/Month);
10) Work order number/Lot: W58148 (W=work order, ###=sequential number);
Expiration date: 2014-11 (Year/Month);
11) Work order number/Lot: W51258 (W=work order, ###=sequential number);
Expiration date: 2014-09 (Year/Month);
12) Work order number/Lot: W54076 (W=work order, ###=sequential number);
Expiration date: 2014-10 (Year/Month);
13) Work order number/Lot: W58181 (W=work order, ###=sequential number);
Expiration date: 2014-11 (Year/Month);
14) Work order numbers/Lots: W57997and W58182(W=work order, ###=sequential
number); Expiration date: 2014-11 (Year/Month);
15) Work order numbers/Lots: W57683 and W58184 (W=work order, ###=sequential
number); Expiration date: 2014-11 (Year/Month)
16) Work order number/Lot: W57684 (W=work order, ###=sequential number);
Expiration date: 2014-11 (Year/Month);
17) Work order numbers/Lots: W57685 and W58187 (W=work order, ###=sequential
number); Expiration date: 2014-11 (Year/Month);
18) Work order number/Lot: W57686 (W=work order, ###=sequential number);
Expiration date: 2014-11 (Year/Month);
19) Work order numbers/Lots: W57687 and W58190 (W=work order, ###=sequential
number); Expiration date: 2014-11 (Year/Month);
20) Work order numbers/Lots: W58192, W58081, and W57688 (W=work order,
###=sequential number); Expiration date: 2014-11 (Year/Month);
21) Work order number/Lot: W58194 (W=work order, ###=sequential number);
Expiration date: 2014-11 (Year/Month);
22) Work order number/Lot: W58195 (W=work order, ###=sequential number);
Expiration date: 2014-11 (Year/Month);
23) Work order numbers/Lots: W57689 and W58197 (W=work order, ###=sequential
number); Expiration date: 2014-11 (Year/Month);
24) Work order number/Lot: W57690 (W=work order, ###=sequential number);
Expiration date: 2014-11 (Year/Month);
25) Work order number/Lot: W58199 (W=work order, ###=sequential number);
Expiration date: 2014-11 (Year/Month)
RECALLING FIRM/MANUFACTURER
Acumed LLC, Hillsboro, OR, by fax or e-mail on February 14, 2008, February 20, March 25, 2008 and July 16, 2008. Firm initiated recall is ongoing.
REASON
Product sterility may be compromised.
VOLUME OF PRODUCT IN COMMERCE
268 pieces
DISTRIBUTION
Nationwide, UK, Australia, and Greece
___________________________________
PRODUCT
Isoloc Software, Version 6.6, 6.5, and 6.0. Part # MT-NW-425-520. Software computer hard disc reads “ISOLOC 6.6 Copyright NMPE Copyright 1997-2004 NMPE Build # 10302006 CIVCO Medical Solutions is an EPID-based (electronic portal imaging device) version of localization software for determining the treatment machine position of radiotherapy targets, Recall # Z-2137-2008
CODE
Versions 6.6, 6.5 and 6.0
RECALLING FIRM/MANUFACTURER
Recalling Firm: Civco Medical Instruments, Inc., Kalona, IA, by letter on June 16, 2008.
Manufacturer: Northwest Medical Physics Equipment, Inc., Everett, WA. Firm initiated recall is ongoing.
REASON
A localization may be produced which has the incorrect moves, and therefore, could place the patient in the incorrect location.
VOLUME OF PRODUCT IN COMMERCE
235 units
DISTRIBUTION
Nationwide, Korea, Portugal, and UK
___________________________________
PRODUCT
GE Precision RXi Digital remote X-Ray Imaging R&F System, model 5117828. The product is used for performing general R&F, radiology, fluoroscopy, interventional and angiography procedures/applications, Recall # Z-2145-2008
CODE
Serial numbers: 100, 106, 107, 111, 112, 136, 145, 146, 147, 148, 149, 157, 158, 164, 165, 167, 168, 173, 176, 183, 184, 188, 193, 198, 205, 211, 212, 213, 221, 225, 230, 233, 242, 244, 252, 254, 261, 264, 283, 284, 285, 291, 292, 299, 304, 306, 308, 323, 324, 327, 328, 334, 339, 366, 380, 388, 390, 392, 394, 421, and 426
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI, by visit beginning May l, 2008.
Manufacturer: General Medical Merate, Seriate, Italy. Firm initiated recall is ongoing.
REASON
The Precision RXi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard.
VOLUME OF PRODUCT IN COMMERCE
61 systems
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) GE Stereotaxy Positioner, model 2405544-2, for use with Senographe DS Full Field
Mammography system, models 2383168, 2383168-2, 2383168-3, 2383168-3-1,
2383168-4-1. The expected use of the Senographe DS Stereotaxy is an optional
accessory for the Senographe system for mammography examinations, Recall # Z-
2146-2008;
b) GE Stereotaxy Positioner, model 2405544-3, for use with Senographe DS Full Field
Mammography system, models 2383168, 2383168-2, 2383168-3, 2383168-3-1,
2383168-4-1. The expected use of the Senographe DS Stereotaxy is an optional
accessory for the Senographe system for mammography examinations, Recall # Z-
2147-2008
CODE
a) Serial numbers: 00000434834BU8, 00000434837BU1, 00000437358BU5,
00000437363BU5, 00000437366BU8, 00000437366BU8, 00000444593BU8,
00000444603BU5, 00000450276BU1, 00000450289BU4, 00000454195BU9,
00000454197BU5, 00000454200BU7, 00000454202BU3, 0000046417BU0,
00000464622BU0, 00000464628BU7, 00000484259BU7, 00000484270BU4,
00000484290BU2, 00000484297BU7, 0000048429BU4, 00000492966BU7,
00000492975BU8, 00000494921BU0, 00000500104BU5, and 00000500118BU5;
b) Serial numbers: 00000509762BU1, 00000509764BU7, 00000543767BU8,
00000546136BU3, 00000546140BU5, 00000546772BU5, 00000546793BU1,
00000546794BU9, 00000546799BU8, 00000550251BU3, 00000550265BU3, and
00000550266BU1
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI, by letter, dated March 3, 2008.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
REASON
GE Healthcare has recently become aware of x-ray emission beyond the edge of the detector primary barrier. This issue occurs when an exam is performed in a specific angulated view associated with use of the Stereotactic Positioner of your Senographe DS Acquisition system and could impact patient safety. If the Stereotactic Positioner is removed when the examination arm is at 33 degrees and, the operator exits the Stereo Medical application, then starts a new examination in standard mode, this allows the user to perform an acquisition that leads to x-ray emission beyond the edge of the detector. There have been no reports of exposure to unintended x-ray emission.
VOLUME OF PRODUCT IN COMMERCE
39 units
DISTRIBUTION
AL, CA, CO, FL, IL, KS, MA, ME, MN,MO, NC, NJ, NM, NY OK, SC, TN, TX, and WI
___________________________________
PRODUCT
a) Flexipet Denuding pipette 130 micron. The product is boxed with 5 vials of 10. The
device is used for the intracytoplasmic single sperm injection of oocytes, Recall # Z-
2176-2008;
b) Flexipet Manipulation pipette 300 micron. The device is used for the intracytoplasmic
single sperm injection of oocytes, Recall # Z-2177-2008
CODE
a) Lot number N74091;
b) Lot number N74173
RECALLING FIRM/MANUFACTURER
Cook Vascular Inc., Vandergrift, PA, by letter on March 3, 2008. Firm initiated recall is complete.
REASON
Mislabeled - 300 micron flexipets labeled as 130 micron and vice versa.
VOLUME OF PRODUCT IN COMMERCE
194 boxes
DISTRIBUTION
CA, FL, GA, IN, NJ, NM, NV, WA, and WI
___________________________________
PRODUCT
a) Hologic Discovery Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2
is indicated for the estimate of bone mineral density, comparison of measured
variables obtained from a given scan to a database of reference values, the estimation
of fracture risk, vertebral deformity assessment, body composition analysis, and
discrimination of bone from prosthetics, Recall # Z-2184-2008;
b) Hologic QDR4500 Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2
is indicated for the estimate of bone mineral density, comparison of measured
variables obtained from a given scan to a database of reference values, the estimation
of fracture risk, vertebral deformity assessment, body composition analysis, and
discrimination of bone from prosthetics, Recall # Z-2185-2008;
c) Hologic Delphi Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is
indicated for the estimate of bone mineral density, comparison of measured variables
obtained from a given scan to a database of reference values, the estimation of fracture
risk, vertebral deformity assessment, body composition analysis, and discrimination of
bone from prosthetics, Recall # Z-2186-2008;
d) Hologic Explorer Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is
indicated for the estimate of bone mineral density, comparison of measured variables
obtained from a given scan to a database of reference values, the estimation of fracture
risk, vertebral deformity assessment, body composition analysis, and discrimination of
bone from prosthetics, Recall # Z-2187-2008;
e) Hologic Oasis Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is
indicated for the estimate of bone mineral density, comparison of measured variables
obtained from a given scan to a database of reference values, the estimation of fracture
risk, vertebral deformity assessment, body composition analysis, and discrimination of
bone from prosthetics, Recall # Z-2188-1991
CODE
a) Serial numbers: 83286 83048 83152 83372 83361 83033 83196 83270 83333 83172 83238 83446 83217 83078 83147 83212 83374 83375 83379 83392 83394 83396
83410 83423 80199 80920 83024 83053 83232 83318 83336 83110 83183 83189
