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U.S. Department of Health and Human Services

Safety

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Enforcement Report for March 3, 2010

 March 3, 2010                                                                                        10-08

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
___________________________________
PRODUCT
Toi Sauce Thai Red Curry (Panang) in 12 fl. oz glass bottle INGREDIENTS: Coconut Milk, Sugar, Fish Sauce (Anchovy, Water, Salt), Tamarind, Red Curry Paste, Salt, Chili Oil, Citric Acid. Recall # F-1292-2010
CODE
940509 on bottle neck
RECALLING FIRM/MANUFACTURER
Rikki USA, Inc., Redmond, WA, by telephone on November 24, 2009 and by press release on November 25, 2009 and December 1, 2009. Firm initiated recall is complete.
REASON
The Product contains undeclared shrimp. Shrimp is contained in the red curry paste, an ingredient added to the Thai Red Curry sauce.
VOLUME OF PRODUCT IN COMMERCE
168 cases
DISTRIBUTION
WA
___________________________________
PRODUCT
Turkish Pinenut Kernels, Kermes brand, product of Turkey, 10 kg (22 lb), packaged in plastic bag in cardboard cartons. Recall # F-1332-2010
CODE
Lot: 20375 P14272
RECALLING FIRM/MANUFACTURER
Recalling Firm: Red River Foods, Inc., Richmond, VA, by telephone on January 11, 2010 and letter on January 14, 2010.
Manufacturer: Kermes Tarim Urunleri Dis Tic. Ltd. Sti., Kozak, Turkey. Firm initiated recall is ongoing.
REASON
The product is contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
200 cartons
DISTRIBUTION
TX
___________________________________
PRODUCT
Harris Teeter Farmers Market Pine Nuts, Net Wt. 8 oz. (227g), UPC 072036 88121 2, packed in foam trays with cellophane wrap. Recall # F-1333-2010
CODE
All lots between December 30, 2009 and January 14, 2010.
RECALLING FIRM/MANUFACTURER
Hines Nut Co., Dallas, TX, by telephone on January 14, 2010. Firm initiated recall is ongoing.
REASON
The product is contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,350 trays
DISTRIBUTION
NC
___________________________________
PRODUCT
Toft's 'One Quality' brand Tin Roof Sundae Ice Cream. The product is an ice cream variety which contains chocolate covered peanuts. The product is packed in 1/2 gallon size cardboard containers 4 1/2 gallon cartons per shipping case The UPC # is: 19473-00732. The plant number for this product is: 39-126. Recall # F-1351-2010
CODE
Code Date: 01.06.10
RECALLING FIRM/MANUFACTURER
Toft Dairy, Inc., Sandusky, OH, by telephone, press release and letter on February 11, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by the Peanut Corp. of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
827 x ½ gallon containers
DISTRIBUTION
OH, MI
___________________________________
PRODUCT
1) Natural Pistachios In Shell R/S, 1 Lb Polyurethane Re-sealable Bags. Recall # F-1358-2010;

2) Bulk Natural Pistachios In Shell R/S, 25 Lb Cases. Recall # F-1359-2010;

3) Platinum Vision Tins Natural Pistachios In Shell R/S, 24 Count Item # 08990-24 & Item # 08999-24. Recall # F-1360-2010;

4) No Logo Natural Pistachios In Shell R/S, 24 Count, Glass Mason Jars-Item # 09675-24. Recall # F-1361-2010;

5) No Logo Natural Pistachios In Shell R/S, Robo Plastic Containers, 72 Count-Item # 09760-72. Recall # F-1362-2010;

6) Natural Pistachios In Shell R/S, 24/3 oz cellophane bags, Item # 09918-24. Packed by Tropical Columbus. Recall # F-1363-2010
CODE
1) Lot #: M25318P2003;

2) Lot #: 25318P2003;

3) Lot #s: M00691, M01591, M03091, M03791, M05591, M07091, M33081, M33081, M33081B, M33981, M35381A, M35381B, M35381C, M02691 & M32381;

4) Lot #s: M00691, M01591, M03091, M03791, M05591, M07091, M33081, M33081, M33081B, M33981, M35381A, M35381B, M 35381C;

5) Lot #s: M34081, M35281, M04091;

6) Lot #: M03691
RECALLING FIRM/MANUFACTURER
Tropical Nut & Fruit Inc., Urbancrest, OH, by press release on April 8, 2009 and by letters on April 9, 2009. Firm initiated recall is complete. 
REASON
The product was manufactured using pistachios recalled by Setton Pistachio Company, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
45,518 packages
DISTRIBUTION
IN, MO, NY, OH, PA, WI & WV

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT
1) Slim Fast Meal Options Creamy Milk Chocolate; 11 Fl oz (325 mL) 4/6 pack, 1/24 fridge pack. Shipping case UPC code: 00008346030491; All other cartons UPC: 008346630493; Can UPC: 008346630493; Slimfast Ready To Drink 1/24 PK Milk Choc Fridge Pack , Shipping Case UPC10008346009005; 24 pack UPC 008346009008, Carton UPC 008346009664; Can UPC 008346017492. Recall # F-1314-2010;

2) Slim Fast Meal Options French Vanilla; 11 Fl oz (325 mL) 4/6 pack. Shipping Case UPC code: 00008346030415; UPC: 008346630417; Can UPC: 008346016969. Recall # F-1315-2010;

3) Slim Fast Meal Options Chocolate Royale; 11 Fl oz (325 mL); 4/6 pack; Shipping Case UPC Code: 00008346030385; All other cartons UPC: 008346630387; Can UPC: 008346016952. Recall # F-1316-2010;

4) Slim Fast Meal Options Strawberry; 11 Fl oz (325 mL) 4/6 pack; Shipping case UPC Code: 00008346030439; All other cartons UPC: 008346630431; Can UPC: 008346016976. Recall # F-1317-2010;

5) Slim Fast 321 Plan Meal Options Cappuccino Delight: 11 FL oz (325 m/L) This product had formally been sold under the Optima line, sold in 4/6 pack; 2/12 pack (Optima) and 6+2 3-8 pk. (Optima); 4/6 pack: shipping case UPC code: 10008346137442; 10008346237446; All other cartons UPC: 008346137442; Can UPC: 008346037445. Optima 2/12/pack: Shipping Case UPC: 00008346224920; All other cartons UPC: 008346224937; Can UPC: 008346037445; Optima 4/6 pack: shipping case UPC: 10008346237446; All other cartons UPC: 008346137442; Can UPC: 008346037445 Optima 6+2 3-8 pack: Shipping Carton UPC: 10008346267443; All other cartons: UPC: 008346167449; Can UPC: 008346037445; Optima 4/6 pk (Deal Pack): Carton UPC 008346137442, can UPC 008346037445. Recall # F-1318-2010

6) Slim Fast 321 Plan Meal Options Creamy Milk Chocolate: 11 FL oz (325 m/L); 4/6 pack; 2/12 pack 1/24 pack, 6+2 3-8, 48 24+6 pack BNS. This product had formally been sold under the Optima line. 4/6 pack - Shipping Case UPC code: 10008346237491, 10008346237491; All other cartons UPC: 008346137497; Can UPC: 008346037490. 2/12/ pack - Shipping case UPC: 10008346238498, 00008346232727; All other cartons UPC: 008346238494, 008346232772; Can UPC: 008346037490, 008346045495; 4/6 Pack (Deal Kit) Case UPC: 1008346237491, Carton UPC: 008346137497, Can UPC 008346037490. Optima 1/24 pack: Shipping Case UPC: 10008346232984; 24 pack carton UPC: 10008346232984; All other cartons UPC: 008346232772; Can UPC: 008346037490 Optima 4/6 pack: Shipping Case UPC: 10008346237491: All other cartons UPC: 10008346237491; Can UPC: 008346037490; Optima 2/12 pack: Shipping Case UPC:10008346238498; All other cartons UPC: 008346138494: Can UPC: 008346037490; Optima 6+2 3-8 pack: Shipping Case UPC: 10008346267498; All other cartons UPC: 008346167494; Can UPC: 008346037490; Optima 48 24 + 6 pk BNS; Shipping Case UPC: 10008346029799; all other cartons UPC: 008346029792: Can UPC: 008346037490. Recall # F-1319-2010;

7) Slim Fast 321 Plan Meal Options French Vanilla: 11 FL oz (325 m/L)L 4/6 pack, 2/12 pack, 1/24 pack, 6+2 3-8 Pack. This product had formally been sold under the Optima line. 4/6 pack: (Deal kit); Carton UPC: 008436137411; can UPC: 0083460370414. 4/6 pack: Shipping Case UPC: 10008346237415; all other cartons: 008346137411, Can UPC: 008346037414. 2/12 packs - Shipping Case UPC: 10008346238412; All other cartons UPC: 008346138418; Can UPC: 008346037414; 1/24 pack- Shipping Case UPC: 10008346232991; 24 pack carton UPC: 008346232994; All other cartons UPC: 008346232789: Can UPC:008346037414; Optima 4/6 deal pack: All other cartons UPC:008346137411; Can UPC: 008346037414; Optima 4/6 pack: Shipping Carton UPC: 10008346237415, Carton UPC: 00846137411m Can UPC: 008346037414 Optima 2/12 pack: Shipping Case UPC: 10008346238412; All other cartons UPC: 008346138418: Can UPC: 008346037414; Optima 6+2 3-8 packL Shipping Case UPC: 10008346267412: All other cartons UPC: 008346167418; Can UPC: 008346037414. Recall # F-1320-2010;

