February 6, 2002 02-05
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________ PRODUCT Prestige Caramel Coyote Canyon Classic ice Cream, Premium Dulce DeLeche Ice Cream with Dulce De Leche Swirl and Mini Caramel Cups Half gallon, Recall # F-277-2. CODE JAN 24 2002 12-356, UPC 2114027053 RECALLING FIRM/MANUFACTURER Recalling Firm: Winn Dixie Stores, (Corporate Headquarters), Jacksonville, FL, by telephone and e-mail on Sept. 5, 2001. Manufacturer: Superbrand Dairies Inc., (Div. of Winn Dixie Stores), Plant City, FL. Firm initiated recall is complete. REASON Undeclared peanut butter. VOLUME OF PRODUCT IN COMMERCE 15,800 half gallons. DISTRIBUTION Nationwide _______________________ PRODUCT Apple Pie flavored Veggie Yogurt,packed in a white, opaque plastic carton with a snap on lid; net wt. 6 OZ. Recall 3 F-278-2. CODE NOV 19, 01 S4R2, UPC 0-77172-66765-2. RECALLING FIRM/MANUFACTURER Galaxy Nutritional Food, Inc. Orlando, FL, by fax and E-mail on Sept. 11, 2001. FDA initiated recall is complete. REASON Undeclared milk allergen from possible cross contamination. VOLUME OF PRODUCT IN COMMERCE 458 cases, 12/6 oz. cartons per case. DISTRIBUTION Nationwide and The Dominican Republic. ________________________ PRODUCT Oriental Mix packed in clear, rigid plastic containers, approximately 0.30 lbs. per plastic container, Recall # F-279-2. CODE All "packed on" "sell by" dates. RECALLING FIRM/MANUFACTURER Asmar Nut Roasting, Inc. (DBA Choconuts, Brooklyn, NY, by visit on Aug. 16 - 19, 2001 and by letter on Aug. 22, 2001. FDA initiated recall is complete. REASON The product contained undeclared cashews and almonds. VOLUME OF PRODUCT IN COMMERCE 129 units. DISTRIBUTION NY. _______________________ PRODUCT a) Hsu & Co. brand, Super Enzymes, 60 & 120 & 180 tablets, Recall # F-280-2; b) Hsu & Co. brand, Super Enzymes, 60 & 180 capsules, Recall # F-281-2; c) Acti-Gest tablets (labeled under numerous brands) -Spatz brand, 90 tablets. -Natural Products/ Natures Way brand, 180 tablets. -Full-O-Life brand, 90 tablets. -Edson Farms Natural Foods brand, 90 & 180 tablets. -Clark's Nutritional Centers brand, 90 tablets. -VP Health Food brand, 90 & 180 tablets. -Nature's Concept The Natural Choice brand, 60 & 90 & 180 tablets. Recall # F-282-2. CODE a) Lots 0050203 & 0090203; b) Lots 0050203 & 0090203; c) Lot 5800204; Lot 5800204; Lot 5800204; Lot 5800204; Lot 5800204; Lot 5800204; Lot 5800204. RECALLING FIRM/MANUFACTURER Recalling Firm: Licata Enterprises, Huntington Beach, CA, by telephone and fax on May 16, 2001. Manufacturer: Horizon Laboratories, Chatsworth, CA. Firm initiated recall is ongoing. REASON Salmonella contamination of raw material Pepsin. VOLUME OF PRODUCT IN COMMERCE 173,702 tablets, 95,008 capsules. DISTRIBUTION CA, OH and MI.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________ PRODUCT Asian Boy (EBQ) Tapioca Stick (Granule de Tapioca) in flexible plastic packages, net wt. 3.5 oz. (100 g). Product of Vietnam. Recall # F-064-2. CODE None. RECALLING FIRM/MANUFACTURER Recalling Firm: B.C.N. Trading Inc., Brooklyn, NY, by letter dated May 30, 2001. Manufacturer: M & N (Minh Nguyet) Co., Ho Chi Minh City. State initiated recall is complete. REASON Product contained an unidentifiable color additive & erythrosine (certifiable as FD&C Red #3). VOLUME OF PRODUCT IN COMMERCE 55 cases. DISTRIBUTION NY, PA, CT, MA, NJ and Washington, DC. _______________________ PRODUCT Shellstock oysters, Recall # F-235-2; Shucked oysters, Recall # F-236-2. All oysters were packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER Gordon's Seafood Tallahassee, FL, by letter on Oct. 5, 2001. State initiated recall is complete. REASON Oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION FL. _______________________ PRODUCT Shellstock oysters, Recall # F-237-2; Shucked oysters, Recall # F-238-2. All oysters were packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters havested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER Davis Seafood, Apalachicola, FL, by letter on Oct. 5, 2001. State initiated recall is complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE 39-1/2 boxes and 11 bags. DISTRIBUTION FL. _______________________ PRODUCT Shellstock oysters, Recall # F-239-2; Shucked oysters, Recall # F-240-2. All oysters were packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER Bill's Seafood, Carrabelle, FL, by letter on Oct. 5, 2001. State initiated recall is complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE 44 Boxes. DISTRIBUTION MD. _______________________ PRODUCT Shellstock oysters, Recall # F-241-2. Shucked oysters, Recall # F-242-2. All oysters were packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters were harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER R. M. Seafood, Eastpoint, FL, by letter on Oct. 5, 2001. State initiated recall is complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION FL, GA and AL. _______________________ PRODUCT Shellstock oysters, Recall # F-243-2. Shucked oysters, Recall # F-244-2. All oysters were packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters were harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER Flowers Seafood, Eastpoint, FL, by letter on Oct. 5, 2001. State initiated recall is complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE 164/60 lb., 15/45 lb. and 349/30 lb. DISTRIBUTION FL. _______________________ PRODUCT Shellstock oysters, Recall # F-245-2; Shucked oysters, Recall # F-246-2. All oysters were packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER Sea Quest Seafood, Apalachicola, FL, by letter on Oct. 5, 2001. State initiated recall is complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE 42,772 pounds. DISTRIBUTION FL. _____________________________ PRODUCT Shellstock oysters, Recall # F-247-2; Shucked oysters, Recall # F-248-2. All oysters were packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters were harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER R.D.'s Seafood, Apalachicola, FL, by letter on Oct. 5, 2001. State initiated recall is complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE 184 bags and 212 boxes. DISTRIBUTION FL. _______________________ PRODUCT Shellstock oysters, Recall # F-249-2; Shucked oysters, Recall # F-250-2. All oysters were packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters were harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER Lombardi's Seafood, Apalachicola, FL, by letter on Oct. 5, 2001. State initiated recall is complete. REASON These oysters were harvested from the same area as oysters assocated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION FL and AL. _______________________ PRODUCT Shellstock oysters, Recall # F-251-2; Shucked oysters, Recall # F-252-2. All oysters were packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters were harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER Two J's Trading Co., Apalachicola, FL, by letter on Oct. 5, 2001. State initiated recall is complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE 32 gallons. DISTRIBUTION GA. _______________________ PRODUCT Shellstock oysters, Recall # F-253-2; Shucked oysters, Recall # F-254-2. All oysters were packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters were harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER Pristine International Seafood, Apalachicola, FL, by letter on Oct. 5, 2001. State initiated recall is complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE 185 gallons. DISTRIBUTION GA. _______________________ PRODUCT Shellstock oysters, Recall # F-255-2; Shucked oysters, Recall # F-256-2. All oysters were packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters were harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER Little Bay II Inc., Eastpoint, FL, by letter on Oct. 5, 2001. State initiated recall is complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION FL and GA. _______________________ PRODUCT Shellstock oysters, Recall # F-257-2; Shucked oysters, Recall # F-258-2. All oysters were packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER Sumatra Seafood Brokers Bristol, FL, by letter on Oct. 5, 2001. State initiated recall is complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION FL and AL. _______________________ PRODUCT Shellstock oysters, Recall # F-259-2. Shucked oysters, Recall # F-260-2. All oysters were packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER David's Seafood, Eastpoint, FL, by letter on Oct. 5, 2001. State initiated recall is complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE 373 bags and 20/30 lb. Boxes. DISTRIBUTION FL and GA. _______________________ PRODUCT Shellstock oysters, Recall # F-261-2; Shucked oysters, Recall # F-262-2. All oysters were packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER D.L. Thomas Seafood, Panacea, FL, by letter on Oct. 5, 2001. State initiated recall is complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE 77/60 lb. bags, 158 boxes, 49 gallons, 210 pints and 72/12 oz. DISTRIBUTION GA. _______________________ PRODUCT Shellstock oysters, Recall # F-263-2; Shucked oysters, Recall # F-264-2. All oysters were packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER R&R Seafood, Panacea, FL, by letter on Oct. 5, 2001. State initiated recall is complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION FL and GA. _______________________ PRODUCT Shellstock oysters, Recall # F-265-2; Shucked oysters, Recall # F-266-2. All oysters were packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER Webb's Seafood Inc., Youngstown, FL, by letter on Oct. 5, 2001. State initiated recall is complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE 288/60 lb. bags and 186/30 lb. boxes. DISTRIBUTION FL and AL. _______________________ PRODUCT Shellstock oysters, Recall # F-267-2; Shucked oysters, Recall # F-268-2. All oysters were packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER Barber's Seafood Inc., Eastpoint, FL, by letter on Oct. 5, 2001. State initiated recall is complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE Unknown DISTRIBUTION FL, GA and AL. _______________________ PRODUCT Shellstock oysters, Recall # F-269-2; Shucked oysters, Recall # F-270-2. All oysters were packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER Bluepoints Int'l Fisher, Apalachicola, FL, by letter dated Oct. 5, 2001. State initiated recall is complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION GA. _______________________ PRODUCT Shellstock oysters, Recall # F-271-2; Shucked oysters, Recall # F-272-2. All oysters were packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER Miller & Ellis Seafood, Southport, FL, by letter on Oct. 5, 2001. State initiated recall is complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION FL. _______________________ PRODUCT Shellstock oysters, Recall # F-273-2; Shucked oysters, Recall # F-274-2. All oysters were packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall RECALLING FIRM/MANUFACTURER Lynn's Quality Oysters, Eastpoint, FL, by letter on Oct. 5, 2001. State initiated recall is complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE 492 /60 lb. bags; 12/30 lb. boxes and 44/40 lb. boxes. DISTRIBUTION FL and GA. _______________________ PRODUCT Shellstock oysters, Recall # F-275-2; Shucked oysters, Recall # F-276-2. All oysters were packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER Fred's Best Seafood, Eastpoint, FL, by letter on Oct. 5, 2001. State initiated recall is complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION FL, GA and SC. _______________________ PRODUCT Jelly beans in 16 oz. bags, sold under the "Country Creek Candy Factory" label. Responsible firm on the label: "Balglobe Fine Foods, Villa St. Laurent, Quebec, Canada H4P21S". Also labeled "PRODUCT of Canada". Recall # F-283-2. CODE 501098. RECALLING FIRM/MANUFACTURER Recalling Firm: Dollars Worth, LLC., Owego, NY, by memo dated Nov. 28, 2001. Manufacturer: Unknown. State initiated recall is complete. REASON The product contains undeclared certifiable colors brilliant blue FCF (certifiable as FD&C Blue #1), erythrosine (certifiable as FD&C Red #3), and allura red AC (certifiable as FD&C Red #40). VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION NY. _______________________ PRODUCT a) DRAGON brand THACH DUA LA DUA Coconut Gel Pandang (Nata de Coco) Net WT: 400 Grs (14 Oz), Product OF VIETNAM. Recall # F-284-2. b) DRAGON brand THACH DUA SOI LA DUA Coconut Gel Stripe Pandang (Nata de Coco) NET WT: 400 Grs (14 Oz), product of