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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.
July 2, 2008
08-26
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PRODUCT
a) Total Body Formula, Tropical Orange flavor, liquid dietary supplement.
The product is packed in 8 oz and 32 fl. oz plastic bottles, Recall # F-308-8;
b) Total Body Formula, Peach Nectar flavor, liquid dietary supplement.
The product is packed in 8 oz and 32 fl. oz plastic bottles, Recall # F-309-8;
c) Total Body Mega Formula, Orange/Tangerine flavor, liquid dietary supplement.
The product is packed in 32 oz plastic bottles. Recall # F-310-8
CODE
a) Lot numbers 4016801, 4024801 and 4031801;
b) Lot number 4016802 and 4031802;
c) Lot number 4031803
RECALLING FIRM/MANUFACTURER
Recalling Firm: Total Body Essential Nutrition, Inc., Woodstock, GA, by telephone starting March 24, 2008, an advisory on March 27, on the web March 28 and by letters on April 7, 2008.
Manufacturer: Texamerican Food Blending, Inc., Hot Springs AK. Firm initiated recall is ongoing.
REASON
The products contain elevated levels of both selenium and chromium and use of the products has been associated with illnesses.
VOLUME OF PRODUCT IN COMMERCE
1484 bottles
DISTRIBUTION
AL, CA, FL, GA, KY, LA, MI, MO, NC, NJ, OH, PA, TN, TX, VA
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PRODUCT
a) Simply Fresh, Fresh Cut Fruit Brand containing cantaloupe packed in plastic trays. Note:
This product was also distributed as "Fancy Fruit Mix", "Fruit Salad" by Bristol Farms and
"Fresh Fruit Salad" by Sofia's, Recall # 402-8;
b) Simply Fresh Fruit Brand food service Fruit Mix in Syrup products packed in plastic pails or jars.
Note: Other food service brands include "Reser's Fine Foods", "C-B-I", "Imperial" and "Sysco Imperial",
Recall # 403-8;
c) Food Service Cantaloupe Chunks in Syrup products packed in plastic pails or jars.
Note: Other food service brands include "Reser's Fine Foods", "C-B-I", "Imperial" and "Sysco Imperial".
This product was also distributed as "Cantaloupe" by Bristol Farms, Recall # 404-8;
CODE
a) Dated "sell by 3-29 8"or earlier;
b) Dated "sell by 4-18 08" or earlier;
c) Dated "sell by 4-08 8" or earlier
RECALLING FIRM/MANUFACTURER
Recalling Firm: SFFI Company Inc dba Simply Fresh Fruit, Vernon, CA, by import alert on March 22, 2008, by telephone beginning on March 24, 2008, letter on March 25, 2008 and by press release on March 27, 2008.
Manufacturer: Agropecuaria Montelibano, Puerto Cortes, Honduras. Firm initiated recall is ongoing.
REASON
Products were manufactured using cantaloupes imported from Agropecuaria Montelibano in Honduras. Cantaloupes imported from Agropecuaria Montelibano have been associated with an outbreak of Salmonella infection.
VOLUME OF PRODUCT IN COMMERCE
196,159 lbs
DISTRIBUTION
Nationwide
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PRODUCT
Double Chocolate Chip Cake in 16-oz. clear plastic container. Packed 18 cakes per case, Recall # F-408-8
CODE
All
RECALLING FIRM/MANUFACTURER
Recalling Firm: Yum Brands, Louisville, KY, by e-mail and press release beginning on April 18, 2008.
Manufacturer: General Mills Bakeries & Food Service, Chanhassen, MN. Firm initiated recall is ongoing.
REASON
Product contains undeclared egg. An ingredient statement does not appear on the cakes label, but Kentucky Fried Chicken’s web site lists wheat, milk, soy and tree nuts as ingredients. Egg is not listed.
VOLUME OF PRODUCT IN COMMERCE
378,209 cases
DISTRIBUTION
Nationwide
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PRODUCT
Sweetwater Valley Farm, Black Pepper, Tennessee Aged, Cheese; wrapped in clear plastic in 5, 7, and 10 oz. bars, Recall # F-409-8
CODE
Lot No. 616-361
RECALLING FIRM/MANUFACTURER
Sweetwater Valley Farm, Philadelphia, TN, by telephone on May 12, 2008 and by letter on May 14, 2008. Firm initiated recall is complete.
REASON
The Tennessee Department of Agriculture's analysis of the product found it contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
100 pounds
DISTRIBUTION
TN, AL
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PRODUCT
NOS® High Performance Energy Drink, Original Passion Fruit Flavor, 16 fl oz 473 mL cans, UPC 80793 80391, Recall # F-406-8
CODE
APR1309 SYC, APR2709 CVE, APR2709 PRC, APR2709 PRD, APR2709 SWD, MAY0409 SYG, MAY1109 CVD, MAY1109 CVE, MAY1809 GGE, MAY1809 GGF, MAY2509 CVE
RECALLING FIRM/MANUFACTURER
Recalling Firm: FUZE Beverages, LLC, Englewood Cliffs, NJ, by email on/about 06/04/2008.
Manufacturer: Coca Cola Bottling Co Consolidated, Charlotte, NC. Firm initiated recall is ongoing.
REASON
Product contains undeclared colors - FD&C Yellow #5 and FD&C Yellow #6.
VOLUME OF PRODUCT IN COMMERCE
25000 cases/24 cans per case
DISTRIBUTION
ID, IN, NC, TN, TX
___________________________________
PRODUCT
Individual units are labeled as Mountain House brand Freeze Dried Ice Cream in .75 oz. foil pouch additionally labeled with UPC 0 41133 53523 0.Pouches are packed 12 to a case. Case labeled in part, "... Mountain House FREEZE DRIED ICE CREAM SANDWICH... 12 pouches 1.13 oz, a) Cases labeled ice cream sandwiches: SKU: 0053-524; b) Neapolitan ice cream pouch: SKU: 0053-523; Code is ink jet into the back of the pouch on the right hand side, Recall # F-407-8
CODE
a) Lot code: Ink jet onto side of case lot "L80767 08064" ### (case #) and lot "L80767 08065" ### (case #) (L = Lot; 8 = last digit of year; 0767 = consecutively issued number; 08064 = Julian date (YYDDD); and ### = consecutive case number ); b) Coding: "08064" HHMM, "08065" HHMM (08064 = Julian date (YYDDD); and HHMM = time (24 hr clock)).
RECALLING FIRM/MANUFACTURER
Oregon Freeze Dry Inc., Albany, OR, by e-mail or telephone on May 8, 2008 and followed up with a letter on May 12, 2008. Firm initiated recall is ongoing.
REASON
Some 0.75 foil packages are incorrectly labeled as Freeze Dried Neapolitan Ice Cream when they actually contain Freeze Dried Ice Cream Sandwich. The Freeze Dried Ice Cream Sandwich contains wheat flour and soy lecithin which are not listed as ingredients on the Freeze Dried Neapolitan Ice Cream label.
VOLUME OF PRODUCT IN COMMERCE
4044 pouches (337 cases - 12 pouches/case)
DISTRIBUTION
Nationwide
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PRODUCT
a) Manischewitz Matzo Ball Soup; Reduced Sodium; Ready to Serve; Net Wt. 24.oz. (680 g)
Kosher for Passover and all year round; UPC 1 72700 10160 8, Recall # F-398-8;
b) Manischewitz Matzo Ball Soup; Ready to Serve; Net. Wt. 24 oz (680 gr);
Kosher for Passover and All year Round; UPC 72700-10181, Recall # F-399-8
CODE
a) Lot Code: 0461(A,B)NMA10160;
b) Lot codes: 0251(A,B)NMA10181; 0461CNMA10181
RECALLING FIRM/MANUFACTURER
R.A.B. Food Group LLC, Newark, NJ, by letters on May 7, 2008. Firm initiated recall is ongoing.
REASON
Soup contains insect larvae (filth).
VOLUME OF PRODUCT IN COMMERCE
3525 cases
DISTRIBUTION
Nationwide
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PRODUCT
Quaker Cinnamon Life Cereal, Net Wt. 21 oz. box, 14 boxes per case, UPC 0 30000 06080 3; Recall # F-405-8
CODE
Best Before Code Dates on the box: MAY 17 09 L "X" 30, MAY 18 09 L "X" 30, MAY 22 09 L "X" 30, MAY 23 09 L "X" 30. Lot Codes on the cases: MAY 22 08 L "X" 30, MAY 23 08 L "X" 30, MAY 27 08 L "X" 30, MAY 28 08 L "X" 30. "X" is a line # that can be a 1, 2, or 3
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pepsi-QTG, Chicago, IL, by telephone and fax beginning on June 3, 2008 and by letters dated June 5, 2008.
Manufacturer: Quaker Tropicana & Gatorade, Cedar Rapids, IA. Firm initiated recall is ongoing.
REASON
The cereal may possibly contain small white plastic particles, less than 2 millimeters in diameter, inadvertently introduced in the production of the product.
VOLUME OF PRODUCT IN COMMERCE
432 cases
DISTRIBUTION
IL, MS, MO, OK, WI
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PRODUCT
a) Aspire36, Next Generation Sexual Enhancer, Liquid Capsule Technology, proprietary blend of herbal
ingredients, 725mg, single blister packs or 3 and 12 count bottles, Recall # D-230-2008;
b) Aspire Lite, Female Sexual Enhancer, Liquid Capsule Technology, proprietary blend of herbal ingredients,
718mg, single blister packs or 3 and 12 count bottles, Recall # D-231-2008
CODE
a) Blister Pack Capsules: 053107, 071707, 102607, 121907,
3 count bottles: 071707, 092607A, 102607, 111707, 121907, 011708,
12 count bottles: 053107, 071707, 092607A, 102607, 111707, 120307, 121907, 011708;
b) Lot #s: 082907, 092607B, 112007, 121907, 011708A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Palo Alto Laboratories Inc., Fort Pierce, FL, by press release on February 22, 2008, and by telephone or email or letter as of February 29, 2008.
Manufacturer: Liquidcapsule Manufacturing LLC, Miami Lakes, FL. Firm initiated recall is ongoing.
REASON
Unapproved New Drug: product found to contain Aildenafil in and Dimethyl sildenafil thione (sulfoaildenafil) analogs of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED).
VOLUME OF PRODUCT IN COMMERCE
1,008,737 Capsules
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
SPIRIVA HandiHaler, tiotropium bromide inhalation powder, 18 mcg per capsule, 30-capsule blister cards (NDC 0597-0075-41) and 90-capsule blister cards (NDC 0597-0075-47), Rx only, Recall # D-224-2008
CODE
Lots: 704577A, exp. 10/08; 705425A, exp. 11/08; 707703A, exp. 02/09; 707703B, exp. 02/09; 707987A, exp. 02/09; 708066A, exp. 02/09; 708307, exp. 03/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, by letters on June 9, 2008.
Manufacturer: Boehringer Ingelheim Pharma KG, Ingelheim, Germany. Firm initiated recall is ongoing.
REASON
Product may not meet specifications for aerodynamic particle size distribution throughout shelf life.
VOLUME OF PRODUCT IN COMMERCE
889,132 units
DISTRIBUTION
Nationwide
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PRODUCT
a) ACEON®, (perindopril erbumine) Tablets, 2 mg, Bottles of 100, Rx Only, NDC 0032-1101-01,
Recall # D-227-2008;
b) ACEON®, (perindopril erbumine) Tablets, 4 mg, Bottles of 100, Rx Only, NDC 0032-1102-01,
Recall # D-228-2008;
c) ACEON®, (perindopril erbumine) Tablets, 8 mg, Bottles of 100, Rx Only, NDC 0032-1103-01,
Recall # D-229-2008
CODE
a) Lot 3064835, Expiration: 08/2009;
b) Lot 3063489, Expiration: 12/2009, Lot 3063490, Expiration: 12/2009, and Lot 3064276, Expiration: 01/2010;
c) Lot 3063493, Expiration: 12/2009, Lot 3064277, Expiration: 01/2010, and Lot 3064278, Expiration: 01/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Solvay Pharmaceuticals, Inc., Marietta, GA, by letter on/about June 19, 2008.
Manufacturer: Patheon – Cincinnati Operations, Cincinnati, OH. Firm initiated recall is ongoing.
REASON
Presence of foreign substance; possibility of trace amounts of latex.
VOLUME OF PRODUCT IN COMMERCE
23,676 units
DISTRIBUTION
Nationwide
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PRODUCT
Carisoprodol, Aspirin and Codeine Phosphate Tablets, USP, 200mg/325mg/16mg, Rx only, 100 tablets, Activis Totowa LLC, NDC 52152-138-02,
Also labeled under Amide Pharmaceutical Inc., NDC 52152-138-02, Soma Compound with Codeine Tablets, USP, Distributed by: MedPointe, NDC 0037-2403-01 and
Qualitest, NDC 0603-2884-21, Recall # D-223-2008
CODE
60341A Apr-08 60484A1 May-08 60485A1 May-08 60713A1 Aug-08 61024A Nov-08 61025A Nov-08 70256A Apr-09 70257A Mar-09 70488A Jun-09 70702A Aug-09
RECALLING FIRM/MANUFACTURER
Actavis Totowa LLC, Totowa, NJ, by letters on May 7, 2008. Firm initiated recall is ongoing.