8) Slim Fast 321 Plan Meal Options Rich Chocolate Royale: 11 FL oz (325 m/L): 4/6 pack, 2/12/ pack, 1/24 pack, 6+ 2 3-8 pack. This product had formally been sold under the Optima line. 4/6 pack Shipping Case UPC code:10008346237385; All other cartons UPC: 008346137381; Can UPC: 008346037384; 1/24 pack - Shipping Case UPC: 10008346232977; 24 pack carton UPC: 008346232970: all other carton UPC: 008346232765: Can UPC:008346037384; 2/12 pack: Shipping Case UPC: 10008346238382; All other cartons UPC: 008346138388; Can UPC: 008346037384: Slimfast Ready To Drink Optima Rich Choc 6+2 3-8 pk Shipping Carton UPC: 10008346267382: Carton UPC: 008346167388: Can UPC: 008346037384: Optima 2/12 pack : Shipping Case UPC: 10008346238382; All other cartons UPC: 008346138388: Can UPC: 008346037384. Optima 4/6 pack - Shipping Case UPC: 10008346237385: all other cartons UPC: 008346137381: Can UPC: 008346037384 4/6 deak kit: carton UPC: 008346137381; can UPC: 008436037384. Recall # F-1321-2010;

9) Slim Fast 321 Plan Meal Options Strawberries 'N Cream: 11 FL oz (325 m/L); 4/6 pack; 2/12 pack This product had formally been sold under the Optima line. 4/6 pack - Shipping Case UPC code:10008346237439; All other cartons UPC: 008346137435; Can UPC: 008346037438; 2/12 pack: Shipping Case UPC: 10008346238436: All other cartons UPC: 008346138432: Can UPC: 008346037438; Optima 4/6 pack: Shipping Case UPC: 10008346237439; all other cartons UPC: 008346137435: Can UPC: 008346037438; Optima 4/6 pk (Deal Kit): Carton UPC: 008346137435: Can UPC: 008346037438: Optima 2/12 pack: Shipping case UPC: 10008346238436: All other cartons: 008346138432: Can UPC: 008346037438; Optima 6+2 3-8 pack: Shipping Case UPC: 10008346267436: All other cartons: 008346167432: Can UPC: 008346037438. Recall # F-1322-2010;

10) Slim Fast 321 Low Carb Meal Options Creamy Chocolate: 11 FL oz (325 mL); 6/4 pack, 1/15 pack. 6/4 pack - Shipping Case UPC code: 10008346237491, 10008346045492; All other cartons UPC: 008346137497, 008346645497: Can UPC: 008346037490, 008346045495 1/15 pack - Shipping Case UPC: 008346045495, 10008346057495; All other cartons UPC: 008346057498, 008346057498; Can UPC: 08346045495, 008346045495. Recall # F-1323-2010;

11) Slim Fast 321 Low Carb Meal Options Vanilla Cream: 11 FL oz (325 mL); 4/6 pack - Shipping Case UPC: 10008346045416; 0008346045416; All other cartons: 008346645411; Can UPC: 008346045419. Recall # F-1324-2010;

12) Slim Fast 321 High Protein Meal Options Extra Cream Chocolate: 11 Fl oz (325 mL); 6/4 pack - Shipping Case UPC: 10008346206893, 10008346206893 All other cartons UPC: 008346106899; Can UPC: 008346006892. Recall # F-1325-2010;

13) Slim Fast High Protein Meal Options Strawberry: 11 FL oz (325 mL); 6/4 pack. This product was discontinued in September 2008. Shipping Case UPC: 10008346209566: Carton UPC: 008346210930. Recall # F-1326-2010;

14) Slim Fast High Protein Meal Options Creamy Vanilla: 11 FL oz (325 mL); 6/4 pack. This product was discontinued in September 2008. Carton UPC code: 10008346026909: Carton UPC: 008346196905: Can UPC: 0083460060908. Recall # F-1327-2010;

15) Slim Fast Easy to Digest Meal Options Chocolate; 11 Fl oz (325 mL); 6/4 pack. This product was discontinued in March 2009. Shipping Carton UPC code: 00008346224173: Carton UPC: 00846224210: Can UPC: 008346224258. Recall # F-1328-2010;

16) Slim Fast Easy to Digest Meal Options Vanilla: 11 Fl oz (325 mL); 6/4 pack. This product was discontinued in March 2009. Shipping Case UPC Code: 0008346224166; Carton UPC: 008346224203; Can UPC: 008346224241. Recall # F-1329-2010;

17) Slim Fast Easy to Digest Meal Options Coffee; 11 Fl oz (325 mL); 6/4 pack This product was discontinued in September 2008. Shipping Case UPC: 00008346224197; Carton UPC: 008346224234: Can UPC: 008346224272. Recall # F-1330-2010
CODE
All lots and expiry dates
RECALLING FIRM/MANUFACTURER
Recalling Firm: Unilever United States, Inc., Englewood, NJ, by press release, letters, e-mail and facsimile on December 3, 2009.
Manufacturer: Unilever Covington, Covington, TN. Firm initiated recall is ongoing.
REASON
The products may be contaminated with Bacillus cereus.
VOLUME OF PRODUCT IN COMMERCE
3,765, 503 cases – all varieties
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Coconut Royelle Spread net wt. 20 lb, held in plastic pail with snap off lid, UPC 10098086503826. Recall # F-1336-2010
CODE
All lot codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Best Brands Corp., Minnetonka, MN, by telephone and letter on September 11, 2009.
Manufacturer: Best Brands, Inc., Dallas, TX. Firm initiated recall is ongoing.
REASON
The Coconut Royelle Spread may have been inadequately acidified to control the growth of pathogens.
VOLUME OF PRODUCT IN COMMERCE
1,991 pails
DISTRIBUTION
AR, LA, TX
___________________________________
PRODUCT
Cafe Fraze' All Natural Coffee Frappe packaged in a brown flexible plastic 64 oz. jug with a sealed top and screw-on plastic lid. Recall # F-1337-2010
CODE
The firm places a sticker on the bottom of each container that identifies the production date in the form of DD/MM/YY (day, month, year). No expiration date is used
RECALLING FIRM/MANUFACTURER
Ice Creams & Coffee Beans, Inc., Ravenel, SC, by telephone on December 7, 2009. Firm initiated recall is ongoing.
REASON
The product may have been inadequately acidified to control the growth of pathogens.
VOLUME OF PRODUCT IN COMMERCE
98/64 oz. containers
DISTRIBUTION
FL, GA, KY, SC
___________________________________
PRODUCT
Plum Organics brand Apple & Carrot Portable Pouch Baby Food in 4.22 oz.; UPC: 890180001221. Recall # F-1338-2010
CODE
Best by Date: May 21, 2010, produced on May 21, 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Nest Collective, Inc., dba Plum Organics, Emeryville, CA, by press release, telephone and e-mail on October 19, 2009.   
Manufacturer: Super-Pufft Snack Corp., Mississauga, Ontario, Canada. Firm initiated recall is ongoing.
REASON
Product is inadequately processed to prevent the outgrowth and toxin production of pathogens of public health concern, particularly Clostridium botulinum.
VOLUME OF PRODUCT IN COMMERCE
703 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Liquid ProSource - No Carb in 1 quart containers. The product is shipped in cases containing 4 bottles. Recall # F-1339-2010
CODE
Lot numbers: 062609, 062909, 072909, and 080609
RECALLING FIRM/MANUFACTURER
Shank’s Extracts, Inc., Lancaster, PA, by telephone and follow-up letter beginning on November 20, 2009. Firm initiated recall is complete.
REASON
The product has slightly elevated pH.
VOLUME OF PRODUCT IN COMMERCE
4,044 containers
DISTRIBUTION
PA
___________________________________
PRODUCT
Potato Chips. Uncle Ray’s Jalapeno Potato Chips in 4.6 oz (130 g Net Wt) plastic bags. UPC 1415606158. Recall # F-1340-2010
CODE
No lot number. Code dates of 2 august 10 and before.
RECALLING FIRM/MANUFACTURER
Uncle Ray’s LLC, Detroit, MI, by letters dated December 15, 2009. Firm initiated recall is ongoing.
REASON
The product contains undeclared sulfites and colors – FD&C Yellow # 5, Red # 40, and Blue # 1.
VOLUME OF PRODUCT IN COMMERCE
129,260 bags
DISTRIBUTION
Canada