83244 83434 83056 83335 83058 83097 83113 83166 83248 83265 83266 83283 83297 83258 83359 83381 83214 83380 83274 83123 83299 83060 83104 83108 83167 83234 83247 83403 83404 83031 83103 83067 83130 83179 83208 83226 83228 83259 83275 83304 83327 83331 83389 83416 83026 83036 83042 83052 83068 83069 83124 83128 83135 83136 83143 83153 83168 83187 83188 83193 83198 83204 83215 83242 83251 83253 83319 83320 83330 83339 83345 83347 83349 83391 83393 83444 83462 83463 83127 83137 83192 83355 83307 83063 83132 83138 83250 83262 83222 83424 83016 83030 83037 83102 83140 83281 83288 83295 83433 83070 83296 83364 83383 83449 83066 83230 83289 83344 83054 83089 83099 83146 83162 82998 83117 83145 83151 83158 83284 83401 83405 83437 83443 83341 83409 83061 83071 83079 83119 83006 83101 83303 83382 83237 83073 83095 83315 82894 82997 83012 83106 83125 83180 83184 83224 83239 83325 83340 83358 83368 83461 83129 83256 83272 83049 83171 83306 83363 83402 82970 83426 83029 83414 83087 83074 82249 80006 83220 82185 83142 83287 82771 83062 83376 83267 83227 80146 83160 83155 83233 83240 83164 83280 80397 83175 83083 80246 82827 83000 83329 83004 80498 83159 82944 83269 83059 83369 83302 83210 83163 83118 83263 81256 83413 82981 80257 82811 83219 81477 83300 83308 83098 83150 83246 82110 83041 83301 83305 81646 82376 83203 83182 83377 83231 83213 83338 83425 83156 83321 83207 83322 83072 82996 83334 83442 83395 83241 83010 82933 83001 83356 82920 82437 81968 83271 83387 83348 81841 83218 83021 83115 80836 83422 83430 83440 83039 83032 83114 81633 83460 83121 83328 83255 83406 83202 83149 81897 83453 83245 83169 83195 83292 82889 82899 83116 83191 83020 83112 83445 83384 83243 83190 83260 80111 83378 83209 83084 80741 82144 83429 83278 83451 83261 81681 80514 83088 83122 83223 82038 81942 83181 83366 83337 83197 83019 82402 81478 83081 83105 83324 83013 83225 83357 81054 83092 83157 83221 83428 83457 83107 83076 83353 83279 83144 83154 83454 83047 83055 83139 83100 83458 83323 82982 83111 83211 83176 83273 83011 83064 82591 83120 81980 83447 83170 83007 83311 83252 83080 81672 83310 82979 82857 83051 83148 83276 80910 83367 83093 83040 83317 83385 82916 80395 83046 83421 83194 83432 83316 83254 83077 83023 83343 83045 81784 81787 82064 82067 83075 83342 83411 83418 83351 81287 83009 83126 83362 83400 83094 83090 83133 83134 83314 83109 83371 83365 82371 83397 83346 83017 83034 83174 83178 83038 83082 83431 83185 83386 83415 83291 83003 83131 83398 83419 83085 83285 83065 83235 83294 83173 81058 83464 82989 82134 83177 83022 83199 83309 83427 83388 83015 83293 82671 83044 81866 83350 82876 83018 83326 80392 82828 83091 83014 83186 83282 83264 83277 83249 81665 80378 83420 83216 82226 83086 82400 80079 80374 83436 81464 82426 83050 83005 83096 82992 82935 81948 82895 83025 83043 83456 82378 83360 83229 83332 80711 83161 83370 83373 83027 83035 83165 83141 83417 83205 83312 83448 83057 83028 82775 83435 83352 83008 83206 83002 80045 83390 80970 81254 83268 83313 and 83200;
b) Serial numbers: 47733C 48128 45692A 45757W 48009C/NCE 48321C/NCE 49477W 50033C 47265C 49113C/CE 49170W/CE 49244C/CE 48815C/NCE 47638C 45801A/CE 47068C 50099C/CE 47758C 48939C 47092C 71239 45100SL 47629C 45273SL 45690SL/CE 47104C 45546A/CE 45744A/CE 45762A/CE 45633A/CE 45442SL 49189C 48783C 48397C/NCE 47763C 45916 49820 49823 49824 47339C 45597SL/CE 45520A/CE 47712C 48157W/CE 47501C 45352SL 48242C/NCE 45853SL/CE 45837SL/CE 47679C 48781C/NCE 48579C 47443 48610C 49423W/CE 49792C/CE 45434SL/CE 49848 47197C 48781C/NCE 47159W 45264 48224 45264A 45759 45759SL/CE 49404C/CE 45708SL/CE 45935SL/CE 48220W/CE 48269C/NCE 47478NCE 49194 48953C/NCE 45479A/CE 45640A/CE 49179 49576C 45496A/CE 45158SL/CE 45537A/CE 45553SL/CE 48789 47034W 45860SL/CE 45197A 45573SL/CE 50051C/CE 47822 49034W/CE 47512C 45674SL 48280C/NCE 48204W/CE 47345C 47677C/CE 45486 48063C 45550SL/CE 48064C/NCE 45668A/CE 49349C/CE 49259C/CE 47564C 47641C 48240C/NCE 49386 45523A/CE 45941SL/CE 45782SL/CE 47061C 47105C 48106C/NCE 49351C/CE 45498A/CE 48384C/NCE 45811SL/CE 49286C/CE 45443SL/CE 48231C/NCE 45492SL/CE 49367C/CE 48858C/NCE 47703C 45688SL/CE 49270W/CE 47262C 47710C 48431C/NCE 49124C/CE 48004C 45620SL/CE 48221W/CE 48963C/NCE 45495SL/CE 49366C/CE 49287C/CE 48990C/NCE 45556A/CE 47435C 45241A 45115A 48958C/NCE 48229C/NCE 45842A/CE 45247A 48899C/NCE 45816A/CE 45104 48021C/NCE 45659A/CE 47760C 45214A and 45725A/CE
c) Serial numbers: 70411W 70456W 71132C 71205W 70007C 70024C 70102C 70129C 70138C 70351C 70379A 70394A 70395C 70414A 70415A 70418A 70419A 70421A 70434W 70512A 70525W 70545W 70561W 70603W 70609C 70677C 70678W 70717C 70721W 70724A 70734A 70744C 70761C 70791C 70817W 70824C 70845C 70855SL 70896SL 70987W 71016C 71035W 71076C 71091C 71151C 71172SL 71188C 71223C 71231W 71239C 71255W 71257C 71287C 71342C and 71386C;
d) Serial numbers: 91108 90941 91022 90952 91032 91127 91126 91193 91065 90885 91222 91070 91141 91057 90970 90969 91107 91050 91013 91014 91015 91016 91017 91018 91019 91020 91043 91044 91045 91046 91047 91048 91049 91151 91152 91153 91154 91155 91213 91214 91215 91218 91238 91239 91240 91241 91242 91243 91253 91254 91256 91257 91262 91263 91265 91266 91268 91269 91051 91099 91165 91100 91143 91054 91012 91039 91076 91258 91224 91260 91261 90920 90924 90934 90938 90923 91028 91029 91031 91026 91030 91113 91114 91128 91180 91186 91187 91183 91210 91212 91226 91208 91227 91229 91252 91034 91205 91281 91111 91211 91202 91228 90939 90945 90953 90971 90972 90942 90976 90995 90996 91009 91033 91036 91060 91071 91072 91068 91069 91059 91105 91106 91118 91123 91124 91133 91137 91138 91181 91182 91221 91223 91225 91259 91283 90911 90978 90994 91066 91103 91104 91125 91250 91064 91075 90988 91174 91271 91109 91110 91132 91135 91184 91094 90954 90955 90956 90957 90958 91097 91098 91101 91102 91136 91146 91147 91148 91149 91150 90977 90984 90985 90986 90987 90997 90998 90999 91001 91002 91003 91007 91008 91052 91053 91055 91077 91078 91079 91080 91085 91086 91087 91157 91158 91159 91198 91199 91168 91169 91170 91171 91172 91093 91167 91173 91176 91177 91234 91235 91236 91179 91237 91244 91245 91264 91275 91276 91277 91278 91279 91207 90992 91006 91063 91084 91119 91161 91232 91246 91255 90982 91142 90993 91062 91083 91120 91121 91122 91130 91145 91160 91162 91163 91164 91196 91247 91248 91273 91274 91185 91190 91027 91156 91280 91203 91042 91081 91082 91131 91233 91061 91021 91000 91004 91267 91067 90990 91134 90937 91140 91197 91175 91091 90981 91117 91178 91209 91251 90940 90980 90983 91035 91115 91144 91231 91092 91249 91270 91272 91010 91011 90979 90991 90989 91025 91056 91058 91088 91089 91090 91095 91096 91112 91116 91139 91188 91192 91194 91189 91204 91191 91195 91230 91206 91005 91040 91200 91201 91216 91217 91219 91220 91166 91037 and 91038;
e) Serial numbers: 11/01/06 B 1/04/08B 11/01/06 A 6/24/05-A 9/25/06-01 9/25/06-02 9/25/06-03 9/25/06-04 9/28/06-01 9/28/06-02 9/28/06-03 9/12/07B 10/02/07B 10/02/07A and 1/04/08A
RECALLING FIRM/MANUFACTURER
Hologic, Inc., Bedford, MA, by letter dated June 27, 2008. Firm initiated recall is ongoing.
REASON
Software densitometer readings for left hip and lumbar spine under certain conditions may be inaccurate.
VOLUME OF PRODUCT IN COMMERCE
1,168 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Plastic Cannula Holdex® Tube Holder, Item number: 450216. It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports, Recall # Z-2198-2008
CODE
Lot#: A030804
RECALLING FIRM/MANUFACTURER
Recalling Firm: Greiner Bio-One North America, Inc., Monroe, NC, by letters on August 6, 2008.
Manufacturer: Greiner Bio-One Gmbh, Kremsmunster, Austria. Firm initiated recall is ongoing.
REASON
At removal of the tube from the holder the needle may dislodge and become stuck in the tube stopper with the blunt end of the needle facing out.
VOLUME OF PRODUCT IN COMMERCE
150,000 pieces
DISTRIBUTION
AL, FL, IN, KS, KY, MO, MN, NC, OH, PA, TN, TX, UT, VA, WI and WV
___________________________________
PRODUCT
MEDTOXscan Reader. Product number: 833062, Recall # Z-2202-2008
CODE
Product number only
RECALLING FIRM/MANUFACTURER
Medtox Diagnostics, Inc., Burlington, NC, by telephone starting February 8, 2008. Firm initiated recall is ongoing.
REASON
Reader was marketed without a 510(k).
VOLUME OF PRODUCT IN COMMERCE
391 Readers
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Acuson CV70 Ultrasound systems Ultrasonic Pulsed echo/doppler imaging system with Software revisions less than 4.0.0b, material number 784539, 7848521, and 7848547. Is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect mechanisms, Recall # Z-2212-2008
CODE
