Enforcement Report

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.

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September 26, 2007
07-39

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS I
___________________________________
PRODUCT
ACME brand New York's original Smoked Nova Salmon, net wt. 4 oz. (113g) and 8 oz.. The product is vacuum packed, Recall # F-515-7
CODE
Code 9428, SELL BY 09 26 07
RECALLING FIRM/MANUFACTURER
Acme Smoked Fish Corp., Brooklyn NY, by press release and telephone on August 14, 2007. Firm initiated recall is complete.
REASON
The specific code of smoked salmon was found to be contaminated with Listeria monocytogenes based on sampling and analysis by the Florida Department of Agriculture & Consumer Services.
VOLUME OF PRODUCT IN COMMERCE
4 oz. – 132 lbs; 8 oz. – 114 lbs.
DISTRIBUTION
FL
___________________________________
PRODUCT
Scharffen Berger Kumasi Sambirano. 68% Cacao. Pure Dark Chocolate. A blend of beans from Ghana and Madagascar. The product is a 3 oz chocolate bar, Recall # F-516-7
CODE
Lots: 09067, 09107, 09117, 09127, and 09137
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hershey Foods Corp., Hershey, PA, by press release on July 6, 2007, and letters and emails.
Manufacturer: Artisian Confections, Berkeley, CA. Firm initiated recall is complete.
REASON
Product contains undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
52,224 bars
DISTRIBUTION
Nationwide, Denmark, Canada, and New Zealand
___________________________________
PRODUCT
American Sports Nutrition Major Egg Pharmaceutical Grade Protein 2.2 lbs (1000 g) Vanilla, Chocolate and Wildberry flavors) 100% Natural, UPC 6 34659 11221 2, Recall # F-527-7
CODE
Lot numbers 60990, 61217, 60624, 61256, 60991, 61187, 60992
RECALLING FIRM/MANUFACTURER
Quality Formulation Laboratories, Inc., Paterson, NJ, by letters on January 31. 2007 . A second letter was scheduled to be sent to non-responders on 2/19/07. Firm initiated recall is ongoing.
REASON
Product contains undeclared milk..
VOLUME OF PRODUCT IN COMMERCE
364 bottles, 2.2 lbs each
DISTRIBUTION
CA, FL, SC, PA and TN as well as Dubai, UAE.

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS II
___________________________________
PRODUCT
Talking Rain spring water in 16.9 oz (500 ml) plastic ribbed bottles, packed 30 per cases, Recall # F-517-7
CODE
7115PRXXXXA or B 7 = year 2007; 115 = Julian date; PR = Preston, WA; next 4 digits represent military time; A or B represents the packaging line.
RECALLING FIRM/MANUFACTURER
Talking Rain Beverage Co Inc, Preston, WA, by email on August 27, 2007 and August 28, 2007. Firm initiated recall is ongoing.
REASON
Levels of bromate in water exceeds the maximum 10 ppb amount allowed.
VOLUME OF PRODUCT IN COMMERCE
4,538 cases each containing 30 16.9 oz. bottles
DISTRIBUTION
WA, OR, ID, and MT
___________________________________
PRODUCT
Kedem Apple Juice, Pasteurized, All Natural in 64 oz. plastic bottles with UPC 0 73490 12355 9, Recall # F-518-7
CODE
A206G, A207G
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kedem Food Products & Royal Wine Corp., Bayonne, NJ, by e-mail and telephone beginning on August 24, 2007.
Manufacturer: Brooklyn Bottling Of Milton, NY, Milton, NY. Firm initiated recall is ongoing.
REASON
Apple juice was contaminated with Clostridium butyricum.
VOLUME OF PRODUCT IN COMMERCE
14,216 cases (8 x 64 ox. bottles/case)
DISTRIBUTION
CA, CT, FL, IL, IN, MD, MA, MN, NJ, NY, OH, VT, England, Panama, Israel and Quebec
___________________________________
PRODUCT
Los Angeles Salad Company Genuine Sweet Baby Carrots; 672 g/1.5 lb plastic bags, 7 oz (198g) plastic bags, 8 oz (227g) plastic bags; UPC 8 31129 00137 7, UPC 8 31129 00617 4, UPC 8 31129 00710 2; Trader Joe's Genuine Sweet Baby Carrots Hand Peeled; 7 oz (198g); UPC 0090 7958; Recall # F-519-7
CODE
Sell By dates up to and including 8 /16 /07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Los Angeles Salad Company, City of Industry, CA, by telephone and press release on August 22, 2007, and by letters on August 23, 2007.
Manufacturer: Manuel Armando Delgado, Ensenada, Mexico. Firm initiated recall is ongoing.
REASON
Baby carrots are associated with Shigella sonnei outbreak.
VOLUME OF PRODUCT IN COMMERCE
5,797 cases
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
a) Knudsen Free Nonfat Cottage Cheese; packaged in 16 oz. plastic cartons/
    12 cartons per case and 32 oz. plastic cartons/6 cartons/case; UPC 49900-10020
    and 49900-10060, Recall # F-523-7;
b) Knudsen Lowfat Cottage Cheese, 2% Milkfat, Small Curd; packaged in 16 oz.
    plastic cartons/12 cartons per case, 32 oz. plastic cartons/6 cartons/case, and 48 oz.
    plastic cartons/6 cartons/case; UPC 49900-34504, 49900-34702, 49900-34630,
    Recall # F-524-7;
c) Knudsen Cottage Cheese, 4% Milkfat, Small Curd; packaged in 16 oz. plastic
    cartons/12 cartons per case and 32 oz. plastic cartons/6 cartons/case;
    UPC 49900-34272 and 49900-34264, Recall # F-525-7;
d) Knudsen Lowfat Cottage Cheese & Pineapple, 1.5% Milkfat, Small Curd;
    packaged in 16 oz. plastic cartons/12 cartons per case; UPC 49900-30270,
    Recall # F-526-7
CODE
Sell By Dates of 31 AUG 2007 or earlier
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kraft Food, Inc., Northfield, IL, by memo, e-mail, fax or visit beginning on August 3, 2007.
Manufacturer: Kraft Foods, Inc., Tulare, CA. Firm initiated recall is ongoing.
REASON
Cottage cheese products are contaminated with yeast and mold.
VOLUME OF PRODUCT IN COMMERCE
179,773 cases
DISTRIBUTION
AZ, CA, CO, NV, OR, UT and WA
___________________________________
PRODUCT
Gilchrist & Soames toothpaste/dentifrice, 0.65 fl.oz., Manufactured in China. Product was distributed to hotels/motels for use by their guests and was distributed both separately and as part of a dental kit with toothpaste, sample kits with toothpaste and a VIP kit with toothpaste, Recall # F-532-7
CODE
All tubes without a lot number embossed into the crimp end.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gilchrist & Soames, Indianapolis, IN, by press release and letter on August 13, 20007.
Manufacturer: Ming Fai Manufactory, Dong Guan, China (Mainland). Firm initiated recall is ongoing.
REASON
Toothpaste contains diethylene glycol.
VOLUME OF PRODUCT IN COMMERCE
658,054 tubes
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Popcorn mixed with marshmallow, peanut halves, and margarine, with colors added
    (popcorn ball type product). Product is known as "Piece-o-cake". Product is
    rectangle in shape (3 1/2 " x 4" x 1") packaged in clear bag with twist tie closure.
   The labeling states "THE POPCORN COLONEL America's Leader in Gourmet
    Popcorn", Recall # F-533-7;
b) Carmel popcorn ball, in clear cello bag with twist tie closures. Labeling states
    "THE POPCORN COLONEL America's Leader in Gourmet Popcorn",
    Recall # F-534-7;
c) Vanilla popcorn ball in clear plastic bag with twist tie closure. Labeling states
    "THE POPCORN COLONEL America's Leader in Gourmet Popcorn",
    Recall # F-535-7
CODE
Product not coded
RECALLING FIRM/MANUFACTURER
The Popcorn Colonel, Great Falls, MT, by visit and letter on August 27, 2007. Firm initiated recall is complete.