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT
Compro prochlorperazine suppositories, USP 25 mg, NDC 0574-7226-12, for rectal use Only, 12 adult suppositories, RX only. Recall # D-338-2010
CODE
Lot No: 9116177 EXPANDED RECALL: Lot No. 8172830
RECALLING FIRM/MANUFACTURER
Paddock Laboratories, Inc., Minneapolis, MN, by letters dated December 30, 2009, February 12, 2010 and February 22, 2010. Firm initiated recall is ongoing.
REASON
Paddock Laboratories, Inc. is conducting a voluntary recall of Compro Prochlorperazine Suppositories, USP, 25 mg, due to the failing dissolution at the 6-month stability time point. EXPANDED RECALL: Paddock has expanded the recall to include lot 8172830 due to failing dissolution results. Use of this product is unlikely to present a health risk
VOLUME OF PRODUCT IN COMMERCE
30,708 Expanded Recall: 12,720 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Amlodipine Besylate and Benazepril HCl Capsules, 5mg/10mg (equivalent to amlodipine 5 mg and benazepril 10 mg), Rx only, 1000 counts, Sandoz, NDC 0781-2272-10. Recall # D-339-2010
CODE
Lot F1031 (exp. MARCH 2012)
RECALLING FIRM/MANUFACTURER
Novartis Pharmaceuticals Corp., Suffern, NY, by letters dated February 2, 2010 and February 3, 20010. Firm initiated recall is ongoing.
REASON
During sample preparation of Amlodipine Besylate & Benazepril HCl 5 mg/10 mg combination product at the 6 month stability interval, one capsule of lot F1031 did not contain the Benazepril 10 mg tablet.
VOLUME OF PRODUCT IN COMMERCE
1,910 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Allergy relief (diphenhydramine HCL) capsules, 25mg, 100-count bottle, OTC; Distributed under the brand names: 1) Target, NDC 11673-310-13, UPC 8 97882 00105 4; Allergy (Diphenhydramine Hydrochloride) capsules, 25 mg, 24-count blisters in a box, OTC; Today's Health, NDC 65905-310-31, UPC 8 43072 00353 7 Multi-Symptom Complete Allergy (Diphenhydramine HCL) capsules, 25 mg, 24-count blisters in a box, OTC; UPC 8 97882 00109 2. The product was distributed under the brand names Target, Diphendryl Allergy; Dollar General, DG Allergy; and Today's Health, Today's Health Allergy.  Recall # D-342-2010
CODE
Lot number BK549
RECALLING FIRM/MANUFACTURER
Kirk Pharmaceuticals, LLC, Fort Lauderdale, FL, by telephone, e-mail and letter dated September 24, 2009. Firm initiated recall is complete.
REASON
Temperature Abuse: Kirk Pharmaceuticals is recalling Diphenhydramine Hydrochloride 25mg capsules, for sub-potent assay results due to improper storage conditions of the product during transit.
VOLUME OF PRODUCT IN COMMERCE
2,674,608 bottles and boxes
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________

PRODUCT
Terazosin HCl Capsules, 5 mg, 1000 count bottles, Rx Only; NDC 59746-385-10. Recall # D-334-2010
CODE
Lot 9P050, exp 12/2010
RECALLING FIRM/MANUFACTURER
Cadista Pharmaceuticals, Inc., Salisbury, MD, by letter on May 4, 2009. Firm initiated recall is complete.
REASON
Pharmaceutical may have been packaged with two dosage strengths of the same drug.
VOLUME OF PRODUCT IN COMMERCE
2,626 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Coats Aloe Vera Liniment (methyl salicylate) 10%, made from Whole Leaf Aloe Vera Gel 1 oz., 8 fl. oz., 1 liter, OTC. Recall # D-335-2010;

2) The Silent Healer by Coats Aloe Liniment Topical Analgesic, (methyl salicylate) 10%, 8 oz., 1 liter, OTC. Recall # D-336-2010;

3) R Pur Aloe International (methyl salicylate) Whole Leaf Aloe Vera Liniment, 10%, 8 oz. bottle, OTC, Made in U.S.A. Recall # D-337-2010;
CODE
1) Lot numbers: 05208g (exp. 08/2010), 03009C (exp. 03/2010), 3509C (exp 03/2010), 02309D (exp 04/2010), 09209F (exp. 7/2010), 05109G (exp 07/2010), and 07609G (exp 07/2010);

2) Lot #05208G (Exp. 08/2010);

3) Lot #09209F (Exp. 07/2010)
RECALLING FIRM/MANUFACTURER
Coats International Holdings, Inc., Dallas, TX, by letter on January 29, 2010. Firm initiated recall is ongoing.
REASON
Sample product failed 6-month ambient test points for assay of active ingredient.
VOLUME OF PRODUCT IN COMMERCE
30,511 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0500-10
CODE
Units: 9918275 (Part 1 and 2)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by letter dated April 17, 2008. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced without the assurance that it met the criteria for a leukoreduced product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0501-10
CODE
Units: 9889041 (Part 1, 2 and 3)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on December 26, 2006. Firm initiated recall is complete.
REASON
Blood products, with a pH lower than the acceptance criteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Source Plasma, For Manufacturing Use Only. Recall # B-0536-10
CODE
Units: FD0444932, FD0445789, FD0446135, FD0446756, FD0447890, FD0449492, FD0449919, FD0450405, FD0451143, FD0451693, FD0453645, FD0454288, FD0454953, FD0455660, FD0456150, FD0442184, FD0442481, FD0444818, FD0456596, FD0457591, FD0458662, FD0461186, FD0461717, FD0463325, FD0463896, FD0464748, FD0465386, FD0465967, FD0466792, FD0467948, FD0468848, FD0469342, FD0469814
RECALLING FIRM/MANUFACTURER
DCI Biologicals LLC, Farmington, NM, by fax on January 22, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
33 units
DISTRIBUTION
NY and UK
___________________________________
PRODUCT
1) Platelets Pooled Leukocytes Reduced Irradiated. Recall # B-0544-10;
2) Red Blood Cells. Recall # B-0545-10 
CODE
1) Unit: W120609382354;
2) Unit: W120609231709
RECALLING FIRM/MANUFACTURER
Recalling Firm: Michigan Community Blood Centers, Saginaw, MI, by facsimile on August 27, 2009.
Manufacturer: Michigan Community Blood Centers, Bay City, MI. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
___________________________________
PRODUCT
Plasma Frozen Cryoprecipitate Reduced. Recall # B-0546-10
CODE
Unit: W0363082878431
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Center of Wisconsin, Inc., Milwaukee, WI, by letter dated August 17, 2009.
Manufacturer: Blood Center of Wisconsin, Inc. Marshfield, WI. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-0550-10
2) Red Blood Cells Leukocytes Reduced. Recall # B-0551-10
CODE
1) Unit: W0410090934641;
2) Units: W041009127044Q, W0410090934641
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., dba United Blood Services, Scottsdale, AZ, by telephone and facsimile on August 13, 2009, by electronic notification on August 14, 2009, and by letter dated September 15, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Switzerland, AZ
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0561-10;
2) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0562-10;
3) Red Blood Cells. Recall # B-0563-10; 
4) Platelets. Recall # B-0564-10
CODE
1) and 2) Unit: W227709060639;
3) and 4) Unit: W227709060908
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by letter dated August 11, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TN
___________________________________
PRODUCT
1) Platelets Pooled Leukocytes Reduced. Recall # B-0565-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0566-10
CODE
1) Unit: W051709803382;
2) Unit: W051709625148
RECALLING FIRM/MANUFACTURER
Rhode Island Blood Center, Providence, RI, by letter dated August 17, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
RI, MI
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0633-10
CODE
Unit: W037909154486 (2 units)
RECALLING FIRM/MANUFACTURER
Blood Center of Iowa, Des Moines, IA, by telephone on August 27, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0634-10
CODE
Unit: W071209020921
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter dated August 5, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Source Plasma. Recall # B-0635-10
CODE
Units: 4590020795, 4590020646
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Jacksonville, FL, by e-mail on August 5, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not receive a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0636-10
CODE
Unit: W117009119803
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific – Irwin Center, San Francisco, CA, by telephone on September 9, 2009 and by letter dated September 14, 2009. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving post donation information concerning an illness following donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0637-10
CODE
Units: W090708027007, W090709012548, W090708022595
RECALLING FIRM/MANUFACTURER
Blood Bank Of The Redwoods, Santa Rosa, CA, by electronic notification on September 28, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0639-10
CODE
Unit: 50E56076
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Toledo, OH, by facsimile and electronic notification on July 25, 2009 and by letter dated July 25, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH  
___________________________________
PRODUCT
Platelets Pooled Leukocytes Reduced. Recall # B-0642-10
CODE
Unit: W120609184065
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on August 17, 2009, August 24, 2009, September 14, 2009 and September 25, 2009. Firm initiated recall is complete.
REASON
Blood product, with a low platelet yield was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0643-10
CODE
Unit: W037909163713 (2 units)
RECALLING FIRM/MANUFACTURER
Blood Center of Iowa, Des Moines, IA, by telephone on September 9, 2009 and by letter dated September 18, 2009. Firm initiated recall is complete.
REASON
Blood products, for which quality control testing was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0647-10;
2) Recovered Plasma. Recall # B-0648-10
CODE
1) and 2) Unit: W036309306241M
RECALLING FIRM/MANUFACTURER
Blood Centers of Wisconsin, Inc, Milwaukee, WI, by fax and e-mail on August 31, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was deferred after disclosing application of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Switzerland, WI
___________________________________
PRODUCT
Source Plasma. Recall # B-0649-10
CODE
Unit: TQ025292
RECALLING FIRM/MANUFACTURER
IBBI dba Knoxville Plasma, Corp., Knoxville, TN, by fax on October 26, 2009. Firm initiated recall is complete.
REASON
Blood product was tested for HIV and HCV by Nucleic Acid Testing (NAT), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________