Serial numbers: AHE0824 D855 HA0771 HAA0008 HAA0101 HAA0102 HAA0103 HAA0104 HAA0105 HAA0106 HAA0107 HAA0108 HAA0109 HAA0110 HAA0111 HAA0112 HAA0113 HAA0114 HAA0115 HAA0116 HAA0117 HAA0118 HAA0119 HAA0120 HAA0121 HAA0122 HAA0123 HAA0124 HAA0125 HAA0126 HAA0127 HAA0128 HAA0129 HAA0130 HAA0132 HAA0133 HAA0134 HAA0135 HAA0136 HAA0137 HAA0138 HAA0139 HAA0140 HAA0141 HAA0142 HAA0143 HAA0144 HAA0146 HAA0147 HAA0148 HAA0149 HAA0150 HAA0151 HAA0152 HAA0153 HAA0154 HAA0155 HAA0156 HAA0157 HAA0158 HAA0159 HAA0160 HAA0161 HAA0162 HAA0163 HAA0164 HAA0166 HAA0167 HAA0168 HAA0169 HAA0170 HAA0171 HAA0172 HAA0173 HAA0174 HAA0176 HAA0177 HAA0178 HAA0179 HAA0180 HAA0181 HAA0182 HAA0183 HAA0184 HAA0185 HAA0186 HAA0187 HAA0188 HAA0189 HAA0190 HAA0191 HAA0192 HAA0193 HAA0194 HAA0195 HAA0196 HAA0197 HAA0198 HAA0199 HAA0200 HAA0201 HAA0202 HAA0203 HAA0204 HAA0205 HAA0206 HAA0208 HAA0209 HAA0210 HAA0211 HAA0212 HAA0213 HAA0214 HAA0215 HAA0216 HAA0217 HAA0218 HAA0219 HAA0222 HAA0224 HAA0225 HAA0231 HAA0244 HAA0245 HAA0246 HAA0247 HAA0248 HAA0250 HAA0262 HAA0263 HAA0265 HAA0266 HAA0267 HAA0268 HAA0269 HAA0270 HAA0271 HAA0272 HAA0273 HAA0274 HAA0275 HAA0276 HAA0278 HAA0279 HAA0280 HAA0282 HAA0283 HAA0284 HAA0285 HAA0286 HAA0287 HAA0289 HAA0290 HAA0291 HAA0292 HAA0294 HAA0296 HAA0297 HAA0298 HAA0299 HAA0300 HAA0301 HAA0302 HAA0303 HAA0304 HAA0305 HAA0306DEL HAA0307 HAA0308 HAA0309 HAA0310 HAA0311 HAA0312 HAA0314 HAA0315 HAA0316 HAA0317 HAA0318 HAA0319 HAA0320 HAA0322 HAA0324 HAA0326 HAA0327 HAA0328 HAA0329 HAA0331 HAA0333 HAA0334 HAA0335 HAA0336 HAA0338 HAA0340 HAA0341 HAA0342 HAA0343 HAA0344 HAA0346 HAA0347 HAA0348 HAA0351 HAA0352 HAA0353 HAA0354 HAA0355 HAA0356 HAA0357 HAA0358 HAA0359 HAA0360 HAA0361 HAA0363 HAA0365 HAA0366 HAA0367 HAA0368 HAA0369 HAA0371 HAA0372 HAA0373 HAA0375 HAA0376 HAA0377 HAA0378 HAA0379 HAA0380 HAA0382 HAA0383 HAA0384 HAA0386 HAA0387 HAA0388 HAA0389 HAA0390 HAA0391 HAA0392 HAA0393 HAA0395 HAA0398 HAA0399 HAA0400 HAA0401 HAA0402 HAA0403 HAA0404 HAA0405 HAA0406 HAA0407 HAA0408 HAA0409 HAA0410 HAA0411 HAA0412 HAA0413 HAA0414 HAA0415 HAA0416 HAA0417 HAA0418 HAA0419 HAA0420 HAA0421 HAA0422 HAA0423 HAA0424 HAA0425 HAA0426 HAA0429 HAA0430 HAA0431 HAA0432 HAA0433 HAA0434 HAA0436 HAA0437 HAA0438 HAA0439 HAA0440 HAA0441 HAA0442 HAA0443 HAA0445 HAA0446 HAA0449 HAA0452 HAA0453 HAA0454 HAA0456 HAA0457 HAA0458 HAA0459 HAA0460 HAA0461 HAA0462 HAA0463 HAA0464 HAA0465 HAA0466 HAA0467 HAA0468 HAA0469 HAA0470 HAA0472 HAA0473 HAA0474 HAA0475 HAA0477 HAA0478 HAA0480 HAA0481 HAA0482 HAA0483 HAA0484 HAA0485 HAA0486 HAA0487 HAA0489 HAA0490 HAA0491 HAA0492 HAA0493 HAA0494 HAA0495 HAA0496 HAA0497 HAA0498 HAA0499 HAA0500 HAA0501 HAA0502 HAA0503 HAA0504 HAA0505 HAA0506 HAA0507 HAA0508 HAA0509 HAA0510 HAA0511 HAA0512 HAA0514 HAA0515 HAA0516 HAA0517 HAA0518 HAA0519 HAA0520 HAA0521 HAA0523 HAA0524 HAA0525 HAA0526 HAA0527 HAA0528 HAA0529 HAA0530 HAA0531 HAA0532 HAA0533 HAA0534 HAA0535 HAA0536 HAA0537 HAA0538 HAA0539 HAA0540 HAA0541 HAA0542 HAA0543 HAA0544 HAA0545 HAA0546 HAA0547 HAA0548 HAA0549 HAA0550 HAA0551 HAA0552 HAA0553 HAA0554 HAA0555 HAA0556 HAA0566 HAA0569 HAA0570 HAA0571 HAA0572 HAA0573 HAA0574 HAA0575 HAA0576 HAA0577 HAA0578 HAA0579 HAA0580 HAA0581 HAA0582 HAA0583 HAA0584 HAA0585 HAA0587 HAA0588 HAA0589 HAA0590 HAAX0114 HAAX0131 HAAX0145 HAAX0184 HAAX0207 HAAX0216 HAAX0235 HAAX0273 HAAX0274 HAAX0277 HAAX0281 HAAX0288 HAAX0295 HAAX0321 HAAX0323 HAAX0332 HAAX0337 HAAX0345 HAAX0350 HAAX0364 HAAX0396 HAAX0397 HAAX0476 HAAX0479 HAAX0488 HAE0002 HAE0003 HAE0004 HAE0005 HAE0006 HAE002 HAE003 HAE005 HAE0101 HAE0102 HAE0103 HAE0104 HAE0105 HAE0106 HAE0107 HAE0108 HAE0109 HAE0110 HAE0111 HAE0112 HAE0113 HAE0114 HAE0115 HAE0116 HAE0117 HAE0118 HAE0119 HAE0120 HAE0121 HAE0122 HAE0123 HAE0124 HAE0125 HAE0126 HAE0127 HAE0128 HAE0129 HAE0130 HAE0131 HAE0132 HAE0133 HAE0134 HAE0135 HAE0136 HAE0137 HAE0138 HAE0139 HAE0140 HAE0141 HAE0142 HAE0143 HAE0145 HAE0146 HAE0147 HAE0148 HAE0149 HAE0150 HAE0151 HAE0152 HAE0153 HAE0154 HAE0155 HAE0156 HAE0157 HAE0158 HAE0159 HAE0160 HAE0161 HAE0162 HAE0163 HAE0164 HAE0165 HAE0166 HAE0167 HAE0168 HAE0169 HAE0170 HAE0171 HAE0172 HAE0173 HAE0174 HAE0175 HAE0176 HAE0177 HAE0178 HAE0179 HAE0180 HAE0181 HAE0182 HAE0183 HAE0184 HAE0185 HAE0186 HAE0187 HAE0188 HAE0189 HAE0190 HAE0191 HAE0192 HAE0193 HAE0194 HAE0195 HAE0196 HAE0197 HAE0198 HAE0199 HAE0200 HAE0201 HAE0202 HAE0203 HAE0204 HAE0205 HAE0206 HAE0207 HAE0208 HAE0209 HAE0210 HAE0211 HAE0212 HAE0213 HAE0214 HAE0215 HAE0216 HAE0217 HAE0218 HAE0219 HAE0220 HAE0221 HAE0222 HAE0223 HAE0224 HAE0225 HAE0226 HAE0227 HAE0228 HAE0229 HAE0230 HAE0231 HAE0232 HAE0233 HAE0234 HAE0235 HAE0236 HAE0237 HAE0239 HAE0240 HAE0241 HAE0242 HAE0243 HAE0244 HAE0245 HAE0246 HAE0247 HAE0248 HAE0249 HAE0250 HAE0251 HAE0252 HAE0253 HAE0254 HAE0255 HAE0256 HAE0257 HAE0258 HAE0259 HAE0260 HAE0261 HAE0262 HAE0263 HAE0264 HAE0265 HAE0266 HAE0267 HAE0268 HAE0269 HAE0270 HAE0271 HAE0272 HAE0273 HAE0274 HAE0275 HAE0276 HAE0278 HAE0279 HAE0280 HAE0281 HAE0282 HAE0283 HAE0284 HAE0285 HAE0286 HAE0287 HAE0288 HAE0289 HAE0290 HAE0291 HAE0292 HAE0293 HAE0294 HAE0295 HAE0296 HAE0297 HAE0298 HAE0299 HAE0300 HAE0301 HAE0302 HAE0303 HAE0304 HAE0305 HAE0306 HAE0307 HAE0308 HAE0309 HAE0310 HAE0311 HAE0312 HAE0313 HAE0314 HAE0315 HAE0316 HAE0317 HAE0318 HAE0319 HAE0320 HAE0321 HAE0322 HAE0323 HAE0324 HAE0325 HAE0326 HAE0328 HAE0329 HAE0330 HAE0331 HAE0332 HAE0333 HAE0334 HAE0335 HAE0336 HAE0337 HAE0338 HAE0339 HAE0340 HAE0341 HAE0342 HAE0343 HAE0345 HAE0346 HAE0347 HAE0348 HAE0349 HAE0350 HAE0351 HAE0352 HAE0353 HAE0354 HAE0355 HAE0356 HAE0357 HAE0358 HAE0359 HAE0360 HAE0361 HAE0362 HAE0363 HAE0364 HAE0365 HAE0366 HAE0367 HAE0368 HAE0369 HAE0370 HAE0371 HAE0372 HAE0373 HAE0374 HAE0375 HAE0376 HAE0377 HAE0378 HAE0379 HAE0380 HAE0381 HAE0382 HAE0383 HAE0384 HAE0385 HAE0386 HAE0387 HAE0388 HAE0389 HAE0390 HAE0391 HAE0392 HAE0394 HAE0395 HAE0396 HAE0397 HAE0398 HAE0399 HAE0400 HAE0401 HAE0402 HAE0403 HAE0404 HAE0405 HAE0407 HAE0408 HAE0409 HAE0411 HAE0412 HAE0413 HAE0414 HAE0415 HAE0416 HAE0417 HAE0418 HAE0419 HAE0420 HAE0421 HAE0422 HAE0423 HAE0424 HAE0425 HAE0426 HAE0427 HAE0428 HAE0429 HAE0431 HAE0432 HAE0433 HAE0434 HAE0435 HAE0436 HAE0437 HAE0438 HAE0439 HAE0441 HAE0442 HAE0443 HAE0444 HAE0445 HAE0446 HAE0447 HAE0448 HAE0449 HAE0450 HAE0451 HAE0452 HAE0453 HAE0456 HAE0457 HAE0458 HAE0459 HAE0460 HAE0461 HAE0462 HAE0463 HAE0464 HAE0465 HAE0466 HAE0467 HAE0468 HAE0469 HAE0471 HAE0472 HAE0473 HAE0474 HAE0475 HAE0476 HAE0477 HAE0478 HAE0479 HAE0480 HAE0481 HAE0482 HAE0483 HAE0484 HAE0485 HAE0486 HAE0487 HAE0488 HAE0489 HAE0490 HAE0491 HAE0492 HAE0493 HAE0494 HAE0495 HAE0496 HAE0497 HAE0498 HAE0499 HAE0500 HAE0501 HAE0502 HAE0503 HAE0505 HAE0506 HAE0507 HAE0508 HAE0509 HAE0510 HAE0511 HAE0512 HAE0513 HAE0514 HAE0515 HAE0516 HAE0517 HAE0518 HAE0519 HAE0520 HAE0521 HAE0522 HAE0523 HAE0524 HAE0525 HAE0526 HAE0527 HAE0528 HAE0529 HAE0530 HAE0531 HAE0532 HAE0533 HAE0534 HAE0535 HAE0536 HAE0537 HAE0538 HAE0539 HAE0540 HAE0541 HAE0542 HAE0543 HAE0544 HAE0545 HAE0546 HAE0547 HAE0548 HAE0549 HAE0550 HAE0551 HAE0552 HAE0553 HAE0554 HAE0555 HAE0556 HAE0557 HAE0558 HAE0559 HAE0560 HAE0561 HAE0562 HAE0563 HAE0564 HAE0565 HAE0566 HAE0567 HAE0568 HAE0569 HAE0570 HAE0571 HAE0572 HAE0573 HAE0574 HAE0575 HAE0576 HAE0577 HAE0578 HAE0579 HAE0580 HAE0581 HAE0582 HAE0583 HAE0584 HAE0585 HAE0586 HAE0587 HAE0588 HAE0589 HAE0590 HAE0591 HAE0592 HAE0593 HAE0594 HAE0595 HAE0596 HAE0597 HAE0598 HAE0599 HAE0600 HAE0601 HAE0602 HAE0603 HAE0604 HAE0605 HAE0606 HAE0607 HAE0608 HAE0609 HAE0610 HAE0611 HAE0612 HAE0613 HAE0614 HAE0615 HAE0616 HAE0617 HAE0618 HAE0619 HAE0620 HAE0621 HAE0622 HAE0623 HAE0624 HAE0625 HAE0626 HAE0627 HAE0628 HAE0629 HAE0630 HAE0631 HAE0632 HAE0633 HAE0634 HAE0635 HAE0636 HAE0637 HAE0638 HAE0639 HAE0640 HAE0641 HAE0642 HAE0643 HAE0644 HAE0645 HAE0646 HAE0647 HAE0648 HAE0649 HAE0650 HAE0651 HAE0652 HAE0653 HAE0654 HAE0655 HAE0656 HAE0657 HAE0658 HAE0659 HAE0660 HAE0661 HAE0662 HAE0663 HAE0664 HAE0665 HAE0666 HAE0667 HAE0668 HAE0669 HAE0670 HAE0671 HAE0672 HAE0673 HAE0675 HAE0676 HAE0677 HAE0678 HAE0679 HAE0680 HAE0681 HAE0682 HAE0683 HAE0684 HAE0685 HAE0686 HAE0687 HAE0688 HAE0689 HAE0690 HAE0691 HAE0692 HAE0693 HAE0694 HAE0695 HAE0696 HAE0697 HAE0698 HAE0699 HAE0700 HAE0701 HAE0702 HAE0703 HAE0704 HAE0705 HAE0706 HAE0707 HAE0708 HAE0709 HAE0710 HAE0711 HAE0712 HAE0713 HAE0714 HAE0715 HAE0716 HAE0717 HAE0718 HAE0719 HAE0720 HAE0721 HAE0722 HAE0723 HAE0724 HAE0725 HAE0726 HAE0727 HAE0728 HAE0729 HAE0730 HAE0731 HAE0732 HAE0733 HAE0734 HAE0735 HAE0736 HAE0737 HAE0738 HAE0739 HAE0740 HAE0741 HAE0742 HAE0743 HAE0744 HAE0745 HAE0746 HAE0747 HAE0748 HAE0749 HAE075 HAE0750 HAE0751 HAE0752 HAE0753 HAE0754 HAE0755 HAE0756 HAE0757 HAE0758 HAE0759 HAE0760 HAE0761 HAE0762 HAE0763 HAE0764 HAE0765 HAE0766 HAE0767 HAE0768 HAE0769 HAE0770 HAE0772 HAE0773 HAE0774 HAE0775 HAE0776 HAE0777 HAE0778 HAE0779 HAE0780 HAE0781 HAE0782 HAE0783 HAE0784 HAE0785 HAE0786 HAE0787 HAE0788 HAE0789 HAE0790 HAE0791 HAE0792 HAE0793 HAE0795 HAE0796 HAE0797 HAE0798 HAE0799 HAE0800 HAE0801 HAE0802 HAE0803 HAE0804 HAE0805 HAE0806 HAE0807 HAE0808 HAE0809 HAE0810 HAE0811 HAE0812 HAE0813 HAE0814 HAE0815 HAE0816 HAE0817 HAE0818 HAE0819 HAE0820 HAE0821 HAE0822 HAE0823 HAE0826 HAE0827 HAE0828 HAE0829 HAE0830 HAE0831 HAE0832 HAE0835 HAE0837 HAE0838 HAE0839 HAE0840 HAE0841 HAE0842 HAE0843 HAE0844 HAE0845 HAE0846 HAE0847 HAE0848 HAE0849 HAE0850 HAE0851 HAE0852 HAE0853 HAE0854 HAE0855 HAE0856 HAE0857 HAE0859 HAE0860 HAE0862 HAE0863 HAE0864 HAE0865 HAE0866 HAE0867 HAE0868 HAE0869 HAE0870 HAE0871 HAE0872 HAE0873 HAE0874 HAE0875 HAE0876 HAE0877 HAE0878 HAE0879 HAE0880 HAE0881 HAE0882 HAE0883 HAE0884 HAE0885 HAE0886 HAE0887 HAE0888 HAE0889 HAE0890 HAE0891 HAE0892 HAE0895 HAE0896 HAE0897 HAE0899 HAE0900 HAE0901 HAE0902 HAE0903 HAE0904 HAE0905 HAE0906 HAE0907 HAE0908 HAE0911 HAE0914 HAE1047 HAE1052 HAE1053 HAE1103 HAE1106 HAE42466 HAJ0106 HEE0325 HUJ0105
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Mountain View, CA, by visit beginning June 4, 2008. Firm initiated recall is ongoing.