Vietnam. Recall # F-285-2. CODE a) barcode # 36183 11232 & no other coding. b) All jar codes including 20122000; barcode # 36183 11233. RECALLING FIRM/MANUFACTURER Recalling Firm: Sincere Trading Co. Inc., Brooklyn, NY, by letter on May 21, 2001. Manufacturer: Hua Heong Food Industries Co., Ltd., Ho Chi Minh, Vietnam. State initiated recall is complete. REASON The products contained undeclared certifiable colors tartrazine (certifiable as FD&C Yellow No. 5) and brilliant blue FCF (certifiable as FD&C Blue No. 1). VOLUME OF PRODUCT IN COMMERCE a) 9 cases (24 jars per case); b) 5 cases (24 jars per case). DISTRIBUTION NY, OH, CT, VA, PA and GA. _______________________ ______________________ PRODUCT Crostatine Montebovi (R) Small Cherry Cake in flexible plastic packages, net wt. 250 grams. Made in Italy. Recall # F-286-2. CODE All including 12 00 Lot 94. Barcode #: 003898 163309. RECALLING FIRM/MANUFACTURER Recalling Firm: Overseas Trading Corp. LLC., Brooklyn, NY, by letter dated Feb. 5, 2001. Manufacturer: Unknown. State initiated recall is complete. REASON PRODUCT contained Ponceau 4R (E124), an unapproved color additive. VOLUME OF PRODUCT IN COMMERCE 250 cases. DISTRIBUTION NY.RECALLS AND FIELD CORRECTIOS: FOODS -- CLASS III
_______________________ PRODUCT Flor del Monte honey syrup, 6.8 ounces (200 ML) bottles, 24 bottles per case, License No. 087. Recall # F-201-2. CODE None. RECALLING FIRM/MANUFACTURER Candy Marker of Puerto Rico, Bayamon, Puerto Rico, by letters on or about April 16, 2001. FDA initiated recall is complete. REASON The product was adulterated since corn syrup was added to the bottle labeled as "Miel de Abejas" (Bee Honey). VOLUME OF PRODUCT IN COMMERCE 75 cases. DISTRIBUTION Puerto Rico.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________________ PRODUCT M.V.I. Pediatric, multi-vitamins for infusion, For Intravenous Infusion Only, Single Dose Vial, sterile, Rx only, Recall # D-090-2. CODE OK1908. RECALLING FIRM/MANUFACTURER Recalling Firm: NeoSan Pharmaceuticals, Wilmington, NC, by letter on Dec. 19, 2001. Manufacturer: DSM Catalytica, Greenville, NC. Firm initiated recall is complete. REASON Lack of assurance of sterility. VOLUME OF PRODUCT IN COMMERCE 9,334 units. DISTRIBUTION Nationwide. _______________________ PRODUCT 1) Otrivin, Pediatric Nasal Drops (0.05% xylometazoline HCl, USP) Nasal Decongestant, .83 fl oz (25ml) bottle, Recall # D-091-2; 2) Otrivin, Nasal Drops ( 0.1% xylometazoline HCl, USP) Nasal Decongestant, .83 fl oz (25ml) bottle, Recall # D-092-2. CODE Pediatric: Lot Exp. LAH001 6/02 LAH006 10/02 LAH008 7/03 LAH011 12/03 LAH015 8/04 LAH019 5/05 Adult: LAE013A 4/02 LAE016 7/02 LAE027 3/03 LAE039 7/03 LAE071 7/04 LAE073 9/04 LAE090 5/05. RECALLING FIRM/MANUFACTURER Recalling Firm: Novartis Consumer Health Inc., Summit, NJ, by letter on Nov. 15, 2001. Manufacturer: Patheon Inc., Mississauga, Ontario, Canada. Firm initiated recall is ongoing. REASON Container closure deficiencies leading to leakage/evaporation and possible higher concentrations of the active ingredient. VOLUME OF PRODUCT IN COMMERCE 231,260 bottles. DISTRIBUTION Nationwide. _______________________ PRODUCT Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Solution USP, Sterile, 10mL with sterilized dropper, Rx only. The product is labeled as Dist. by: Falcon Pharmaceuticals, Ltd., Fort Worth, TX. Recall # D- 094-2. CODE Codes: Lot Number Expiration 0C1782 7/2002 0C1783 7/2002 0C1784 7/2002 0C1785 7/2002 0C1786 8/2002 0C1787 8/2002 0C1788 8/2002 0C1789 8/2002 0F2139 10/2002. RECALLING FIRM/MANUFACTURER Recalling Firm: King Pharmaceuticals Inc., Bristol, TN, by letter dated Dec. 18, 2001, Manufacturer: DSM Catalytica Pharmaceuticals, Greenville, NC. Firm initiated recall is ongoing. REASON Lack of assurance of sterility (glassware defects). VOLUME OF PRODUCT IN COMMERCE 410,154 units. DISTRIBUTION TX, NV and MD. _______________________ PRODUCT Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Suspension USP, Sterile, 10 mL with Sterilized Dropper, Rx only. The product is labeled as distributed by Falcon Pharmaceuticals, Ltd., Forth Worth, TX, Recall # D-095-2. CODE Codes: Lot Number Expiration 0J1494 4/2003 0C1643 4/2002 0C1644 4/2002 0C1775 4/2002 0C1776 4/2002 0C1777 5/2002 0C1779 5/2002 0C1780 5/2002 0C1781 5/2002 0D1790 5/2002 0F2249 7/2002 0F2139 7/2002 0G2335 10/2002 0H2488 10/2002 0I1410 3/2003 0I1409 2/2003 0I1408 2/2003 1B1419 5/2003 1B1418 5/2003 1B1456 6/2003 1B1309 4/2003 0I1411 2/2003. RECALLING FIRM/MANUFACTURER Recalling Firm: King Pharmaceuticals Inc., Bristol, TN, by letter dated Dec. 18, 2001. Manufacturer: DSM Catalytica Pharmaceuticals, Greenville, NC. Firm initiated recall is ongoing. REASON Lack of assurance of sterility. VOLUME OF PRODUCT IN COMMERCE 1,164,571 units. DISTRIBUTION TX, NV and MD. _______________________ PRODUCT Pediotic Suspension Sterile, 7.5mL with sterilized dropper, (Neomycin and Polymyxin B Sulfates and Hydrocoritsone otic Suspension, USP) For use in ears only, Rx only, Recall # D-096-2. CODE Lots: 0F2247 (Exp 8/2002), 0F2248 (Exp 8/2002/), 0C1661 (Exp 8/2002/), 0G2420 (Exp 8/2002), and 0I1412 (Exp 11/2002). RECALLING FIRM/MANUFACTURER Recalling Firm: King Pharmaceuticals Inc., Bristol, TN, via letter dated 12/18/2001. Manufacturer: DSM Catalytica Pharmaceuticals, Greenville, NC. Firm initiated recall is ongoing. REASON Lack of assurance of sterility. VOLUME OF PRODUCT IN COMMERCE 110,663 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Cortisporin Otic Suspension Sterile (Neomycin and Polymyxin B Sulfates and Hydrocortisone Suspension), 10mL with sterilized dropper, For use in ears only, Rx only, Recall # D-097-2. CODE Lot 0B1436 (Expiration 3/2002) and 0I1407 (Expiration (11/2002). RECALLING FIRM/MANUFACTURER Recalling Firm: King Pharmaceuticals Inc., Bristol, TN, by letter dated Dec. 18, 2001. Manufacturer: DSM Catalytica Pharmaceuticals, Greenville, NC. Firm initiated recall is ongoing. REASON Lack of assurance of sterility. VOLUME OF PRODUCT IN COMMERCE 109,559 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Cortisporin Otic Solution Sterile(neomycin and polymyxin B sufates, and hydrocortisone otic solution,USP), 10mL with sterilized dropper, Rx only, Recall # D-098-2. CODE 0D1791 (Expiration 8/2002). RECALLING FIRM/MANUFACTURER Recalling