PRODUCT
Red Blood Cells. Recall # B-0650-10
CODE
Unit: W141609171504
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter dated October 22, 2009.
Manufacturer: Puget Sound Blood Center and Program, Olympia, WA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III 
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0638-10
CODE
Unit: 50E56076
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Toledo, OH, by facsimile and electronic notification on July 25, 2009 and by letter dated July 25, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
1) Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-204, 8 x 40, Sterile EO. Intended for palliation of malignant neoplasms in the biliary tree. Recall # Z-0801-2010;

2) Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-205, 8 x 60, Sterile EO. Intended for palliation of malignant neoplasms in the biliary tree. Recall # Z-0802-2010;

3) Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-206, 8 x 80, Sterile EO. Intended for palliation of malignant neoplasms in the biliary tree. Recall # Z-0803-2010;

4) Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-208, 10 x 40, Sterile EO. Intended for palliation of malignant neoplasms in the biliary tree. Recall # Z-0804-2010;

5) Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-209, 10 x 60, Sterile EO. Intended for palliation of malignant neoplasms in the biliary tree. Recall # Z-0805-2010;

6) Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-210, 10 x 80, Sterile EO. Intended for palliation of malignant neoplasms in the biliary tree. Recall # Z-0806-2010
CODE
1) Lot Numbers: F727578A and IML4466A;

2) Lot Numbers: F727579A and IML4457A;

3) Lot Numbers: F727580A and IML4456A;

4) Lot Numbers: F727581A, IML4481A and IML4482A;

5) Lot Numbers: F727582A, IML 4476A, IML4480A, IML4531A, IML 4573A and IML 4593A;

6) Lot Numbers: F727583A, IML4453A, IML4487A, IML4488A and IML4533A
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT, by telephone and letter beginning January 28, 2010. Firm initiated recall is ongoing.
REASON
Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent.
VOLUME OF PRODUCT IN COMMERCE
165 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) LifeShield Latex-Free Primary SYMBIQ Set, Piggyback with Backcheck Valve, 3 Prepierced Y-Sites, 106 inch, Non-DEHP, 15 drops/mL; an Rx sterile single use fluid path way for administration of I.V. fluids using the Symbiq infusion pump; 48 sets per case; list number 16096-28. List Number: 16096-28. Recall # Z-0808-2010;