REASON
Superpotent; Codeine Phosphate
VOLUME OF PRODUCT IN COMMERCE
17,044 bottles: 8967 Amide, 4188 MedPointe, 1825 Qualitest
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Hydrocortisone and Acetic Acid Otic Solution, USP, 10mL bottle, Rx only, NDC 0603-7039-39, Recall # D-225-2008
CODE
Lots: L003M06, exp. 6/08; L038E07A, exp.11/08; L055E07, exp. 11/08; L037G07, exp. 1/09; L033H07, exp. 2/09; L034H07, exp. 2/09; L035H07, exp. 2/09; L013K07, exp. 4/09
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC, Huntsville, AL, by letter on June 5, 2008. Firm initiated recall is ongoing.
REASON
Product fails specification for individual impurity.
VOLUME OF PRODUCT IN COMMERCE
52,259 units
DISTRIBUTION
Nationwide
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PRODUCT
PREMPRO® (conjugated estrogens/medroxyprogesterone acetate tablets) 0.45 mg/1.5 mg, Rx only, NDC 0046-0937-09. One carton contains 3 EZ-DIAL® Dispensers of 28 tablets each. 1 EZ-DIAL® Dispenser (NDC 0046-0937-08) contains 28 gold PREMPRO® Tablets containing 0.45 mg of the conjugated estrogens found in Premarin® and 1.5 mg of medroxyprogesterone acetate Recall # D-226-2008
CODE
Lot: C61131, exp. January 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Philadelphia, PA, by letters on June 12, 2008.
Manufacturer: Wyeth Pharmaceuticals, Inc., Rouses Point, NY. Firm initiated recall is ongoing.
REASON
Failed USP dissolution test requirements
VOLUME OF PRODUCT IN COMMERCE
23,391 cartons of 3 dispensers
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Access Ultra sensitive Insulin Assay Kit, Part Number 33410. The product is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of insulin levels in human serum and plasma (EDTA) using the Access Immunoassay Systems, Recall # Z-1160-2008
CODE
Lot Numbers: 714362 (Exp. 3/31/09), 716129 (Exp. 6/30/09), 718258 (Exp. 7/31/09), 519096 (Exp. 10/31/07), 521487 (Exp. 2/28/08), 616274 (Exp. 7/31/08), 617890 (Exp. 7/31/08), 617891 (Exp. 7/31/08) and 620204 (Exp. 12/31/08)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter on September 19, 2007.
Manufacturer: Beckman Coulter, Inc., Chaska, MN. Firm initiated recall is ongoing.
REASON
False negative results when used to test serum samples (as compared to plasma samples).
VOLUME OF PRODUCT IN COMMERCE
8,537 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
S/5 iCentral, Cardiovascular Monitoring Devices, Versions L-NET03, L-NETC03, L-NET05 and L-NETC05, Recall # Z-1161-2008
CODE
CZC7244NXM CZC5510Y6G CZC61030GC CZC5492LL2 5100648 5100649 5100650 5100651 5100653 5100654 5100655 5115314 5123573 5123574 5123575 5123578 5132670 5132671 5132672 5132673 5132674 5132675 5132676 5132677 5132678 5132679 5132680 5132681 5140814 5148398 5148399 5148404 5148405 5148406 5148407 5148408 5156075 5156076 5156077 5156078 5156079 5156080 5156081 5156284 5165853 5165868 5171824 5173135 5178892 5178893 5178894 5178895 5178896 5178898 5178899 5178900 5182706 5182709 5182710 5182711 5182718 5199055 5199063 5199080 5205776 5205777 5213714 5213715 5213716 5213717 5213718 5213719 5213720 5213721 5213722 5213723 5213724 5213725 5213727 5213728 5213729 5213730 5213731 5213732 5213733 5213734 5213741 6004804 6161335 6161447 6186167 6299938 6315252 C2C528245B CZC5240Q16 CZC5240Q18 CZC5240Q1G CZC5240Q1J CZC5240Q1L CZC5240Q1Q CZC5280BS7 CZC5280BSD CZC528244Y CZC528245B CZC53003B3 CZC53003B8 CZC53003B9 CZC53003BQ CZC53003BR CZC53003BX CZC5391VDQ CZC5391VF4 CZC5391VFJ CZC5391VFS CZC5391VG5 CZC5391VGL CZC5472F8J CZC5492LJQ CZC5492LK5 CZC5492LKS CZC5492LLD CZC5492LLH CZC5492LLM CZC5510Y60 CZC5510Y63 CZC5510Y64 CZC5510Y6B CZC5510Y6J CZC5510Y6M CZC5510Y6N CZC61030G8 CZC61030GH CZC61030H0 CZC6130L2N CZC6130L2P CZC6130L2S CZC6130L30 CZC6130L3B CZC6130L3F CZC6181MSZ CZC6181MT0 CZC6181MT1 CZC6181MT8 CZC6261MW4 CZC6261MW5 CZC6261MWM CZC6261MWT CZC6261MWZ CZC62803TK CZC62803TR CZC6291WTP CZC6291WTR CZC63128WC CZC63128WT CZC63128X5 CZC6322Q7L CZC6322Q85 CZC6322Q88 CZC6394DFG CZC6394DGV CZC64006JT CZC64006JY CZC64006K3 CZC64006KB CZC642559H CZC642559M CZC642559Z CZC64255BK CZC64255BX CZC64511L8 CZC64511LK CZC6482WKB CZC6482WKL CZC6482WKM CZC6482WKT CZC6482WKY CZC7132V6M CZC7132V6P CZC7132V6V CZC7132V76 CZC7132V79 CZC7132V7D CZC7132V7Z CZC7132V80 CZC7132V83 CZC7212G4K CZC7212G51 CZC7212G52 CZC7215009 CZC721500C CZC721500D CZC721500M CZC721500R CZC721500T CZC7215010 CZC72414B9 CZC7244NXG CZC7244NXJ CZC7250WNJ CZC7272RLH CZC7272RLS CZC7272RM2 CZC7272RM6 CZC7290DYF CZC7290DZ1 CZC73312RZ CZC7363P2Z CZC7363P3M CZC7364RTL CZC7364RV2 CZC7364RV6 CZC7414GGD CZC7414GJH FRB4210XQ9 FRB4210XQZ FRB4210XSV FRB4250QGW FRB4250SM6 FRB4250SM8 FRB4250SZY FRB4250T0D FRB4250T0H FRB4250T0Q FRB4250T10 FRB4250T11 FRB4260139 CZC5492LLJ CZC7244NXQ CZC5391VF7 5100635 5100637 5100640 5100652 5115311 5126769 5126770 5140808 5148400 5170751 5170752 5199050 5205317 5213739 5225432 5225433 6120270 CZC5240Q12 CZC5240Q15 CZC5240Q19 CZC5240Q1B CZC5460C82 CZC5462HW6 CZC6030779 CZC6130L37 CZC6181MTD CZC6181MTG CZC6181MTS CZC6181MTT CZC6181MTY CZC62803T3 CZC62803TG CZC62803TX CZC6322Q86 CZC6394DG6 CZC64255C5 CZC7080QKF CZC7132V7S CZC7132V7Y CZC7212G4Y CZC7212G53 CZC721500Y FRB4250T0F FRB426012Z CZC528244Z CZC603077D CZC61030GC 5077175 5126785 5132684 5156286 5156287 5156288 5156289 5156290 5165839 5165840 5165841 5165842 5165843 5165844 5165845 5165846 5165847 5165848 5165849 5165850 5165851 5165852 5175459 5175467 5175468 5182673 5182692 5182696 5199062 5205307 5205316 5205321 5205323 5205329 5205780 5213738 5222755 5225444 5225448 6111282 6111283 6161279 6161280 6161281 6161302 6161303 6161318 6161319 6161320 6161321 6161334 6161354 6161355 6161356 6161357 6161358 6161359 6161361 6161362 6161363 6161364 6161365 6161366 6161367 6161368 6161369 6161370 6161371 6161372 6161373 6161374 6161375 6161376 6161377 6161392 6161393 6161394 6161395 6161396 6161397 6161398 6161399 6161400 6161401 6161402 6161403 6161404 6161405 6161406 6161407 6161408 6161409 6161410 6161411 6161412 6161413 6161414 6161415 6161416 6161427 6161437 6161446 6186166 6186171 6197698 6203596 6203824 6269008 6315249 CZC5240Q10 CZC5240Q17 CZC5240Q1Y CZC5240Q20 CZC5280BRZ CZC5280BS1 CZC5280BS8 CZC5280BSG CZC5280BSH CZC5280BSP CZC5280BSV CZC5282452 CZC5282458 CZC528245D CZC530039Z CZC53003B0 CZC53003BD CZC53003BT CZC53003BY CZC5391VDY CZC5391VF5 CZC5391VF8 CZC5391VG0 CZC5391VG1 CZC5391VG7 CZC5391VG8 CZC5391VGB CZC5391VGH CZC5391VGM CZC5391VGS CZC5460C7X CZC5460C7Z CZC5462BV2 CZC5462BV9 CZC5472F7T CZC5472F8G CZC5492LK8 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5225437 5225438 6004814 6048672 6049786 6049787 6061486 6061487 6061488 6061489 6061490 6061491 6061492 6095066 6161298 6279448 6315265 CZC5240Q1M CZC5280BS4 CZC5280BSF CZC5280BSM CZC5280BST CZC5282454 CZC5391VDV CZC5441LL0 CZC5462BV6 CZC5492LJV CZC5492LJZ CZC5510Y5W CZC5521M42 CZC5521M46 CZC5521M4P CZC5521M4Q CZC6130L2V CZC61544W0 CZC61544V9 CZC61544VH CZC61544VL CZC61544VQ CZC61544VV CZC61544VY CZC6181MTV CZC6394DFY CZC6394DG4 CZC6394DG8 CZC6394DGH CZC6394DGK CZC6394DH0 CZC6394DH9 CZC64006K9 CZC64006KL CZC64006KR CZC64006KW CZC642558N CZC64511L6 CZC6482WK7 CZC6482WKX CZC6482WL3 CZC6482WLB CZC7105QF0 CZC7132V6T CZC7132V70 CZC7132V73 CZC7132V7K CZC7212G42 CZC73312RQ CZC73312RR CZC73312RW CZC7364RTR CZC7414GGT CZC7414GGZ FRB4250QG5 FRB4250QGR FRB4250QGY FRB4250QH3 FRB4250SWV FRB4250SWW FRB4250SZ9 FRB4250SZW FRB4250SZZ FRB4250T02 FRB4250T04 FRB4250T0M FRB426011Q FRB4260129 FRB426013N FRB426013Z FRB4260140 CZC7364RTZ 5182721 5089743 5089745 5089746 5140815 5156050 5205320 5205322 6061496 6111274 6111275 6228473 6228586 CZC5240Q1C CZC5391VFY CZC5391VG6 CZC5492LKT CZC5492LL6 CZC62803TH CZC7364RS5 FRB426014P 5165859 5170762 5170766 5171811 5171812 5175448 5182684 5182693 5182699 5182705 5182707 5182708 5182722 5199041 5199042 5205301 5222765 6004796 6065625 6095050 CZC5240Q1D CZC5240Q1H CZC5391VFQ CZC5391VFV CZC5391VG2 CZC5391VGD CZC5391VGJ CZC5460C7F CZC5460C7N CZC5460C7Q CZC5460C86 CZC5492LJX CZC5492LKC CZC5521M4M CZC5521M4Z CZC6130L2Y CZC6261MWC CZC63128WY CZC6322Q7R CZC64006KS CZC64006KY CZC642558Q CZC642559D CZC64255BW CZC7080QJ7 CZC7364RS9 CZC7414GGV 5132682 5148395 5148396 5148397 5165864 5165865 5165866 5165867 5171809 5182715 5182716 5182717 5199051 5205310 5205311 5225447 CZC5492LKB CZC5510Y5X CZC5521M4W CZC6181MTH CZC62803TN CZC6394D67 FRB4250SMJ CZC5391VGG CZC642558M CZC6425592 5182713 5170760 CZC551046P CZC7105QDV CZC7364RTW FRB4210XS1 FRB4250SZN CZC6425594 5165858 5225425 CZC5280BRW CZC5460C87 CZC5492LKL CZC603076N CZC61030G6 CZC6322Q7F CZC6322Q7K CZC6322Q7S CZC6394DGG CZC642558P CZC6425597 CZC642559B CZC7080QJ8 CZC7080QK7 FRB426012P FRB426012T 5126774 5129986 5129987 5129988 5156272 