Firm: King Pharmaceuticals Inc., Bristol, TN, by letter dated 12/18/2001. Manufacturer: DSM Catalytica Pharmaceuticals, Greenville, NC. Firm initiated recall is ongoing. REASON Lack of assurance of sterility. VOLUME OF PRODUCT IN COMMERCE 42,433 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Cortisporin Opthalmic Suspension Sterile (Neomycin and Polymyxin B Sulfates and Hydrocortisone Opthalmic Suspension,USP), 7.5 mL Drop Dose, Rx only, Recall # D-099-2. CODE Codes: Lot Number Expiration 0A1319 1/2002 0A1320 1/2002 0A1321 1/2002 0A1322 1/2002 0A1323 2/2002 0A1324 2/2002 0A1326 4/2002 0A1327 4/2002 0B1437 4/2002 0D1923 6/2002 0D1924 6/2002 0D1925 6/2002 0E2048 6/2002 0E2049 6/2002 0E2051 6/2002 9J1934 12/2001 9J1935 12/2001 9J1936 12/2001 0G2333 8/2002 0G2334 8/2002 0G2415 9/2002 0I1399 10/2002 0I1400 11/2002 0I1401 11/2002 0I1402 11/2002 0I1403 11/2002 0I1404 11/2002 0I1405 11/2002 0I1406 1/2003 0J1619 1/2003 0J1620 2/2003 0J1622 4/2003 RECALLING FIRM/MANUFACTURER Recalling Firm: King Pharmaceuticals Inc., Bristol, TN, by letter dated Dec. 18, 2001. Manufacturer: DSM Catalytica Pharmaceuticals, Greenville, NC Firm initiated recall is ongoing. REASON Lack of assurance of sterility. VOLUME OF PRODUCT IN COMMERCE 693,718 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Neosporin G.U. Irrigant Sterile (Neomycin Sulfate and Polymixin B Sulfate solution for irrigation), Not for Injection, 20mL Multiple Dose Vial, Rx only, Recall # D-100-2. CODE Lot 9J2127, Expiration 11/2003. RECALLING FIRM/MANUFACTURER Recalling Firm: King Pharmaceuticals Inc., Bristol, TN, by letter dated Dec. 18, 2001. Manufacturer: DSM Catalytica Pharmaceuticals, Greenville, NC. Firm initiated recall is ongoing. REASON Lack of assurance of sterility (glassware defects). VOLUME OF PRODUCT IN COMMERCE 13,223 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Septra I.V. Infusion Sterile, 20 mL Multiple dose vial, (trimethoprim and sulfamethoxazole 16mg/80mg), Rx only, Recall # D-101-2. CODE Lot 0D1933, Expiration 6/2003. RECALLING FIRM/MANUFACTURER Recalling Firm: King Pharmaceuticals Inc., Bristol, TN, by letter dated Dec. 18, 2001. Manufacturer: DSM Catalytica Pharmaceuticals, Greenville, NC. Firm initiated recall is ongoing. REASON Lack of assurance of sterility (glassware defects). VOLUME OF PRODUCT IN COMMERCE 1427 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Hydralazine Hydrochloride Injection, USP, 20 mg/mL, For IM or IV use, 1 mL single dose vial. This product is packed under two brand labels. Gensia Sicor (NDC 0703-8201-04) and NovaPlus (NDC 0703-8201-94), Recall # D-103-2. CODE The following lots are affected: 00B119 00C116 00H113 00J105 00K111 00K118 00K128 01A125 01D113 01D118 01K107. RECALLING FIRM/MANUFACTURER Gensia Sicor Pharmaceuticals Inc., Irvine, CA, by letter Oct. 26, 2001 and Dec. 17, 2001. Firm initiated recall is ongoing. REASON Particulate matter specification failure (visual). VOLUME OF PRODUCT IN COMMERCE 1,665,200 vials. DISTRIBUTION Nationwide and Puerto Rico. _______________________ PRODUCT Canasa, Mesalamine Suppositories, 500 mg, 30 suppository unit carton, For Rectal Use Only, Rx only, Recall # D-104-02. CODE 1C057 and 1C058. RECALLING FIRM/MANUFACTURER Recalling Firm: Scandipharm, Inc., Birmingham, AL, by letter dated Jan. 3, 2002. Manufacturer: Axcan Pharma, Quebec, CA. Firm initiated recall is ongoing. REASON Dissolution Failure (6 month stability station). VOLUME OF PRODUCT IN COMMERCE 3220 boxes of 30 units. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________ PRODUCT Hydrocodone Bitartrate 2.5 mg and Acetaminophen 500 mg Tablets, USP, 100 tablet bottles under the Vintage and Qualitest labels, Recall # D-093-2. CODE 063040A and 063040B. RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals Inc., Charlotte, NC, by letter dated April 16, 2001. Firm initiated recall is complete. REASON Sub-potency (stability). VOLUME OF PRODUCT IN COMMERCE 2,924 bottles. DISTRIBUTION AL. _______________________ PRODUCT Pain Relieving Rub, Greaseless, Stainless Analgesic Cream, (Menthol 10%, Methyl Salicylate 15%), 4 oz net weight tube. This is a white, smooth homogeneous cream that contains 10% (w/w) Menthol and 15% Methyl Salicylate as its active ingredients. The recalled lots, 0045-3 and 0095-3, were packaged into one of the four following PVC tubes: 1) G & W generic tube labeled in part "Greaseless / Stainless *** Pain relieving rub *** Analgesic Cream *** For Muscle Aches and Arthritis Pain" 2) HY-TOP tube labeled in part "NDC 61795-28304 *** Penetrating *** Muscle Rub *** Greaseless / Stainless Analgesic Cream" 3) Shop Rite tube labeled in part "Greaseless / Stainless ANALGESIC CREAM *** Pain relieveing rub *** For muscle aches and arthritis pain" 4) H-E-B Pharmacy tube labeled in part "Muscle Rub *** Greaseless Pain Relieving Cream *** For Muscle Aches & Arthritis Pain" The recalled lots were packaged into one of the five following boxes: 1) G & W box labeled in part "Greaseless/Stainless Analgesic Cream *** Pain relieving rub *** For Muscle Aches and Arthritis Pain *** Arthritis, Backaches, Muscle Aches". The Universal Product Code (UPC) number on the bottom of the box is 0713-0283-04 2) HY-TOP box labeled in part "NDC 61795-28304 *** Penetrating *** Muscle Rub *** Greaseless / Stainless Analgesic Cream". The UPC number on the bottom of the box is 50700-05861 . 3) Shop Rite box labeled in part "Greaseless / Stainless Analgesic Cream *** Pain relieving rub *** for muscle aches and arthritis pain". The UPC number on the bottom of the box is 41190-21816 . 4) H-E-B Pharmacy box labeled in part "Muscle Rub *** Greaseless Pain Relieving Cream *** For Muscle Aches & Arthritis Pain". The UPC number on the bottom of the box is 41220-52909 . 5) 1st Choice Box labeled in part "Greaseless/Stainless Analgesic Cream *** Pain relieving rub *** For muscle aches and arthritis pain". The UPC number on the bottom of the box is 39131-28304 Each tube was placed in its corresponding box (ie. HY-TOP tube in the HY-TOP box and H-E-B tube in the H-E-B box) except that the G & W generic tube was placed in both the G & W and 1st Choice box. Recall # D-102-2. CODE Lot Numbers: 0045-3 Exp. 3/2002; 0095-3 Exp. 4/2002. RECALLING FIRM/MANUFACTURER G&W Laboratories Inc., South Plainfield, NJ, by letter on Nov. 8, 2001. Firm initiated recall is ongoing. REASON Subpotent: active ingredient Methyl Salicylate. VOLUME OF PRODUCT IN COMMERCE Lot 0045-3 -- 7632 pieces; Lot 0095-3 -- 11,136 pieces. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT Red Blood Cells, Recall # B-0677-2. CODE Unit 2911333425. RECALLING FIRM/MANUFACTURER Lancaster Regional Medical Center, Lancaster, PA, by letter dated June 1, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION PA. _______________________ PRODUCT Red Blood Cells, Pheresis, Recall # B-0713-2. CODE Unit 3874929. RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by fax dated Aug. 29, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor taking Profasi, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION TX. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0714-2; b) Recovered Plasma, Recall # B-0715-2. CODE a) and b) Units 1795701, 1755876. RECALLING FIRM/MANUFACTURER South Florida Blood Banks Inc., West Palm Beach, FL, by letter dated July 5, 2001. Firm initiated recall is complete. REASON Blood products, which tested negative for the antibody to the human T- lymphotropic virus type I/II (anti-HTLV-I/II), but were collected from a donor who on two occasions previously tested repeatedly reactive for anti-HTLV-I/II, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION FL. ______________________ PRODUCT Red Blood Cells, Recall # B-0718-2. CODE Unit 24KZ27851. RECALLING FIRM/MANUFACTURER American National Red Cross Blood Services, River Valley Region, Louisville, KY, by letter dated Oct. 3, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who reported having lived in an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION KY. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0724-2. CODE Unit LN47506. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone on Feb. 12 and by letter on Feb. 16, 2001. Firm initiated recall is complete. REASON Blood product, which tested initially reactive for anti-HBcore, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WI. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-0725-2; b) Platelets, Recall # B-0726-2; c) Fresh Frozen Plasma, Recall # B-0727-2. CODE a); b) and c) Unit T70265. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin Inc., Milwaukee, WI, by telephone and letter on Aug. 22, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who provided post-donation information related to having tested positive for hepatitis, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION WI. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0746-2. CODE Unit 32FE81402. RECALLING FIRM/MANUFACTURER Recalling Firm: American Red Cross Blood Services, Badger-Hawkeye Region, Madison, WI, by telephone on Sept. 18, 2000. Manufacturer: Badger-Hawkeye Region-Waterloo Facility, Waterloo, IA. Firm initiated recall is complete. REASON Blood product, collected in a manner that may have compromised the sterility of the unit, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WI. _______________________ PRODUCT Platelets, Recall # B-0747-2. CODE Units 32GR13615, 32GR13616, 32GR13617, 32GR13618, 32GR13619, 32GR13620. RECALLING FIRM/MANUFACTURER Recalling Firm: American Red Cross Blood Services, Badger-Hawkeye Region, Madison, WI, by letter dated Feb. 24, 2000. Manufacturer: Badger-Hawkeye Region-Green Bay Facility, Green Bay, WI. Firm initiated recall is complete. REASON Platelets, with decreased platelet counts, were distributed. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION IL. _______________________ PRODUCT Platelets, Pheresis, Leukoreduced, Recall # B-0749-2. CODE Units R13249, KM34373, LH59355. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin Inc., Milwaukee, WI, by telephone on Sept. 10 and by letter dated Sept. 11, 2001. Firm initiated recall is complete. REASON Blood products, which had a low platelet count, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION WI. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0750-2. CODE Unit FW09803. RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin Inc., Milwaukee, WI, by telephone on Oct. 6, 2000. Firm initiated recall is complete. REASON Blood product, collected from a donor with a history of engaging in high- risk behavior, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WI. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0781-2; b) Recovered Plasma, Recall # B-0782-2. CODE a) Unit 16L40248; b) Unit 16L40248. RECALLING FIRM/MANUFACTURER American Red Cross, Central Ohio Region, Columbus, OH, by letter dated Feb. 28, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor who provided post donation information related to a positive test for hepatitis, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION OH.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Allergenic Extract Special Preparation, 15 ML, Recall # B-0719-2. CODE Lot 17099003 RECALLING FIRM/MANUFACTURER Allergy Laboratories of Ohio Inc., Columbus, OH, by telephone on Nov. 22, 2000. Firm initiated recall is complete. REASON Allergenic extract was labeled with an extended expiration date. VOLUME OF PRODUCT IN COMMERCE 1 vial. DISTRIBUTION OH. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0722-2; b) Recovered Plasma for Further Manufacture of Injectables. Recall # B-0723-2 CODE a) and b) Unit 29FN34981. RECALLING FIRM/MANUFACTURER American Red Cross, Mid-Atlantic Regional Blood Services, Norfolk, VA, by letters dated Feb. 14 and 21, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with von Willebrand's disease, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION VA and CA. _______________________ PRODUCT Fresh Frozen Plasma, Recall # B-0730-2. CODE Unit number 084GS17440. RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern California Region, Oakland, CA, by letters on Nov. 15, 1999. Firm initiated recall is complete. REASON Blood product, manufactured from a unit of Whole Blood with a discrepant collection time, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Fresh Frozen Plasma, Recall # B-0731-2. CODE Unit number 084Q52217. RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern California Region, Oakland, CA, by letter on Nov. 15, 1999. Firm initiated recall is complete. REASON Blood product, manufactured from a unit of Whole Blood with a discrepant collection time, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Fresh Frozen Plasma, Recall # B-0732-2. CODE Unit number 084GS16012. RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern California Region, Oakland, CA, by letter on Nov. 15, 1999. Firm initiated recall is complete. REASON Blood product, manufactured from a unit of Whole Blood with a discrepant collection time, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT a) Fresh Frozen Plasma, Recall # B-0733-2; b) Cryoprecipitated AHF, Recall # B-0734-2. CODE a) and b) Unit number 084Q51444. RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern California Region, Oakland, CA, by letter on Nov. 15, 1999. Firm initiated recall is complete. REASON Blood products, manufactured from a unit of Whole Blood with a discrepant collection time, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _______________________ PRODUCT Red Blood Cells, Recall # B-0748-2. CODE (Split units-2), Units 24210-0071. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on Jan. 10, 2001. Manufacturer: United Blood Services, Rapid City, SD. Firm initiated recall is complete. REASON Blood products, collected under conditions where the sterility may have been compromised, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MA.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________ PRODUCT Vitros Immunodiagnostics Products - PSA Reagent Pack 100 Test Units. Responsible firm on the label: "Manufactured by: Centocor, Diagnostics of PA, Inc. USA, Distributed by Ortho-Clinical Diagnostics, Amersham, United Kingdom. Recall # Z-0451-02. CODE Cat 188 6704. Lot Numbers: 130, Exp. 6 August 2001 140, Exp. 29 August 2001 150, Exp. 24 September 2001 160, Exp. 2 November 2001. RECALLING FIRM/MANUFACTURER Recalling Firm: Ortho-Clinical Diagnostics Inc., Rochester, NY, by letter, E-mail and fax on Nov. 27, 2001. Manufacturer: Fujirebio Diagnostics Inc., Malvern, PA. Firm initiated recall is ongoing. REASON Positive bias on patient samples. VOLUME OF PRODUCT IN COMMERCE Domestic - 544 packs; International - 550 packs. DISTRIBUTION Nationwide and internationally. _______________________ PRODUCT Symmetry Aortic Connector System, Model Numbers CAN-4550, Recall # Z-0508-02. CODE Lots 53739, 54085, 54296, 54330, and 54616. RECALLING FIRM/MANUFACTURER St. Jude Medical ATG Inc., Maple Grove, MN, by retrieving the product beginning Oct. 6, 2001. Firm initiated recall is complete. REASON The tubeset was not securely held within the handle of the delivery system on some units. VOLUME OF PRODUCT IN COMMERCE 228 units. DISTRIBUTION France, Netherlands, Finland and Australia. _______________________ PRODUCT M/DN Intramedullary Fixation Humeral Nail. Catalog # 00-2254-255-10, Recall # Z-0510-02. CODE Lot 20855000. RECALLING FIRM/MANUFACTURER Zimmer Inc., Warsaw, IN, by letter dated Oct. 30, 2001. Firm initiated recall is ongoing. REASON Proximal angled hole is oriented in the wrong direction and does not line up when a drill guide is used. VOLUME OF PRODUCT IN COMMERCE 17. DISTRIBUTION Nationwide and Australia, Honduras, Japan, Spain and the United Kingdom. _______________________ PRODUCT Duracon Total Knee Posterior Stabilizer (PS) Tibial Insert with Locking Screw, Recall # Z-0511-02. CODE Medium Tibial Inserts Catalog numbers/sizes 6632-4-209, 9mm 6632-4-211, 11mm 6632-4-213, 13mm 6632-4-216, 16mm 6632-4-219, 19mm 6632-4-222, 22mm 6632-4-225, 25mm Large Tibial Inserts Catalog Numbers/Sizes 6632-4-309, 9mm 6632-4-311, 11mm 6632-4-313, 13mm 6632-4-316, 16mm 6632-4-319, 19mm 6632-4-322, 22mm 6632-4-325, 25mm Extra Large Tibial Inserts Catalog Numbers/Sizes 6632-4-409, 9mm 6632-4-411, 11mm 6632-4-413, 13mm 6632-4-416, 16mm 6632-4-419, 19mm 6632-4-422, 22mm 6632-4-425, 25mm All lots manufactured from 1993 through 1997. RECALLING FIRM/MANUFACTURER Howmedica Osteonics Corp., Rutherford, NJ, by letter on Sept. 18, 2001 and by E-mail on Aug. 1, 2001. Firm initiated recall is ongoing. REASON The polyethylene post of the Duracon PS Tibial Inserts reportedly fracturing. VOLUME OF PRODUCT IN COMMERCE 11797 units. DISTRIBUTION Nationwide and internationally. _______________________ PRODUCT LifeScan brand One Touch Profile Meter, Blood Glucose Meter, Recall # Z- 0513-02. CODE All codes/serial numbers. RECALLING FIRM/MANUFACTURER Lifescan Inc., Milpitas, CA, by letter on Jan. 2, 2001. Firm initiated recall is ongoing. REASON Some One Touch Profile Meters may develop display problems. VOLUME OF PRODUCT IN COMMERCE Approx. 3,000,000 units. DISTRIBUTION Nationwide and internationally. _______________________ PRODUCT Preface Guiding Sheath, Recall # Z-0514-02. CODE Catalog numbers; 301-803A; 301-803M; 301-803MS; 301-803P; 301-805M. All lots manufactured since November 1998. RECALLING FIRM/MANUFACTURER Cordis Webster Inc., Baldwin Park, CA, by letter on Nov. 21, 2001. Firm initiated recall is ongoing. REASON Unacceptable tip wall thickness variation. VOLUME OF PRODUCT IN COMMERCE 5,654. DISTRIBUTION Nationwide and internationally. _______________________ PRODUCT Toxoplasma IgM Elisa diagnostic kit, Product No. 508- A1(Lots 128H6484, 108H6339), Product No. 508B (Lots #128H6485, 019H6449) Recall # Z-0515-02. This kit is an enzyme-linked immunosorbent assay (ELISA) designed to the presumptive qualitative determination of IgM antibodies to Toxoplasma gondii in human serum ad for presumptive diagnosis of acute, recent, or reactive Toxoplasma gondii infection. A) Production # 508-A1 Lot 128H6484A - ELISA Plate is labeled in part: " *** T 2682 TOXOPLASMA IgM *** 1 Set *** ELISA PLATE *** (12x1x8 wells) *** Storage: 2-8 C *** Lot 128H6484A *** BIOHAZARD *** For In Vitro Diagnostic Use *** Exp:07/13/2000 *** Prepared for Sigma *** STIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA ***." - Conjugate Anti-Human vial is labeled in part: "*** C 9221 TOXOPLASMA IgM *** 15 mL *** CONJUGATE *** Storage: 2-8 C *** Lot: 128H6484B *** Exp:08/05/2000 *** SIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA ***." - High Positive Control vial is labeled in part: "*** C 9221 TOXOPLASMA IgM *** HIGH POSITIVE CONTROL 0.2 mL *** Lot: 128H6484C *** Exp: 08/05/2000 *** BIOHAZARD *** Storage: 2-8 C *** SIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA ***." - Low Positive Standard vial is labeled in part: "*** L 2032 *** TOXOPLASMA