REASON
System may either display incorrect mechanical and thermal index values, or fail to display them altogether.
VOLUME OF PRODUCT IN COMMERCE
1,230 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Metal Hemiarthroplasty, MDL E536687, Part # 03-6000-1, 03-6000-02, 03-600-03, 03-6000-04. Hemi is designed to supplement first metatarsal Phalangeal joint arthroplasty, Recall # Z-2228-2008
CODE
Lot numbers: OP-1628, OP-1620, OP-1550, OP-1549, OP-1545, OP-1525, OP-1524, OP-1523, OP-1522, OP-1521, OP-1520, OP-1519, OP-1426, OP-1425, OP-1424, OP-1423, OP-1422, OP-1421, OP-1419, OP-1420, and 07-0310
RECALLING FIRM/MANUFACTURER
Recalling Firm: OrthoPro LLC, Salt Lake City, UT, verbally notified on May 29, 2008.
Manufacturer: Thortex (Malaysia) Sdn Bhd, Penang, Malaysia. Firm initiated recall is complete.
REASON
Labeling presented conflicting information as to whether device was sterile or not.
VOLUME OF PRODUCT IN COMMERCE
210 implants
DISTRIBUTION
AZ, CA, CO, FL, HI, IL, IN, MI, NY, OH, OR, PA, RI, TX, UT, VA, and WA
___________________________________
PRODUCT
Reflex Revision Screwdriver Inner Shaft is an orthopedic manual surgical instrument that is a nonpowered, hand held device intended for medical purposes to manipulate tissue or for use with other devices in orthopedic surgery. Ref Number 48500900; Non Sterile, Recall # Z-2238-2008
CODE
Lot codes: 26719, 047377, 047570, 065167, 06A167, and 072689
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Spine, Allendale, NJ, by letters beginning June 5, 2008.
Manufacturer: Stryker Spine, Cestas, Aquitane, France. Firm initiated recall is ongoing.
REASON
The Inner Shaft does not extend far enough from the tip of the Revision Screwdriver to fully engage the bone screw.
VOLUME OF PRODUCT IN COMMERCE
35 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
ARCHITECT i1000SR System Assay CD ROM WW (excluding US) Special edition Version 1.01 and Version 2.0; list 01P61-01 and 01P61-02. The device is intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity, Recall # Z-2239-2008
CODE
Lot number: 63062P100
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Abbott Park, IL, by letter on June 16, 2008. Firm initiated recall is ongoing.
REASON
When running the Automated Dilution Protocol with the assay files "CMV IgG" or "Toxo IgG" on the ARCHITECT i1000SR system, a software error [9010 (Pipettor Robotics) preventing (Process Path) from operating] is generated and the instrument stops running. No results are generated.
VOLUME OF PRODUCT IN COMMERCE
75 CD-ROMS
DISTRIBUTION
Austria, Belgium, Czech Republic, Denmark, France, Germany, Iceland, India, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Sweden, Saudi Arabia, Spain, United Arab Emirates
___________________________________
PRODUCT
Medtronic SPECIFY, 3998, Lead Kit for Spinal Cord Stimulation (SCS). Contents of the inner package are STERILE. Method of sterilization: Ethylene Oxide. Model 3998 lead is an implantable, permanent lead. It is used to deliver electrical pulses to the dorsal aspect of the spinal cord. The lead consists of two polyurethane lead bodies joined to one silicone rubber paddle. The lead has two parallel rows of four platinum iridium electrodes on the distal end, Recall # Z-2241-2008
CODE
Serial Numbers: V004442, V004456, V004457, V004541, V004644, V005789, V005838, V005884, V005952, V006010, V006011, V006497, V006610, V006732, V006888, V006937, V007136, V007224, V007342, V007451, V007565, V007729, V007781, V007911, V008174, V008257, V008387, V008638, V008639, V008729, V008902, V009060, V009191, V009278, V009352, V009353, V009630, V010099, V010124, V010125, V010366, V010367, V010602, V010744, V010896, V011057, V011091, V011215, V011257, V011299, V011406, V011457, V011552, V011610, V011627, V011860, V011958, V011977, V012040, V012123, V012202, V012238, V012260, V012411, V012571, V012618, V012935, V013158, V013231, V013331, V013489, V013615, V013745, V013787, V013837, V013862, V014190, V014320, V014426, V014454, V014660, V014785, V015071, V015166, V015327, V015626, V016195, V016445, V016489, V017182, V017731, V017927, V019145, V019452, V019569, V019909, V020188, V020688, V020904, V021560, V021753, V022880, V023339, V023517, V025268, V025500, V025707, V026020, V026436, V027462, V027804, V028474, V029383, V029983, V030442, V031317, V032070, V032560, V034825, V034832, V035769, V036156, V036810, V036857, V038530, V041066, V041365, V042627, V043757, V043759, V044336, V044850, V045723, V047365, V050371, V052566, V053142, V054607, V056045, V057371, V060415, V062321, V068860, V069647, V077531, V080086, V082162, V084570, V086942, V090294, V091959, V095777, V102426
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neuromodulation, Minneapolis, MN, by letters in May 2008.
Manufacturer: Medtronic Puerto Rico Inc., Villalba, PR. Firm initiated recall is ongoing.
REASON
Package mislabeling issue. The package labeling incorrectly states the lead length is 28 cm in length when it should state 20 cm.
VOLUME OF PRODUCT IN COMMERCE
3669 (however only 962 units are scope of recall, because they are sold or in consignment and are not registered implants
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Zimmer NEXGEN Complete Knee Solution MIS Total Knee Procedure Tibial Broach Impactor (a pounding instrument used during knee surgery), nonsterile; REF 5951-90, Recall # Z-2301-2008
CODE
All units
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN, by letter dated June 30, 2008. Firm initiated recall is ongoing.
REASON
The instrument may fracture during use, resulting in metal fragments being left in the patient post-surgery, which could cause implant failure.
VOLUME OF PRODUCT IN COMMERCE
1,439 units
DISTRIBUTION
Nationwide, Australia, China, England, France, Germany, India, Italy, Japan, Korea, Singapore and Taiwan
___________________________________
PRODUCT
Abiomed: Abiocor Implantable Heart Replacement Kit System; Catalog Number: 0034-8401-HD. The product is intended to be implanted in the thoracic cavity and replaces operation and function of the native heart, Recall # Z-2304-2008
CODE
Serial Number: 1028043
RECALLING FIRM/MANUFACTURER
Abiomed, Inc., Danvers, MA, by letter and on site visit on May 13, 2008. Firm initiated recall is complete.
REASON
Subassembly incorrectly aligned.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag The product is used with Quantum pump to deliver ready-to-hang (RTH) product in enterally-fed patients. List #50604, Recall # Z-2305-2008
CODE
Lot #47822RY Use By DEC 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Columbus, OH, by letters on June 27, 2008.
Manufacturer: Abbott Ireland, Sligo, Ireland. Firm initiated recall is ongoing.
REASON
Product was incorrectly labeled as “Top-Fill Enteral Nutrition Bag” instead of “Flexiflo Quantum Pump Set.
VOLUME OF PRODUCT IN COMMERCE
57,120 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
ArthroCare ArthroWand Covator with Integrated Cable Wand, Catalog number AC4340-01. The product is a medical device for human use in electrosurgical cutting and coagulation accessories. Product is indicated for resection, ablation and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures, Recall # Z-2309-2008
CODE
Lot numbers: C401580-A, C401770-A, C405180-A, C409550-A, C411570-A, C412350-A, C415070-A, C415970-A, C416150-A, C423570-A, C424960-A, C430270-A, C432770-A, C434670-A
RECALLING FIRM/MANUFACTURER
ArthroCare Corp., Sunnyvale, CA, by letters on April 9, 2008, May 13, 2008 and June 24, 2008. Firm initiated recall is ongoing.
REASON
Product is not secure in packaging, and movement may damage the product or render it non-sterile.
VOLUME OF PRODUCT IN COMMERCE
3,644 units
DISTRIBUTION
Nationwide, Australia, Germany, Italy, UK, Austria, Netherlands, Switzerland, Denmark, South Africa, Finland, Singapore, Spain, Russia and Poland
___________________________________
PRODUCT
AMO WaveScan WaveFront System Version 3.90/3.901, Part Number 0070-1478. The device is used in conjunction with the VISX STAR S4 and STAR S4 IR Excimer Laser Systems, which are indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. The WaveScan System is a diagnostic instrument intended for the automated measurement, analysis and recording of refractive errors of the eye. Recall # Z-2310-2008
CODE
Serial Numbers: 10560 70250 70594 75133 12280 70252 70608 75137 14480 70259 70620 75172 70026 70260 70647 75183 70029 70261 70653 75192 70032 70267 70654 75198 70049 70268 70664 75233 70050 70271 70679 75241 70053 70274 70681 75248 70064 70278 70685 75263 70068 70279 70689 75267 70070 70328 70696 75276 70079 70334 70699 75278 70080 70354 70706 75280 70082 70362 70716 75297 70089 70366 70732 75301 70094 70376 70746 75305 70096 70386 70755 75354 70098 70391 70765 75401 70099 70406 70769 75412 70102 70421 70779 75445 70107 70425 70784 76014 70113 70427 70803 76062 70114 70429 70834 76080 70120 70451 70851 76105 70122 70453 70862 76117 70125 70456 70879 76118 70127 70475 70882 76190 70133 70495 70889 76195 70140 70496 70890 76216 70146 70497 75023 76217 70148 70501 75031 76223 70158 70504 75037 76233 70166 70506 75040 76259 70185 70512 75058 76273 70188 70537 75065 76274 70189 70539 75102 76356 70208 70548 75103 76384 70232 70549 75121 70241 70587 and 75126
RECALLING FIRM/MANUFACTURER
Recalling Firm: VISX Inc., a Subsidiary of AMO, Inc., Santa Clara, CA, by letter on June 9, 2008.
Manufacturer: AMO Manufacturing USA, LLC, Milpitas, CA. Firm initiated recall is ongoing.
REASON
Inaccurate measurements may be generated by the device, which could result in improper treatment and deterioration of patient eyesight.