5170746 5170747 5213726 5225424 5225430 5225435 CZC5240Q1F CZC5462BV3 CZC6181MT4 CZC6181MTN CZC6181MTQ CZC7244NXM CZC7244NXQ CZC5472F88 CZC5472F8S 5213735 5225441 CZC53003BK CZC6130L2H CZC6291WTN CZC63128WM CZC64511M0 CZC72414B3 CZC72414B6 CZC7250WNB CZC7364RRG CZC7364RTK 5175454 5140807 5156083 5213707 5225426 5225436 CZC53003B2 CZC53003B5 CZC5492LK4 CZC63128X1 CZC642559F CZC64255B1 CZC7105QF1 CZC724149T FRB4210XSD FRB4250SWZ FRB426011G FRB426013M 5182679 5089740 5123579 5123580 5123581 5156273 5156274 5156280 5182677 5199043 5199044 5199047 5199069 5199071 5199072 5225442 CZC5280BSS CZC53003B1 CZC5460C7B CZC5462BTZ CZC6130L3C CZC64006L6 CZC642559Q CZC642559T CZC642559W CZC64255B6 CZC64255B9 CZC64255BD CZC64255BL CZC64255BV CZC64255C7 CZC7080QJM CZC7105QDR CZC7132V7P CZC7414GGC FRB4260120 FRB4260124 FRB4260125 FRB426013X 5100641 5115306 5156055 5156057 5165854 5170738 5170748 5170749 5171820 5171821 5171822 5171823 5175464 5175465 5182683 5205319 5205772 5205773 5205774 5205775 CZC5240Q13 CZC5240Q14 CZC5460C85 CZC5462HW5 CZC5492LL3 CZC61030G4 CZC61030GD CZC61030H2 CZC61544VD CZC61544VM CZC61544VZ CZC6261MWH CZC6322Q7Q CZC64255BT CZC64255BY CZC7105QF2 CZC7105QF9 CZC7105QFD CZC7105QFJ CZC72126A6 CZC7212G4J 5100633 5100643 5140822 5148392 5156049 5170744 5213709 5213746 5213747 5213749 6064621 6064622 6064623 6064624 6064625 6064626 6064627 6064628 6064629 6064630 6064631 6064632 6064633 CZC5521M4K CZC61030GX CZC6130L3G CZC6181MT5 CZC6181MT9 CZC6181MTM CZC62803TC CZC62803TQ CZC62803TT CZC62803V0 CZC63128WD CZC63128WJ CZC63182WL CZC642558L CZC6425595 CZC642559V CZC64255C1 CZC64255CJ CZC64511LQ CZC73312RY CZC7364RRR CZC7364RTQ CZC7364RVD FRB4250SMF FRB4250SMH FRB4250SWS CZC6383VVK CZC6391G9W CZC6391G9X CZC64006KN CZC64006KT CZC64006KV CZC64006L3 CZC72414B4 CZC7364RRY CZC7244NXD CZC7244NXP 5065152 5065156 5065157 5065158 5065159 5077167 5077168 5148393 5156278 5156279 5156281 5175445 5175446 5175447 5175449 5199076 5199077 5199078 5199079 CZC5280BS5 CZC5280BSK CZC5460C7Y CZC5462HW0 CZC5462HW8 CZC5462HVY CZC5472F8T CZC5492LJS CZC5521M44 CZC6130L2J CZC6130L2L CZC6130L2T CZC63128WF CZC63128WZ CZC63128X7 CZC63128X8 CZC63128XQ CZC64006JH CZC64255BC CZC64255BJ CZC64255C2 CZC64255CD CZC6482WKG CZC7080QHY CZC7105QDY CZC7105QF8 CZC7105QFB CZC7105QFQ CZC7132V72 CZC7212G50 CZC721500K CZC7244NX4 CZC7244NX8 CZC7244NXC CZC7250WNP CZC7364RSH CZC7364RSS CZC7414GGL CZC7414GHT CZC5460C7K CZC7105QFF 5065150 5065151 5065153 5065154 5065155 5077171 5077174 5126775 5126776 5126779 5140806 5140819 5140820 5140821 5156052 5156053 5156275 5156276 5156282 5156285 5165861 5170757 5175442 5182694 5182695 5182701 5182712 5182714 5199054 5199064 5199065 5213703 5225427 5225429 5225445 6120325 6161422 6197653 CZC528245K CZC5391VFC CZC5391VFG CZC5391VFR CZC5391VFW CZC5391VGN CZC5472F8L CZC5492LJY CZC5510Y5T CZC62803T5 CZC62803TL CZC62803TS CZC63128WW CZC6394DH7 CZC64006JK CZC64006JR CZC64006KM CZC642558J CZC6425599 CZC64255CH CZC64511LN CZC64511LS CZC64511M9 CZC7105QDP CZC7105QDT CZC7105QDZ CZC7105QFG CZC7105QFR CZC7105QFS CZC7132V7X CZC7212G4P CZC7212G4Q CZC7244NX5 CZC7244NXF CZC7364RSK CZC7364RSL CZC7364RSV FRB4250QH1 FRB426012S 5205318 5213708 5213736 5213744 5213750 5225434 CZC6394DG3 CZC6482WK8 CZC6130L33 CZC7080QK5 CZC7244NX7 5126781 5126782 5126783 5126784 5140824 5148389 CZC6482WJS CZC6482WKF CZC6482WLG CZC6482WLJ CZC7250WNN
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Wauwatosa, WI, by letter on December 13, 2007.
Manufacturer: GE Healthcare Finland Oy, Helsinki, Finland. Firm initiated recall is ongoing.
REASON
Failure to alarm: An active monitor could become disconnected from the unit without any notification or alarm.
VOLUME OF PRODUCT IN COMMERCE
2,146 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) 1 Liter Latex-Free Breathing Bags; Reservoir Bag; Vendor Part Number: 720059B,
Medline Item Number: 40056; Available in various Anesthesia Circuit Kits and
Complete Delivery System kits including:
1) Item Number CDS980230I, NICU-OR CDS;
2) Item Number DYNJ22691, Basin Supply Pack;
3) Item Number DYNJ24724, Spine-Crani Anesthesia Kit;
4) Item Number DYNJAAHY11, Hyperinflation System-UHS-1L;
5) Item Number DYNJAP0010, Anesthesia Circuit Ped-LF;
6) Item Number DYNJAP0011A, Pediatric Circuit-LF;
7) Item Number DYNJAP0012, Pediatric Anesthesia 40 In. CI;
8) Item Number DYNJAP0100, Pedi Breathing Circuit-LF;
9) Item Number DYNJAP0101, Anesthesia Circuit-Ped;
10) Item Number DYNJAP4012, Anesthesia Circuit Ped;
11) Item Number DYNJAP4013, Anesthesia Circuit;
12) Item Number DYNJAP4702A, Anesth Circuit Ped GS Line;
13) Item Number DYNJAP4707, Anesth Circuit 40in Ped-LF;
14) Item Number DYNJAP4722, Anes Cir 40 Ped GSEPW HYBABYH;
15) Item Number DYNJAP4729A, Circ Ped Anes Super-LF;
16) Item Number DYNJAP4730A, Circuit Pediatric Anesthesia;
17) Item Number DYNJAP4732, Anesth Circ Ped 40in 2B/V;
18) Item Number DYNJAP4740, Anesth Circ 40in Ped;
19) Item Number DYNJAP6101, Anesthesia Circuit;
20) Item Number DYNJAP6105, Anesth Circuit 60in Ped;
21) Item Number DYNJAP6106, Anes Circ Ped 60in BI GSE-LF;
22) Item Number DYNJAP6107, Anesth Circ Ped 60in ANG HME;
23) Item Number DYNJAP6108, Anesth Circuit 60in Ped;
24) Item Number DYNJAP6109, Anesth Circ Ped 60in B/V 1L-LF;
25) Item Number DYNJAP6111, Anes Cir Ped 60 GSEPW PALL FIL;
26) Item Number DYNJAP6112, Anesthesia-Peds Circuit;
27) Item Number DYNJAP6113, Circuit Pedi 60in;
28) Item Number DYNJAP6114, Anesth Circ 60in Ped;
29) Item Number DYNJAP6116, Anesth Circ 60in Ped;
30) Item Number DYNJAP6120A, Pediatric Circuit 40in LF;
31) Item Number DYNJAP6124, Anesth Circ Pedi 60in 1L GSL;
32) Item Number DYNJAP6127, Anes Circ Pedi 60in-LF;
33) Item Number DYNJAP6130, Anesth Circ Ped 60in 1L-LF;
34) Item Number DYNJAP6132A, Circuit Pediatric Anesthesia;
35) Item Number DYNJAP6133, Anesth Circuit Peds 60in-LF;
36) Item Number DYNJAP6136, Circuit Peds Anesthesia;
37) Item Number DYNJAP6137, Circuit Pediatric Anesthesia;
38) Item Number DYNJAP7217A, Anesth Circuit 72in Exp Ped BI;
39) Item Number DYNJAP7225A, Circuit Pediatric Anesthesia;
40) Item Number DYNJAP7227, Anes. 90in Exp Pedi -LF;
41) Item Number DYNJAP7233, Anes. Circuit 90in Exp Pedi-LF;
42) Item Number DYNJAP7234A, Anesthesia 72in Pediatric Exp;
43) Item Number DYNJAP7235A, Anesth Circ 72in Ped;
44) Item Number DYNJAP7236A, Anesthesia Pedi 72in;
45) Item Number DYNJAP7237, Circuit Pedi 90in EXP;
46) Item Number DYNJAP7241A, Circuit Pediatric Anesthesia;
47) Item Number DYNJAP7243B, Circ Anesth Ped 2 B/V LFree;
48) Item Number DYNJAP7246C, Circuit Pediatric Anesthesia;
49) Item Number DYNJAP7247, Anes Circ Peds 90in Exp;
50) Item Number DYNJAP7248, Anesth Circ Ped 72in Exp;
51) Item Number DYNJAP7261, Circuit Pediatric Anesthesia;
52) Item Number DYNJAP7262, Circuit Pediatric Anesthesia;
53) Item Number DYNJAP7263, Pediatric Anesthesia Circuits;
54) Item Number DYNJAP9005, Anesthesia Circuit;
55) Item Number DYNJAP9721A, Anesth Circuit Pedi HMEF LF;
56) Item Number DYNJAP9725, Pedi Expand Circuit;
57) Item Number DYNJAP9726, Anesth Circ Ped 90in;
58) Item Number DYNJAP9729, Anesth Circ 90in Exp Ped;
59) Item Number DYNJAP9730A, Circuit Pediatric 60in CORR-LF;
60) Item Number DYNJAP9732A, Circuit Pediatric Anesthesia;
61) Item Number DYNJAP9735, Peds Circuit;
62) Item Number DYNJAP9739, Circuit Pediatric Anesthesia;
63) Item Number DYNJAP9740, Circuit Pediatric Anesthesia;
64) Item Number DYNJAP9743, Circuit Pediatric Anesthesia;
65) Item Number DYNJAPF6003, Anesth Circ 60in Ped Unilimb;
66) Item Number DYNJAPF6005A, Anesth Circ 60in Uni Peds;
67) Item Number DYNJAPF6006, Anes Circ Peds 60in Uni;
68) Item Number DYNJAPF6009, Peds Anesthesia Circuit-LF;
69) Item Number DYNJAPF6011, Circuit Pediatric Anesthesia;
70) Item Number DYNJAPF6013, Circuit Pediatric Anesthesia;
71) Item Number DYNJAPF6014, Pediatric Circuit;
72) Item Number DYNJQ9160A, T&A Procedure,
Recall # Z-1162-2008;
b) 3 Liter Latex-Free Breathing Bag; Reservoir Bag; Vendor Part Number: 720057B,
Medline Item Number: 40053; Available in various Anesthesia Circuit Kits and
Complete Delivery System Kits including:
1) Item Number DYNJ09422, Anesthesia Kit-LF;
2) Item Number DYNJAA9010A, Anesthesia Circuit Adult Expand;
3) Item Number 00-GS2675K, Pacemaker Kit;
4) Item Number ACC010004A, Anesthesia Drawer 6;
5) Item Number ACC010015, Anesthesia Drawer 8;
6) Item Number ACC010015A, Anesthesia Drawer 8;
7) Item Number ACC010031, Anesthesia Case Cart Drawer 6;
8) Item Number ACC010036, Anesthesia Drawer 6;
9) Item Number ACC010056, Anesthesia Cart Drawer 6;
10) Item Number CDS760048M, D&C CDS;
11) Item Number CDS760050L, Vag Hyster CDS;
12) Item Number CDS760054F, Laparoscopy CDS;