IgM *** LOW POSTIVE STANDARD 0.4 mL *** CF=0.48 *** Lot: 128H6484D *** Exp: 08/05/2000 *** BIOHAZARD *** Storage: 2-8 C *** SIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA ***." - Negative Control vial labeled in part: "*** N 5030 *** TOXOPLASMA IgM *** NEGATIVE CONTROL 0.2 mL *** Lot: 128H6484E *** Exp:08/05/2000 *** BIOHAZARD *** Storage: 2-8 C *** SIGMA DIAGNOSTICS, INC. ST. LOUIS , MO 63178 USA ***." Product #: 508-A1, Lot 108H6339 - ELISA Plate is labeled in part: " *** T 2682 TOXOPLASMA IgM *** 1 Set *** ELISA PLATE *** (12x1x8 wells) *** Storage: 2-8 C ** Lot: 108H6339A *** BIOHAZARD *** For In Vitro Diagnostics Use *** Exp: 04/16/2000 *** Prepared for Sigma *** Sigma DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA ***." - CONJUGATE Anti-Human vial is labeled in part: "*** C 9221 TOXOPLASMA IgM ** 15mL *** CONJUGATE *** Storage: 2-8 C *** Lot: 108H6339B *** Exp:05/11/2000 ** SIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA ***." - High Positive Control vial is labeled in part: " *** H 9529 *** TOXOPLASMA IgM *** HIGH POSITIVE CONTROL 0.2 mL *** Lot: 108H6339C *** Exp: 05/11/2000 *** BIOHAZARD *** Storage: 2-8 C *** SIGMA DIAGNOSTICS< INC. ST. LOUIS, MO 63178 USA ***." - Low Positive Standard vial is labeled in part: "*** L 2032 *** TOXOPLASMA IgM *** LOW POSITIVE STANDARD 0.4 mL *** CF=0.48 *** Lot: 108H6339D *** Exp: 05/11/2000 *** BIOHAZARD *** Storage: 2-8 C *** SIGMA DIAGNOSTICS, INC. LOUIS, MO 63178 USA ***." - Negative Control vial labeled in part: "*** N 5030 *** TOXOPLASMA IgM *** NEGATIVE CONTROL 0.2 mL *** Lot: 108H6339E ** Exp:08/05/2000 *** BIOHAZARD *** Storage: 2-8 C *** SIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA ***." Product #: 508B, Lot 019H6449 - ELISA Plate is labeled in part: "*** T 2682 TOXOPLASMS IgM *** 1 Set *** ELISA PLATE *** (12x1x8 wells) *** Storage: 2-8 C *** Lot: 019H6449A *** BIOHAZARD *** For In Vitro Diagnostics Use *** Exp: 7/13/2000 *** Prepared for Sigma *** SIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA ***." - Conjugate Anti-Human vial is labeled in part. "*** C 9221 TOXOPLASMA IgM *** 30mL *** CONJUGATE *** Storage: 2-8 C *** Lot: 019H6449B *** Exp: 09/02/2000 *** SIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA***." - High Positive Control vial is labeled in part: "*** H 9529 ** TOXOPLASMA IgM *** HIGH POSITIVE CONTROL 0.5 mL *** Lot: 019H6449C *** Exp: 08/05/2000 *** BIOHAZARD *** Storage: 2-8 C *** SIGMA DIAGNOSITCS, INC. ST. LOUIS, MO 63178 USA ***." - Low Positive Standard vial is labeled in part: "*** L 2032 *** TOXOPLASMA IgM *** LOW POSITIVE STANDARD 0.5 mL *** CF=0.46 *** Lot: 019H6449D *** Exp: 08/05/2000 *** BIOHAZARD *** Storage: 2-8 C *** SIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA ***." - Negative Control vial labeled in part: "*** N 5030 *** TOXOPLASMA IgM *** NEGATIVE CONTROL 0.5 mL *** Lot: 019H6449E *** Exp: 08/05/2000 *** BIOHAZARD *** Storage: 2-8 C *** SIGMA DIAGNOSITCS, INC. ST. LOUIS, MO 63178 USA ***." Product #: 508B, Lot 128H6485A - ELISA Plate is labeled in part: " *** T 2682 TOXOPLASMA IgM *** 1 Set*** ELISA PLATE *** (12x1x8 wells) *** Storage: 2-8 C *** 128H6485A *** BIOHAZARD *** For In Vitro Diagnostics Use *** Exp: 07/13/2000 *** Prepared for Sigma *** SIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA ***." - Conjugate Anti-Human vial is labeled in part: "*** C 9221 TOXOPLASMA IgM *** 30mL *** CONJUGATE *** Storage: 2-8 C *** Lot: 128H6485B *** Exp:08/04/2000 *** SIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 64178 USA ***." - High Positive Control vial is labeled in part: " *** H 9529 *** TOXOPLASMA IgM *** HIGH POSITIVE CONTROL 0.5 mL *** Lot: 128H6485C *** Exp: 08/05/2000 *** BIOHAZARD *** Storage: 2-8 C *** SIGMA DIAGNOSTIC, INC. ST. LOUIS, MO 63178 USA ***." - Low Positive Standard vial is labeled in part: "*** L 2032 *** TOXOPLASMA IgM *** LOW POSTIVE STANDARD 0.5 mL *** CF=0.46 *** Lot: 128H6485D *** Exp: 08/05/2000 *** BIOHAZARD *** Storage: 2-8 C *** SIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA ***." - Negative Control vial labeled in part: "*** N 5030 *** TOXOPLASMA IgM *** NEGATIVE CONTROL 0.5 mL *** Lot: 128H6485E *** Exp: 08/05/2000 *** BIOHAZARD *** Storage: 2-8 C *** SIGMA DIAGNOSTICS, INC. ST. LOUIS, MO 63178 USA ***." Product # 8Z8651M, Lot # 8TOXO02819 - Primary carton labeled in part: Product NO:8Z8651M *** TOXO *** IgM *** 96 TEST *** THIS KIT CONTAINS: *** ZEUS ELISA *** MANUFACTURED BY: Zeus Scientific, Inc. *** Raritan, NJ 08869 *** lot: 8TOXO02918 EXP: 02/29/2000 ***" - Top inside flap of primary carton labeled in part: " *** COMPONENT LOT NUMBERS AND EXPIRATION DATES *** Description: TOXOPLASMA IgM ELISA KIT *** Kit Exp. Date: 02/29/2000 *** Kit Lot No: 8TOXO02918 *** COMPONENT *** LOT NUMBER *** EXP. DATE ***" - ELISA Plate labeled in part " *** NO.8652 *** ONE *** TOXO *** ELISA Plate *** 12, 1x8 WELLS *** Reseal for storage of unsealed strips *** For in vitro diagnostics use *** Store at 2 C- 8 C *** Lot: KX728 *** Exp: 04/16/2000 **MANUFACTURED BY: Zeus Scientific, Inc. *** Raritan, NJ 08869***" - Conjugate Anti-Human IgM labeled in part: "*** No 8653M *** TOXO IgM *** Horseradish Peroxidase Conjugated Anti-Human IgM *** DO NOT DILUTE *** READ TO USE *** 15 mL ***MANUFACTURED BY: Zeus Scientific, Inc. *** Raritan, NJ 08869 *** Lot: KX729 *** EXP: 05/11/2000 ***" - High Positive Serum Control vial labeled in part:" *** NO 8653-HM *** TOXO IgM *** Human High Positive Serum Control *** 0.2 mL *** MANUFACTURED BY: Zeus Scientific, Inc. *** Raritan, NJ 08869 *** Lot: KX732 *** EXP: 05/11/2000 ***" - Negative Serum Control vial labeled in part:" *** NO 8655M *** TOXO IgM *** Human Negative Serum Control *** 0.2 mL *** MANUFACTURED BY: Zeus Scientific, Inc. *** Raritan, NJ 08869 *** Lot: KX731 *** EXP: 05/11/2000 ***" - Human Low Positive Serum Standard vial labeled in part: " *** NO 8654-LM *** TOXO IgM *** Human Low Positive Serum Standard *** 0.4 mL *** MANUFACTURED BY: Zeus Scientific, Inc. *** Raritan, NJ 08869 *** Lot: KX733 *** CF=0.40 *** EXP: 05/11/2000 ***" CODE The product number and corresponding lot numbers are as follows: PRODUCT No. Kit Lot Number Kit Expires 508-A1 128H6484 3/31/2000 508-A1 108H6339 3/31/2000 508B 128H6485 7/13/2000 508B 019H6449 7/13/2000 8663780 8TOXO02918 2/19/2000 The