VOLUME OF PRODUCT IN COMMERCE
160 software kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Advantage Workstation version 4.2P, 4.3 and 4.4 with Volume Viewer 2 and Volume Viewer 3. Model Numbers 5183652 & 5142878, Recall # Z-2312-2008
CODE
Serial Numbers: 00000004592AW2 00000515058BU6 000000S7330007 000000M7309002 00000043494GE4 00000111595GE5 00000121784GE3 00000048049GE1 00000025782GE4 00000020959GE3 00000115777GE5 00000061266GE3 00000053396GE8 00000121783GE5 00000039991AW5 00000006077AW2 00000004473AW5 00000096726VE5 00000096716VE6 00000096588VE9 00000027640AW2 00000028924AW9 00000028941AW3 00000039721AW6 00000050165AW0 000000ANT24284 000000A7229008 000000F7334003 000000S7348002 000000F7354002 000000N8017003 000000H7352006 000000D8023004 000000D8059004 000000C8059001 000000E8081002 000000C7256009 000000G8138019 000000C7326002 000000C7326003 00000073366VE7 000000C7326001 00000028965AW2 00000027857AW2 000000ANT21808 000000Q7285002 00000531935BU5 00000050148AW6 000000M7320009 000000N8037003 000000L7302001 00000039954AW3 000000ANT21955 00000059507AW4 000000Y7296007 00000109197VE4 000000H7295003 00000027865AW5 00000006079AWB 000000Q7285001 00000027863AW0 00000531934BU8 00000014466AW7 00000014465AW9 00000005408AW0 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RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI, by letter dated March 13, 2008.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
REASON
A possible mismatch between the label of the tracked vessel and the underlying image associated with the cardio- vascular applications of the Advantage workstation that may impact patient safety.
VOLUME OF PRODUCT IN COMMERCE
5,249 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
The St. Jude Medical Livewire TC" Ablation Catheter, 8mm Tip w/Thermocouple & Thermistor REF 402196, Length 115 cm, Sterile EO The St. Jude Medical Livewire TC" Ablation Catheter is a flexible electrode catheter constructed of a radiopaque polyurethane insulation/shaft and incorporated platinum electrode. The distal tip portion may be deflected by a remote control handle located a t the proximal end of t the catheter, Recall # Z-2313-2008
CODE
Lot # 2056960
RECALLING FIRM/MANUFACTURER
St. Jude Medical Cardiovascular Division, Minnetonka, MN, by letter on June 5, 2008. Firm initiated recall is ongoing.
REASON
The product was mis-labelled as having an 8 mm tip instead of 4 mm tip. This could potentially result in elevated temperatures and formation of coagulum at the tip electrode. If this coagulum were to detach from the product, the worst case this could potentially result in embolization.
VOLUME OF PRODUCT IN COMMERCE
39 devices
DISTRIBUTION
Canada and Belgium
___________________________________
PRODUCT
Spacelabs Medical Temperature Probe Adaptor PN-700-0031-00. Device is packaged in clear plastic bags with an attached insert card Insert card reads "TruLink series Dual Temperature Cable REF 700-0032-00”, Recall # Z-2314-2008
CODE
Lot numbers: OSC 01/07, OSC 02/07, OSC 03/07, OSC 04/07 and OSC 07/07
RECALLING FIRM/MANUFACTURER
Spacelabs Healthcare, Inc., Issaquah, WA, by letter beginning July 3, 2008. Firm initiated recall is ongoing.
REASON
Intermittent contact of temperature probe adaptors can cause a loss of temperature monitoring which can cause a delay in care when an alarm is missed.
VOLUME OF PRODUCT IN COMMERCE
2,635 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Universal SlingBar 350 Product Number: 3156074 Used with the: Viking XS, Viking
S, Viking M, Viking L Patient Lifts, Recall # Z-2315-2008;
b) Universal SlingBar 450 Product Number: 3156075 Used with the: Viking XS, Viking
S, Viking M, Viking L Patient Lifts, Recall # Z-2316-2008;
c) Universal SlingBar 600 Product Number: 3156076 Used with the: Viking XS, Viking
S, Viking M, Viking L Patient Lifts, Recall # Z-2317-2008;
d) Universal SlingBar 350 with Quick-release Hook Product Number: 3156084 Used in
combination with all lifts from Liko, i.e. mobile lifts and overhead lifts, Recall # Z-
2318-2008;
e) Universal SlingBar 450 with Quick-release Hook Product Number: 3156085 Used in
combination with all lifts from Liko, i.e. mobile lifts and overhead lifts, Recall # Z-
2319-2008;
f) Universal SlingBar 600 with Quick-release Hook Product Number: 3156086 Used in
combination with all lifts from Liko, i.e. mobile lifts and overhead lifts, Recall # Z-
2320-2008
CODE
Serial numbers: 1200101-1245680, 121204-121499, 12222407-12225241
RECALLING FIRM/MANUFACTURER
Liko AB, Lulea, Sweden, by letter dated June 30, 2008. Firm initiated recall is ongoing.
REASON
A component securing the Universal SlingBar to the patient lift, may experience a nut unthreading resulting in the sling bar detaching from the lift causing the patient to fall.
VOLUME OF PRODUCT IN COMMERCE
4,000 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Medline RF Detect Sterile X-Ray Detectable USP Type VII Gauze; 8" x 4", 12-ply, 100% cotton sponges, 10 sponges per pack, 80 packs per case; Made in China; reorder: NON21432RF, Recall # Z-2321-2008
CODE
Lot Numbers: CM130002052, CM130002062, CM130002075, CM130002068, CM130002079, CM130002110
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medline Industries Inc., Mundelein, IL, by letter dated June 13, 2008.
Manufacturer: Allmed Medical Products Co Ltd, Shanzen, China. Firm initiated recall is ongoing.
REASON
There is the potential for the RF ID tag to separate from the retaining pouch.
VOLUME OF PRODUCT IN COMMERCE
295 cases
DISTRIBUTION
CA, IN, MO, OH, OK, PA, TX, and WA
___________________________________
PRODUCT
Ventlab-assembled Anesthesia breathing bags. The recall involves (NC Facility): a) Part #720057B (3 Liter bags); b) Part #720058B (2 Liter bags); and c) Part #720059B (1 Liter); (China Facility): a) Part #720057B; b) Part #720058B; and c) Part #720059B, latex free bags used with Medline anesthesia circuit kits. The bags are sold in bulk, Recall # Z-2324-2008
CODE
(North Carolina Facility):
a) Lot #63069, 64872, 65226, 66781, 67068, 67068;
b) Lot#63660, 64877, 65225, 68752;
c) Lot#63661, 64878, 65227;
(China Facility): a) Lot #3B0001, 3B0002, 3B0005, 3B0004, 3B0005;
b) Lot #1B0001, 1B0002, 1B0003; c) Lot #2B0002
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ventlab Corp., Mocksville, NC, by letter on/about December 5, 2007.
Manufacturer: Amerasia Industries, Guangdong, China. Firm initiated recall is ongoing.
REASON
During setup and potentially during procedures, the breathing bag can become separated from the taped bushing that is part of the breathing bag assembly.
VOLUME OF PRODUCT IN COMMERCE
571,500 units
DISTRIBUTION
IL
___________________________________
PRODUCT
a) Evita 2 dura Critical Care Ventilator. Continuous (Respirator). Catalog number
8411800. Products recalled had the CO2 Carrier Printed Circuit Board (PCB) part
number 8306611 replaced between January 2005 and May 2008, Recall # Z-2325-
2008;
b) Evita 4 Critical Care Ventilator. Continuous (Respirator); Catalog number 8411900,
Recall # Z-2326-2008;
c) Evita XL Critical Care Ventilator. Continuous (Respirator). Catalog number 8414900,
Recall # Z-2327-2008
CODE
Serial number: CO2 Carrier PCBs have a prefix of ARW, ARX, or ARY
RECALLING FIRM/MANUFACTURER
Recalling Firm: Draeger Medical, Inc., Telford, PA, by letter dated July 2, 2008.
Manufacturer: Draeger Aerospace Gmbh, Lubeck, Germany. Firm initiated recall is ongoing.
REASON
Audible power failure alarm was not enunciated at the required volume.
VOLUME OF PRODUCT IN COMMERCE
83 units
DISTRIBUTION
AZ, CA, CO, FL, GA, IL, KY, MA, MI, MS, NJ, NY, PA, TN, TX, UT and WA
___________________________________
PRODUCT
Propper short gas-chex EO sterilization indicators, 250 strips per box, Reorder No. 269001, Recall # Z-2330-2008.
CODE
Lot numbers: 6081, 6043, 6021, 7042, and 7013
RECALLING FIRM/MANUFACTURER
Propper Manufacturing Co., Inc., Long Island City, NY, by letters dated February 7, 2008. Firm initiated recall is ongoing.
REASON
A production specification discrepancy may cause the indicators to show an inaccurate result.
VOLUME OF PRODUCT IN COMMERCE
1,757 cases (7,030 boxes)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Cotton-Leung Biliary Stent., CLSO-10-5, Stent Diameter: 10 FR, Stent Length: 5cm,
Disposable-Single use only, Rx Only. Used to train obstructed biliary ducts, Recall #
Z-2331-2008;
b) Cotton-Leung Biliary Stent. CLSO-10-10, Stent Length:10cm in length, Disposable-
Single use only, Rx Only. Used to train obstructed biliary ducts, Recall # Z-2332-2008
CODE
a) Lot number: W512494;
b) Lot number: W2512492
RECALLING FIRM/MANUFACTURER
Cook Endoscopy, Winston-Salem, NC, on/about July 11, 2008. Firm initiated recall is ongoing.
REASON
The product packaging label indicates the stent is 5cm, but the actual stent inside the packaging measures 10cm.
VOLUME OF PRODUCT IN COMMERCE
40 units
DISTRIBUTION
MO, NC, NV, TX, UT and India
___________________________________
PRODUCT
Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107, 03116, 03108, 03109, 05756, 53420, 05765, 03634, 03633, and 05747); Model #: PY244RU, PY252RU, PY258RU, REFINO58RU, REFINO 52RJU, REFINO 44RJU, REFINO48RJU, BIS/IS-15, BIS/BIS-17, VKU-10V, MP52PV, MP40PV, C/IS-10; Pacing and sensing of the ventricle and/or atrium of the heart in conjunction with a compatible, implantable pulse generator/pacemaker, Recall # Z-2333-2008
CODE
Lot numbers: 02-01502, 02-01812, 02-01436, 02-01440, 02-02016, and 02-01945
RECALLING FIRM/MANUFACTURER
Oscor, Inc., Palm Harbor, FL, by letters on January 24, 3008. Firm initiated recall is ongoing.
REASON
The O-rings are over tolerance making it hard to connect the leads to the pacemaker.
VOLUME OF PRODUCT IN COMMERCE
783 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
ZOLL OneStep Multi-Function Electrode; Adult Complete Part #: 8900-0214-01. The electrodes are indicated for the following clinical applications: Defibrillation, Cardioversion, Noninvasive pacing, and Electrocardiograph monitoring, Recall # Z-2334-2008
CODE
Lot numbers: 2108 and 2208
RECALLING FIRM/MANUFACTURER
BioDetek, Inc., Pawtucket, RI, by letter dated June 16, 2008. Firm initiated recall is ongoing.
REASON
Multi-function electrode programmed as a Pediatric instead of Adult.
VOLUME OF PRODUCT IN COMMERCE
400 units
DISTRIBUTION
MA
___________________________________
PRODUCT
Radiation Reduction Gloves, sterile, Latex-free, Catalog No. SSR1-7.5, SSR1-8.0, Recall # Z-2335-2008
CODE
Lot numbers: W0806178, W0806179, and W0806177
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integra Pain Management, Salt Lake City, UT, by telephone and letter on July 3, 2008.
Manufacturer: Protech Leaded Eyewear, Palm Beach Gardens, FL. Firm initiated recall is ongoing.
REASON
Radiation reduction gloves were labeled as "Latex-free", but contain natural rubber latex.
VOLUME OF PRODUCT IN COMMERCE
140 boxes
DISTRIBUTION
AL, CA, FL, LA, NY, SC, TX
___________________________________
PRODUCT
a) PLV-100 Portable Lifecare Ventilator Life support ventilation. The device is intended
to mechanically control or assist patient breathing by delivering a predetermined
percentage of oxygen in the breathing gas. Life support ventilation. Model/Catalog
number PLV-100, Recall # Z-2344-2008;
b) Power Board Kit for use with the PLV-100 Portable Lifecare repairs. Model/Catalog
number PLV-100. Circuit board part numbers 1034786 version 5 or 1036038 version
3, Recall # Z-2345-2008
CODE
Version 3 and Version 5
RECALLING FIRM/MANUFACTURER
Respironics, Inc., Murrysville, PA, by letter dated July 8, 2008. Firm initiated recall is ongoing.