13) Item Number CDS780080J, Major Spinal CDS;
14) Item Number CDS780081G, Minor Spine CDS-LF;
15) Item Number CDS780127C, Lumbar CDS;
16) Item Number CDS780150A, Craniotomy CDS-LF;
17) Item Number CDS780151A, Spinallami-Fusion-Disk-Lumb-LF;
18) Item Number CDS840144B, Open Heart CDS;
19) Item Number CDS840270C, Carotid CDS;
20) Item Number CDS840325B, Major Vascular CDS;
21) Item Number CDS840336A, Heart-LF;
22) Item Number CDS840337A, Vascular Minor CDS-LF;
23) Item Number CDS840338A, Carotid Endarectomy CDS-LF;
24) Item Number CDS840384A, Open Heart CDS;
25) Item Number CDS840429, Arrowhead Open Heart CDS;
26) Item Number CDS840463A, Accessory Pack;
27) Item Number CDS840494, AV Fistula CDS;
28) Item Number CDS860094C, Laparoscopic Colon Resection;
29) Item Number CDS860109A, Laparoscop Bilat Tubal Lig-LF;
30) Item Number CDS860159, Major ABD Procedure CDS-Pack A;
31) Item Number CDS860159A, Major ABD Procedure CDS;
32) Item Number CDS860160A, Minor ABD Procedure CDS;
33) Item Number CDS860161, Lithotomy Major CDS;
34) Item Number CDS860161A, Lithotomy Major CDS;
35) Item Number CDS860200, Lap Appy Kit;
36) Item Number CDS860200A, Lap Appy Kit;
37) Item Number CDS860201, Lap Chole Kit;
38) Item Number CDS860201A, Lap Chole Kit;
39) Item Number CDS860202, Lap Nissen Kit;
40) Item Number CDS860202A, Lap Nissen Kit;
41) Item Number CDS920108C, Laparoscopy CDS;
42) Item Number CDS930145C, Lap Chole CDS;
43) Item Number CDS930178F, Lap Chole Somc CDS-LF;
44) Item Number CDS930183A, Lap Chole CDS-LF;
45) Item Number CDS930208B, Lap Chole CDS;
46) Item Number CDS940836B, Shoulder CDS;
47) Item Number CDS940836C, Shoulder CDS;
48) Item Number CDS940837B, Knee CDS;
49) Item Number CDS940844C, Shoulder Arthroscopy CDS;
50) Item Number CDS940859C, Arthroscopy CDS-LF;
51) Item Number CDS940896F, Arthroscopy CDS;
52) Item Number CDS940900F, Shoulder CDS;
53) Item Number CDS941067A, Knee Replacement Total-LF;
54) Item Number CDS941068B, Total Hip CDS-LF;
55) Item Number CDS941248, Extremity Ortho CDS;
56) Item Number CDS941248A, Extremity Ortho CDS;
57) Item Number CDS941325, Dr Zeegan Total Hip Encino;
58) Item Number CDS941326, Dr Zeegan Total Hip Encino;
59) Item Number CDS980153B, Basic CDS;
60) Item Number CDS980211C, O.R. Turnover Kit;
61) Item Number CDS980228K, Breast Biopsy CDS;
62) Item Number CDS980232L, Plastic CDS;
63) Item Number CDS980395, D&C/Vaginal Minor CDS-LF;
64) Item Number CDS980510D, Neuro Associates Laminectomy;
65) Item Number CDS980701, Shoulder Arthroscopy Procedure;
66) Item Number CDS980702, Knee Arthroscopy Procedure;
67) Item Number CDS980703, Extremity Procedure;
68) Item Number CDS980704, Spine Procedure;
69) Item Number CDS980749, Minor CDS;
70) Item Number CDS980794, Lithotomy CDS;
71) Item Number CDS980796, Knee Arthroscopy CDS;
72) Item Number CDS980797, Gyn Abd CDS;
73) Item Number CDS980798, C-Section CDS;
74) Item Number CDS980799, Lap Chole CDS;
75) Item Number CDS980800, Hand CDS-Dr Casey;
76) Item Number CDS980801A, Lap Gastric CDS;
77) Item Number CDS980817, Total Hip CDS;
78) Item Number CDS980818, AV Fistula CDS;
79) Item Number CDS980819, Knee Arthroscopy CDS;
80) Item Number CDS980820, Shoulder Arthroscopy CDS;
81) Item Number CDS980821, Spine CDS;
82) Item Number CDS980822, Total Knee CDS;
83) Item Number CDS980823, Hand CDS;
84) Item Number CDS980831, Gastric Bypass CDS;
85) Item Number CDS980846, Spinal CDS-LF;
86) Item Number CDS980847, Laparoscopy CDS-LF;
87) Item Number CDS980848, Universal Drape CDS;
88) Item Number CDS980849, Vascular Split Drape CDS;
89) Item Number CDS980850, Laminectomy CDS;
90) Item Number CDS980851, Head and Neck CDS;
91) Item Number CDS980904, Minor Procedure CDS;
92) Item Number CMPJ21747A, Extremity Pack;
93) Item Number CMPJY0146D, Peripheral Vascular-LF;
94) Item Number DYNJAA0063, Anesthesia Super Circuit;
95) Item Number DYNJAA0261B, Anesthesia Super Circuit-LF;
96) Item Number DYNJAA0266A, Anesth Super Circ 60in Uni;
97) Item Number DYNJAA0283B, Anesth Circ 40in Adult 3LTR-LF;
98) Item Number DYNJAA4751, Custom Circuit-Adult;
99) Item Number DYNJAA4755A, Anesthesia Circuit;
100) Item Number DYNJAA4757A, Anesth Circ 40in Adult Discnct;
101) Item Number DYNJAA4761, Anesth Circ 40in Adult;
102) Item Number DYNJAA4765C, Kit Anesthesia Accessory;
103) Item Number DYNJAA4774, Anesth Circ 40in Adult;
104) Item Number DYNJAA4776A, Circuit Adult Anesthesia;
105) Item Number DYNJAA4778, Anesth Circ Adult 40in 2BV SWI;
106) Item Number DYNJAA4791A, Circuit Adult Anesthesia;
107) Item Number DYNJAA4792, Circuit Anes Adult 40in Corr;
108) Item Number DYNJAA4798, Anes Circ 40 Ltx Free Gas Lin;
109) Item Number DYNJAA4805, Circuit Adult Anesthesia;
110) Item Number DYNJAA4808, Adult Anesthesia Circuit;
111) Item Number DYNJAA4808A, Adult Anesthesia Circuit;
112) Item Number DYNJAA4809, Circuit Adult Anesthesia-LF;
113) Item Number DYNJAA4809A, Circuit Adult Anesthesia-LF;
114) Item Number DYNJAA4811A, Circuit Adult Anesthesia;
115) Item Number DYNJAA4812, Adult Anesthesia Circuit;
116) Item Number DYNJAA4815, Adult Anesthesia Circuit;
117) Item Number DYNJAA4816, Circuit Adult Anesthesia;
118) Item Number DYNJAA4817, Circuit Adult Anesthesia;
119) Item Number DYNJAA4819, Anesthesia Circuit Adult Kit;
120) Item Number DYNJAA4820, Circuit Adult Anesthesia;
121) Item Number DYNJAA4821, Adult Anesthesia Circuit;
122) Item Number DYNJAA4828, Circuit Adult Anesthesia;
123) Item Number DYNJAA6420B, AVH Breathing Circuit-LF;
124) Item Number DYNJAA6445, Anesthesia Circuit 60 LFree;
125) Item Number DYNJAA6453, Anesth Circ Adult 60in;
126) Item Number DYNJAA6459A, Anesthesia Circuit;
127) Item Number DYNJAA6461B, Anes Circ Adult 90in EXP-LF;
128) Item Number DYNJAA6474, Circuit Adult Anesthesia;
129) Item Number DYNJAA6475, Circuit Adult Anesthesia;
130) Item Number DYNJAA6483, Circuit Adult Anesthesia;
131) Item Number DYNJAA6485A, Adult Anesthesia Circuit;
132) Item Number DYNJAA6486, Circuit Adult Anesthesia;
133) Item Number DYNJAA6489, Circuit Adult Anesthesia;
134) Item Number DYNJAA6490, Adult Anesthesia Circuit;
135) Item Number DYNJAA9010A, Anesthesia Circuit Adult Exp;
136) Item Number DYNJAA9040, Anesthesia Circuit;
137) Item Number DYNJAA9700B, Circuit Adult Anesthesia;
138) Item Number DYNJAA9714C, Nurses Kit-LF;
139) Item Number DYNJAA9717, Anesth Circuit 90 Inch HME-LF;
140) Item Number DYNJAA9724A, Anesthesia Circuit Adult;
141) Item Number DYNJAA9726, Anesthesia Circuit;
142) Item Number DYNJAA9729A, Anesth Circuit 60 HME;
143) Item Number DYNJAA9748, Anesthesia Circuit-LF;
144) Item Number DYNJAA9762, Anesth Circuit 90in EXP Adult;
145) Item Number DYNJAA9774A, Anesth Circuit Expan Swiv;
146) Item Number DYNJAA9777C, Circuit Adult Anesthesia;
147) Item Number DYNJAA9779, Anesth Circ 90in EXP Adult;
148) Item Number DYNJAA9783, Adult Anesthesia;
149) Item Number DYNJAA9814, Adult Expandable Circuit;
150) Item Number DYNJAA9819, Anesth Circuit 90in EXP-LF;
151) Item Number DYNJAA9821, Anesth Circ Adult 90in EXP;
152) Item Number DYNJAA9833, Anesth Circ 120in EXP Adult;
153) Item Number DYNJAA9834, Adult Circuit 90in Expandable;
154) Item Number DYNJAA9835B, Circuit Adult Anesthesia;
155) Item Number DYNJAA9836, Anesth Circ 90inch EXP Adult;
156) Item Number DYNJAA9837, Anesth Circ 90in EXP Adult;
157) Item Number DYNJAA9840, Circuit Adlt 90in Expand;
158) Item Number DYNJAA9842, Anesth Circ 90in EXP Adult-LF;
159) Item Number DYNJAA9844B, Circ Anesth 90in GSP 2 B/V-LF;
160) Item Number DYNJAA9845, Anesth Circuit 90in Swivel;
161) Item Number DYNJAA9864A, Circuit Adult Anesthesia;
162) Item Number DYNJAA9865, Anesthesia Circuit;
163) Item Number DYNJAA9871, Circuit Adult 90in EXP-LF;
164) Item Number DYNJAA9874, Anesthesia Circuit;
165) Item Number DYNJAA9879, Circuit Anes Adult 90in EXP-LF;
166) Item Number DYNJAA9880, Circuit Adult Anes 90in EXP;
167) Item Number DYNJAA9884, Circuit Adult 90in EXP-LF;
168) Item Number DYNJAA9888, Adult Anesthesia Circuit-LF;
169) Item Number DYNJAA9889B, Anesthesia Circuit Adult;
170) Item Number DYNJAA9890, Circuit Adult Anesthesia;
171) Item Number DYNJAA9894, Circuit Adult Anesthesia;
172) Item Number DYNJAA9898, Circuit Adult Anesthesia;
173) Item Number DYNJAA9899, Circuit Adult Anesthesia;
174) Item Number DYNJAA9900, Circuit Adult Anesthesia;
175) Item Number DYNJAA9900B, Circuit Adult Anesthesia;
176) Item Number DYNJAA9902, Circuit Adult Anesthesia;
177) Item Number DYNJAA9903, Circuit Adult Anes-SM-MRMC-RC;
178) Item Number DYNJAA9905, Circuit Adult Anesthesia;
179) Item Number DYNJAA9907, Circuit Adult Anesthesia;
180) Item Number DYNJAA9915, Circuit Adult Anesthesia;