REASON
a) Lack of ingredient statement - undeclared allergens: peanuts, skim milk, milkfat,
    soy lecithin, yellow #5, yellow 5 lake, yellow #6, yellow 6 lake, blue 1 lake,
    red 40 lake, blue 2 lake, red #3, red #40, blue #1;
b) Lack of ingredient statement - undeclared allergens: , soy lecithin, yellow #5,
    yellow #6, red #3, red #40, blue #1;
c) Lack of ingredient statement - undeclared allergens: soy lecithin, yellow #5,
    yellow #6, red #3, red #40, blue #1
VOLUME OF PRODUCT IN COMMERCE
Piece-o-cake - 245 Popcorn balls - 80, Caramel popcorn balls - 80
DISTRIBUTION
MT

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS III
___________________________________
PRODUCT
Pure Encapsulations Vitamin B12 Liquid, hypo-allergenic dietary supplement, Amber 30 ml (1 oz) bottle with a dropper UPC 7 6629800937 7, Recall # F-521-7
CODE
Lot number: 4450707 Best by Date 07/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pure Encapsulation, Inc., Sudbury, MA, by telephone on August 7, 2007 and follow-up letter on August 9, 2007.
Manufacturer: Atrium Innovations, Inc., Quebec, Canada. Firm initiated recall is ongoing.
REASON
Product may be contaminated with mold.
VOLUME OF PRODUCT IN COMMERCE
501 X 30 ml bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Attends Personal Cleansing Washcloths" Large; Adult Wet Washcloths packaged 70 washcloths per low profile tub (Catalog #22574) and Refill Pack (Catalog #22573), Recall # F-522-7
CODE
Lot numbers: 06300 0220715, 06301 0220715, 06302 0220715, 06303 0220715, 06304 0220715, 06305 0220715, 06306 0220715, 06307 0220715
RECALLING FIRM/MANUFACTURER
Rockline Industries, Springdale, AK, by e-mail, telephone and letter beginning on May 1, 2007. Firm initiated recall is ongoing.
REASON
Adult wipes used for perineal cleaning have an off-odor and are discolored.
VOLUME OF PRODUCT IN COMMERCE
14,642 cases
DISTRIBUTION
NC and CA
___________________________________
PRODUCT
a) Hi-C Blast, Orange Flavored Fruit Drink, 1 gallon (128 Fl Oz) 3.78 L,
    UPC 02500001138-2, Recall # F-528-7;
b) Hi-C Blast, Fruit Punch, 1 gallon (128 Fl Oz) 3.78 L, UPC: 02500001139-9,
    Recall # F-529-7;
c) Hi-C Blast, Berry Blue, Raspberry Flavored Fruit Drink, 1 gallon (128 Fl Oz)
    3.78 L, UPC: 02500001171-9, Recall # F-530-7;
d) Hi-C Blast, Wildberry Flavored Fruit Drink, 1 gallon (128 Fl Oz) 3.78 L,
    UPC: 02500001400-0, Recall # F-531-7
CODE
a) End of Shelf Life Dates (EOSL): on or past OCT2307, but before APR0608;
b) (EOSL): on or past NOV0507, but before APR0608;
c) (EOSL): on or past JAN2408, but before APR0608;
d) (EOSL): on or past MAR2508, but before APR0608
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Coca-Cola Company (Corporate Offices), Atlanta, GA, by telephone, letter, fax and email on/about August 6, 2007.
Manufacturer: Coca Cola North America, Paw Paw, MI. Firm initiated recall is ongoing.
REASON
Fruit-flavored beverages contain mold.
VOLUME OF PRODUCT IN COMMERCE
150,000 four-pack cases
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
a) DentaPro Cavity Fighting Fluoride Toothpaste, Spearmint flavor, 6.4 oz tubes,
    labeled ingredients include Sodium monofluorophosphate 0.8% and Diglycol.
    Made in China, Item #9112, Recall # D-975-2007;
b) BrightMax Fluoride Toothpaste, 6.4 oz tubes. Made in China. Item #9111,
    Recall # D-976-2007;
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Donnamax Inc., Brooklyn, NY, by press release on August 7, 2007 and by letters on/about August 21, 2007.
Manufacturer: Goldcredit International Enterprises, Wuxi, Jiangsu, China (Mainland). Firm initiated recall is ongoing.
REASON
Toothpaste from China contains the poisonous chemical diethylene glycol (DEG).
VOLUME OF PRODUCT IN COMMERCE
185 cases
DISTRIBUTION
NY, PA, MA, MI, OH, IL, MS, SC, GA, FL, ID

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Product is labeled as Goldline Genebs Extra Strength Caplets 500 mg Pain Reliever/Fever Reducer. 1000 caplets, Recall # D-970-2007
CODE
Lot No. 6G024
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAAX Pharmaceuticals, Miami, FL, by letter on August 20, 2007.
Manufacturer: Kirk Pharmaceuticals, Inc., Fort Lauderdale, FL. Firm initiated recall is ongoing.
REASON
Foreign capsule found in a 1000 count bottle of Acetaminophen (APAP) 500 mg.
VOLUME OF PRODUCT IN COMMERCE
4,620 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-1340-07;
b) Red Blood Cells, Leukoreduced, Recall # B-1341-07;
c) Red Blood Cells, Leukoreduced, Irradiated, Recall # B-1342-07;
d) Recovered Plasma, Recall # B-1343-07
CODE
a) Units: 53FE76367 53FE76370 53GF47139 53GF46948 53FE76400 53GF47913
    53GF46312 53FE76466 53FE76881 53GF46550 53GF47233 53GF47940
    53GF47830 53GF47602 53FE76512 53FE76526 53GF47524 53GF47526
    53GF47277 53GF46308 53GF46106 53FC18397 53GF45926 53GF46327
    53GF46329 53FE76369 53GF46094 53GF46109 53GF47907 53FE76866
    53FE76767 53FE76511 53GF47527 53GF47532 53FE76390 53GF47272
    53GF47235 53GF46476 53GF46309 53GF46315 53GF45791 53GF47136
    53GF47107 53GL18307 53GF47903 53FE76472 53GF46759 53FC18393
    53FE76879 53FE76501 53FE76477 53GF47297 53FE76355 53GF47238
    53GF47242 53FE76078 53GF46792 53GF46307 53GF46102 53GF46584
    53GF47834 53FE76489 53FE76475 53GF47369 53GF47302 53GF47113
    53GF47810 53FE76409 53FE76337 53FE76362 53GF46702 53GF46762
    53GF46784 53GF47263 53FE76817 53GF46306 53FE76334 53GF47245
    53GF47718 53FE76378 53GF46581 53GF46588 53GF46576 53FC18383
    53GF46283 53GF46131 53GF46134 53GF46138 53GF46124 53GF46129;
b) Units: 53FE76390 53FE76866 53GF47473 53GF47825 53FE76526
    53GF47238 53FE76859 53GF47602 53FE76406 53FE76413 53GF47824
    53GF47532 53FE76335 53FE76339 53FE76902 53FE76851 53FE76510
    53FE76512 53FE76360 53GF47233 53GF47834 53GF47527 53FE76370
    53GF47526 53GF47465 53FE76403 53GL18330 53GF47893 53GF47895
    53GF47898 53GF47901 53FE76881 53FE76809 53FE76799 53FE76806
    53FE76805 53GF47617 53FE76511 53GL18310 53FE76879 53FE76507
    53FE76519 53FE76516 53FE76341 53GL18307 53GF47949 53FE76334
    53GF47971 53GF47966 53GF47471 53GF47363 53GF47372 53GF47830
    53GF47467 53FE76362 53FE76367 53GF47378 53GF47992 53GF47988
    53GF47978 53GF47974 53GF47965 53GL18311 53GL18335 53GF47933
    53GF47935 53GF47938 53GF47907 53FE76861 53FE76868 53FE76870
    53GF47625 53FE76501 53FE76475 53FE76410 53GF47524 53GL18325
    53GF47453 53GF47470 53GF47903 53GF47913 53FE76801 53FE76817
    53FE76808 53GF47718 53FE76489 53FE76337 53FE76909 53GF47625
    53GF47593 53GF47364 53GF47629 53GF47620 53GF47627 53FE76378
    53FE76386 53GL18337 53GL18306 53GF47810 53FE76477 53FE76767
    53FE76472 53FE76409 53FE76355 53FE76369 53FE76365 53GF47622
    53GF47993 53GF47997 53FE76769 53FE76486 53GF47599 53GF47940
    53FE76468 53FE76757 53FE76474 53GF47604 53GF47606 53FE76400
    53FE76470 53GF47995 53GF47586 53FE76984 53FE76752 53Y99491
    53GF47589 53GF47914 53GF47591;
c) Unit: 53FE76753;