2) LifeShield Latex-free Primary I.V. Set, convertible P.P. yellow key slide clamp, backcheck valve, 4 Clave ports, piggyback with Option-Loc, attached extension set, 122 inch, 15 drops/mL; an Rx sterile single use fluid path way for administration of I.V. fluids; 48 sets per case; list number 19689-01; List Number: 19689-01. Recall # Z-0809-2010
CODE
1) Lot: 82-028-5H;
2) Lot Number: 81-147-5H
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, by letter dated January 8, 2010.
Manufacturer: Hospira Holdings de, Costa Rica Ltd., La Aurora de Heredia, Costa Rica. Firm initiated recall is ongoing.
REASON
There is a potential for fluid to leak from the backcheck valve which could result in inaccurate delivery and occupational exposure.
VOLUME OF PRODUCT IN COMMERCE
49,440 sets
DISTRIBUTION
MN, UT
___________________________________
PRODUCT
Locator Restorative Abutment, ILOA002, Certain Locator Abutment, 4.1 mm(D) X 2mm(H), Sterile. For use on tissue supported removable over-dentures on 2 to 4 implants, partially edentulous overdentures with one or more implants, limited interarch distance, angle correction with up to 40 degrees between divergent implants. Recall # Z-0810-2010
CODE
Lot 877423
RECALLING FIRM/MANUFACTURER
Biomet 3i, LLC, Palm Beach Gardens, FL, by telephone and faxed letter dated November 23, 2009. Firm initiated recall is ongoing.
REASON
Package labeled as sterile may have an incomplete or partial seal thereby possibly compromising sterility.
VOLUME OF PRODUCT IN COMMERCE
97 units
DISTRIBUTION
Nationwide, Middle East, Italy, Europe, and Greece
___________________________________
PRODUCT
Biphasic LIFEPAK 12 defibrillator / monitor. Part Number: LP12, VLP12-02-(various dash numbers). Recall # Z-0811-2010
CODE
Serial Numbers (non-contiguous): 8529728, 8529728, 9210418, 9210419, 9599334, 10128750, 10132851, 10248200, 10389064, 11120818, 11244332, 11252979, 11252980, 11252981, 11289300, 11311777, 11311778, 11311782, 11311787, 11316922, 11372139, 11424301, 11424819, 11471546, 11568711, 11610477, 11766215, 11766216, 11766222, 11767531, 11767565, 11877154, 12007118, 12007124, 12007129, 12007131, 12007135, 12009524, 12009528, 12030152, 12209828, 12209830, 12209832, 12209834, 12551932, 12551934, 12551936, 12551937, 12551939, 12776733, 12776734, 12779439, 12779439, 12789243, 13165363, 13269232, 13423039, 13434816, 13434837, 13522303, 13536842, 13704769, 13704770, 13870608, 13993048, 14008074, 14008075, 14201185, 14201186, 14201187, 30646561, 32117838, 32117838, 32117839, 32117839, 32117840, 32117840, 37125611, 37125612, 37125617, 37125743, 37125751, 37125752, 37125753, 37126327, 37126328, 37126329, 37126330, 37126331, 37126332, 37126333, 37126334, 37126335, 37126336, 37126342, 37126369, 37128467, 37128482, 37128485, 37128642, 37128643, 37128644, 37128646, 37128651, 37128652, 37128653, 37128660, 37128661, 37128662, 37128663, 37128666, 37128667, 37128668, 37128669, 37128670, 37128674, 37128678, 37135341, 37135394, 37135396, 37135397, 37135398, 37135418, 37135423, 37135424, 37135425, 37136603, 37136622, 37136623, 37136670, 37138749, 37138751, 37138756, 37138759, 37138769, 37138777, 37139181, 37139182, 37139183, 37139184, 37139186, 37139187, 37139188, 37139189, 37139190, 37139191, 37139192, 37139193, 37139194, 37139202, 37139203, 37139204, 37139205, 37139206, 37139207, 37139252, 37139254, 37139315, 37139317, 37139318, 37139324, 37139932, 37139933, 37140146, 37140147, 37143216, 37143418, 37143420, 37143457, 37143531, 37143636, 37146769, 37148809, 37148812, 37148863, 37148863, 37148864, 37148864, 37148865, 37148865, 37148867, 37148868, 37148868, 37148872, 37148878, 37148881, 37148881, 37148882, 37148882, 37154928, 37154936, 37158763, 37158766, 37158767, 37158768, 37158772, 37158773, 37158774, 37159196, 37159205, 37159231, 37159249, 37159250, 37159251, 37159264, 37159272, 37159273, 37159329, 37159330, 37159334, 37159337, 37159338, 37159339, 37159340, 37159341, 37170142, 37170143, 37170147, 37170149, 37170152, 37170750, 37170993, 37178695, 37178738, 37178742, 37190161, 37190162, 37190163, 37190165, 37190166, 37190167, 37190168, 37190169, 37190172, 37190173, 37190174, 37190175, 37190176, 37190177, 37190178, 37190179, 37190180, 37190181, 37190182, 37190183, 37190184, 37190185, 37190186, 37190187, 37190979, 37190981, 37193009, 37193409, 37193415, 37193417, 37193419, 37193420, 37193424, 37193425, 37193434, 37193435, 37193438, 37193439, 37193509, 37193512, 37193513, 37193514, 37193515, 37193516, 37193517, 37193518, 37193518, 37193519, 37193522, 37193527, 37193528, 37193529, 37193530, 37193531, 37193643, 37193650, 37193660, 37193716, 37193717, 37193719, 37193750, 37193753, 37193754, 37193755, 37193757, 37193758, 37193759, 37193760, 37193761, 37193776, 37193781, 37193783, 37193786, 37193788, 37193790, 37193791, 37200151, 37205122, 37205127, 37205127, 37205175, 37205175, 37205178, 37205185, 37205189, 37205190, 37205194, 37205198, 37205297, 37205298, 37205299, 37205301, 37205302, 37205303, 37205304, 37205305, 37205306, 37205307, 37205308, 37205309, 37205310, 37205311, 37205312, 37205313, 37205350, 37205591, 37205594, 37205594, 37205597, 37205597, 37205598, 37205598, 37207554, 37207577, 37207578, 37207579, 37207580, 37207581, 37207582, 37207583, 37207584, 37207585, 37207586, 37207587, 37207588, 37207589, 37207590, 37207591, 37207592, 37207690, 37208504, 37208516, 37208519, 37208520, 37208521, 37208524, 37208527, 37208563, 37208564, 37208565, 37208566, 37208567, 37208568, 37208569, 37208570, 37208654, 37208655, 37208656, 37208712, 37208713, 37208714, 37208715, 37208716, 37208717, 37208722, 37208723, 37208724, 37208767, 37208768, 37211021, 37211041, 37211044, 37211045, 37211098, 37211099, 37211100, 37211386, 37211389, 37211392, 37211406, 37211414, 37211642, 37211643, 37211644, 37211645, 37211646, 37211647, 37211648, 37212070, 37212391, 37212409, 37212412, 37212414, 37212424, 37212429, 37212827, 37213069, 37213095, 37213129, 37213174, 37213188, 37213220, 37213249, 37213502, 37213503, 37213504, 37213505, 37213541, 37213542, 37213574, 37213575, 37213576, 37216010, 37216669, 37216670, 37216774, 37216775, 37216883, 37216884, 37216886, 37216905, 37216906, 37216907, 37216908, 37216911, 37216916, 37216934, 37217051, 37217190, 37217191, 37217192, 37217194, 37217198, 37217199, 37217203, 37219856, 37219882, 37219883, 37219884, 37219922, 37219924, 37219927, 37219936, 37219981, 37219991, 37219998, 37219999, 37220007, 37220008, 37220009, 37220010, 37220011, 37220024, 37220091, 37220092, 37220210, 37220210, 37220211, 37220211, 37223009, 37223012, 37223036, 37223092, 37223096, 37223098, 37223099, 37223100, 37223101, 37223102, 37223103, 37223104, 37223105, 37223106, 37223107, 37223108, 37223109, 37223110, 37223114, 37223115, 37223116, 37223118, 37223122, 37223123, 37223124, 37223192, 37223198, 37223199, 37223202, 37223203, 37223544, 37223545, 37224052, 37224063, 37224064, 37224134, 37224135, 37224142, 37224147, 37224148, 37224160, 37226315, 37226316, 37226330, 37226331, 37226332, 37226333, 37226334, 37226335, 37226336, 37226337, 37226338, 37226339, 37226348, 37226349, 37226350, 37226351, 37226352, 37226353, 37226410, 37226411, 37226412, 37226413, 37226416, 37226420, 37226511, 37231960, 37231961, 37232006, 37234694, 37234695, 37234696, 37234697, 37234698, 37234699, 37234700, 37234701, 37234702, 37234703, 37234704, 37234705, 37234706, 37234708, 37234709, 37234710, 37234711, 37234712, 37234746, 37235337, 37235338, 37235365, 37235368, 37237465, 37237552, 37237553, 37237554, 37237563, 37237571, 37237818, 37237821, 37237824, 37237825, 37240785, 37240792, 37240793, 37240794, 37240795, 37240796, 37240798, 37240799, 37240800, 37240801, 37240802, 37240803, 37240804, 37240805, 37240806, 37240808, 37240810, 37240811, 37240812, 37240813, 37241075, 37241087, 37241117, 37245319, 37245771, 37245772, 37245780, 37245781, 37246017, 37246018, 37246354, 37246355, 37246356, 37246493, 37246499, 37249345, 37250362, 37250365, 37250372, 37250375, 37250379, 37250382, 37259407, 37259408, 37259409, 37259410, 37259411, 37259412, 37259413, 37259414, 37259418, 37259420, 37259421, 37259422, 37259423, 37259424, 37259426, 37259427, 37259428, 37259429, 37259430, 37259434, 37259442, 37259450, 37259451, 37259455, 37259457, 37259460, 37259463, 37259644, 37259668, 37259933, 37260513, 37260525, 37260526, 37260527, 37260589, 37260590, 37260591, 37260594, 37260596, 37260600, 37260606, 37260617, 37260623, 37260630, 37263770, 37263771, 37263772, 37263773, 37263774, 37263874, 37263875, 37263876, 37263877, 37263878, 37263920, 37263922, 37263931, 37263941, 37263949, 37263950, 37263951, 37263952, 37263953, 37263954, 37263955, 37263956, 37264340, 37264341, 37264342, 37264345, 37264346, 37264347, 37264350, 37264351, 37264358, 37264365, 37264365, 37264374, 37264375, 37264376, 37264377, 37264378, 37264379, 37264698, 37264714, 37268732, 37268860, 37268861, 37268862, 37268863, 37268864, 37268865, 37268866, 37268878, 37268879, 37268880, 37268881, 37268882, 37268896, 37268898, 37268915, 37273926, 37274137, 37274138, 37274139, 37274140, 37274141, 37274142, 37274143, 37274144, 37274145, 37274146, 37274147, 37274148, 37274149, 37274150, 37274151, 37274152, 37274153, 37274154, 37274155, 37274156, 37274157, 37274158, 37274159, 37274160, 37274161, 37274162, 37274510, 37274511, 37274512, 37274513, 37274514, 37274515, 37274516, 37274517, 37275262, 37275272, 37275272, 37275273, 37275273, 37275274, 37275274, 37275275, 37275275, 37275282, 37275312, 37288407, 37288408, 37288409, 37288410, 37288411, 37288433, 37288453, 37288454, 37288455, 37288456, 37288474, 37288475, 37288478, 37288598, 37288603, 37288610, 37288614, 37288647, 37288649, 37288650, 37288653, 37288654, 37288655, 37288656, 37288657, 37288660, 37288661, 37288663, 37288664, 37288665, 37288666, 37288667, 37288668, 37288669, 37288670, 37288671, 37288672, 37288819, 37288821, 37288822, 37288823, 37288825, 37288826, 37288894, 37298226, 37298227, 37298229, 37298232, 37298236, 37298243, 37298246, 37305892, 37305897, 37305897, 37305901, 37305901, 37305902, 37305902, 37305903, 37305903, 37305904, 37305904, 37306051, 37306051, 37306052, 37306052, 37306053, 37306053, 37306054, 37306054, 37306058, 37306058, 37306059, 37306059, 37306455, 37306456, 37306457, 37306458, 37306459, 37306460, 37306461, 37306462, 37315264, 37357985, 37357986, 37357987, 37357988, 37357989, 37357990, 37357991, 37357992, 37357993, 37357994, 37358010, 37358011, 37358012, 37358020, 37358021, 37358026, 37358027, 37358028, 37358033, 37358035, 37358053, 37358066, 37358069, 37358070, 37358071, 37358074, 37358075, 37358082, 37358083, 37358116, 37358147, 37358150, 37358155, 37358158, 37358167, 37358204, 37358207, 37358235, 37358239, 37358241, 37358285, 37358286, 37358287, 37358449, 37358450, 37358451, 37358460, 37358463, 37358464, 37358465, 37358480, 37358481, 37358547, 37359127, 37359128, 37359129, 37359396, 37359410, 37359428, 37359487, 37359491, 37359495, 37359496, 37359497, 37359498, 37359499, 37359500, 37359501, 37359502, 37359503, 37359505, 37359506, 37359507, 37359508, 37359509, 37359510, 37359511, 37361533, 37361849, 37361883, 37361934, 37361935, 37361939, 37361940, 37361941, 37361947, 37362070, 37362071, 37362072, 37362265, 37362266, 37362270, 37362276, 37362281, 37362282, 37362286, 37362300, 37362301, 37362302, 37362302, 37362303, 37362304, 37362305, 37362941, 37362941, 37362942, 37362942, 37362968, 37362968, 37362976, 37362976, 37363070, 37363070, 37363071, 37363146, 37363213, 37363224, 37363224, 37363229, 37363231, 37363231, 37363234, 37363237, 37363249, 37363252, 37363456, 37363456, 37363465, 37363465, 37363466, 37363467, 37363467, 37363472, 37363486, 37363487, 37363494, 37363500, 37363629, 37363633, 37363635, 37363636, 37363637, 37363638, 37363650, 37365624, 37365631, 37365672, 37365676, 37365678, 37365679, 37365681, 37365682, 37365684, 37365698, 37365699, 37365704, 37365705, 37365706, 37365707, 37365708, 37365709, 37365712, 37365723, 37366277, 37366278, 37366282, 37366342, 37366816, 37366817, 37366984, 37366998, 37367004, 37367019, 37367025, 37367037, 37367063, 37367069, 37367328, 37367567, 37367582, 37367613, 37367615, 37367615, 37367621, 37367622, 37367623, 37367624, 37367625, 37370902, 37370903, 37370914, 37370915, 37370919, 37370922, 37370925, 37370928, 37370929, 37370930, 37370931, 37370942, 37371050, 37371092, 37371096, 37371099, 37371101, 37371104, 37371107, 37371116, 37371118, 37371122, 37371123, 37371130, 37371131, 37371133, 37371134, 37371134, 37371135, 37371135, 37371136, 37371137, 37371139, 37371154, 37371155, 37371159, 37371164, 37371165, 37371174, 37371178, 37371180, 37371500, 37371500, 37371547, 37371548, 37372195, 37372585, 37372586, 37372589, 37372592, 37372736, 37372941, 37372942, 37372943, 37372946, 37373092, 37373294, 37377735, 37377816, 37380563, 37380589, 37380590, 37380611, 37380612, 37380613, 37380614, 37380615, 37380616, 37380617, 37380664, 37380680, 37380681, 37381174, 37381175, 37381682, 37381690, 37381692, 37381693, 37381696, 37381697, 37381701, 37381702, 37381703, 37381704, 37381707, 37381708, 37381711, 37381714, 37381719, 37381722, 37381724, 37381730, 37381734, 37385933, 37386729, 37386730, 37386731, 37386732, 37398412, 37404258, 37404270, 37410107, 37410669, 37410737, 37426060, 37441282, 37475899, 37475900, 37488841, 37488908, 37488910, 37494355, 37494355, 37494356, 37494356, 37494447, 37494454, 37494458, 37494461, 37494462, 37494680, 37494682, 37494685, 37494689, 37494733, 37494736, 37494738, 37494741, 37494744, 37494747, 37494763, 37494809, 37494890, 37494964, 37494966, 37495059, 37495123, 37495131, 37495441, 37495483, 37495484, 37495486, 37495487, 37495488, 37499017, 37499017, 37499200, 37499201, 37499202, 37499203, 37499204, 37499205, 37499224, 37499345, 37499351, 37499497, 37499557, 37499657, 37499659, 37499661, 37502162, 37502164, 37502167, 37502168, 37502169, 37502170, 37502171, 37502894, 37502897, 37502898, 37502901, 37503118, 37503121, 37503122, 37503124, 37503126, 37503127, 37503128, 37503129, 37503130, 37503131, 37503133, 37503196, 37503244, 37503245, 37503246, 37503247, 37503248, 37503423, 37503423, 37505870, 37506943, 37506944, 37506945, 37506946, 37506947, 37506948, 37506953, 37506975, 37513568, 37513569, 37513596, 37513666, 37513669, 37513671, 37513673, 37513675, 37513677, 37513680, 37513685, 37513686, 37513687, 37513689, 37513698, 37513701, 37518148, 37518174, 37518175, 37518180, 37518181, 37518186, 37518189, 37518189, 37518190, 37518190, 37518198, 37518228, 37518229, 37518316, 37521298, 37521299, 37521304, 37521305, 37521311, 37521328, 37521330, 37521331, 37521332, 37521333, 37521334, 37521335, 37521336, 37521337, 37521338, 37521339, 37521340, 37521341, 37521343, 37521344, 37521345, 37521346, 37524484, 37524489, 37524491, 37524531, 37524538, 37524557, 37524559, 37524560, 37524563, 37524569, 37524575, 37524581, 37524582, 37524583, 37524636, 37524639, 37525432, 37525433, 37525434, 37525435, 37525437, 37525438, 37525442, 37525870, 37534823, 37534968, 37534969, 37534970, 37535205, 37535206, 37536810, 37536816, 37536831, 37536832, 37536971, 37537170, 37537175, 37539183, 37539184, 37539185, 37539486, 37539487, 37539488, 37540470, 37540471, 37540558, 37540841, 37540842, 37542689, 37542990, 37542994, 37542995, 37542996, 37543000, 37543001, 37543005, 37543038, 37543062, 37543065, 37543067, 37543077, 37543080, 37543081, 37543082, 37543083, 37543084, 37543087, 37543088, 37543090, 37543091, 37543093, 37543100, 37543106, 37543108, 37543231, 37543563, 37543564, 37543565, 37546843, 37546844, 37546845, 37546846, 37546847, 37546850, 37546851, 37546853, 37546854, 37546855, 37546857, 37546858, 37546859, 37546862, 37553469, 37553474, 37553475, 37553476, 37553482, 37554331, 37563996, 37563997, 37563998, 37563999, 37564505, 37564506, 37564507, 37564969, 37564969, 37565641, 37569249, 37569256, 37569257, 37569258, 37569259, 37569260, 37569261, 37569265, 37569266, 37569327, 37569341, 37569391, 37569689, 37573492, 37573493, 37574329, 37574330, 37574331, 37574333, 37574334, 37574336, 37574340, 37574341, 37584475, 37585125, 37585128, 37586088, 37586089, 37589197, 37589397, 37592029, 37592042, 37592042, 37592043, 37592043, 37592092, 37592093, 37592094, 37593313, 37593313, 37593314, 37593314, 37593316, 37593316, 37593318, 37593318, 37593319, 37593319, 37595719, 37595720, 37595721, 37595722, 37596072, 37596073, 37596074, 37596076, 37596077, 37596093, 37596094, 37596099, 37596100, 37596104, 37596106, 37596111, 37596115, 37596119, 37596120, 37596962, 37604552, 37604553, 37604554, 37604569, 37604582, 37604583, 37604584, 37604585, 37604586, 37604640, 37604661, 37604698, 37604739, 37604758, 37604778, 37604779, 37604789, 37604816, 37604823, 37604827, 37604834, 37604851, 37604852, 37604857, 37604873, 37605119, 37605120, 37605133, 37605134, 37605140, 37605144, 37605145, 37605145, 37605153, 37605219, 37607894, 37607897, 37607917, 37607918, 37607919, 37607921, 37607922, 37607923, 37607924, 37607925, 37607926, 37607927, 37607928, 37607930, 37607931, 37607932, 37607933, 37607934, 37607935, 37607936, 37607938, 37607939, 37607940, 37607941, 37607942, 37607943, 37607945, 37607946, 37607947, 37607949, 37607950, 37607951, 37607952, 37607953, 37607954, 37607955, 37607956, 37607957, 37607958, 37607959, 37607960, 37607961, 37607962, 37607963, 37607964, 37607965, 37607966, 37607967, 37607968, 37607969, 37607970, 37608253, 37608276, 37608277, 37608278, 37609291, 37609294, 37609303, 37611851, 37611857, 37611858, 37611859, 37611863, 37611867, 37611870, 37611871, 37611872, 37611877, 37611881, 37611907, 37611908, 37611909, 37611910, 37611911, 37611912, 37611913, 37611914, 37611915, 37611916, 37611917, 37611918, 37611933, 37612135, 37612136, 37613013, 37613014, 37613014, 37613015, 37613015, 37613016, 37613016, 37613017, 37613017, 37613018, 37613018, 37613019, 37613019, 37613031, 37613032, 37613033, 37613034, 37613035, 37613036, 37613037, 37613038, 37613039, 37613040, 37613043, 37613048, 37613049, 37613050, 37613051, 37613052, 37613055, 37613072, 37613109, 37613515, 37613515, 37613516, 37613516, 37613517, 37613517, 37613518, 37613518, 37613519, 37613519, 37613520, 37613520, 37616722, 37616723, 37616724, 37616725, 37616726, 37616727, 37616728, 37616729, 37616730, 37616731, 37620258, 37620259, 37620260, 37620261, 37620262, 37620263, 37620264, 37620265, 37620266, 37620267, 37620268, 37620269, 37620270, 37620271, 37620272, 37620273, 37620274, 37620275, 37620276, 37620277, 37620278, 37620279, 37620280, 37620281, 37620282, 37620283, 37620284, 37620285, 37620286, 37620287, 37620288, 37624306, 37624310, 37624311, 37624312, 37624315, 37624318, 37624613, 37624979, 37624979, 37625061, 37625062, 37625124, 37625125, 37625126, 37625127, 37625145, 37625146, 37625147, 37625161, 37625163, 37625167, 37628407, 37628550, 37628551, 37628552, 37628553, 37628554, 37628555, 37628556, 37628557, 37628558, 37628559, 37628560, 37628561, 37628562, 37628563, 37628564, 37628565, 37628566, 37628567, 37628568, 37628569, 37628570, 37628571, 37628572, 37628573, 37628574, 37628575, 37628576, 37628577, 37628578, 37628579, 37628580, 37628581, 37628582, 37628583, 37628584, 37628585, 37628586, 37628587, 37628588, 37628589, 37628590, 37628591, 37628592, 37628593, 37628594, 37628595, 37628596, 37628597, 37628598, 37628599, 37628600, 37628601, 37628602, 37628603, 37628604, 37628605, 37628606, 37628607, 37628608, 37628609, 37628610, 37628611, 37628612, 37628613, 37632499, 37632500, 37632501, 37632502, 37632503, 37632504, 37632918, 37632922, 37632941, 37632945, 37632946, 37632947, 37632948, 37632951, 37632952, 37632953, 37632955, 37632956, 37632958, 37632959, 37632960, 37632961, 37632963, 37632964, 37632967, 37633634, 37633636, 37636570, 37636571, 37636572, 37636573, 37636574, 37636575, 37636576, 37636577, 37636578, 37636579, 37636659, 37652880, 37652883, 37652883, 37660898, 37660902, and 37661630