181) Item Number DYNJAA9918, Adult Anesthesia Circuit-LF;
182) Item Number DYNJAA9919, Circuit Adult Anesthesia;
183) Item Number DYNJAA9920, Circuit Adult Anesthesia;
184) Item Number DYNJAA9921, Circuit Adult Anesthesia;
185) Item Number DYNJAA9924, Adult Anesthesia Circuit;
186) Item Number DYNJAA9925, Anesthesia Circuits;
187) Item Number DYNJAA9927, Anesthesia Super Circuit Kit;
188) Item Number DYNJAA9928, Adult Anesthesia Circuit;
189) Item Number DYNJAA9930, Adult Anesthesia Circuit;
190) Item Number DYNJAA9931, Anesthesia Circuit;
191) Item Number DYNJAAF6258A, Anesthesia Circuit;
192) Item Number DYNJAAF6262, Anesthesia Circuit Valley Hlth;
193) Item Number DYNJAAF6288A, Circuit Adult Uni 50in-LF;
194) Item Number DYNJAAF6293, Anesth Circ 72in Unilimb Adult;
195) Item Number DYNJAAF6295, Anesth Circ Adult Uni;
196) Item Number DYNJAAF6297A, Adult Anes Circuit-LF;
197) Item Number DYNJAAF6298A, Adult Anes Circuit-LF;
198) Item Number DYNJAAF6302, Adult Anesthesia Circuit;
199) Item Number DYNJAAF6324, Adult Anesthesia Circuit;
200) Item Number DYNJAAF6326, Circuit Adult Anesthesia;
201) Item Number DYNJAAF6327, Adult Anesthesia Circuit;
202) Item Number DYNJAAF6329, Circuit Adult Anesthesia;
203) Item Number DYNJAAF6330, Anesthesia Circuit Adult;
204) Item Number DYNJAAF6331, Adult Anesthesia Circuit;
205) Item Number DYNJAAF6341, Adult Anesthesia Circuit;
206) Item Number DYNJAAF6342, Circuit Adult Anesthesia;
207) Item Number DYNJAAF6343, Circuit Adult Anesthesia;
208) Item Number DYNJAAF6344, Circuit Adult Anesthesia;
209) Item Number DYNJAAF6345, Adult Anesthesia Circuit;
210) Item Number DYNJAAF6346, Anesth Circuit 72in Uni Adult;
211) Item Number DYNJAAHY13, Circuit Anes Mapleson D-LF;
212) Item Number DYNJAAHY14, Circuit Adult Uni 192in GSE;
213) Item Number DYNJT2590, Lap General CDS;
214) Item Number DYNJT2591A, Knee ACL CDS,
Recall # Z-1163-2008;
c) 2 Liter Latex-Free Breathing Bag; Reservoir Bag; Vendor Part Number: 720058B,
Medline Item Number: 40054; Available in various Anesthesia Circuit Kits and
Complete Delivery System Kits including:
1) Item Number CDS980652A, Thoracic Anesthesia Pack;
2) Item Number CDS980955, Affinity Shoulder Arthroscopy;
3) Item Number CDS980956, Affinity Total Hip CDS;
4) Item Number CDS980957, Affinity Total Knee CDS;
5) Item Number DYNJAA4758B, Circuit Adult Anesthesia;
6) Item Number DYNJAA4777, Adult 40in Anesth w/HME-LF;
7) Item Number DYNJAA9796, Anes Circuit 90in EXP Adult-LF;
8) Item Number DYNJAA9847A, Adult Circuit;
9) Item Number DYNJAA9904, Circuit Adult Anesthesia;
10) Item Number DYNJAA9904A, Circuit Adult Anesthesia;
11) Item Number DYNJAA9906, Circuit Adult Anesthesia;
12) Item Number DYNJAA9933, Anesthesia Super Circuit;
13) Item Number DYNJAAF6318A, Adult Anesthesia Circuit;
14) Item Number DYNJAP4726, Pedi Circuit 40in;
15) Item Number DYNJAP4737A, Circuit Pediatric Anesthesia;
16) Item Number DYNJAP4737B, Circuit Pediatric Anesthesia;
17) Item Number DYNJAP4737C, Circuit Pediatric Anesthesia;
18) Item Number DYNJAP4744, Pediatric Anesthesia Circuit;
19) Item Number DYNJAP6138, Circuit Pediatric Anesthesia;
20) Item Number DYNJAP7258, Circuit Pediatric Anesthesia;
21) Item Number DYNJAP7259, Peds Anesthesia Circuit;
22) Item Number DYNJAPF6007, Circuit Ped Uni 60in-LF;
23) Item Number DYNJAPF6012,
Recall: Z-1164-2008
CODE
a) All lots manufactured after October 2006:
1) Lot Numbers: 07JB0905;
2) Lot Number: 07HD1853;
3) Lot Number: 07KB5026;
4) Lot Number: 07HD3686;
5) Lot Number: 07KD3028;
6) Lot Numbers: 07HD4225, 07JD4412 and 07KD0167;
7) Lot Numbers: 07JD3974 and 07KD2230;
8) Lot Numbers: 07ID1739, 07ID3570 and 07JD2943;
9) Lot Number: 07ID2242;
10) Lot Numbers: 07ID1545, 07JD2944 and 07JD3987;
11) Lot Number: 07ID1524;
12) Lot Number: 07HD3333;
13) Lot Numbers: 06LD3453, 07HD2988 and 07JD3927;
14) Lot Number: 07ID2432;
15) Lot Numbers: 07ID4021 and 07JD4476;
16) Lot Number: 07HD3649;
17) Lot Numbers: 07ED4394 and 07KB1986;
18) Lot Numbers: 07ID0168, 07ID2021, 07ID4063, 07JD1340 and 07JD4573;
19) Lot Number: 07JD1161;
20) Lot Numbers: 07ID0137 and 07KD2092;
21) Lot Number: 07KD0278;
22) Lot Number: 07JD0779;
23) Lot Numbers: 07ID0135 and 07JD0018;
24) Lot Numbers: 07HD4400, 07JD0205 and 07KD2228;
25) Lot Numbers: 07ID1373 and 07KB4359;
26) Lot Number: 07ID1546;
27) Lot Number: 07HD4394;
28) Lot Numbers: 07HD3332 and 07KD0567;
29) Lot Number: 07ID2441;
30) Lot Number: 07ID1521;
31) Lot Numbers: 07HD3288, 07JD0019 and 07KD0358;
32) Lot Number: 07ID2266;
33) Lot Numbers: 07HD3650 and 07KD0363;
34) Lot Number: 07JD0020;
35) Lot Number: 07JD0206;
36) Lot Number: 07KD1036;
37) Lot Number: 07GD2133;
38) Lot Numbers: 07CD3854 and 07DD3017;
39) Item Number: DYNJAP7225A, Lot Numbers: 07GD1534 and 07HD3562;
40) Lot Number: 07JD1538;
41) Lot Numbers: 07CD0839 and 07ED0027;
42) Lot Numbers: 07HD3459 and 07ID2630;
43) Lot Number: 07ID2244;
44) Lot Numbers: 07HD1578 and 07ID0169;
45) Lot Numbers: 06KD0647, 06LD3890, 07BD0978, 07BD3099, 07CD3597,
07DD3536, 07GD3218, 07HD3876, 07JD1158 and 07JD3969;
46) Lot Number: 07HD3110;
47) Lot Numbers: 07DD3540, 07ED4104, 07GD1839 and 07JD1190;
48) Lot Numbers: 07IB2772 and 07JD0023;
49) Lot Number: 07JD1541;
50) Lot Number: 07KD1275;
51) Lot Numbers: 07HD2917, 07ID3527 and 07JD2945;
52) Lot Number: 07HD3564;
53) Lot Number: 07ID0954;
54) Lot Number: 07HD1253;
55) Lot Numbers: 07ID2017 and 07KD2298;
56) Lot Number: 07JB3948;
57) Lot Number: 07HD2409;
58) Lot Number: 07JD2946;
59) Lot Number: 07ID1106;
60) Lot Numbers: 07CD1687, 07ED0308, 07GD2552, 07HD2648, 07JD0024
and 07KD2223;
61) Lot Number: 07DD4279;
62) Lot Numbers: 07DD0014 and 07DD3537;
63) Lot Number: 07DD1134;
64) Lot Numbers: 07ID0387, 07ID1751, 07JD1148, 07KD0651 and 07KD1360;
65) Lot Numbers: 07CD1292, 07DD2344, 07ED0732, 07GD3088 and 07HD1080;
66) Lot Number: 07ID1348;
67) Lot Numbers: 07HD2210 and 07ID2019;
68) Lot Numbers: 07ID2076 and 07JD3978;
69) Lot Number: 07HD4155;
70) Lot Numbers: 07ED3128, 07GD1327 and 07ID1374;
71) Lot Number: 07ID0924;
72) Lot Numbers: 07BB1382, 07CB0600 and 07CB2528;
b) All lots manufactured after October 2006:
1) Lot Number(s): 07AD2431, 07ED1171, 07FD0986 and 07GD2699;
2) Lot Number(s): 06KD0470, 06LD3329, 07AD3822, 07AD4358
and 07HD3295;
3) Lot Number(s): 07ID2989;
4) Lot Number(s): 07HD1850;
5) Lot Number(s): 07ED3319 and 07GD1409;
6) Lot Number(s): 07ID2781;
7) Lot Number(s): 07ID3356;
8) Lot Number(s): 07GD3908;
9) Lot Number(s): 07JD0955;
10) Lot Number(s): 07IB2033;
11) Lot Number(s): 07HB0383;
12) Lot Number(s): 07HD0309;
13) Lot Number(s): 07ID3376;
14) Lot Number(s): 07HD2880;
15) Lot Number: 07AD4385, 07DD3000, 07EB2335 and 07FB0786;
16) Lot Number(s): 07BD1234, 07ED3375, 07FB2636, 07HB0382,
7HB1155 and 07HB2927;
17) Lot Number(s): 07BD4019, 07CD2926, 07FD1473, 07GB1293 and 07IB3415;
18) Lot Number(s): 07CD2326;
19) Lot Number(s): 07CD2354;
20) Lot Number(s): 07BD1712;
21) Lot Number(s): 07AD3267, 07GD3398, 07HB0377, 07HB1614 and 07IB2544;
22) Lot Number(s): 07AD4393, 07EB1526 and 07HB2822;
23) Lot Number(s): 07BD1721, 07EB1377, 07EB2694 and 07JB0441;
24) Lot Number(s): 07BB2640, 07EB1713, 07HB3147 and 07IB0469;
25) Lot Number(s): 07FB2624, 07GB3695 and 07IB2392;
26) Lot Number(s): 07JD1168;
27) Lot Number(s): 07JD1170;
28) Lot Number(s): 07HD2053;
29) Lot Number(s): 07GB0028, 07HB1342, 07HB2825 and 07IB1735;
30) Lot Number(s): 07BD0203 and 07CD3891
31) Lot Number(s): 07EB0667, 07FB2140, 07GB2805 and 07HB2823;
32) Lot Number(s): 07GB1298;
33) Lot Number(s): 07AD2448, 07BD2109 and 07CD3361;
34) Lot Number(s): 07EB0665, 07FB2520 and 07IB2854;
35) Lot Number(s): 07CB0292 and 07GB1777;
36) Lot Number: 07HB3748;
37) Lot Number(s): 07CB0971, 07GB0032 and 07HB3327;
38) Lot Number(s): 07IB2695 and 07IB3323
39) Lot Number: 07CB0724;
40) Lot Number: 07IB2397;
41) Lot Number: 07IB2040;
42) Lot Number(s): 07BD0419 and 07BD1236;
43) Lot Number: 07HD3194;
44) Lot Number(s): 07ED2055, 07FB2141, 07GB1198, 07HB0185 and
07IB0688;
45) Lot Number(s): 07HD2395, 07HD2894, 07ID0410, 07ID1525 and
07ID3717;
46) Lot Number(s): 07BB0310, 07BB2177, 07DB1981 and 07FB0922;
47) Lot Number(s): 07HB2928;
48) Lot Number(s): 07BB0816, 07CB1831, 07EB2017, 07GB2618, 07IB2042
and 07JB1297;
49) Lot Number: 07HD0758;
50) Lot Number: 07ID1408;
51) Lot Number(s): 07HB2923 and 07IB2386
52) Lot Number(s): 07HB2830 and 07JB0623
53) Lot Number(s): 07AD3293, 07GB3699 and 07IB3416;
54) Lot Number(s): 07BD4018, 07CD2932, 07EB2149, 07FB2398 and
07HB0187;
55) Lot Number: 07BD0238;
56) Lot Number(s): 07FB0011, 07GB0862 and 07HB2926;
57) Lot Number(s): 07AB2984, 07DB1789 and 07EB0575;
58) Lot Number(s): 07AB3152 and 07DB1429;
59) Lot Number(s): 07GD2828 and 07ID3811;