d) Units: 53FE76174 53FE76192 53FE76194 53FE76198 53FE76199 53FE76219 53FE76230 53FE76232 53FE76237 53FE76239 53FE76241 53FE76243 53FE76244 53FE76752 53FE76753 53FE76757 53FE76769 53FE76799 53FE76801 53FE76805 53FE76806 53FE76808 53FE76809 53FE76842 53FE76851 53FE76859 53FE76861 53FE76868 53FE76870 53FE76902 53FE76908 53FC18337 53FC18352 53FC18354 53FC18355 53FC18358 53FC18360 53FC18361 53FC18369 53FC18392 53FC18395 53FE76332 53FE76335 53FE76341 53FE76202 53GF47078 53GF47081 53GF47083 53GF47085 53GF47087 53GF47068 53GF47144 53GF47146 53GF47453 53GF47465 53GF47467 53GF47470 53GF47471 53GF47473 53GF47586 53GF47589 53GF47591 53GF47593 53GF47599 53GF47604 53GF47606 53GF46975 53FE76174 53FE76192 53FE76194 53FE76198 53FE76199 53FE76219 53FE76230 53FE76232 53FE76237 53FE76239 53FE76241 53FE76243 53FE76244 53GF45980 53GF45982 53GF46114 53GF46116 53GF46118 53GF46123 53GF46689 53GF46930 53GF46933 53GF46935 53GF46938 53GF46941 53GF46944 53GF46973 53GF47273 53GF47274 53GF47279 53GF47364 53GF47372 53GF47378 53GF45919 53GF45922 53GF45925 53GF45999 53GF46000 53GF46004 53GF46005 53GF46010 53GF46011 53GF46012 53GF46060 53GF46062 53GF46064 53GF46317 53GF46324 53GF46333 53GF46395 53GF46398 53GF46401 53GF46403 53GF46419 53GF46422 53GF46814 53GF46819 53GF46820 53GF46825 53GF46829 53GF46833 53GF46835 53GF46842 53GF46846 53GF46849 53GF46852 53GF47006 53GF47007 53GF47009 53GF47010 53GF47020 53GF47022 53GF47040 53GF47041 53GF47043 53GF47045 53GF47047 53GF46546 53GF46553 53GF46555 53GF46557 53GF46559 53GF46586 53GF46590 53GF46594 53GF46710 53GF46712 53GF46714 53GF46715 53GF46751 53GF46754 53GF46757 53GF46763 53GF46767 53GF46770 53GF46783 53GF46786 53GF46791 53FE76360 53FE76365 53FE76375 53FE76386 53FE76392 53FE76403 53FE76406 53FE76410 53FE76413 53FE76468 53FE76470 53FE76474 53FE76507 53FE76510 53FE76514 53FE76516 53FE76519 53GF45759 53GF45778 53GF45782 53GF45788 53GF45793 53GF46424 53GF46428 53GF46429 53GF46432 53GF46450 53GF46465 53GF46467 53GF46468 53GF46470 53GF46472 53GF46481 53GF46491 53GF46494 53GF46500 53GF46514 53GF46515 53GF46519 53GF46522 53GF46524 53GF46528 53GF46530 53FE76910 53FE76912 53FE76914 53GF47258 53GF47301 53GF47824 53GF47825 53GF47898 53GF47617 53GF47620 53GF47622 53GF47625 53GF47627 53GF47629
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by letter and telephone December 25, 2002 through December 28, 2002. Firm initiated recall is complete.
REASON
Blood donor records were not completed and the blood collected from the donors and shipped to consignees increased the health risk to recipients.
VOLUME OF PRODUCT IN COMMERCE
441 components
DISTRIBUTION
MD, VA, D.C., CA and Switzerland

___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1385-07
CODE
Units: 163843652, 163831997
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc, Scottsdale, AZ, by letter on August 04, 2006.
Manufacturer: Blood Systems Inc/dba United Blood Services, Meridian, MS. Firm initiated recall is complete.
REASON
Platelets, mislabeled as leukoreduced, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MS
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1422-07
CODE
Unit: FW73341
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by letter dated January 29, 2004. Firm initiated recall is complete.
REASON
Blood product, for which viral marker testing was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-1425-07
CODE
Unit: 53GK42471
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD, by facsimile on May 30, 2006. Firm initiated recall is complete.
REASON
Blood product, associated with a platelet unit that was possibly contaminated with coagulase negative Staphylococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-1528-07
CODE
Unit: 4320139
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shrewsbury, NJ, by telephone on May 2, 2006. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Propionibacterium acnes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1531-07
CODE
Unit: 71X383024
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on March 6, 2006. Firm initiated recall is complete.
REASON
Blood product, with an unacceptable platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1532-07
CODE
Unit: 71X439522
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax February 7, 2006. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
a) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1537-07;
b) Platelets Pheresis Leukocytes Reduced, Recall # B-1538-07
CODE
a) Units: 03FK27860 (1 & 2), 03FK27864, 03FK27882, 03FK27897, 03FK27902,
    03FK27930 (1 & 2), 03FK27972, 03FK27975, 03FK27981, 03FK27992 (1 & 2),
    03FK28000 (1 & 2), 03FK28001 (1 & 2), 03FK28011, 03FK28027, 03FK28042;
b) Units: 03FK27864, 03FK27867, 03FK27875 (1 & 2), 03FK27882, 03FK27890,
    03FK27893, 03FK27897, 03FK27902, 03FK27910, 03FK27915, 03FK27922,
    03FK27924, 03FK27937 (1 & 2), 03FK27941, 03FK27947, 03FK27957 (1 & 2),
    03FK27959 (1 & 2), 03FK27962, 03FK27968, 03FK27972, 03FK27975,
    03FK27981, 03FK27988, 03FK28005 (1 & 2), 93FK28013, 03FK28017 (1 & 2),
    03FK28020 (1 & 2), 03FK28021, 03F28032 (1 & 2), 03FK28033 (1 & 2),
    03FK28036, 03FK28037, 03FK28043
RECALLING FIRM/MANUFACTURER
American National Red Cross, Atlanta, GA, by letter dated June 10, 2002. Firm initiated recall is complete.
REASON
Blood products, labeled as leukoreduced, but which did not meet the criteria for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
62 units
DISTRIBUTION
GA
___________________________________
PRODUCT
Source Plasma, Recall # B-1546-07
CODE
Units: LU0093233, LU0095425, LU0110653
RECALLING FIRM/MANUFACTURER
DCI Biologicals Lubbock, LLC, Lubbock, TX, by facsimile on July 21, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided post donation information regarding multiple high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC
___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1547-07;
b) Platelets, Leukocytes Reduced, Recall # B-1548-07;
c) Fresh Frozen Plasma, Recall # B-1549-07
CODE
a), b) and c) Unit: 032KE89305
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by letter dated February 24, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to Hepatitis C virus (anti-HCV), but were collected from a donor who previously tested positive for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IL
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1550-07
CODE
Unit: 5794152
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by telephone on December 28, 2005 or by email on December 29, 2005. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor who was previously deferred for testing repeat reactive for the antibody, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA and Switzerland
___________________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-1563-07
CODE
Unit: 1196786
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by telephone on July 15, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Platelets that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-1564-07
CODE
Unit: 247491246
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by telephone on November 22, 2004.