REASON
Certain PLV-100 ventilators may not trigger a signal to activate third-party remote alarms or nurse call systems upon device failure.
VOLUME OF PRODUCT IN COMMERCE
197 units
DISTRIBUTION
NC, IL, NJ, MO, TX , OH, IA, OK, Japan, Denmark, Korea, Australia, Finland, Canada, Argentina, New Zealand, Hong Kong, and India
___________________________________
PRODUCT
Rejuvenate Broach Catalog No: 1601-1005, 1601-1006, 1601-1007, 1601-1008, 1601-1009, 1601-1010. Contours the proximal femur to the geometry of the stem to provide a complimentary fit of the stem to the bone. The broaches are designed with a series of teeth that are intended to seat against highly densified cancellous bone for the interference press-fit in the uncemented application, Recall # Z-2349-2008
CODE
All lot codes
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letter on January 25, 2008. Firm initiated recall is complete.
REASON
Rejuvenate Broach system was designed in a manner that may result in the potential for a medical calcar fracture.
VOLUME OF PRODUCT IN COMMERCE
78 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
FloSeal Endoscopic Applicator , Product Code 1500181. The product is indicated in surgical procedures (other than in neurosurgical, opthalmic, and urological) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. Product Code: 1500181, Recall # Z-2340-2008
CODE
Lot Numbers: 05H035, 06N005, 06N017, 07A043, 07B044, 07E025, 07F010, 07G031, 07H016, 07J029, 07K034, 07N007, 088048, 08C020, 08D017, 08D053, and 08E041
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Bioscience, Westlake Village, CA, by letter dated August 4, 2008.
Manufacturer: Baxter Healthcare Corp., Medication Delivery Division, Irvine, CA. Firm initiated recall is ongoing.
REASON
The recall is being conducted as a precautionary measure due to potential discoloration of the FloSeal material noted in six (6) non-medical complaints during delivery by the Endoscopic Applicator.
VOLUME OF PRODUCT IN COMMERCE
10,345 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips,
Tests for feed water and rinse water down to 0.1 ppm (mg/l), packaged in bottles
containing 100 strips each, 5 bottles per kit, Part #811909. The firm name on the
label is Hach, Ames, IA. The product is used in measuring for low levels of total
chlorine (including chloramines and free chlorine) in feed water used to prepare
dialysate, Recall # Z-2352-2008;
b) HACH SteriChek Sensitive Total Chlorine Reagent Strips, Tests for water and rinse
water down to 0.1 mg/l (ppm), packaged 1/100-strip btl. per carton, 12 cartons per
shipping case, Product #821972. The product is used in measuring for low levels of
total chlorine (including chloramines and free chlorine) in feed water used to prepare
dialysate, Recall # Z-2353-2008;
c) RPC E-Z Chek Sensitive Total Chlorine and Chloramines Test Strips, Tests Water for
Total Chlorine & Chloramines down to 0.1 ppm (mg/l), packaged in a 1/100-strip
bottle, 60 bottles per tray, 5 trays per shipping case, Product code K100-0106 (HACH
Part #812004). The product is used in measuring for low levels of total chlorine
(including chloramines and free chlorine) in feed water used to prepare dialysate,
Recall # Z-2354-2008;
d) HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips,
tests for feed water and rinse water down to 0.1 ppm (mg/l), packaged in bags
containing 1/100-strip bottle, one medicine cup, and one insert. Each bag is sealed
and labeled "812144 SteriChek Sensitive, Bagged," 56 bags per cardboard tray,
5 trays per shipping case. Product code 812144 The product is used in measuring
for low levels of total chlorine (including chloramines and free chlorine) in feed
water used to prepare dialysate, Recall # Z-2355-2008
CODE
a) Lot numbers 6248, 6254, 6264, 6266, 6280, 6305, 6312, 6317, 6334, 6347, 6353,
6355, 7002, 7012, 7015, 7031, 7044, 7066, 7072, 7073, 7085, 7094, 7121, 7131,
7049, 7150, 7152, 7163, 7167, 7177, 7295, 7296, 7309, 7325, 7340, 7352, 7355,
8028, 8045, 8066, 8084, 8094, 8106, 8123, 8144, 8155, 8166, 8171, 7179, 7200,
7220, 7236, 7239, 7250, and 7282;
b) Lot numbers 6233, 6278, 6313, 6326, 6341, 7039, 7071, 7092, 7127, 7171, 7193,
7213, 7253, 7255, 7302, 7339, 7339, 8008, 8029, 8063, 8081, 8096, 8125, and 8150;
c) Lot numbers 6265, 6310, 7008, 7054, 7086, 7130, 7183, 7201, 7234, 7284, 7313,
8010, 8030, 8057, 8078, 8108, and 8160;
d) Lot numbers 7264, 7267, 7268, 7270, 7344, 7360, 7362, 8085, 8128, 8152, 8164,
and 8173
RECALLING FIRM/MANUFACTURER
Hach Co., Ames, IA, by telephone on May 22, 2008, July 1-2, 2008 and by letters on July 21, 2008. Firm initiated recall is ongoing.
REASON
Inconsistencies in total chlorine and free chlorine levels may result in providing inaccurate false positive or false negative results.
VOLUME OF PRODUCT IN COMMERCE
163,090 bottles
DISTRIBUTION
Nationwide, Canada and Denmark
___________________________________
PRODUCT
a) GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, (The system consists of
an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital
detector) The product is indicated for use in generating fluoroscopic images of human
anatomy for vascular angiography diagnostic and interventional procedures and
optionally, rotational imaging procedures. It is also intended for generating
fluoroscopic images of human anatomy for cardiology, diagnostic and interventional
procedures, Recall # Z-2356-2008;
b) GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, (The system
consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system
and a digital detector) The product is indicated for use in generating fluoroscopic
images of human anatomy for vascular angiography diagnostic and interventional
procedures and optionally, rotational imaging procedures. It is also intended for
generating fluoroscopic images of human anatomy for cardiology, diagnostic and
interventional procedures, Recall # Z-2357-2008;
c) GE Innova 4100 / 4100 IQ. , (The system consists of an a monoplane positioner, a
vascular or cardiac table, an X-ray system and a digital detector) The product is
indicated for use in generating fluoroscopic images of human anatomy for vascular
angiography diagnostic and interventional procedures and optionally, rotational
imaging procedures. It is also intended for generating fluoroscopic images of human
anatomy for cardiology, diagnostic and interventional procedures, Recall # Z-2358-
2008;
d) Advantx-E The Advantx imaging system is intended to be used for general purpose
diagnostic angiographic fluoroscopy and radiographic studies, Recall # Z-2359-
2008;
e) Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging System. The Innova
Biplane systems are the first and only digital flat panel biplane systems with a full
sized lateral plane to cover lateral anatomy without requiring multiple contrast
injections and radiation exposures. The product is indicated for use in generating
fluoroscopic images of human anatomy for diagnostic and interventional cardiac
angiography procedures. These systems can be operated in a mobile or fixed site
environment, Recall # Z-2360-2008;
f) Innova 2000 The principle system components include a C-arm, image acquisition,
processing and archiving capabilities. The product is indicated for use in generating
fluoroscopic images of human anatomy for diagnostic and interventional cardiac
angiography procedures. These systems can be operated in a mobile or fixed site
environment, Recall # Z-2361-2008
CODE
a) Serial Numbers: 00000536885BU7 00000524151BU8 00000807/61010 123100037 1203100026 1203100029 00000507807BU6 00000520244BU5 00000460530BU9 00000469400bu6 00000452842BU8 00000112420VE5 00000469349BU5 00000469380BU0 00000307/50876 00000524122BU9 00000453185BU1 00000460590BU3 00000105/30212 9110080 00000469377BU6 00000504/10092 00000704/20116 00000507774BU8 00000493795BU9 00000307/50891 00000507773BU0 00000460632BU3 00000112399VE1 00000407/50915 00000483688BU8 704120117 00000536842BU8 00000112423VE9 00001004-20153 00000524162BU5 00000536835BU2 00000048698BU7 00000507811BU8 00000807/61019 00000507/50956 00001204/30190 00000507817BU5 00000469368BU5 00001204/30187 00000452891BU5 00000452866BU7 00000707/60982 00001204/30191 00000493809BU8 00000112407VE2 00000112409VE8 00000499188BU1 00000499133BU7 00000507792BU0 00000536845BU1 00000469343BU8 00000524118BU7 00000536848BU5 00000460550BU7 00000524167BU4 00000469355BU2 00000483704BU3 00000520268BU4 00000307/50878 00000407/50910 00000469359BU4 00000112427VE0 00000469354BU5 00000493804BU9 00000604-10104 00000507814BU2 00000453182BU8 00000307/50883 00000460580BU4 00000453184BU4 0000M04/200013 304110059 00000707/60979 00000507770BU6 00000499138BU6 00000307/50900 00000483685BU4 00000520280BU9 00000499152BU7 00000460557BU2 00000469410NU5 00000307/50872 00000536892BU3 00000112414VE8 00000460621BU6 00000520265BU0 00000524152BU6 00000807/61020 00000204/10054 00000499175BU8 00000466696BU2 00000493796BU7 00000507791BU2 00000499157BU6 00000524156BU7 00000536910BU3 00000524153BU4 00000507804BU3 1204930184 00000907/60185 00001004/20148 00000469352BU9 000000M0420A3A 00000306/40566 00000499153BU5 00000453180BU2 00000520271BU8 00000466723BU4 00000105/30152 00000904/20011 00001004/20143 00000507/50940 00000704/20106 00000536855BU0 00000536856BU8 00000452884BU0 00000520239BU5 00001104/20029 00000466690BU5 304110067 00000452853BU5 00000453191BU9 00000469329BU7 00000460626BU5 00000536830BU3 00000499132BU9 00000460602BU6 00000112417VE1 00000704/10107 00000507809BU2 00000452846BU9 00000107/50809 00000536851BU9 00000112425VE4 00000466712BU7 00001005/40426 00000460610BU9 00000112432VE0 00000307/50905 00000520296BU5 00000469347BU9 00000460603BU4 00000507/50935 00000452850BU1 00000307/50893 1203100022 00000536901BU2 00000407/50913 00000452857BU6 00000460559BU8 00000112433VE8 00000536849BU3 00000107/50819 00000536905BU3 00000807/61013 00000105/30213 00000520246BU0 00000520301BU3 00000460614BU1 00000105/30204 00000904/20136 00000507810BU0 00001003/00013 00000507802BU7 00000452887BU3 00000407/50168 00000907/61025 00001007/61036 00000520249BU4 00000452852BU7 00000707/60174 00001107/61043 00001107/61049 00000520275BU9 00001207/61086 00000453189BU3 00000807/61016 00001007/61031 00000108/61111 00001207/61083 00000452825BU3 00000108/61108 00000304/10062 00001007/61041 00000460587BU9 00000460571BU3 00000807/61021 00000452858BU4 00000807/61023 00000704/20104 00001207/61089 00000536890BU7 00000904/20139 00000520282BU5 00000469361BU0 00000707/60977 00000507803BU5 00000483703BU5 00000520288BU2 00000460624BU0 00000407/50912 00000469395BU8 00000307/50903 00000404/10085 00000507779BU7 00000499155BU0 00000469300BU8 00001104/20156 