60) Lot Number(s): 07BB2436, 07EB0679, 07FB0908, 07GB2130, 07IB0877
and 07IB2043;
61) Lot Number: 07JB0431;
62) Lot Number: 07JB0875;
63) Lot Number(s): 07FB0342, 07GB0023 and 07HB2936;
64) Lot Number: 07JG0038;
65) Lot Number(s): 07GB1780 and 07HB1153;
66) Lot Number: 07GB1908;
67) Lot Number(s): 07FB2626, 07HB2824 and 07HB3284;
68) Lot Number(s): 07GB2450 and 07JB1024
69) Lot Number(s): 07JD0762 and 07JD1353;
70) Lot Number: 07GG1799;
71) Lot Number: 07HG0901;
72) Lot Number: 07HG0336;
73) Lot Number: 07HG0424;
74) Lot Number(s): 07HG0426 and 07HG0678;
75) Lot Number: 07HB3544;
76) Lot Number: 07HB2940;
77) Lot Number: 07ID3858;
78) Lot Number: 07ID2696;
79) Lot Number: 07ID2697;
80) Lot Number: 07ID2698;
81) Lot Number(s): 07ID2699;
82) Lot Number: 07ID3857;
83) Lot Number: 07ID2700;
84) Lot Number: 07HB3758;
85) Lot Number(s): 07IB2156 and 07IB3031;
86) Lot Number: 07IB2155 and 07JB1326;
87) Lot Number: 07ID2895;
88) Lot Number: 07ID2892;
89) Lot Number: 07ID2893;
90) Lot Number: 07ID2894;
91) Lot Number: 7JD1193;
92) Lot Number: 07CD3683;
93) Lot Number: 07JD0233;
94) Lot Number(s): 07BD1218, 07FD2268 and 07GD3483;
95) Lot Number: 07HD3458;
96) Lot Number(s): 07BD0007, 07CD3097, 07FD0995, 07GD3474 and 07JD0008;
97) Lot Number(s): 07DD2175, 07GD2614, 07ID2910 and 07JB0510;
98) Lot Number: 07FD1245;
99) Lot Number: 06JD1180;
100) Lot Number(s): 06JD3969, 06LD0329, 07AD3249, 07CD2866, 07FD1850,
07GD3141 and 07ID3529;
101) Lot Number(s): 07ED3321, 07HD2674 and 07JB0815;
102) Lot Number: 07HD3543;
103) Lot Number(s): 07IB3301, 07AD3250, 07FD1249 and 07GD3473;
104) Lot Number: 07ID0143;
105) Lot Number(s): 07JB0818, 07DD1385, 07GD1823 and 07ID2682;
106) Lot Number(s): 06KD1613, 07AD1653, 07FD1363, 07HD0086 and
07JD0392;
107) Lot Number(s): 07JB0819, 07ED3324 and 07GD2939;
108) Lot Number(s): 07JB1563, 07FD0991, 07FD2266 and 07ID2691;
109) Lot Number(s): 07CD4296, 07FD1247 and 07GD3573;
110) Lot Number(s): 07DD2013 and 07DD2013Z;
111) Lot Number(s): 07JB0475 and 07GD3595;
112) Lot Number(s): 07CD3606, 07DD3012, 07ED3339 and 07GD1601;
113) Lot Number(s): 07HD2208 and 07JD1189;
114) Lot Number: 07HD3460;
115) Lot Number(s): 07FD1852, 07HD4223 and 07JD0947;
116) Lot Number(s): 07GD1570 and 07ID0400;
117) Lot Number(s): 07JB1109 and 07HD2035;
118) Lot Number: 07HD2542;
119) Lot Number: 07ID3545;
120) Lot Number: 07ID3132;
121) Lot Number: 07ID3133;
122) Lot Number: 07ID3566;
123) Lot Number(s): 07BD1213, 07CD3099, 07FD1853 and 07ID2690;
124) Lot Number(s): 06KD1164, 07AD2804, 07ED3419, 07FD2065, 07GD1811
and 07ID3544;
125) Lot Number(s): 06JD3029, 07BD3638, 07CD3860, 07FD0992, 07HD0227
and 07JD0013;
126) Lot Number(s): 07GD1321 and 07ID2684;
127) Lot Number(s): 07BD0562, 07CD4301, 07FD2267, 07GD1509, 07HD2211
and 07JB1650;
128) Lot Number(s): 06JD3397, 07BD3634, 07GD1830, 07HD2654, 07HD4142
and 07ID0705;
129) Lot Number(s): 06JD0389, 06LD2328, 07AD3246, 07CD1502Z, 07DD0723,
07ED3328, 07FD1856, 07HD3287 and 07JD0745;
130) Lot Number(s): 07FD1846, 07GD1843, 07HD2647 and 07ID2666;
131) Lot Number(s): 07GD3936, 07HD2036 and 07ID4039;
132) Lot Number: 07HD0572;
133) Lot Number: 07ID3824;
134) Lot Number: 07JD0595;
135) Lot Number(s): 06KD0470, 06LD3329, 07AD3822, 07AD4358 and
07HD3295;
136) Lot Number(s): 07AD3240, 07CD3101 and 07DD2177;
137) Lot Number(s): 07DD1140, 07GD2265, 07HD0692 and 07ID3879;
138) Lot Number(s): 07ED3325, 07GD1511 and 07HD3481;
139) Lot Number(s): 07ED3329, 07GD2196 and 07ID2683;
140) Lot Number(s): 07JB0816, 07BD0292, 07FD1412 and 07HD4093;
141) Lot Number(s): 07AD4482, 07CD2681, 07ED3543, 07FD0971,
07HD2212 and 07ID3883;
142) Lot Number(s): 07ED3330, 07HD2213 and 07ID2688;
143) Lot Number(s): 07DD0241, 07DD0241Z, 07FD1625 and 07GD1837;
144) Lot Number(s): 07JB0478, 07ED3331 and 07HD3334;
145) Lot Number(s): 07AD4951, 07FD1409, 07GD2198 and 07HD4257;
146) Lot Number(s): 07GD3594, 07HD0690, 07ID3119 and 07JD0230;
147) Lot Number(s): 07BD0195, 07BD2655, 07ED3332, 07GD1507 and 07HD4255;
148) Lot Number(s): 07DD2803 and 07ID3880;
149) Lot Number(s): 06KD1949, 07AD4956, 07CD4293, 07FD1627, 07HD2037
and 07ID3124;
150) Lot Number(s): 07BD2651, 07DD2181, 07HD2048 and 07IB2728;
151) Lot Number: 06JD4351;
152) Lot Number(s): 07BD3652, 07DD0227, 07FD1248, 07HD3316 and 07ID3878;
153) Lot Number(s): 07DD0228, 07DD0228Z, 07GD1542 and 07HD3315;
154) Lot Number(s): 07AD4084, 07ED3322, 07FD1858 and 07ID2692;
155) Lot Number(s): 07AD3251, 07AD4952, 07ED3320, 07FD2072,
07HD2049 and 07ID2909;
156) Lot Number(s): 07DD0726, 07FD0993, 07GD3476 and 07JD0203;
157) Lot Number(s): 07DD0239, 07DD0239Z, 07GD1869 and 07ID3382;
158) Lot Number(s): 07BD3943, 07CD3102 and 07HD2047;
159) Lot Number(s): 07AD3253, 07BD3123, 07CD3103, 07FD0987, 07GD1600,
07HD2050, 07HD2922, 07ID2934 and 07JD0781;
160) Lot Number(s): 07CD3623, 07GD2195 and 07JD0015;
161) Lot Number(s): 07BD2911, 07DD0495, 07GD2283, 07ID2908 and 07JB0842;
162) Lot Number(s): 07BD3257, 07ED3326, 07GD2670 and 07JD1188;
163) Lot Number(s): 07BD0553, 07BD2637, 07CD3863 and 07HD0081;
164) Lot Number(s): 07DD0694, 07GD1508 and 07ID3882;
165) Lot Number(s): 07JB0820, 07GD1308 and 07HD2408;
166) Lot Number(s): 07BD0559, 07FD1845, 07GD3938 and 07ID3117;
167) Lot Number(s): 07JB0503, 07BD3945, 07CD4294, 07FD0972, 07GD2668
and 07ID2687;
168) Lot Number(s): 07BD2490, 07DD0684, 07FD1243, 07GD2930 and 07JD0942;
169) Lot Number: 07ID0134;
170) Lot Number: 07BD0189, 07CD2682, 07FD1859 and 07HD4256;
171) Lot Number: 07BD2306;
172) Lot Number(s): 07FD0970, 07GD1510, 07GD3937 and 07ID2686;
173) Lot Number(s): 07BD2907, 07FD1860, 07HD0578 and 07ID3565;
174) Lot Number: 07FD1246;
175) Lot Number: 07IB3073;
176) Lot Number(s): 07DD2343, 07FD0973, 07GD1490, 07HD0577,
07ID3094 and 07JD0946;
177) Lot Number(s): 07CD3620, 07GD1506 and 07ID3125;
178) Lot Number(s): 07ED3323, 07GD3571 and 07JD0778;
179) Lot Number: 07GD1370;
180) Lot Number: 07FD1861;
181) Lot Number: 07GD2288;
182) Lot Number(s): 07GD1599 and 07ID0405;
183) Lot Number(s): 07GD1598 and 07ID3531;
184) Lot Number(s): 07HD1779 and 07JD0958;
185) Lot Number: 07HD1793;
186) Lot Number: 07HD2215;
187) Lot Number: 07ID2681;
188) Lot Number: 07ID0371;
189) Lot Number: 07ID2680;
190) Lot Number: 07JD0364;
191) Lot Number(s): 07BD2652, 07DD0242, 07FD0994, 07GD2201 and 07ID2689;
192) Lot Number(s): 07BD1511, 07DD0240, 07ED3544, 07FD1410, 07GD2938,
07HD3304 and 07ID3538;
193) Lot Number(s): 06JD2484, 06LD2319, 07DD0709, 07GD1498 and 07HD3552;
194) Lot Number(s): 07IB2810, 07BD2650, 07ED3327, 07GD1543 and 07HD3871;
195) Lot Number: 07BD2915;
196) Lot Number(s): 06KD0463, 06LD3452, 07AD4085, 07FD1406 and 07GD3142;
197) Lot Number(s): 07IB3086, 06JD3221, 06LD0318, 07CD4297, 07GD2194,
07HD3480 and 07ID3741;
198) Lot Number(s): 07FD1844, 07GD3572 and 07ID2685;
199) Lot Number(s): 07BD3422, 07CD3540, 07FD2069 and 07HD4247;
200) Lot Number(s): 07CD2879, 07CD3617, 07FD0974, 07FD1848, 07GD3260,
07HD0922, 07ID3091 and 07JD0933;
201) Lot Number: 07ID3089;
202) Lot Number(s): 07DD1133, 07ED3333 and 07GD3794;
203) Lot Number(s): 07DD1125, 07GD1863 and 07ID1104;
204) Lot Number(s): 07FD1244 and 07HD4285;
205) Lot Number(s): 07HD2038 and 07ID3093;
206) Lot Number(s): 07GD1337 and 07GD2157;
207) Lot Number(s): 07HD0226 and 07ID3807;
208) Lot Number(s): 07HD3162; 209) Lot Number: 07ID0138;
210) Lot Number: 07JD0231;
211) Lot Number(s): 06JD2830, 07AD1669, 07CD2886, 07FD1420, 07HD0675
and 07ID1346;
212) Lot Number: 06KD3560;
213) Lot Number: 07JB0017;
214) Lot Number: 07JB0632
c) All lots manufactured after October 2006:
1) Lot Number: 07JD0594;
2) Lot Number: 07KD0352;
3) Lot Number: 07KD0281;
4) Lot Number: 07KD0282;
5) Lot Number(s): 07DD2346, 07ID2931 and 07KB2367;
6) Lot Number(s): 07DD2800, 07DD4133, 07ID3130, 07JB1784, 07KB3600;
7) Lot Number(s): 07DD1377, 07DD2347, 07GD1504, 07ID3383, 07JB2589;
8) Lot Number(s): 07FD0840, 07FD3218, 07ID2679 and 07KB1977;
9) Lot Number(s): 07ED1416, 07ED3547 and 07FD1256;
10) Lot Number: 07JB2027;
11) Lot Number(s): 07DD2538 and 07FD0568;
12) Lot Number(s): 07JD1295 and 07KD2315;
13) Lot Number(s): 07ID3358, 07JD0005 and 07KD3034;
14) Lot Number(s): 07DD1381 and 07KD1419;
15) Lot Number: 07AD0945;
16) Lot Number: 07DD2005;
17) Lot Number(s): 07ID3877 and 07KD2238;
18) Lot Number: 07GD1491;
19) Lot Number: 07ID3357;
20) Lot Number: 07KB4822;
21) Lot Number(s): 07GD1121 and 07JD0740; 22) Lot Number: 07GD1295;
23) Lot Number: 07DD3724
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medline Industries, Inc., Mundelein, IL, by letter on December 5, 2007.
Manufacturer: Ventlab Corp., Mocksville, NC. Firm initiated recall is ongoing.
REASON
Separation from Bushing: The breathing bag may separate from the bushing during use.