Manufacturer: Blood Systems, Inc., Rapid City, SD. Firm initiated recall is complete.
REASON
Blood product, which had an unacceptable platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SD
___________________________________
PRODUCT
Platelets, Recall # B-1565-07
CODE
Unit: 1116726
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by letter dated April 28, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with a red cell unit that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN and Switzerland
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1570-07
CODE
Unit: 1055793
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Pau, MN, by email on October 22, 2004 or by letter dated November 16, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor who was previously deferred for testing repeat reactive for the antibody, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN and Switzerland
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1571-07
CODE
Unit: 247480870
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Rapid City, SD, by telephone or email on September 17, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a complete medical history interview, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ and Switzerland
___________________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-1573-07
CODE
Units: 040GV51818, 040GV51830, 040GW63644, 040GW63694, 040GW63706, 040LF11195, 040LF11211, 040LF11221, 040LF11276, 040LT22357
RECALLING FIRM/MANUFACTURER
American National Red Cross Heart of America Region, Peoria, IL, by telephone on February 2, 2007 and by facsimile on February 8, 2007. Firm initiated recall is complete.
REASON
Blood products, which were not frozen within the required one hour following manufacture, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
IL
___________________________________
PRODUCT
Source Plasma, Recall # B-1593-07
CODE
Units: LP037521, LP037537, LZ014098, LZ014334
RECALLING FIRM/MANUFACTURER
Recalling Firm: Interstate Blood Bank Inc., Memphis, TN, by facsimile on December 23, 2005.
Manufacturer: Interstate Blood Bank Inc Mo, Saint Louis, MO. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor that subsequently tested positive for anti-HIV-1/2, were not properly quarantined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA and Austria

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1495-07
CODE
Unit: 5795028
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by email on February 17, 2006. Firm initiated recall is complete.
REASON
Blood product, stored at an elevated temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Red Blood Cells, Leukocytes, Reduced, Irradiated, Washed, Recall # B-1529-07
CODE
Unit: FQ66331 (Part 4)
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by letter dated April 14, 2004. Firm initiated recall is complete.
REASON
Blood product, which may have been exposed to unacceptable temperature during shipment, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
Red Blood Cells, Recall # B-1530-07
CODE
Unit: W70584
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saginaw, MI, by telephone on March 6, 2007. Firm initiated recall is complete.
REASON
Blood product, which was not labeled for an unexpected antibody, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1551-07
CODE
Unit: 5794152
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Alexandria, LA, by telephone on December 28, 2005 or by email on December 29, 2005. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor who was previously deferred for testing repeat reactive for the antibody, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA and Switzerland
___________________________________
PRODUCT
Source Plasma, Recall # B-1552-07
CODE
Unit: 386015730
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Waukegan, IL, by telephone on January 23, 2007 and by facsimile on January 30, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection or general appearance of the donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-1566-07
CODE
Unit: FC2012231 (Parts A & B)
RECALLING FIRM/MANUFACTURER
Community Blood Council of New Jersey, Inc., Trenton, NJ, by facsimile on August 24, 2005. Firm initiated recall is complete.
REASON
Blood products, collected using an expired blood collection set, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ
___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1567-07
CODE
Units: K68754, K73490
RECALLING FIRM/MANUFACTURER
Regional Health, Resource Center, Urbana, IL, by telephone on March 30, 2007. Firm initiated recall is complete.
REASON
Blood products, which were out of controlled storage for more than 30 minutes during leukoreduction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1568-07
CODE
Unit: 123772091
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on June 28, 2007.
Manufacturer: Blood System, Inc., Albuquerque, New Mexico. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1569-07
CODE
UNIT: 1055793
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Pau, MN, by email on October 22, 2004 or by letter dated November 16, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor who was previously deferred for testing repeat reactive for the antibody, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN and Switzerland
___________________________________
PRODUCT
Recovered Plasma, Recall # B-1572-07
CODE
Unit: 247480870
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Rapid City, SD, by telephone or email on September 17, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a complete medical history interview, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ and Switzerland
___________________________________
PRODUCT
a) Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-1574-07;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-1575-07
CODE
a) Units: 129385216 (Parts 1 & 2) and 129388802;
b) Units: 129378337, 129382089, 129382313, 129382320, 129383462,129384765,
129384762, 129384758, 129384300
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on June 29, 2007.
Manufacturer: Blood System, Inc., Albuquerque, NM. Firm initiated recall is complete.
REASON
Blood products, which may have been exposed to unacceptable storage temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
AZ and NM

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
___________________________________
PRODUCT
Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, Buffalo Grove, Illinois; Model AED 20, Catalog Numbers 972213, 972214, 972215, 972216 (Part Numbers 972200E, 972211E, 972212E, 972213E, 972214E, 972215E, 972216E), Recall # Z-1223-2007
CODE