RECALLING FIRM/MANUFACTURER
Physio Control, Inc., Redmond, WA, by letter dated March 2009. Firm initiated recall is ongoing.
REASON
Affected devices contain a Biphasic PCBA that may have a solder defect on the H Bridge component that could prevent the device from providing a defibrillation shock. There could be a delay in therapy or prevention of defibrillation therapy if the defibrillator were needed in a cardiac arrest situation. Delay or prevention of defibrillation therapy may contribute to the death of a viable patient.
VOLUME OF PRODUCT IN COMMERCE
1,718 units
DISTRIBUTION
Nationwide, Australia, Brazil, Canada, Colombia, Costa Rica, Germany, Hong Kong, Mexico, Netherlands
___________________________________
PRODUCT
CellSearch Circulating Tumor Cell Kit (Epithelial) IVD REF 7900001 Veridex LLC, a Johnson & Johnson Company. Recall # Z-0819-2010
CODE
Lot number 0019, Exp 1/8/2010; 0019B, Exp 1/8/2010; 0039, Exp 3/16/2010; 0059, Exp 3/6/2010, 0079, Exp 2/20/2010; 0099, Exp 6/24/2010.
RECALLING FIRM/MANUFACTURER
Veridex, LLC, Raritan, NJ, by letters on August 12, 2009. Firm initiated recall is ongoing.
REASON
Veridex has received 4 complaints regarding reagent bottles having been incorrectly placed or duplicate bottles places within the reagent tray of CellSearch Circulating Tumor Cell Kit.
VOLUME OF PRODUCT IN COMMERCE
1641 kits in US, 380 internationally
DISTRIBUTION
Nationwide, Belgium, France, Germany, Italy, Spain, United Kingdom, Netherlands, Norway and Israel
___________________________________
PRODUCT
Encore Medical Foundation Knee Revision Baseplate, Part Number 321-01-106, Size 6, Left. Recall # Z-0826-2010
CODE
Lot 53944312
RECALLING FIRM/MANUFACTURER
Encore Medical, Lp, by letter on December 11, 2009. Firm initiated recall is ongoing.
REASON
Partial lot of product was not manufactured to specification. Central locking screw was missing threads. There is a potential for dissociation because the screw is not able to be used as a secondary fixation method.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
TX, FL, GA, CA, AZ, Japan
___________________________________
PRODUCT
1) RambaChrom KPC M/N 11500. Recall # Z-0827-2010;
2) RambaChrom VRE M/N 11600. Recall # Z-0828-2010
CODE
1) Lot # 8273017 Exp. Date 11/18/2008; Lot# 8357002 Exp. Date 2/9/2009; Lot# 9099062 Exp. Date 5/28/2009; Lot# 9121097 Exp. Date 6/19/2009; Lot# 9132038 Exp. Date 6/30/2009; Lot# 9134085 Exp. Date 7/2/2009; Lot# 9139025 Exp. Date 7/7/2009; Lot# 9166026 Exp. Date 8/3/2009; Lot# 9177131 Exp. Date 8/14/2009; Lot# 9194004 Exp. Date 8/31/2009; Lot# 9212080 Exp. Date 9/18/2009; Lot# 9222002 Exp. Date 9/28/2009; Lot# 9232053 Exp. Date 10/8/2009; Lot# 9275097 Exp. Date 11/20/2009; Lot# 9288050 Exp. Date 12/3/2009; Lot# 9306001 Exp. Date 12/21/2009; Lot# 9322047 Exp. Date 1/6/2010;
 