VOLUME OF PRODUCT IN COMMERCE
571,500 packs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Zoll E Series Defibrillator with 12 Lead ECG, Automated external defibrillator, Software Version 3.00 and higher, Recall # Z-1167-2008
CODE
Serial Numbers: AB05D000031 AB05D000034 AB05F000276 AB05F000277 AB05F000278 AB05F000279 AB05F000280 AB05F000281 AB05F000282 AB05F000283 AB05F000284 AB05F000286 AB05F000287 AB05F000288 AB05F000289 AB05F000290 AB05F000291 AB05F000292 AB05F000293 AB05F000294 AB05F000295 AB05F000296 AB05F000297 AB05F000298 AB05F000299 AB05F000300 AB05F000301 AB05F000302 AB05F000303 AB05F000304 AB05F000305 AB05F000306 AB05F000307 AB05F000308 AB05F000309 AB05F000310 AB05F000311 AB05F000312 AB05F000313 AB05F000314 AB05F000315 AB05F000316 AB05F000317 AB05F000318 AB05F000319 AB05F000320 AB05F000321 AB05F000322 AB05F000323 AB05F000324 AB05F000325 AB05F000326 AB05F000327 AB05F000328 AB05F000329 AB05F000330 AB05F000331 AB05F000332 AB05F000333 AB05F000334 AB05F000335 AB05F000336 AB05F000337 AB05F000338 AB05F000339 AB05F000340 AB05F000341 AB05F000342 AB05F000343 AB05F000344 AB05F000345 AB05F000346 AB05F000347 AB05F000348 AB05F000349 AB05F000350 AB05F000351 AB05F000352 AB05F000353 AB05F000354 AB05F000355 AB05F000356 AB05F000357 AB05F000358 AB05F000359 AB05F000360 AB05F000361 AB05F000362 AB05F000363 AB05F000364 AB05F000365 AB05F000366 AB05F000367 AB05F000368 AB05F000369 AB05F000370 AB05F000371 AB05F000372 AB05F000373 AB05F000374 AB05F000375 AB05F000376 AB05F000377 AB05F000378 AB05F000379 AB05F000380 AB05F000381 AB05F000382 AB05F000384 AB05F000385 AB05F000386 AB05F000387 AB05F000388 AB05F000389 AB05F000390 AB05F000391 AB05F000392 AB05F000393 AB05F000395 AB05F000396 AB05F000397 AB05F000398 AB05F000399 AB05F000401 AB05F000402 AB05F000403 AB05F000404 AB05F000405 AB05F000406 AB05F000407 AB05F000408 AB05F000409 AB05F000411 AB05F000412 AB05F000413 AB05F000414 AB05F000415 AB05F000416 AB05F000417 AB05F000419 AB05F000420 AB05F000421 AB05F000422 AB05F000423 AB05F000424 AB05F000425 AB05F000426 AB05F000427 AB05F000429 AB05F000430 AB05F000431 AB05F000432 AB05F000433 AB05F000434 AB05F000436 AB05F000437 AB05F000438 AB05F000439 AB05F000440 AB05F000441 AB05F000442 AB05F000443 AB05F000444 AB05F000445 AB05F000446 AB05F000447 AB05F000448 AB05F000449 AB05F000450 AB05F000451 AB05F000452 AB05F000453 AB05F000454 AB05F000455 AB05F000456 AB05F000457 AB05F000458 AB05F000459 AB05F000460 AB05F000461 AB05F000462 AB05F000463 AB05F000464 AB05F000465 AB05F000466 AB05F000467 AB05F000468 AB05F000469 AB05F000470 AB05F000471 AB05F000472 AB05F000473 AB05F000474 AB05F000475 AB05F000476 AB05F000477 AB05F000478 AB05F000479 AB05F000480 AB05F000481 AB05F000482 AB05F000483 AB05F000484 AB05F000485 AB05F000486 AB05F000487 AB05F000488 AB05F000489 AB05F000491 AB05F000492 AB05F000493 AB05F000494 AB05F000495 AB05F000496 AB05F000497 AB05F000498 AB05F000499 AB05F000500 AB05F000501 AB05F000502 AB05F000503 AB05F000504 AB05F000505 AB05F000506 AB05F000508 AB05F000511 AB05F000512 AB05F000513 AB05F000514 AB05F000515 AB05F000579 AB05H000516 AB05H000517 AB05H000518 AB05H000519 AB05H000520 AB05H000521 AB05H000522 AB05H000523 AB05H000524 AB05H000525 AB05H000526 AB05H000527 AB05H000528 AB05H000529 AB05H000530 AB05H000531 AB05H000532 AB05H000533 AB05H000534 AB05H000535 AB05H000536 AB05H000537 AB05H000538 AB05H000539 AB05H000540 AB05H000541 AB05H000542 AB05H000543 AB05H000544 AB05H000545 AB05H000546 AB05H000547 AB05H000548 AB05H000549 AB05H000550 AB05H000551 AB05H000552 AB05H000553 AB05H000554 AB05H000555 AB05H000556 AB05H000557 AB05H000558 AB05H000559 AB05H000560 AB05H000561 AB05H000562 AB05H000563 AB05H000564 AB05H000565 AB05I000566 AB05I000567 AB05I000568 AB05I000569 AB05I000570 AB05I000571 AB05I000572 AB05I000574 AB05I000575 AB05I000576 AB05I000577 AB05I000578 AB05I000579 AB05I000580 AB05I000581 AB05I000582 AB05I000583 AB05I000584 AB05I000585 AB05I000586 AB05I000587 AB05I000588 AB05I000589 AB05I000590 AB05I000591 AB05I000592 AB05I000593 AB05I000594 AB05I000595 AB05I000596 AB05I000597 AB05I000598 AB05I000599 AB05I000601 AB05I000602 AB05I000603 AB05I000604 AB05I000605 AB05I000606 AB05I000607 AB05I000608 AB05I000609. 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AB07I005310 AB07I005311 AB07I005312 AB07I005313 AB07I005314 AB07I005315 AB07I005316 AB07I005317 AB07I005318 AB07I005319 AB07I005320 AB07I005321 AB07I005322 AB07I005323 AB07I005324 AB07I005327 AB07I005328 AB07I005329 AB07I005330 AB07I005331 AB07I005332 AB07I005333 AB07I005334 AB07I005335 AB07I005336 AB07I005337 AB07I005338 AB07I005339 AB07I005340 AB07I005341 AB07I005342 AB07I005343 AB07I005344 AB07I005345 AB07I005346 AB07I005363 AB07I005364 AB07I005365 AB07I005366 AB07I005368 AB07I005369 AB07I005370 AB07I005372 AB07I005373 AB07I005374 AB07I005375 AB07I005376 AB07I005377 AB07I005378 AB07I005379 AB07I005380 AB07I005381 AB07I005382 AB07I005383 AB07I005384 AB07I005385 AB07I005386 AB07I005387 AB07I005388 AB07I005389 AB07I005390 AB07I005393 AB07I005394 AB07I005396 AB07I005397 AB07I005398 AB07I005399 AB07I005400 AB07I005402 AB07I005403 AB07I005404 AB07I005405 AB07I005406 AB07I005407 AB07I005408 AB07I005409 AB07I005410 AB07I005412 AB07I005413 AB07I005414 AB07I005415 AB07I005416 AB07I005417 AB07I005418 AB07I005419 AB07I005420 AB07I005421 AB07I005422 AB07I005423 AB07I005424 AB07I005426 AB07I005428 AB07I005429 AB07I005430 AB07I005431 AB07I005432 AB07I005434 AB07I005435 AB07I005436 AB07I005437 AB07I005438 AB07I005439 AB07I005440 AB07I005441 AB07I005443 AB07I005444 AB07I005445 AB07I005446 AB07I005447 AB07I005449 AB07I005450 AB07I005451 AB07I005452 AB07I005453 AB07I005454 AB07I005455 AB07I005456 AB07I005457 AB07I005458 AB07I005459 AB07I005460 AB07I005461 AB07I005462 AB07I005463 AB07I005464 AB07I005466 AB07I005467 AB07I005470 AB07I005471 AB07I005472 AB07I005473 AB07I005474 AB07I005475 AB07I005476 AB07I005477 AB07I005478 AB07I005479 AB07I005480 AB07I005481 AB07I005482 AB07I005483 AB07I005484 AB07I005485 AB07I005486 AB07I005487 AB07I005488 AB07I005489 AB07I005490 AB07I005491 AB07I005493 AB07I005494 AB07I005495 AB07I005496 AB07I005497 AB07I005499 AB07I005500 AB07I005501 AB07I005502 AB07I005503 AB07I005504 AB07I005505 AB07I005506 AB07I005507 AB07I005508 AB07I005509 AB07I005510 AB07I005511 AB07I005512 AB07I005513 AB07I005514 AB07I005515 AB07I005517 AB07I005518 AB07I005519 AB07I005520 AB07I005523 AB07I005524 AB07I005525 AB07I005526 AB07I005527 AB07I005528 AB07I005529 AB07I005530 AB07I005531 AB07I005532 AB07I005537 AB07I005539 AB07I005541 AB07I005542 AB07I005543 AB07I005544 AB07I005545 AB07I005546 AB07I005547 AB07I005548 AB07I005549 AB07I005551 AB07I005552 AB07I005553 AB07I005554 AB07I005555 AB07I005556 AB07I005557 AB07I005558 AB07I005559 AB07I005560 AB07I005561 AB07I005562 AB07I005563 AB07I005564 AB07I005566 AB07I005567 AB07I005568 AB07I005570 AB07I005571 AB07I005572 AB07I005573 AB07I005574 AB07I005575 AB07I005576 AB07I005577 AB07I005578 AB07I005579 AB07I005581 AB07I005582 AB07I005583 AB07I005584 AB07I005585 AB07I005586 AB07I005587 AB07I005588 AB07I005589 AB07I005590 AB07I005591 AB07I005593 AB07I005594 AB07I005595 AB07I005596 AB07I005597 AB07I005598 AB07I005599 AB07I005600 AB07I005601 AB07I005602 AB07I005603 AB07I005604 AB07I005605 AB07I005606 AB07I005608 AB07I005610 AB07I005611 AB07I005614 AB07I005615 AB07I005616 AB07I005617 AB07I005618 AB07I005619 AB07I005620 AB07I005621 AB07I005622 AB07I005623 AB07I005625 AB07J005626 AB07J005627 AB07J005628 AB07J005629 AB07J005630 AB07J005631 AB07J005632 AB07J005633 AB07J005634 AB07J005635 AB07J005636 AB07J005637 AB07J005638 AB07J005639 AB07J005640 AB07J005641 AB07J005642 AB07J005643 AB07J005644 AB07J005645 AB07J005646 AB07J005647 AB07J005648 AB07J005649 AB07J005650 AB07J005651 AB07J005652 AB07J005653 AB07J005656 AB07J005657 AB07J005658 AB07J005659 AB07J005660 AB07J005661 AB07J005662 AB07J005663 AB07J005664 AB07J005665 AB07J005666 AB07J005667 AB07J005668 AB07J005669 AB07J005670 AB07J005671 AB07J005672 AB07J005673 AB07J005674 AB07J005675 AB07J005676 AB07J005677 AB07J005678 AB07J005679 AB07J005680 AB07J005681 AB07J005682 AB07J005683 AB07J005684 AB07J005685 AB07J005686 AB07J005687 AB07J005688 AB07J005690 AB07J005691 AB07J005692 AB07J005693 AB07J005694 AB07J005695 AB07J005696 AB07J005697 AB07J005698 AB07J005699 AB07J005700 AB07J005701 AB07J005702 AB07J005703 AB07J005704 AB07J005705 AB07J005708 AB07J005709 AB07J005710 AB07J005711 AB07J005712 AB07J005713 AB07J005714 AB07J005715 AB07J005716 AB07J005717 AB07J005718 AB07J005719 AB07J005720 AB07J005721 AB07J005722 AB07J005723 AB07J005724 AB07J005725 AB07J005726 AB07J005727 AB07J005728 AB07J005729 AB07J005730 AB07J005731 AB07J005732 AB07J005733 AB07J005734 AB07J005735 AB07J005736 AB07J005737 AB07J005738 AB07J005739 AB07J005740 AB07J005741 AB07J005742 AB07J005743 AB07J005744 AB07J005745 AB07J005746 AB07J005747 AB07J005748 AB07J005749 AB07J005750 AB07J005751 AB07J005752 AB07J005753 AB07J005754 AB07J005755 AB07J005756 AB07J005757 AB07J005758 AB07J005759 AB07J005760 AB07J005761 AB07J005762 AB07J005763 AB07J005767 AB07J005768 AB07J005769 AB07J005771 AB07J005772 AB07J005773 AB07J005777 AB07J005778 AB07J005779 AB07J005780 AB07J005781 AB07J005782 AB07J005783 AB07J005784 AB07J005785 AB07K005840 AB07K005841 AB07K005842 AB07K005843 AB07K005844 AB07K005845 AB07K005846 AB07K005847 AB07K005849 AB07K005850 AB07K005852 AB07K005853 AB07K005854 AB07K005856 AB07K005857 AB07K005858 AB07K005859 AB07K005860 AB07K005861 AB07K005862 AB07K005864 AB07K005867 AB07K005868 AB07K005869 AB07K005870 AB07K005871 AB07K005872 AB07K005873 AB07K005874 AB07K005879 AB07K005880 AB07K005883 AB07K005885 AB07K005887 AB07K005888 AB07K005889 AB07K005890 AB07K005891 AB07K005892 AB07K005893 AB07K005894 AB07K005895 AB07K005896 AB07K005898 AB07K005899 AB07K005900 AB07K005902 AB07K005903 AB07K005904 AB07K005905 AB07K005906 AB07K005907 AB07K005908 AB07K005909 AB07K005910 AB07K005911 AB07K005912 AB07K005913 AB07K005915 AB07K005916 AB07K005917 AB07K005918 AB07K005919 AB07K005921 AB07K005922 AB07K005923 AB07K005924 AB07K005925 AB07K005927 AB07K005928 AB07K005929 AB07K005930 AB07K005931 AB07K005932 AB07K005933 AB07K005934 AB07K005935 AB07K005936 AB07K005937 