Serial number range - 205787 - 207509 (non-contiguous) 205787, 205788, 205789, 205790, 205791, 205793, 205794, 205795, 205796, 205797, 205798, 205799, 205800, 205801, 205802, 205803, 205804, 205805, 205807, 205808, 205809, 205810, 205811, 205812, 205813, 205814, 205815, 205816, 205817, 205818, 205819, 205820, 205821, 205822, 205823, 205824, 205825, 205826, 205827, 205828, 205829, 205830, 205831, 205832, 205833, 205834, 205835, 205836, 205837, 205838, 205839, 205840, 205841, 205842, 205843, 205844, 205845, 205846, 205847, 205848, 205849, 205850, 205851, 205852, 205853, 205854, 205855, 205856, 205857, 205858, 205860, 205861, 205862, 205863, 205864, 205865, 205866, 205867, 205868, 205869, 205870, 205871, 205872, 205873, 205874, 205875, 205876, 205877, 205878, 205879, 205880, 205881, 205882, 205883, 205884, 205885, 205886, 205887, 205888, 205889, 205890, 205891, 205892, 205893, 205894, 205897, 205898, 205899, 205900, 205901, 205902, 205903, 205904, 205905, 205906, 205908, 205909, 205910, 205911, 205912, 205913, 205914, 205915, 205916, 205917, 205918, 205919, 205920, 205921, 205922, 205923, 205924, 205925, 205926, 205927, 205928, 205929, 205930, 205931, 205932, 205933, 205934, 205935, 205936, 205937, 205938, 205939, 205940, 205941, 205942, 205943, 205944, 205945, 205946, 205947, 205948, 205949, 205950, 205951, 205952, 205953, 205954, 205956, 205957, 205958, 205959, 205960, 205961, 205962, 205963, 205964, 205965, 205966, 205967, 205968, 205969, 205970, 205971, 205972, 205973, 205974, 205975, 205976, 205977, 205978, 205979, 205980, 205981, 205982, 205983, 205984, 205985, 205986, 205987, 205988, 205989, 205990, 205991, 205992, 205994, 205995, 205996, 205997, 205998, 205999, 206000, 206001, 206002, 206003, 206004, 206005, 206006, 206007, 206008, 206009, 206010, 206011, 206012, 206013, 206014, 206015, 206016, 206017, 206018, 206019, 206020, 206021, 206022, 206023, 206024, 206025, 206026, 206027, 206028, 206029, 206030, 206032, 206033, 206034, 206035, 206036, 206037, 206038, 206039, 206040, 206041, 206042, 206043, 206044, 206045, 206046, 206047, 206048, 206049, 206050, 206051, 206052, 206053, 206054, 206055, 206056, 206057, 206059, 206060, 206061, 206062, 206063, 206064, 206065, 206066, 206067, 206068, 206069, 206070, 206071, 206072, 206074, 206075, 206076, 206077, 206078, 206079, 206080, 206081, 206082, 206083, 206084, 206085, 206086, 206087, 206088, 206089, 206090, 206091, 206092, 206093, 206094, 206095, 206096, 206097, 206098, 206099, 206100, 206101, 206102, 206103, 206104, 206105, 206106, 206107, 206108, 206109, 206110, 206111, 206112, 206113, 206114, 206115, 206116, 206118, 206119, 206120, 206121, 206122, 206123, 206124, 206125, 206126, 206127, 206128, 206129, 206130, 206131, 206132, 206133, 206134, 206135, 206136, 206137, 206138, 206139, 206140, 206141, 206142, 206143, 206144, 206145, 206147, 206148, 206149, 206150, 206151, 206152, 206153, 206154, 206155, 206156, 206157, 206158, 206159, 206160, 206161, 206162, 206163, 206164, 206165, 206167, 206168, 206169, 206170, 206171, 206172, 206173, 206174, 206175, 206176, 206177, 206178, 206179, 206180, 206181, 206182, 206183, 206184, 206185, 206186, 206187, 206188, 206189, 206190, 206191, 206192, 206193, 206194, 206195, 206196, 206197, 206198, 206199, 206200, 206201, 206202, 206203, 206204, 206205, 206206, 206207, 206208, 206209, 206210, 206211, 206212, 206213, 206214, 206215, 206216, 206217, 206218, 206219, 206220, 206221, 206222, 206223, 206224, 206225, 206226, 206227, 206228, 206229, 206230, 206231, 206232, 206233, 206234, 206235, 206236, 206237, 206238, 206239, 206240, 206241, 206242, 206243, 206244, 206245, 206246, 206247, 206248, 206249, 206250, 206251, 206252, 206253, 206254, 206255, 206256, 206257, 206258, 206259, 206260, 206261, 206263, 206264, 206265, 206266, 206267, 206268, 206269, 206270, 206271, 206272, 206273, 206274, 206275, 206276, 206277, 206278, 206279, 206280, 206281, 206282, 206283, 206284, 206285, 206286, 206287, 206288, 206289, 206290, 206291, 206292, 206293, 206294, 206296, 206297, 206298, 206299, 206300, 206301, 206302, 206303, 206304, 206305, 206306, 206307, 206308, 206309, 206310, 206311, 206312, 206313, 206314, 206315, 206316, 206317, 206318, 206319, 206320, 206321, 206322, 206323, 206324, 206325, 206326, 206327, 206328, 206329, 206331, 206332, 206333, 206334, 206335, 206336, 206337, 206338, 206339, 206340, 206341, 206342, 206343, 206344, 206345, 206346, 206347, 206348, 206349, 206350, 206351, 206352, 206353, 206354, 206355, 206356, 206357, 206358, 206359, 206360, 206361, 206362, 206363, 206364, 206365, 206366, 206367, 206368, 206369, 206370, 206371, 206372, 206373, 206375, 206376, 206377, 206378, 206379, 206380, 206381, 206382, 206383, 206384, 206385, 206386, 206387, 206388, 206389, 206390, 206391, 206392, 206394, 206395, 206396, 206397, 206398, 206399, 206400, 206401, 206402, 206403, 206404, 206405, 206406, 206407, 206410, 206411, 206412, 206413, 206414, 206415, 206416, 206417, 206418, 206419, 206420, 206421, 206422, 206423, 206424, 206425, 206426, 206427, 206428, 206429, 206430, 206431, 206432, 206433, 206434, 206435, 206436, 206437, 206438, 206439, 206440, 206441, 206442, 206443, 206444, 206445, 206446, 206447, 206448, 206449, 206450, 206451, 206452, 206453, 206454, 206455, 206456, 206457, 206458, 206459, 206460, 206461, 206462, 206463, 206464, 206465, 206466, 206467, 206468, 206469, 206470, 206471, 206472, 206473, 206474, 206475, 206476, 206477, 206478, 206479, 206480, 206481, 206482, 206483, 206484, 206485, 206486, 206488, 206489, 206490, 206491, 206492, 206493, 206494, 206496, 206497, 206498, 206499, 206500, 206501, 206502, 206503, 206504, 206505, 206506, 206507, 206508, 206509, 206510, 206511, 206512, 206513, 206514, 206515, 206516, 206517, 206518, 206519, 206520, 206521, 206522, 206523, 206524, 206525, 206526, 206527, 206528, 206529, 206530, 206531, 206532, 206533, 206534, 206535, 206536, 206537, 206538, 206539, 206540, 206541, 206542, 206543, 206544, 206545, 206546, 206547, 206549, 206550, 206551, 206552, 206553, 206554, 206555, 206556, 206557, 206558, 206560, 206561, 206562, 206563, 206564, 206565, 206566, 206567, 206569, 206571, 206572, 206575, 206576, 206577, 206578, 206579, 206580, 206581, 206582, 206583, 206584, 206585, 206586, 206587, 206588, 206589, 206590, 206591, 206592, 206593, 206594, 206595, 206596, 206597, 206598, 206599, 206600, 206602, 206603, 206604, 206605, 206606, 206607, 206608, 206609, 206610, 206611, 206612, 206613, 206614, 206617, 206618, 206619, 206620, 206621, 206622, 206623, 206624, 206625, 206626, 206627, 206628, 206629, 206630, 206631, 206632, 206633, 206634, 206635, 206636, 206637, 206638, 206639, 206641, 206642, 206643, 206644, 206645, 206646, 206647, 206648, 206649, 206650, 206651, 206652, 206653, 206654, 206655, 206656, 206657, 206658, 206659, 206660, 206661, 206662, 206663, 206664, 206665, 206666, 206667, 206668, 206669, 206670, 206671, 206672, 206673, 206674, 206675, 206676, 206677, 206678, 206679, 206680, 206681, 206682, 206683, 206684, 206685, 206686, 206687, 206688, 206689, 206690, 206691, 206692, 206693, 206694, 206695, 206696, 206697, 206698, 206699, 206700, 206701, 206703, 206704, 206705, 206706, 206707, 206708, 206709, 206710, 206711, 206712, 206713, 206715, 206716, 206717, 206718, 206719, 206720, 206721, 206722, 206724, 206725, 206726, 206727, 206728, 206729, 206730, 206731, 206732, 206733, 206734, 206735, 206736, 206737, 206738, 206739, 206740, 206741, 206742, 206743, 206744, 206745, 206746, 206747, 206748, 206749, 206750, 206751, 206752, 206753, 206754, 206755, 206756, 206757, 206758, 206759, 206760, 206761, 206762, 206763, 206764, 206765, 206766, 206768, 206769, 206770, 206771, 206772, 206773, 206775, 206776, 206777, 206778, 206779, 206780, 206781, 206782, 206783, 206784, 206785, 206786, 206787, 206788, 