00000460599BU4 00000407/50920 00000452893BU1 00000307/50865 00000520235BU3 00000469239BU8 00000469247BU1 00000469416BU2 00000499170BU9 00000607/50964 00000466689BU7 00000466758BU0 00000507828BU2 00000469235BU6 00000536920BU2 00000607/50969 00000469293BU5 00000469277BU8 00000460517BU6 00000466715BU0 00000452822BU0 00000469242BU2 00000466732BU5 00000466698BU8 00000469318BU0 00000105/30153 00000807/60626 00000707/50607 00000466694BU7 00000469286BU9 00000407/50589 00000507829BU0 00000453151BU3 00000407/50592 00000469249BU7 00000407/50597 00000469260BU4 00000466725BU9 00000452833BU7 00000452820BU4 00000507831BU6 00000466729BU1 00000466708BU5 00000499163BU4 00000607/50606 00000536908BU7 00000453137BU2 00000807/60625 00000453157BU0 00000507808BU4 00000460565BU5 00000466720BU0 00000904/20133 00000469419BU6 00000536853BU5 00000507782BU1 00000460547BU3 00000507790BU4 00000460574BU7 00000112411VE4 00000407/50919 00000507/50958 00000524149BU2 00000907/61026 00000112442VE9 00000407/50166 00000108/61118 00000460548BU1 00000536919BU4 00000707/60997 00000707/50973 00000520260BU1 00000453143BU0 00000469301BU6 00000507785BU4 00000469255BU4 00000453147BU1 00000460541BU6 00000524126BU0 00000507/50960 00000493806BU4 00000499139BU4 00000453215BU6 00000507/50942 00000453171BU1 00000520297BU3 00000483690BU4 00000536841BU0 00000469254BU7 00000453209BU9 00000452911BU1 00000466759BU8 00000520236BU1 00000536879BU0 00000452881BU6 00001107/61056 00000112451VE0 00000524142BU7 00000307/50867 00000507/50933 00000507/50949 00000469376BU8 00000604/10089 00000520256BU9 00000469374BU3 00000407/50917 00000507/50934 00000507/50955 00000520284BU1 00000469229BU9 00000452802BU2 00000466692BU1 00000466726BU7 00000707/50612 00000407/50593 00000536893BU1 00000466722BU6 00000460529BU1 00000469319BU8 00000304/20127 00000499137BU8 00000524132BU8 00000407/50588 00000469270BU3 00000507/50945 and 00000507/50946;
b) Serial Numbers: 00000466713BU5 00000466705BU1 00000524119BU5 00000536916BU0 00000112428VE8 00000460509BU3 00000507823BU3 00000460516BU8 00000469271BU1 00000460505BU1 00000460528BU3 00000466687BU1 00000536866BU7 00000405/40253 00000466707BU7 00000307/50880 00000520248BU6 00000460549BU9 00000307/50896 00000469345BU3 00000112416VE3 00000466740BU8 00000460554BU9 00000469342BU0 00000466739BU0 00000466743BU2 00000466677BU2 00000460504BU4 00000466762BU2 00000307/50866 00000460623BU2 00000407/50914 00000536903BU8 00000707/60983 00000507796BU1 00000524158BU3 00000469363BU6 00000520259BU3 00000536827BU9 00000707/60999 00000466754BU9 00000493790BU0 00000520267BU6 00000112421VE3 00000493801BU5 00000407/50170 00000469344BU6 00000452845BU1 00000112418VE9 00000469335BU4 00000112431VE2 00000807/61017 00000469351BU1 00000460631BU5 00000469312BU3 00000452829BU5 00000520264BU3 00000536837BU8 00000605/00051 00000460609BU1 00000520276BU7 00000112419VE7 00000469370BU1 00000469358BU6 00000493805BU6 00000524117BU9 00000460520BU0 00000466675BU6 00000460511BU9 00000483699BU5 00000536839BU4 00000460615BU8 00000469328BU9 00000207-50843 00000466751BU5 00000469263BU8 00000507/50938 00000524147BU6 00000452812BU1 00000460569BU7 00000452921BU0 00000453224BU8 00000466767BU1 00000460503BU6 00000206/40463 00000524124BU5 00000460597BU8 00000407/50916 40372 00000452901BU2 404110077 00000466684BU8 00000536876BU6 00000536850BU1 00000536913BU7 00000466756BU4 00000469269BU5 00000507813BU4 00000112405VE6 00000112410VE6 00000460576BU2 00000466685BU5 00000466714BU3 00000466671BU5 00000536836BU0 00000108/60209 00000108/61090 00000707/60992 00000452836BU0 00001207/61063 00000907/60631 00000460585BU3 00000460563BU0 00000536904BU6 00000536922BU8 00000469372BU7 00000112447VE8 00000207/50856 00000460562BU2 00000520294BU0 00000707/60614 00000466674BU9 00000452840BU2 00000466734BU1 00000469299BU2 00000452826BU1 00000466700BU2 00000460532BU5 00000452841BU0 00000112452VE8 00000469302BU4 00000469244BU8 00000453158BU8 00000466735BU8 00000469224BU0 00000469282BU8 00000112400VE7 00000607/50602 00000469297BU6 00000466717BU6 00000524113BU8 00000507/50957 00000452927BU7 00000112436VE1 00001007/61039 00001007/61038 00000493808BU0 00000460510BU1 00000469272BU9 00000466681BU4 00000469288BU5 00000807/50176 00000520293BU2 00000469289BU3 00000469294BU3 00000469256BU2 00000469275BU2 00000460589BU5 00000536838BU6 00000460538BU2 00000466752BU3 00000307/50881 00000520274BU2 00000507/50950 00000520257BU7 00000524135BU1 00000507781BU3 00000507775BU5 00000536865BU9 00000707/50970 00000524161BU7 00000507797BU9 00000507784BU7 00000469401BU4 00000450567BU1 00000524143BU5 00001107/61052 00000469245BU5 00000806/00082 00000907/00156 00000460540BU8 00000460531BU7 00000460605BU9 00000112449VE4 00000607/50967 00000466730BU9 00000460526BU7 00000507/50922 00000469375BU0 00000460542BU4 00000469325BU5 00000499146BU9 00000499147BU7 00000520292BU4 00000469238BU0 00000460553BU1 00000469257BU0 00000520298BU1 00001107/61050 00000469259BU6 00000520258BU5 00000466747BU3 00000493803BU1 00000536891BU5 00000907/60637 00001107/60657 00000469399BU0 00000407/50586 00000407/50590 00000407/50596 00000469276BU0 00000507837BU3 00000469248BU9 00000507830BU8 00001207/60664 00000507838BU1 00000407/50165 00000520270BU0 00000469261BU2 00000507788BU8 00000707/50610 00000536923BU6 00000466742BU4 00000536854BU3 00000469290BU1 00000524150BU0 00000469281BU0 00000469258BU8 00000499178BU2 00000507772BU2 00000483696BU1 00000452934BU3 00000493794BU2 00000499180BU8 00000536832BU9 00000452914BU5 00000452908BU7 00000407/50164 00000483691BU2 00000452900BU4 00000807/60183 00000112456VE9 00000469333BU9 00000469387BU5 00000499154BU3 00000707/60980 00000469307BU3 00000466697BU0 00000469233BU1 00000524133BU6 00000112446VE0 00000707/50609 00000466731BU7 00000466718BU4 00000307/50882 00000460620BU8 00000469396BU6 00000524172BU4 00000469386BU7 00000524171BU6 00000507836BU5 00000707/60984 00000707/60617 00000469324BU8 00000707/50976 00000452831BU1 00000520240BU3 00000307/50889 00000469284BU4 00000520253BU6 00000607/50604 00000507839BU9 00000507/50952 00000469360BU2 and 00000307/50909;
c) Serial Numbers: 00000469348BU7 00000536877BU4 404110063 00000452883BU2 00000504/10096 00000460596BU0 00000469365BU1 00000704/20115 704120114 00000536912BU9 00000460572BU1 00000052416BU0 00000460630BU7 00000307/50895 120310008 00001104/20158 00000507/50928 00000460594BU5 00000452882BU4 00000453177BU8 00000461253BU7 00000307/50879 20116 00001004/20116 00000307/50884 1003100012 00000536843BU6 00000469338BU8 00000112413VE0 50410084 00000452854BU3 00000453150BU5 00000453167BU9 00000524168BU2 904120023 00000452892BU3 00000112412VE2 00000524121BU1 00000469322BU2 00000112461VE9 00000507/50921 00000507767BU2 00000469371BU9 00000112408VE0 00000905/40399 00000453140BU6 00000907/61022 00001003/00003 00000469364BU4 1203100039 00000452885BU7 00000469346BU1 404110064 00000452862BU6 00000507812BU6 00000499183BU2 00000499131BU1 00000483701BU9 00000452873BU3 1203100032 00000466706BU9 0000066706BU94 00000452871BU7 00000536900BU4 00000112403EV1 00000112403VE1 1203100034 1003 00000453165BU3 00000469337BU0 404110079 00000469264BU6 00000466763BU0 00000520277BU5 110310015 00000469330BU5 00000524129BU4 00001004/20145 00000404/10086 104100047 304110017 00000GD60U6-GE 00000904/20130 00000453213BU1 00000469394BU1 1103100020 00000461251BU1 1203100033 110420162 00000469367BU7 00000466688BU9 00000469381BU8 00000469350BU3 00000460560BU6 504110085 00000112397VE5 00000307/50868 00000507832BU4 00000307/50877 00000452828BU7 00000524154BU2 00000GD60U4-GE 00000469407BU1 904 00000524163BU3 00000460611BU7 00000466709BU3 00000460579BU6 00000104/00046 00000461252BU9 00000460568BU9 0000CA04110576 00000112434VE6 00000466755BU6 00000704/20106 00000520281BU7 00000499151BU9 00000469227BU3 00000469240BU6 00000460591BU1 00000104/00042 1204130176 00000499150BU1 00000507805BU0 00000452848BU5 604120099 00000307/50886 00000105/30203 00000105/32203 00000452880BU8 00000907/60635 1204130198 00000307/50885 00000469310BU7 00000804/20123 00001003/00007 1003100004 00000507815BU9 00000493792BU6 00000105/30201 00000460570BU5 00000507/50937 00000707/60995 00000461250BU3 00000524155BU9 00000507771BU4 00000524137BU7 00000452861BU8 00000507818BU3 00000104/00048 00000404/10074 00001204/30196 00000112398VE3 00000520251BU0 00000520278BU3 00001207/61080 00000507766BU4 00000805/40266 00000469317BU2 00000404/16671 00001207/61071 00000108/61116 00001207/60662 00001207/61067 00001104/20129 00000807/61014 00000108/61106 00000524114BU6 00000452811BU3 00001207/61087 00001007/61035 00001207/61064 00000460601BU8 00001207/60196 00001207/61081 00000453211BU5 00000469273BU7 00000108/61099 00000460577BU0 00000466745BU7 00000404/10066 00000707/60981 00000452879BU0 00000707/61001 00000453170BU3 00001004/20119 00001007/61034 00000108/61095 00000707/60988 00000707/61000 00001004/20146 00000460618BU2 00001207/60200 00000536872BU5 00000507/50931 00000507/50932 00000520299BU9 00001206/30188 00000507793BU8 00001104/20170 00000307/50888 00000536917BU8 00000524164BU1 00000452800BU6 00000507827BU4 00000469305BU7 00000520242BU9 00000507/50951 304110070 00000536832BU1 00000469393BU3 00001203/00034 00000112438VE7 00001203/00030 00000460566BU3 00000604/20097 00000469379BU2 00000507/50954 00000807/60622 00000807/61006 00000453135BU6 00000507/50953 00000407/50587 00000469391BU7 00000460575BU4 00000707/50975 00001104/20134 00000499165BU9 00000469241BU4 00000469253BU9 00000466761BU4 00000499189BU9 00000469331BU3 1204130137 00000499142BU8 00000108/60208 00000112454VE4 00000493796BU3 00000112401VE5 00000407/50918 00000469339BU6 00000507824BU1 00000452803BU0 00000507/50930 00000208/61132 00000404/10074 00000466703BU6 00000524130BU2 00000524160BU9 00001107/61060 00000507799BU5 and 00000807/60623;
d) Serial Numbers: 00001104/20163 00000453208BU1 00000604/20009 00000452923BU6 00001104/20026 1003000011 106100046 304110016 00000483694BU6 1103100017 00000483695BU3 00001004/20125 00000452904BU6 00000905/40049 50410007 00000904/20132 00000904/20010 00001103/20127 00000404/10003 00000466738BU2 1203100011 00000453217BU2 00001103/00006 00000045295BU1 1203100009 120340010 00000461244BU6 00000499182BU4 00000453148BU9 00000460515BU0 00000461241BU2 00001204/30194 00000453153BU9 00000705/40244 00000452906B01 00000452906BU1 00000453194BU3 00000453146BU3 00000604/20019 00000466737BU4 00001107/61054 00000453132BU3 00000453154BU7 00000453156BU2 00000453161BU2 00000469231BU5 00000452821BU2 00000461245BU3 00000112406VE4 00000461242BU0 00000453152BU1 00000461246BU1 00000461247BU9 00000461243BU8 00001107/00019 00000469389BU1 00000452835BU2 00000466670BU7 00000469265BU3 00000466721BU8 00000453149BU7 and 00000453216BU4;