AB07K005938 AB07K005939 AB07K005940 AB07K005944 AB07K005947 AB07K005948 AB07K005949 AB07K005950 AB07K005951 AB07K005952 AB07K005953 AB07K005954 AB07K005955 AB07K005956 AB07K005957 AB07K005958 AB07K005959 AB07K005960 AB07K005961 AB07K005962 AB07K005963 AB07K005964 AB07K005965 AB07K005966 AB07L005968 AB07L005969 AB07L005970 AB07L005972 AB07L005973 AB07L005974 AB07L005975 AB07L005976 AB07L005977 AB07L005978 AB07L005979 AB07L005980 AB07L005981 AB07L005982 AB07L005983 AB07L005984 AB07L005985 AB07L005986 AB07L005987 AB07L005988 AB07L005989 AB07L005990 AB07L005991 AB07L005992 AB07L005993 AB07L005994 AB07L005995 AB07L005996 AB07L005998 AB07L005999 AB07L006000 AB07L006001 AB07L006002 AB07L006003 AB07L006004 AB07L006005 AB07L006006 AB07L006007 AB07L006008 AB07L006009 AB07L006010 AB07L006011 AB07L006012 AB07L006013 AB07L006014 AB07L006015 AB07L006017 AB07L006018 AB07L006019 AB07L006020 AB07L006023 AB07L006024 AB07L006025 AB07L006027 AB07L006028 AB07L006029 AB07L006030 AB07L006031 AB07L006032 AB07L006033 AB07L006034 AB07L006035 AB07L006036 AB07L006038 AB07L006039 AB07L006040 AB07L006041 AB07L006042 AB07L006043 AB07L006044 AB07L006045 AB07L006046 AB07L006047 AB07L006048 AB07L006049 AB07L006052 AB07L006053 AB07L006054 AB07L006055 AB07L006056 AB07L006057 AB07L006058 AB07L006060 AB07L006063 AB07L006067 AB07L006071 AB07L006072 AB07L006073 AB07L006075 AB07L006079 AB07L006080 AB07L006081 AB07L006082 AB07L006083 AB07L006084 AB07L006085 AB07L006086 AB07L006087 AB07L006088 AB07L006089 AB07L006090 AB07L006091 AB07L006093 AB07l006095 AB07L006096 AB07L006098 AB07L006099 AB07L006100 AB07L006101 AB07L006102 AB07L006103 AB07L006104 AB07L006105 AB07L006106 AB07L006107 AB07L006108 AB07L006109 AB07L006110 AB07L006111 AB07L006112 AB07L006113 AB07L006114 AB07L006115 AB07L006116 AB07L006118 AB07L006119 AB07L006120 AB07L006121 AB07L006122 AB07L006123 AB07L006125 AB07L006126 AB07L006127 AB07L006128 AB07L006129 AB07L006130 AB07L006132 AB07L006133 AB07L006134 AB07L006135 AB07L006136 AB07L006137 AB07L006138 AB07L006139 AB07L006140 AB07L006141 AB07L006142 AB07L006143 AB07L006144 AB07L006146 AB07L006147 AB07L006149 AB07L006151 AB07L006152 AB07L006153 AB07L006154 AB07L006155 AB07L006156 AB07L006157 AB07L006158 AB07L006160 AB07L006161 AB07L006163 AB07L006164 AB07L006165 AB07L006166 AB07L006167 AB07L006169 AB07L006172 AB07L006173 AB07L006174 AB07L006175 AB07L006176 AB07L006177 AB07L006178 AB07L006179 AB07L006181 AB07L006182 AB07L006184 AB07L006186 AB07L006187 AB07L006188 AB07L006190 AB07L006193 AB08A006203 AB08A006206 AB08A006207 AB08A006210 AB08A006213 AB08A006214 AB08A006216 AB08A006219 AB08A006220 AB08A006221 AB08A006223 AB08A006224 AB08A006227 AB08A006228
RECALLING FIRM/MANUFACTURER
Zoll Medical Corporation, World Wide Headquarters, Chelmsford, MA, by letter on January 14, 2008. Firm initiated recall is ongoing.
REASON
Incorrect Patient Records: Patient records that have been stored, then later transmitted or printed may not be the correct record. Records that are transmitted or printed immediately following acquisition are correct.
VOLUME OF PRODUCT IN COMMERCE
5,018 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Reusable Ohmeda Compatible Finger Clip Sensor, Model Number: E403-02, Product Code: PS2225. To monitor oxygen saturation level of patients under doctor's care, Recall # Z-1188-2008
CODE
Serial Numbers: YE508/001, YE508/002, YE508/003, YE508/004, YE508/005, YE508/006, YE508/007, YE508/008, YE508/009, YE508/010; ZC502/001, ZC502/002, ZC502/003, ZC502/004, ZC502/005, ZC502/006; ZG512/001, ZG512/002, ZG512/003, ZG512/004, ZG512/005, ZG512/006, ZG512/007, ZG512/008, ZG512/009, ZG512/010, ZG512/011, ZG512/012, ZG512/013, ZG512/014, ZG512/015; PA514/001, PA514/002, PA514/003, PA514/004, PA514/005, PA514/006, PA514/006, PA514/007, PA514/008, PA514/009, PA514/010; PA515/001, PA515/002, PA515/003, PA515/004, PA515/005, PA515/006, PA515/007, PA515/008, PA515/009, PA515/010, PA515/011, PA515/012, PA515/013, PA515/014, PA515/015, PA515/016, PA515/017, PA515/018, PA515/019, PA515/020, PA515/021, PA515/022, PA515/023, PA515/024, PA515/025, PA515/026, PA515/027, PA515/028, PA515/029, PA515/030, PA515/031, PA515/032, PA515/033, PA515/034 and PA515/035
RECALLING FIRM/MANUFACTURER
Kentec Medical Inc., Irvin, CA, by telephone on May 18, 2007 and by letter dated May 23, 2007. Firm initiated recall is ongoing.
REASON
Incompatible components: The Finger Clip Sensors - with a Serial Number prefix of PA514, PA515, YE508, ZC502 and ZG512 - are missing an additional diode and higher resistor in its existing configuration making them inoperable when used to interface with those Ohmeda Tuffsat monitors previously re-configured by Ohmeda to include a detection circuit for diodes.
VOLUME OF PRODUCT IN COMMERCE
41 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) INTELECT INTELECT XT, Model No. 2760. Made in the USA, Recall # Z-1218-2008;
b) INTELECT LEGEND XT, Model No. 2763, Made in the USA, Recall # Z-1219-2008;
c) VECTRA GENISYS, Model No. 2761, Made in the USA, Recall # Z-1220-2008;
d) VECTRA GENISYS, Model No. 2764, Made in the USA, Recall # Z-1221-2008;
e) VECTRA TRANSPORTABLE, Model No. 2783, Made in the USA, Recall # Z-1222-2008;
f) INTELECT VET, Model No. 2756, Made in the USA, Recall # Z-1223-2008;
g) INTELECT VET, Model No. 2843, Made in the USA, Recall # Z-1224-2008;
h) INTELECT ADVANCED, Model No. 2752CC. Made in the USA, Not for sale in the U.S.A,
Recall # Z-1225-2008;
i) INTELECT ADVANCED, Model No. 2755CS, Made in the USA, Not for sale in the U.S.A,
Recall # Z-1226-2008;
j) INTELECT ADVANCED, Model No. 2762CC. Made in the USA, Not for sale in the U.S.A,
Recall # Z-1227-2008;
k) INTELECT ADVANCED, Model No. 2765CS. Made in the USA, Not for sale in the U.S.A,
Recall # Z-1228-2008;
l) INTELECT ADVANCED, Model No. 2772MC. Made in the USA, Not for sale in the U.S.A,
Recall # Z-1229-2008;
m) INTELECT ADVANCED STIM, Model No. 2773MS. Made in the USA, Not for sale in the U.S.A,
Recall # Z-1230-2008;
n) INTELECT MOBILE COMBO, Model No. 2778. Made in the USA, Not for sale in the U.S.A,
Recall # Z-1231-2008;
o) INTELECT MOBILE, Model No. 2777. Made in the USA, Not for sale in the U.S.A,
Recall # Z-1232-2008
CODE
a) Serial numbers 1000 – 5886;
b) Serial numbers 1000 – 1683;
c) Serial numbers 1000 – 5047;
d) Serial numbers 1000 – 1713;
e) Serial numbers 1000 – 1615;
f) Serial numbers 1000 – 1140;
g) Serial numbers 1000 – 1015;
h) Serial numbers 1000 – 1079;
i) Serial numbers 1000 – 1017;
j) Serial numbers 1000 – 3993;
k) Serial numbers 1000 - 1452;
l) Serial numbers 1000 - 3002;
m) Serial numbers 1000 - 2018;
n) Serial numbers 1000 - 3541;
o) Serial numbers 1000 - 2799
RECALLING FIRM/MANUFACTURER
Chattanooga Corp Inc., Hixson, TN, by letters beginning on December 17, 2007. Firm initiated recall is ongoing.
REASON
Device malfunction: causing electric shock and burn.
VOLUME OF PRODUCT IN COMMERCE
20,000 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Solar HA Humeral Stem with Plasma Coating 7mm to 17 mm Product Catalog Number: 5351-4307, 7mm; 5351-4308, 8mm; 5351-4309, 9mm; 5351-4310, 10mm; 5351-4311, 11mm; 5351-4312, 12mm; 5351-4313, 13mm; 5351-4314, 14mm; 5351-4315, 15mm; 5351-4316, 16mm; and 5351-4317, 17mm. For use as a Shoulder Replacement. Made in USA, Recall # Z-1236-2008
CODE
All Lot Codes for the above catalog numbers.
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on November 28, 2007. Firm initiated recall is ongoing.
REASON
Delamination: Loosening of the titanium plasma coating on the product was observed on twelve non-distributed units.
VOLUME OF PRODUCT IN COMMERCE
915 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Agfa HeartLab Cardiovascular DICOMstore, Model # L9M8E. The software is used in the Agfa HeartLab Cardiovascular System, Recall # Z-1241-2008
CODE
Software version: 2.04.40.00
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by telephone on June 21-26, 2007 and by letter on July 2, 2007.
Manufacturer: Heartlab, Inc., Westerly, RI. Firm initiated recall is ongoing.
REASON
Misidentification: The electrocardiogram (ECG) data of one patient is misidentified as the data of another patient.
VOLUME OF PRODUCT IN COMMERCE
43 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Agfa HeartLab Cardiovascular Results Management Product, Model Number: L58RZ and L9MWQ, Recall # Z-1242-2008
CODE
Version: 2.03 and 2.04
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by telephone on July 27, 2007 to August 16, 2007 and by letter on July 27, 2007.
Manufacturer: Heartlab, Inc., Westerly, RI. Firm initiated recall is ongoing.
REASON
Incorrect Results: Erroneous echocardiographic measurement values due to mathematical formula being mis-configured.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
IMPAX® 6.2.1 Network Gateway Server, License Key. Catalog # ABC. The product is used to transfer medical imaging data,
Recall # Z-1306-2008
CODE
Code EXEGE000
RECALLING FIRM/MANUFACTURER
AGFA Corp., Greenville, SC, by e-mail on December 11, 2007. Firm initiated recall is ongoing.
REASON
Failure of Data Transmission: No imaging data could be transmitted by the device, because a key value needed for data transmission was incorrectly entered in the affected units by AGFA Healthcare.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Dimension Total Prostate Specific Antigen (TPSA) Flex Reagent Cartridge (RF451), Recall # Z-1606-2008
CODE
Lot number GB9021 exp 2009-01-21 and Lot number GB9029 exp 2009-01-29
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated March 25, 2008. Firm initiated recall is ongoing.
REASON
False Results: The product may exhibit falsely elevated results. The affected lots demonstrate sporadic variability in recovery of calibrator and quality control; therefore this issue may not be readily detected upon calibration or during routine processing of Quality Control.
VOLUME OF PRODUCT IN COMMERCE
1,631 cartons
DISTRIBUTION
Nationwide, Germany, Singapore, Canada, Japan and AE
END OF ENFORCEMENT REPORT FOR JULY 2, 2008
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