206789, 206790, 206791, 206792, 206793, 206794, 206795, 206796, 206797, 206798, 206799, 206800, 206801, 206802, 206803, 206804, 206805, 206806, 206807, 206808, 206809, 206810, 206811, 206812, 206813, 206814, 206815, 206816, 206817, 206818, 206819, 206820, 206821, 206822, 206823, 206824, 206825, 206826, 206827, 206828, 206829, 206830, 206831, 206832, 206833, 206834, 206835, 206836, 206837, 206838, 206839, 206840, 206841, 206842, 206843, 206844, 206845, 206846, 206847, 206848, 206849, 206850, 206851, 206852, 206853, 206854, 206855, 206856, 206858, 206860, 206861, 206862, 206863, 206864, 206867, 206868, 206869, 206870, 206871, 206872, 206873, 206874, 206875, 206876, 206877, 206878, 206879, 206880, 206881, 206882, 206883, 206884, 206885, 206886, 206887, 206888, 206889, 206890, 206891, 206892, 206893, 206894, 206895, 206896, 206897, 206898, 206899, 206900, 206901, 206902, 206903, 206904, 206905, 206906, 206907, 206908, 206909, 206910, 206911, 206912, 206913, 206914, 206915, 206916, 206917, 206918, 206919, 206920, 206921, 206922, 206923, 206924, 206925, 206926, 206927, 206928, 206929, 206930, 206931, 206932, 206933, 206934, 206935, 206936, 206937, 206938, 206939, 206940, 206941, 206942, 206943, 206944, 206945, 206946, 206947, 206948, 206949, 206950, 206951, 206952, 206953, 206954, 206955, 206956, 206957, 206958, 206959, 206960, 206961, 206962, 206963, 206964, 206965, 206966, 206967, 206969, 206970, 206971, 206972, 206973, 206974, 206975, 206976, 206977, 206978, 206979, 206980, 206981, 206982, 206983, 206984, 206985, 206986, 206987, 206988, 206989, 206990, 206991, 206992, 206993, 206994, 206995, 206996, 206997, 206998, 206999, 207000, 207001, 207002, 207003, 207004, 207005, 207006, 207007, 207008, 207009, 207010, 207011, 207012, 207013, 207015, 207016, 207017, 207018, 207020, 207022, 207023, 207024, 207026, 207027, 207028, 207029, 207030, 207031, 207032, 207033, 207034, 207035, 207036, 207037, 207039, 207040, 207041, 207042, 207043, 207044, 207045, 207046, 207047, 207048, 207049, 207050, 207051, 207052, 207053, 207054, 207055, 207056, 207057, 207058, 207059, 207060, 207061, 207062, 207063, 207064, 207065, 207066, 207067, 207068, 207069, 207070, 207071, 207072, 207073, 207074, 207075, 207076, 207077, 207078, 207079, 207080, 207081, 207082, 207083, 207084, 207085, 207086, 207087, 207088, 207089, 207090, 207091, 207092, 207093, 207094, 207095, 207096, 207097, 207098, 207099, 207100, 207101, 207102, 207103, 207104, 207105, 207106, 207107, 207108, 207110, 207111, 207112, 207113, 207114, 207115, 207116, 207117, 207118, 207119, 207120, 207121, 207122, 207123, 207124, 207125, 207126, 207127, 207128, 207129, 207130, 207131, 207132, 207133, 207134, 207135, 207137, 207138, 207139, 207140, 207141, 207142, 207143, 207144, 207145, 207146, 207147, 207148, 207149, 207150, 207151, 207152, 207153, 207154, 207155, 207156, 207157, 207158, 207159, 207160, 207161, 207162, 207164, 207165, 207166, 207169, 207171, 207172, 207173, 207174, 207175, 207176, 207177, 207178, 207179, 207180, 207181, 207182, 207183, 207184, 207185, 207186, 207187, 207188, 207189, 207190, 207191, 207192, 207194, 207195, 207196, 207197, 207198, 207199, 207200, 207201, 207202, 207203, 207204, 207205, 207206, 207207, 207208, 207210, 207211, 207212, 207213, 207214, 207215, 207216, 207217, 207218, 207219, 207220, 207221, 207222, 207223, 207224, 207225, 207226, 207227, 207228, 207229, 207230, 207231, 207232, 207233, 207234, 207235, 207237, 207238, 207239, 207240, 207241, 207242, 207243, 207244, 207245, 207246, 207247, 207248, 207249, 207250, 207251, 207252, 207253, 207254, 207255, 207256, 207257, 207258, 207259, 207260, 207261, 207262, 207263, 207264, 207265, 207266, 207267, 207268, 207270, 207271, 207272, 207273, 207274, 207275, 207276, 207277, 207278, 207279, 207280, 207282, 207283, 207284, 207285, 207286, 207287, 207288, 207289, 207290, 207291, 207292, 207293, 207294, 207295, 207296, 207297, 207298, 207299, 207300, 207301, 207302, 207303, 207304, 207305, 207306, 207307, 207308, 207309, 207310, 207311, 207312, 207313, 207314, 207315, 207316, 207317, 207318, 207319, 207320, 207321, 207322, 207323, 207324, 207325, 207326, 207327, 207328, 207329, 207330, 207331, 207332, 207333, 207334, 207335, 207336, 207337, 207338, 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RECALLING FIRM/MANUFACTURER
Recalling Firm: Welch Allyn Protocol, Inc., Beaverton, OR, by press release on August 23, 2007 and letters on August 29, 2007.
Manufacturer: MRL, Inc., A Welch Allyn Company, Buffalo Grove, IL. Firm initiated recall is ongoing.
REASON
Failure to deliver shock: The Welch Allyn AED20 Defibrillators may display a "Defib Comm" error message on the device display during use which may result in failure of the device to analyze the patient's ECG and deliver the appropriate therapy.
VOLUME OF PRODUCT IN COMMERCE
1,722 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Baxter Colleague CX Single Channel Volumetric Infusion Pumps; product code 2M8161, Recall # Z-1224-2007
CODE
Serial numbers: 14051565CC, 15034273CC, 15034492CC, 15040255CC, 15041116CC, 15041169CC, 15041170CC, 15041172CC, 15041181CC, 15041194CC, 15041199CC, 15041206CC, 15041212CC, 15041218CC, 15041241CC, 15041288CC, 15041290CC, 15041317CC, 15050020CC, 15050034CC, 15050045CC, 15050061CC, 15050080CC, 15050117CC, 15050129CC, 15060087CC, 15060217CC, 15060253CC, 15060479CC, 15060489CC, 15060549CC, 15060557CC, 15060600CC, 15060738CC, 15060790CC, 15060827CC, 15060939CC, 15060940CC, 15060968CC, 15063211CC, 15075371CC, 15075103CC
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letter dated August 15, 2007.
Manufacturer: Baxter Healthcare Corp., Singapore, Singapore. Firm initiated recall is ongoing.
REASON
Some of the pumps were upgraded by one service technician who failed to replace prisms and batteries as required in the upgrade.
VOLUME OF PRODUCT IN COMMERCE
42 pumps
DISTRIBUTION
FL and CA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
Stryker Medical – Wheeled Electric Stretcher, Model 1550, Recall # Z-1009-2007
CODE
Serial numbers 0508083666, 0509069531, 0509069532, 0509069533, 0509069534, 0509069535, 0509069542, 0509069564, 0509069565, 0509069566, 0509069567, 0509069568, 0509069569, 0509069588, 0509069589, 0509069590, 0509069591, 0509069662, 0509069663, 0509069664, 0509069665, 0509069693, 0509069694, 0509069695, 0509069696, 0509069697, 0509069698, 0509069699, 0509069700, 0509069701, 0509069770, 0509069771, 0509069772, 0509069773, 0509069774, 0509069775, 0509069776, 0509069777, 0509069778, 0509069795, 0509069796, 0509069806, 0509069816, 0509069817, 0509069818, 0509069819, 0509069832, 0509069835, 0509069836, 0509069837, 0509069838, 0509069839, 0509069840, 0509069841, 0509069848, 0509069849, 0509069873, 0509069874, 0509069875, 0509069876, 0509069877, 0510071024, 0510071025, 0510071026, 0510071032, 0510071033, 0510071034, 0510071035, 0510071036, 0510071037, 0510071038, 0510071039, 0510071040, 0510071041, 0510071042, 0510071043, 0510071154, 0510071155, 0510071156, 0510071157, 0510071158, 0510071159, 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RECALLING FIRM/MANUFACTURER
Stryker Medical Div. of Stryker Corporation, Portage, MI, by letter dated May 7, 2007. Firm initiated recall is ongoing.