2) Lot # 8256101 Exp. Date 11/21/2008; Lot # 8260028 Exp. Date 11/25/2008; Lot # 8289053 Exp. Date 12/24/2008; Lot # 8291088 Exp. Date 12/26/2008; Lot # 8308002 Exp. Date 1/12/2009; Lot # 8344022 Exp. Date 2/17/2009; Lot # 9015084 Exp. Date 3/26/2009; Lot # 9034041 Exp. Date 3/24/2009; Lot # 9043079 Exp. Date 4/23/2009; Lot # 9072081 Exp. Date 5/22/2009; Lot # 9077047 Exp. Date 5/27/2009; Lot # 9100101 Exp. Date 6/19/2009; Lot # 9128102 Exp. Date 7/17/2009; Lot # 9159001 Exp. Date 8/17/2009; Lot # 9170108 Exp. Date 8/28/2009; Lot # 9175051 Exp. Date 9/2/2009; Lot # 9196042 Exp. Date 9/23/2009; Lot # 9210041 Exp. Date 10/7/2009; Lot # 9215002 Exp. Date 10/12/2009; Lot # 9224046 Exp. Date 10/31/2009; Lot # 9240088 Exp. Date 11/6/2009; Lot # 9264003 Exp. Date 11/30/2009; Lot # 9287031 Exp. Date 12/23/2009; Lot # 9296067 Exp. Date 1/2/2010; Lot # 9315031 Exp. Date 1/20/2010; Lot # 9321020 Exp. Date 1/26/2010
RECALLING FIRM/MANUFACTURER
Gibson Laboratories Inc., Lexington KY, by letters on December 10, 2009. Firm initiated recall is ongoing.
REASON
Discrepancies between the product package label and technical insert are conflicting and may be misleading to user. The technical insert included the statement for In Vitro Diagnostic Use. The product insert should have indicated for Research Use Only instead of for In Vitro Diagnostic Use.
VOLUME OF PRODUCT IN COMMERCE
1) 15330 units; 2) 3440 units
DISTRIBUTION
Nationwide and France
___________________________________
PRODUCT
1) Cybernet Medical MedStar Telemedicine System; Model 533-210. The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data over a phone line. Recall # Z-0852-2010;

2) Cybernet Medical MedStar Telemedicine System; Model 533-380. The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data over a phone line. Recall # Z-0853-2010;

3) Cybernet Medical MedStar Telemedicine System; Model 533-386. The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data over a phone line. Recall # Z-0854-2010;

4) Cybernet Medical MedStar Telemedicine System; Model 533-381. The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data over a phone line. Recall # Z-0855-2010
CODE
1) Serial number range affected was 2778 through 4085. Serial numbers 2826, 3719, 3726, 4045 and 4048 have not yet been corrected;

2) Serial number range affected is 3554 through 3798. Serial numbers 3554, 3559, 5375, 3579, 3584, 3586, 3587, 3594, 3615, 3655, 3664, 3669 ,3670, 3676, 3680, 3682, 3683, 3694, 3696, 3703, 3708, 3725, 3744 and 3798 have not yet been corrected.

3) Serial numbers 3812, 3814 and 3824 have not yet been corrected. No others were in need of correction.

4) Serial number 3657. This unit has been corrected
RECALLING FIRM/MANUFACTURER
Cybernet Systems Corp., Ann Arbor, MI, by letter dated October 27, 2009. Firm initiated recall is ongoing.
REASON
A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions for use.
VOLUME OF PRODUCT IN COMMERCE
88 units
DISTRIBUTION
CA, FL, GA, IL, LA, MI, MS, NY, OK, WV
___________________________________
PRODUCT
EXXCEL Soft Standard Wall EPTFE Vascular Graft; D:8 mm: L: 50 mm straight; Product Code: M002004910580. Recall # Z-0866-2010
CODE
Lot # 12633379, Exp: 4/2012
RECALLING FIRM/MANUFACTURER
Maquet Cardiovascular, LLC, Wayne, NJ, by letters on January 20, 2010. Firm initiated recall is ongoing.
REASON
Labeling mix up: Shelf Carton label for Exxcel Soft Thin Wall Vascular Grafts, were mislabeled as Exxcel Soft Standard Wall Grafts. Bleeding could occur if wrong product is used.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
TX, TN, CT, AR, AZ, Austria and France

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT
Percutaneous Catheter Introducer Set, VNUS Medical Technologies Cath Shth Intro 7F x 7cm, catalog number IS-7F07, Disposable, Single Use, Do Not Re-sterilize. For catheter exchange or placement of closed end catheters utilizing the Desilets-Hoffman technique. Recall # Z-0764-2010
CODE
Lot 99715418, Exp 2014-05
RECALLING FIRM/MANUFACTURER
Argon Medical Devices, Inc., Athens, TX, by letter dated January 6, 2010. Firm initiated recall is ongoing.
REASON
One lot of Percutaneous Catheter Introducer Set contained incorrect size needle.
VOLUME OF PRODUCT IN COMMERCE
500 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) IDEAL MAXPAC TOTAL SYSTEM (USA), Sterile and Nonpyrogenic, ETO or Gamma Sterilized, Medtronic Perfusion Systems, Model: TS9453R29, TS9453R30, TS1470R1, TS1442R1, TS9800R32, TS8299R4. Recall # Z-0868-2010;

2) ONE SOURCE PACK, Model TK2S24, EE2S048 (OUS). Recall # Z-0869-2010
CODE
1) Lot #: 1058285, 10059556, 1099512, 1106926, 1106983, 1001369;
2) Lot #: 1093645, 1102929, 1139554
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Inc., Minneapolis, MN, by letter dated December 14, 2009.
Manufacturer: Medtronic Cardiovascular Revascularization & Surgical Therap, Brooklyn Park, MN. Firm initiated recall is ongoing.
REASON
Medtronic has identified a small number of Autotransfusion One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates (UBD) on the outer kit package label. The UBD on the outer label of the kit/pack does not accurately reflect the UBD of the components within the kit/Pack. For affected product, the outer label lists a date which may be later than the USB of the components included in the kit/pack.
VOLUME OF PRODUCT IN COMMERCE
36 units
DISTRIBUTION
CA, CO, Japan, China
___________________________________

PRODUCT
ERIC (Electronic RapID Compendium) Version 1.0.77, Catalog Number R8323600, used in conjunction with: remel RapID Yeast Plus System is a qualitative micromethod employing conventional and chromogenic substrates for the identification of medically important yeast, yeast-like, and related organisms isolated from human clinical specimens. A complete listing of the organisms addressed by the RapID Yeast Plus System is given in the RapID Yeast Plus Differential Chart. RapID" YEAST PLUS System, Catalog No. R8311007. 4 hour identification of yeast based on enzyme technology. Database includes over 40 taxa. Requires Inoculation Fluid, REF R8325106. CE, 20 Panels/Kit. Recall # Z-0870-2010
CODE
Lot No. 0001096277
RECALLING FIRM/MANUFACTURER
Remel, Inc., Lenexa, KS, by letter dated October 29, 2009. Firm initiated recall is complete.
REASON
There is an error in Version 1.0.77 of the electronic code compendium (ERIC) software. The error is limited to the database corresponding to the R8311007 RapID Yeast Plus System. The database erroneously includes Candida dubliniensis as well as displays an incorrect temperature range as an accessory test for codes with an overlap between Candida albicans and Candida dubliniensis. When using the RapID Yeast Plus panel, selecting "Display All Accessory Tests" indicated Growth at 37 o C for Candida albicans vs "No Growth" for Candida dubliniensis. The appropriate temperature range for resolving this overlap is 42-45 o C, at which C. albicans should exhibit growth but C. dubliniensis should not. The Instructions for Use for the RapID Yeast Plus System have recently been revised to address the biochemical similarities between these two species and indicates the correct methods to help distinguish between them. A software patch has been issued to modify the RapID Yeast Plus Database file. The patch is downloadable and will delete all data and references related to Candida dubiniensis from the database.
VOLUME OF PRODUCT IN COMMERCE
143 units
DISTRIBUTION
Nationwide, Europe and Canada

 RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS I
___________________________________
PRODUCT
Carmelyx 18% Multi Species Supplement Tub, Net Weight 125 lbs. (56.51 Kg) and Net Weight 225 lbs (102.2 Kg). Recall # V-015-2010
CODE
All lots shipped since April 6, 2009 through October 30, 2009. Lot #s include: NOV 08 2008; JAN 09 2009; JAN 22 2009; JAN 27 2009; FEB 09 2009; FEB 13, 2009; FEB 20 2009; FEB 21 2009; MAR 09 2009; MAR 10 2009; MAR 18 2009; MAR 19 2009; MAR 20 2009; MAR 24 2009; MAR 26 2009; MAR 29 2009; APR 02 2009; APR 03 2009; APR 04 2009; APR 06 2009; APR 08 2009; APR 09 2009; APR 10 2009; APR 15 2009; APR 16 2009; APR 17 2009; APR 19 2009; APR 20 2009; APR 21 2009; APR 22 2009; APR 23 2009; APR 24 2009; APR 28 2009; APR 29 2009; APR 30 2009; MAY 01 2009; MAY 02 2009; MAY 04 2009; MAY 06 2009; MAY 07 2009; MAY 08 2009; MAY 09 2009; MAY 15 2009; MAY 18 2009; MAY 19 2009; MAY 21 2009; MAY 22 2009; MAY 26 2009; JUN 03 2009; JUN 04 2009; JUN 09 2009; JUN 11 2009; JUN 12 2009; JUN 13 2009; JUN 15 2009; JUN 18 2009; JUN 19 2009; JUN 22 2009; JUN 25 2009; JUN 29 2009; JUN 30 2009; JUL 02 2009; JUL 05 2009; Jul 06 2009; JUL 07 2009; JUL 08 2009; JUL 09 2009; JUL 10 2009; JUL 11 2009; JUL 13 2009; JUL 14 2009; JUL 15 2009; JUL 16 2009; JUL 17 2009; JUL 18 2009; JUL 21 2009; JUL 22 2009; JUL 25 2009; JUL 28 2009; JUL 29 2009; JUL 30 2009; JUL 31 2009; AUG 03 2009; AUG 08 2009; AUG 09 2009; AUG 10 2009; AUG 13 2009; AUG 14 2009; AUG 17 2009; AUG 19 2009; AUG 20 2009; AUG 21 2009; AUG 23 2009; AUG 24 2009; AUG 26 2009; AUG 28 2009; AUG 30 2009; SEP 01 2009; SEP 02 2009; SEP 04 2009; SEP 05 2009; SEP 09 2009; SEP 15 2009; and SEP 19 2009
RECALLING FIRM/MANUFACTURER
Cargill, Inc - Animal Nutrition Division, Seguin, TX, by phone on October 30, 2009. 
Manufacturer: Positive Feed, Inc., Sealy, TX. Firm initiated recall is ongoing.
REASON
Product has the potential to contain elevated levels of copper.
VOLUME OF PRODUCT IN COMMERCE
365 tons
DISTRIBUTION
TX

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II
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PRODUCT
1) Medicated dairy feed supplement, 4 custom blends, bulk. Bulk product not labeled. Consignee provided with documentation listing product name, ingredients, mixing directions, product code. Products include: 1) Vreugdenhil Close up, 2) Vanderwaal Close up, 3) RTJ Dry Cow; and 4) Meadow Park Close up. Recall # V-036-2010;

2) Non-Medicated dairy feed supplement, 7 custom blends, bulk. Bulk product not labeled. Products include: 1) Marmel Close up; 2) Bajema Close up; 3) Vanmiddendorp Close up; 4) Deck Close up; 5) Debruin Dry Cow; 6) Blankers Dry Cow; and 7) Dejong Close up. Recall # V-037-2010
CODE
1) Code and run number not provided on any affixed label. Information provided on product sheets provided to each consignee specific to their blend. 1) Vreugdenhil Close up, Product Code 229423VC, Run 10202; 2) Vanderwaal Close up, Product Code 229423KC, Run 10234; 3) RTJ Dry Cow, Product Code 229500RD, Run 10318; 4) Meadow Park Close up, Product Code 229500ED, Run 10377;

2) Products are not labeled. Identification information provided to FDA by recalling firm: 1) Marmel Close up, Formula 229423MD, Run 10186; 2) Bajema Close, Formula 229423RU, Run 10187; 3) Vanmiddendorp Close up, Formula 229423VU, Run 10235; 4) Deck Close up Formula 229424JD, Run 10331; 5) Debruin Dry Cow, Formula 229426DD, Run 10370; 6) Blankers Dry Cow, Formula 229423BC, Run 10386; 7) Dejong Close up, Formula 229424DD, Run 10570
RECALLING FIRM/MANUFACTURER
Cargill Animal Nutrition, Ferndale, WA, by phone or personal visit on January 12, 2010. Firm initiated recall is complete.
REASON
Undeclared urea - urea inadvertently added to the product.
VOLUME OF PRODUCT IN COMMERCE
29,040 lbs of medicated feed, 46,986 lbs. non-medicated feed
DISTRIBUTION
WA
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PRODUCT
1) AC power cords used with Bair Hugger Temperature Management Units: Models 505 & 750. Arizant Healthcare Inc. is initiating a nationwide voluntary recall of 100/110-volt power cords (Arizant part number 502221 Model 90024) attached to its temperature management units and pressure infusion power pack (Bair Paws Temperature Management Units: Models 850 and 875 Bair Hugger Temperature Management Units: Models 500/OR, 505 (Human & Vet.), 750 (Human & Vet) and 775 Ranger Blood/Fluid Warming Units: Models 245 (Human & Vet) and 247 Ranger Pressure Infusion Power Pack, Part # 90033). Recall # V-038-2010;

2) AC power cords used with Ranger Blood/Fluid Warming Unit, Model 245. Arizant Healthcare Inc. is initiating a nationwide voluntary recall of 100/110-volt power cords (Arizant part number 502221 Model 90024) attached to its temperature management units and pressure infusion power pack (Bair Paws Temperature Management Units: Models 850 and 875 Bair Hugger Temperature Management Units: Models 500/OR, 505 (Human & Vet.), 750 (Human & Vet) and 775 Ranger Blood/Fluid Warming Units: Models 245 (Human & Vet) and 247 Ranger Pressure Infusion Power Pack, Part # 90033). Recall # V-039-2010
CODE
Part and Model numbers only
RECALLING FIRM/MANUFACTURER
Arizant Inc., Eden Prairie, MN, by letter dated December 17, 2009. Firm initiated recall is ongoing.
REASON
The affected power cords may crack and fail at/inside the plug. This recall is being issued in response to a small number of customer reports of melting, smoking or fire within the power cord plug. Multiple medical device manufacturers have recently reported power cord concerns to the FDA. Arizant has not received any reports of patient or clinician harm relating to this problem. However, the potential risks from this power cord failure include electric shock, delay in setup and therapy, interruption of therapy, device failure, and fires.
VOLUME OF PRODUCT IN COMMERCE
84,537 US, 7,380 OUS
DISTRIBUTION
Nationwide, Germany, Granada, Italy

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS III
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PRODUCT
1) Wysong Senior Canine Diet packaged in 4 lb and 8 lb bags. The bags are sold individual or in cases of 4 bags. The bags are shiny silver foil with black print and a picture of rising sun and a dog. UPC 8583504001. Recall # V-040-2010;

2) Wysong Maintenance Canine Diet packaged in 4 lb and 8 lb bags. The bags are sold individual or in cases of 4 bags. The bags are shiny silver foil with black print and a picture of rising sun and a dog. UPC 8583503001. Recall # V-041-2010;

3) Wysong Synorgon Canine Diet packaged in 4 lb and 8 lb bags. The bags are sold individual or in cases of 4 bags. The bags are shiny silver foil with black print and a picture of rising sun and a dog. UPC 8583504036. Recall # V-042-2010
CODE
1) Lots 090623 and 090811;
2) Lots 090617, 090624, 090706, 090720, 090817;
3) Lot 090629
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wysong Medical Corp., Midland, MI, by email on September 29, 2009, October 12, 2009 and October 27, 2009. 
Manufacturer: Nutrition First Processing (NFP), Lake Mills, WI. Firm initiated recall is ongoing.
REASON
The firm received complaints of mold in dog food products.
VOLUME OF PRODUCT IN COMMERCE
363, 328
DISTRIBUTION
Nationwide and Canada, Hong Kong and Singapore

END OF ENFORCEMENT REPORT FOR MARCH 3, 2010

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