e) Serial Numbers: 00000483707BU6 00000452932BU7 00000208/00036 00000452935BU0 00001107/00021 00000907/00004 00000208/00039 00001107/00016 00001007/00009 00000707/00001 00000907/00003 00000907/00008 00001007/00014 00000907/00010 00000907/00003 00000907/00005 00000907/00009 00000208/00035 00000907/00007 00001107/00012 00000907/00006 00001007/00011 00000907/00002 00000452928BU5 00000208/00033 00001107/00022 Unknown 00000536861BU8 00001007/60645 00001107/61044 00000907/60638 00000105/30208 00000469378BU4 00000524123BU7 00000604/10099 00000460514BU3 00000536894BU9 204110064 304110062 304110071 404110070 404110087 00000105/30033 00000105/30151 00000105/30154 00000105/30155 00000105/30202 00000105/30205 00000108/00027 00000108/00029 00000108/00030 00000108/60206 00000108/60207 00000108/60210 00000108/60673 00000108/60675 00000108/60676 00000108/60677 00000108/61091 00000108/61104 00000108/61105 00000108/61107 00000108/61109 00000108/61110 00000108/61113 00000108/61114 00000108/61115 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00000108/00028 00000108/61092 00000452898BU0 00000907/00002 00000907/60188 00001007/61033 00000307/50901 00000907/60636 00000453134BU9 00000907/00004 00000907/61029 00001007/00017 00000520303BU9 00000108/61098 00000452805BU5 00000907/60632 00001107/61051 00000108/60672 00000108/61097 00000453210BU7 00000460534BU1 00000499184BU0 00000524146BU8 00000807/61003 S0000607/50962 5126893 00000108/00031 00000108/00032 00000108/61100 00000108/61112 00000112430VE4 00000112435VE3 00000112444VE5 00000112455VE1 00000208/00034 00000407/50169 00000452796BU6 00000452847BU7 00000452876BU6 00000452877BU4 00000452902BU0 00000452910BU3 00000452912BU9 00000452924BU4 00000453212BU3 00000453214BU9 00000466741BU6 00000466750BU7 00000483692BU0 00000499171BU7 00000499174BU1 00000499176BU6 00000499179BU0 00000499187BU3 00000499190BU7 00000520300BU5 00000536898BU0 00000607/50968 00000707/50608 00000907/60186 00000907/60193 00001107/00023 00001107/61058 00000499160BU0 00000507789BU6 00000524141BU9 00000108/60205 00000907/60195 00001107/60659 00001007/00016 00001007/61037 00000499161BU8 00001207/60197 00000707/60987 00000907/61030 00001007/61032 00000520304BU7 00000112453VE6 00000453176BU0 00000453181BU0 00000466728BU3 00000469283BU6 00000493798BU3 00000707/60618 00000807/51008 00000807/60619 00000807/60620 00000108/60666 00000407/50594 00000407/50599 00000507/50943 00000507/50947 00000507/50948 00001107/61042 00000452913BU7 00000499177BU4 00000807/50178 00001107/00020 00000507/50925 and 00000536847BU7;
f) Serial Numbers: 00000108/61094 1003100013 0000010031000L 00000452818BU8 00000704/20108 1103100019 1103100019 00000404/10070 104100053 104100051 104100057 00000452834BU5 1104120128 00000452889BU9 00000452890BU7 00000524134BU4 00001104/20167 909110081 1103100025 00000452863BU4 000005041A0050 0000904/201135 00000405/40184 00001104/20157 00000704/20105 00000452867BU5 00000604/10092 00000452856BU8 1103100021 00000569/100S1 204110065 00000452886BU5 00000607/60971 00000469421BU2 106100066 1003100009 00000453141BU4 00001204/30186 00001104/20172 00000466711BU9 00000704/20102 00000469228BU1 1103100017 00000707/50172 30177 100300002 110300023 1103100026 00001003/00002 00001103/00023 00000452894BU9 609110902 00000304/20129 00000404/10078 00000704/20112 00000105/30149 00000466679BU8 104100050 00000707/60998 00000469313BU1 00000307/50908 00000807/61002 00000805/40289 00000452817BU0 00001207/61076 00000105/30150 00000469278BU6 00001004/20007 00001207/60203 00000469262BU0 00001207/61070 00000524144BU3 00000807/61012 00000469252BU1 00000707/50611 00000524120BU3 00000807/61005 00000805/40263 00001107/60651 00000405/40252 00001003/00006 00000453164BU6 00001204/30189 204110049 00000536915BU2 00000452844BU4 00001204/30200 00000507826BU6 00000536925BU1 00000460519BU2 00000466701BU0 00000452849BU3 1203100025 00000104/00052 00000452839BU4 00000536863BU4 00000460617BU4 00000452815BU4 00000452838BU6 1203100041 304110072 24110061 204110061 00000466746BU5 00001003/00012 00001203/00035 00000453138BU0 110360007 00000104-00014 00001004/20150 00000604/20095 00000604/20098 00000704/20111 00000453136BU4 00000453179BU4 00000452868BU3 00000452797BU4 00000461248BU7 00001204/30197 00000104/00044 00001204/30147 00000460593BU7 1203100038 00000466744BU0 00000452810BU5 704120118 00000452819BU6 00000507/50936 00000604/10087 00000112450VE2 00000460543BU2 00001003/00008 00000452816BU2 00000499172BU5 and 00000499169BU1
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI, by letter dated May 2008.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
REASON
GE Healthcare has become aware of 2 potential conditions that could occur with the MAVIG GD Monitor Suspension that is used with Advantx-E, Innova 2000, 21000IQ, 3100/3100IQ, 4100/4100IQ and 2121 IQ/3131IQ cardiovascular systems. The two conditions include 1). Due to insufficient securing of the connecting elements, the LCD vertical monitor support may disengage from its arm and fall on the table or into the table vicinity and 2). Only Service personnel working inside the suspension may potentially experience this condition: Incorrect cable routing on side, inside the LCD monitor suspension arm, may cause the ECG monitor power cable to be damaged, potentially resulting in a short circuit that could cause sparks. The potential risk of an electrical shock affects only Service personnel working inside the Mavig suspension without first tuning off both power supplies of the X-ray equipment and of the ECG monitor.
VOLUME OF PRODUCT IN COMMERCE
1,628 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) 10ml Control Syringe, REF/CAT No.: CCX011 Version A, Sterile EO. The product
is used for injections of contrast medium during Coronary or Peripheral Angiography
and Angioplasty, Recall # Z-2366-2008;
b) 12ml Control Syringe, REF/CAT No.: CCS601 Version B, Sterile R. The product is
used for injections of contrast medium during Coronary or Peripheral Angiography
and Angioplasty, Recall # Z-2367-2008;
c) 12ml Control Syringe / Smart Tip, REF/CAT No.: ST601, Sterile EO. The product is
used for injections of contrast medium during Coronary or Peripheral Angiography
and Angioplasty, Recall # Z-2368-2008
CODE
a) Lot Number: F621152;
b) Lot Number: F620653;
c) Lot Number: F620922
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT, by letters dated July 9, 2008. Firm initiated recall is ongoing.
REASON
Control Syringes may be non-sterile due to holes in the packaging.
VOLUME OF PRODUCT IN COMMERCE
1,298 units
DISTRIBUTION
CA, FL, GA, ID, IL, IN, KS, LA, MO, MT, OH, PA, TN, WA and Japan
___________________________________
PRODUCT
BD 60 ml Syringe, Luer-Lok Tip Sterile; Cases: 160 (4 x 40) Shelf Carton: 40 BD; Made in USA. Syringes for use in aspiration and injection of medications. Reorder Number: 309653, Recall # Z-2374-2008
CODE
Lot numbers beginning with the numbers 5, 6, or 7 and also the following lot numbers. 8010954, 8014571, 8031115, 8031117, 8031119, 8031124, 8031133, 8038154, 8038158, 8045564, 8045567, 8058890, 8058896, 8058898, 8058900, 8058902, 8072401, 8072409, 8072414, 8072419, 8079645, and 8079656
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co., Franklin Lakes, NJ, by letters on July 15, 2008.
Manufacturer: Becton Dickinson & Co., Columbus, NB. Firm initiated recall is ongoing.
REASON
Becton Dickinson identified the presence of open seals during an internal inspection process.
VOLUME OF PRODUCT IN COMMERCE
1,246 lots
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) VERTIER Surgical Table, Catalog #0788-100-000 (Standard table); Is an AC
powered, general purpose, mobile surgical table with electro-hydraulically controlled
movements which are part of a control feedback system, Recall # Z-2376-2008;
b) VERTIER Surgical Table, Catalog #0788-100-001 (Standard table with 5th wheel);
Is an AC powered, general purpose, mobile surgical table with electro-hydraulically
controlled movements which are part of a control feedback system, Recall # Z-2377-
2008;
c) VERTIER Surgical Table, Catalog #0788-100-000S (SIDNE-enabled standard table);
Is an AC powered, general purpose, mobile surgical table with electro-hydraulically
controlled movements which are part of a control feedback system, Recall # Z-2378-
2008;
d) VERTIER Surgical Table, Catalog #0788-100-001S (SIDNE-enabled standard table
with 5th wheel); Is an AC powered, general purpose, mobile surgical table with
electro-hydraulically controlled movements which are part of a control feedback
system, Recall # Z-2379-2008
CODE
All lot codes/serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Communications Corp., Flower Mound, TX, by letters on July 2, 2008.
Manufacturer: Merivaara Corp., Lahti, Finland. Firm initiated recall is ongoing.
REASON
Hydraulic lines responsible for tilting the surgical table have the potential to be severed when articulating table to its lowest position, possibly resulting in the unexpected and rapid movement of the table.
VOLUME OF PRODUCT IN COMMERCE
90 units
DISTRIBUTION
AR, CA, FL, GA, ID, IL, IN, KS, KY, MN, MO, ND, NJ, NY, OH, OK, OR, SD, TX, UT, VA and Washington DC
___________________________________
PRODUCT
Xpect Giardia/Cryptosporidium Kit, Ref 24050520, 20 tests per kit, For In Vitro Diagnostic Use. A rapid test for the direct qualitative detection of Giardia and Cryptosporidium antigens in fecal specimens, Recall # Z-2432-2008
CODE
Lot numbers 597374, Exp. 2008.10.08; 607636, Exp. 2008.11.06; 615970, Exp. 2008.12.02; 615971, Exp. 2008.12.02; 621187, Exp. 2008.12.02; 622617, Exp. 2009.04.02; 624618, Exp. 2009.01.02; 635553, Exp. 2009.04.17; 635554, Exp. 2009.04.24; 640609, Exp. 2009.05.01; 654829, Exp. 2009.05.30; and 658878, Exp. 2009.05.30
RECALLING FIRM/MANUFACTURER
Remel, Inc., Lenexa, KA, by letters dated June 19, 2008. Firm initiated recall is ongoing.
REASON
Faint grey test lines for Cryptosporidium may be visible which may be interpreted as false positive.
VOLUME OF PRODUCT IN COMMERCE
3,974 kits
DISTRIBUTION
Nationwide, Canada and U.K
___________________________________
PRODUCT
BD Visitec Disposable Instrument (plastic handle) Capsulorhexis Forceps, Sterile Ref: 581440, Used during cataract and other ophthalmic surgery procedures to grasp lens capsule, Recall # Z-2433-2008
CODE
Lot Number: 8067450 Exp. Date: March 2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson and Co., Waltham, MA, telephone on July 7, 2008.
Manufacturer: Becton Dickinson Ophthalmic Systems, Warwickshire, UK. Firm initiated recall is ongoing.
REASON
Metal particulates present.
VOLUME OF PRODUCT IN COMMERCE
260 units
DISTRIBUTION
CA, IL, KY, MS, PA, and TX
END OF ENFORCEMENT REPORT FOR OCTOBER 15, 2008
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