REASON
The internal power cord may become damaged due to wear and, if this occurs, a shock hazard exists.
VOLUME OF PRODUCT IN COMMERCE
1048 (1009 in the U.S. plus 39 international)
DISTRIBUTION
Nationwide, Latin America, Mexico and Spain

___________________________________
PRODUCT
Newport HT50 Ventilator (all Models), Recall # Z-1192-2007
CODE
All models, all serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Newport Medical Instruments Inc., Costa Mesa, CA, by Important Medical Correction letters on September 14, 2007.
Manufacturer: Flight Medical Ltd., Lod, Israel. Firm initiated recall is ongoing.
REASON
Battery Life: With use over time, the internal battery begins losing its ability to hold a charge resulting in shortened ventilator operation time. Specifically, Newport has received a number of reports concerning the internal battery not lasting as long as expected followed by ventilator shut down with less advance warning than when the battery was new.
VOLUME OF PRODUCT IN COMMERCE
8,160 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
IVF Pasteur Pipettes, glass, cotton plugged, length 9", in boxes of 90 consisting of 30 nylon tube packages of 3 pipettes each. Item # PP-9-90PL, Recall # Z-1220-2007
CODE
Lot # 160306022 EXP 1/22/2010 160306046 EXP 2/15/2010 160306065 EXP 3/6/2010
RECALLING FIRM/MANUFACTURER
Humagen Fertility Diagnostics, Inc., Charlottesville, VA, by telephone and e-mail on May 7, 2007. Firm initiated recall is complete.
REASON
Pasteur pipettes for laboratory use were labeled as sterile but may have become contaminated.
VOLUME OF PRODUCT IN COMMERCE
160 boxes
DISTRIBUTION
IL, UK, Greece, Australia, United Arab Emirates, the Netherlands, and Israel
___________________________________
PRODUCT
LTX XP Miniplant, Dental Implant, Sterile, Model No. LTX3211 and Model No. LTX3213, Recall # Z-1221-2007
CODE
Lot No. 606199 and Lot No. 606191
RECALLING FIRM/MANUFACTURER
Biomet 3i, Palm Beach Gardens, FL, by e-mail and fax letter on August 3, 2007. Firm initiated recall is ongoing.
REASON
The LTX XP Miniplant, BIOMET 3i dental implant, was labeled incorrectly. The 13MM implants were labeled and packaged as 11.5MM implants and 11.5MM implants were labeled and packaged as 13MM implants.
VOLUME OF PRODUCT IN COMMERCE
240 parts (120 parts per lot)
DISTRIBUTION
Internationally
___________________________________
PRODUCT
ARCHITECT Prolactin MasterCheck; a single analyte control - each kit contains 1 - 2 mL bottle of Architect Prolactin MasterCheck Level 0 containing HEPES buffer with protein (bovine) stabilizers, and 4 - 2 mL bottles of Architect Prolactin MasterCheck Levels 1, 2, 3 and 4 containing prolactin (human) prepared in HEPES buffer with protein (bovine) stabilizers; list 6C27-05, Recall # Z-1222-2007
CODE
Lot 82900M
RECALLING FIRM/MANUFACTURER
Abbott Laboratories MPG, Abbott Park, IL, by letter dated July 6, 2007.
Manufacturer: Bio-Rad Diagnostics Group, Irvine, CA. Firm initiated recall is ongoing.
REASON
The Architect Prolactin MasterChecks may not be stable at the recommended storage conditions of 2 to 8 degrees C through the expiration dating (15 months). The MasterChecks may exceed the suggested tolerance limits listed in the Reportable Range/Calibration Verification section in Appendix B of the Architect iSystem Operations Manual.
VOLUME OF PRODUCT IN COMMERCE
57 kits
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
BMSI "MicroJack" PN 672-510000 patient interface electrode connection device used during electroencephalography (EEG) /Epilepsy Monitoring evaluations with various EEG monitoring systems. The MicroJack is used with BMSI Models 2000, 3000, 4000, 5000 & 6000, and is used with the BMSI kit upgraded with NicoletOne, Recall # Z-1225-2007
CODE
Models BMSI 2000, 3000, 4000, 5000 & 6000 and BMSI kit upgraded with NicoletOne, marketed prior to May 2007.
RECALLING FIRM/MANUFACTURER
Nicolet Biomedical Div of Viasys Healthcare, Madison, WI, by letters on July 17, 2007. Firm initiated recall is ongoing.
REASON
The BMSI "MicroJack" patient interface electrode connection device used with the EEG monitor systems was found to be mis-wired. A complainant alleged that during depth electrode EEG study of a patient in preparation for brain surgery there was an observation that was perceived as non-logical data output.
VOLUME OF PRODUCT IN COMMERCE
2,102 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
ReliOn 0.5cc 30 g x 8mm Blister Pak U-100 syringe 30 gauge x 5/16" length, for subcutaneous injection of insulin, Catalog number 326743, Recall # Z-1226-2007
CODE
Batch number 6297350
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letters on June 21, 2007.
Manufacturer: BD Medical - Diabetes Care, Holdrege, NB. Firm initiated recall is ongoing.
REASON
Complaints received indicating open seals on blister paks, potentially compromising the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE
644,500 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Medtronic Intersept 3608 Sterile tubing (8') 1/2 x 3/32 in. Quantity 10, Lot 7626621, Use by 2009-07-31. Different components and tubing sets are included within the Custom Pack depending on customer requirements. Tubing sets are placed within a plastic tray, which then is wrapped and placed inside a header bag and sealed at the plastic side. This bag serves as the product sterile barrier, Recall # Z-1227-2007
CODE
Catalogue# / lot #: 3608/7626621, CB2E25R7/7760483, CB2E28R/7760491, CB4Q86R/7226272, 9156R2/8105907, 1D41R10/7372026, 1F61R4 / 7038360, 1E04R7 / 7277651, 9156R2 / 8105907, 1X37R / 7760774, 3608 / 7626621, 0X01R7 / 7278478, 2567R41/ 6577695, 1E97R2 / 7828564, 5G01R / 7734883, CB5305R1 / 7346602, CB4Q86R / 7226272, 2T10R1 / 7252235, 1D91R1 / 7843300, 1A45R3 /7584969, 3M16R5 / 7411494, CB2J35R3 / 7352341, CB3R62R / 7668062, 4V60R / 7934463, DLP2X90R /7504957, 3608 /7626621, 3608/ 7626621, 3C86R9/ 7656387, 3608/ 7626621, 3608/ 7626621, HY2K51R14/ 7438662, 2H08R2/ 7668273, 3608/ 7626621, 1A05R15/ 7038597, CB4826R3 / 7843481, 3608/ 7626621, TL4K84R7/ 7900108, CB3K45R6/ 7626276, 9295R2/ 7934447, 2100R3/ 7694869, CB3U51R7 / 7695001, 9156R2/ 8105907, 9182R3/ 7694914, 0M14R12/ 7694762, 2C50R/ 7760791, 3608/ 7626621, 2K98R1/ 7668290, CB0U83R11/ 7721206, 2997R27/ 7438443, 9156R2/ 8105907, TL3E97R5/ 7722225, TL4J32R8/ 7761048, 2Z75R5/ 7960821, CB2E25R7 /7760483, 4W91R/ 7843431, 3608/ 7626621, 9156R2/ 8105907, 1G69R7/ 7760715, 3608/ 7626621, 2T28R1/ 7899872, 9156R2/ 8105907, 1F77R3/ 7722348, 1F77R3/ 7722348, 1F77R3/ 7722348, DLP4X54R/ 7761021, 3608/ 7626621, 3608/ 7626621
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Perfusion Systems, Brooklyn Park, MN, by letters dated August 1, 2007.
Manufacturer: Medtronic Mexico, S. De R. L. De C.V., Tijuana, Baja California, Mexico. Firm initiated recall is ongoing.
REASON
Medtronic Custom Tubing Packs might have open header bag seals.
VOLUME OF PRODUCT IN COMMERCE
853 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
NxStage Cartridge Express, CAR-170, for hemodialysis, Recall # Z-1228-2007
CODE
Lot Numbers: 7037802, 703803, 703804, 7047702, 7047703, 7047704, 7047705, 7057702, 7057703, 7057704, 7057705, 7057706, 7057707, 7057708, 7057709, 7067701, 7067702,7067703, 7067705, 7067709, 7067710, 7067711, 7067712, 7067713, 7067714, 7067715, 7077703
RECALLING FIRM/MANUFACTURER
Recalling Firm: NxStage Medical, Inc., Lawrence, MA, by letter, on August 24, 2007.
Manufacturer: Medimexico, S. de R.L. de C.V., Tijuana, Mexico. Firm initiated recall is ongoing.
REASON
Potential for dialysate leaks from the cartridge during treatment.
VOLUME OF PRODUCT IN COMMERCE
12,085 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems, Product Code 5583705, Recall # Z-1229-2007
CODE
Lot Numbers: 22FMA202, 22IMO531, 22KMO573, 22DN2914, 22FN5232, 22GN5835, 22GN5878, 22HN6574, 22BO6078, 22BO6163, 22FO6086, 22GO6026, 22HO6101, 22IO6111, 22KO6124, 22CP6268, 22EP6831, REPG0035, REPG0643, REPH0954, REPK0058, REPK0729, REPL0298, REQB0030, REQB0224, REQD0200, REQF0429, REQF0736, REQJ0282, REQK0875, RERC0052, RERD0719
RECALLING FIRM/MANUFACTURER
Bard Access Systems, Inc., Salt Lake City, UT, by letter on August 10, 2007. Firm initiated recall is ongoing.
REASON
Metal guidewires used in Hemodialysis Catheters may have been reverse loaded within the dispenser. Potential exists for the stiff end of the guidewire to be inserted into the patient instead of the flexible end.
VOLUME OF PRODUCT IN COMMERCE
7,225 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Stryker Radius Locking Caps, Catalog Number: 486610000, Recall # Z-1239-2007
CODE
Lot: 06C516, 06C358, 06C515, 06C581, 06C447, 06C579, 06C446, 06C467, 06A858 and 06C357
RECALLING FIRM/MANUFACTURER
Stryker Spine, Allendale, NJ, by letters on July 10, 2007. Firm initiated recall is ongoing.
REASON
Product dissembled in the tray or prior to being loaded onto the inserter or tightening on the rod.
VOLUME OF PRODUCT IN COMMERCE
1,300 U.S.; 123 Italy
DISTRIBUTION
Nationwide and Italy

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT
5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530, Recall # Z-1230-2007
CODE
Serial numbers: 0028-05, 0035-05, 0069-05, and 0092-05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mentor Texas, Inc., Irving, TX, by letter on July 27, 2007.
Manufacturer: Misonix, Inc., Farmingdale, NY. Firm initiated recall is ongoing.
REASON
Mis-identified and mis-labeled surgical probes were distributed. 5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530 was shipped, instead of LySonix 5mm x 30cm Hollow Bullet Tip Ultrasonic Probe, Catalog Number 5610-530.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
25-Hydroxyvitamin D 125 I RIA Kit, in vitro diagnostic. REF:68100E, Recall # Z-1237-2007
CODE
Lot # 119604A
RECALLING FIRM/MANUFACTURER
Diasorin, Inc., Stillwater, MN, by telephone and letter on August 21, 2007. Firm initiated recall is ongoing.
REASON
25 Hydroxyvitamin D RIA kits may contain the incorrect lot of tracer.
VOLUME OF PRODUCT IN COMMERCE
117 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor, Catalog Numbers: 340400, 3404001, and 3404002, Recall # Z-1240-2007
CODE
Catalog number/Serial number: 3404001/AI05110052/ AI05120000/ AI05120011/ AI05120012/ AI05120013/ AI05120018/ AI06060015/ AI06070047/ AI06100004/ AI06100005/ AI06100006/,
3404001S/AI05110000/ AI05110001/ AI05110002/ AI05110003/ AI05110004/ AI05110005/ AI05110006/ AI05110007/ AI05110008/ AI05110009/ AI05110010/ AI05110011/ AI05110012/ AI05110013/ AI05110014/ AI05110015/ AI05110016/ AI05110017/ AI05110018/ AI05110019/ AI05110020/ AI05110021/ AI05110022/ AI05110023/ AI05110024/ AI05110025/ AI05110026/ AI05110027/ AI05110028/ AI05110029/ AI05110030/ AI05110031/ AI05110032/ AI05110033/ AI05110034/ AI05110035/ AI05110036/ AI05110037/ AI05110038/ AI05110039/ AI05120010/ AI05120016/ AI05120017/ AI05120019/ AI06010042/ AI06010043/ AI06060003/ AI06060004/ AI06060005/ AI06060006/ AI06060007/ AI06060008/ AI06060009/ AI06060010/ AI06060011/ ,
3404002/AI05090021/ AI05090024/ AI05110049/ AI05120015/ AI06010035/ AI06010036/ AI06010049/ AI06040000/ AI06040001/ AI06040002/ AI06040003/ AI06040004/ AI06040005/ AI06040006/ AI06040007/ AI06040008/ AI06040009/ AI06040010/ AI06040011/ AI06040012/ AI06040013/ AI06040014/ AI06040015/ AI06040016/ AI06040017/ AI06040018/ AI06040020/ AI06060012/ AI06060013/ AI06060014/ AI06060017/ AI06060018/ AI06060019/ AI06060020/ AI06070037/ AI06070038/ AI06070039/ AI06070040/ AI06070042/ AI06070043/ AI06070044/ AI06070045/ AI06090053/ AI06100011/ AI06100012/ AI07010057/ AI07010058/ ,
3404002E/AI05110040 AI05110041/ AI05110042/ AI05120001/ AI05120002/ AI05120005/ AI05120006/ AI05120007/ AI05120008/ AI05120009/ AI05120024/ AI06010041/ AI06010044/ AI06010045/ AI06010046/ AI06010048/ AI06040019/ AI06040023/ AI06040024/ AI06070041/ AI06070046/ AI06070048/ AI06070049/ AI06090050/ AI06090051/ ,
3404002F/AI07010067/ AI07010068/ ,
3404002G/AI05110050/ AI05110051/ AI05120003/ AI05120004/ AI06060021/ AI06060022/ AI06060023/ AI06070035/ AI06070036/ AI06090054/ AI06090055/ AI06090056/ AI06090057/ AI06090058/ AI06100008/ AI06100009/ AI06100010/ AI06100018/ ,
3404002S/AI05110043/ AI05110044/ AI05110045/ AI06010037/ AI06010038/ AI06010039/ AI06010040/ AI06060000/ AI06060001/ AI06060002/ AI06060016/ AI06090052/ AI06100019/ AI06100020/ AI06100021/ AI06100022/ AI06100023/ AI06100024/ AI07010050/ AI07010051/
RECALLING FIRM/MANUFACTURER
Smiths Medical PM, Inc., Waukesha, WI, by letter on July 18, 2007. Firm initiated recall is ongoing.
REASON
Phantom pacer spikes caused by a damaged resistor.
VOLUME OF PRODUCT IN COMMERCE
178 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Duracon Total Knee Modular Femoral Component; Non-Porous Right Medium Assembly, Product No. 6632-0-325, Recall # Z-1241-2007
CODE
Lot code UCVO
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on October 17, 2006. Firm initiated recall is complete.
REASON
Loose fixation pegs: One lot of femoral components may have loose fixation pegs.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA, IN, and Sweden

END OF ENFORCEMENT REPORT FOR SEPTEMBER 26, 2007

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