lot numbers on the ELISA plate have the suffix "A", Conjugate have a lot number with a suffix "B", high positive standard have a lot number with a suffix "C", low positive standard have a lot number with a suffix "D", Negative control has a lot number with a suffix "E." RECALLING FIRM/MANUFACTURER Zeus Scientific Inc., Branchburg, NJ., by letter on April, 1999. Firm initiated recall is ongoing. REASON False positives; the positive standard has degraded. VOLUME OF PRODUCT IN COMMERCE 487 kits. DISTRIBUTION MO. _______________________ PRODUCT Guide Wires and Guide Pins (Class I devices, no 510k) Recall # Z-0516-02. Catalog Numbers Descriptions 1806-0050S K-Wire, 3 x 285mm 1806-0085S Guide Wire (Ball Tip), 3 x 1000mm 3371-1-015 Gamma System Driver Blunt Guide Wire (Ball Tip), 3.0 x 750mm 702336S A/R Guide Wire (Ball Tip), 3.0 x 1000mm 5235-6-032 Alta System Guide Wire (Smooth Tip), 3.2 x 1000mm 1210-6450S Gamma System Guide Pin, 3.2 x 450mm 3212-3-010 Gray system GK Guide Wire (Ball Tip), 3.0 x 1000mm 3212-3-125 Gray system GK Guide Wire (Smooth Tip) 2.8 x 600mm 3212-3-030 Gray system GK Guide Wire (Drill Tip), 3.0 x 1000mm 3812-6-250 Humeral system GK Humeral Guide Pin (Ball Tip) 2.0mm 3251-1-232 GK Guide Pin (Ball Tip), 3.2 x 1000mm 3212-3-110 Gray system GK Guide Wire (Ball Tip), 3.0 x 600mm 3212-3-130 Gray system GK Guide Wire (Smooth Tip), 2.0 x 600mm, CODE All lots manufactured from 1993 to 1997. RECALLING FIRM/MANUFACTURER Recalling Firm: Howmedica Osteonics Corp., Rutherford, NJ, by fax on July 5, 2001. Firm initiated recall is complete. REASON Possible loss of sterile seal integrity. VOLUME OF PRODUCT IN COMMERCE 7509 -- domestic; 500 -- international; 4317 - frozen. DISTRIBUTION Nationwide. _______________________ PRODUCT All DataCare Systems Software, as follows: A) DataCare Server/Workstation Computer for DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9200. Sold in the U.S. B) DataCare Networked Client Computer for DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog GD9201. Dist. in U.S. C) DataCare Server/Workstation Kit for customer that includes manual and software (sent in conjunction with DataCare Server/Workstation Computer for DataCare ABG Data Management System for use in a blood gas point of care testing environment); Catalog BP9251; D) DataCare Networked Client Kit for customer that includes manual and software (sent in conjunction with DataCare Networked Client Computer for DataCare ABG Data Management System for use in a blood gas point of care testing environment; Catalog BP9252; E) DataCare Server/Workstation Computer for DataCare POC Software Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9200. Dist. in U.S., Canada and the United Kingdom; F) DataCare Networked Client Computer for DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9201. Dist. in U.S., Canada and the United Kingdom; G) DataCare Networked Client Computer for DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9206. Dist. U.S., Canada and the United Kingdom; H) DataCare Power Class Server Computer for DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9207. Dist. U.S., Canada and the United Kingdom; I) DataCare Laptop Computer for DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog GD9208. Dist. U.S., Canada and the United Kingdom; J) DataCare Server/Workstation Kit for customer that includes manual and software (sent in conjunction with DataCare Server/Workstation Computer for DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog BP9251. Dist. U.S., Canada and the United Kingdom; K) DataCare Networked Client Kit for customer that includes manual and software (sent in conjuction with DataCare POC Data Management System for use in a blood gas, glucose and coagulation point of care testing environment; Catalog BP9252. Dist. U.S., Canada and the United Kingdom; L) DataCare Server/Workstation Computer for DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9202. Dist. U.S.; M) DataCare Networked Client Computer for DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9209. Dist. U.S.; N) DataCare Server Class Computer for DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9210. Dist. U.S.; O) DataCare Power Class Server Computer for DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9211. Dist. U.S.; P) DataCare Laptop Computer for DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog GD9212. Dist. U.S.; Q) DataCare Server/Workstation Kit for customer that includes manual and software (sent in conjunction with DataCare Server/Workstation Computer for DataCare GM Data Management System for use in a glucose only point of care testing environment); Catalog BP9215. Dist. U.S.; R) DataCare Networked Client Kit for customer that includes manual and software for use in conjunction with DataCare Networked Client Computer for DataCare GM Data Management System for use in a glucose only point of care testing environment; Catalog BP9216; Dist. U.S. Recall # Z-0517-02. CODE All units. RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp, Indianapolis, IN, by letter dated Dec. 28, 2001. Manufacturer: Roche Diagnostics Corp., Roswell, GA. Firm initiated recall is ongoing. REASON Possible sample results mismatch with patient information. VOLUME OF PRODUCT IN COMMERCE Approx. 450 installations. DISTRIBUTION Nationwide, Canada and the United Kingdom.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________ PRODUCT LocaLisa IntraCardiac Navigation System, Model Numbers 9670000, 9670025, Recall # Z-0506-02. CODE BBJ0106OO1, BBJ0107OO2, BBJ0107OO3, BBJ0107OO4, BBJ0107OO6, BBK0106OO1, and BBK0107OO2. RECALLING FIRM/MANUFACTURER Medtronic Inc., Minneapolis, MN, by letter beginning Sept. 6, 2001. Firm initiated recall is complete. REASON A read only CD drive was installed in the system in place of a read-write CD drive. VOLUME OF PRODUCT IN COMMERCE 7 units. DISTRIBUTION FL and IA, Medtronic, B.V., Kerkrade, Netherlands and Europe. _______________________ PRODUCT Mammography Film, New CM-H Size 18 x 24 Emulsion Series 6107, Recall # Z- 0512-02. CODE Catalog # Size Item Lot (Emulsion)# 0136318 (18x24 cm) 29476 6107 0136324 (24x30 cm) 29477 2107. RECALLING FIRM/MANUFACTURER Recalling Firm: Konica Medical Imaging, Wayne, NJ, by letter on Oct. 14, 2001. Manufacturer: Konica Corp. Shinjuku-ku, Tokyo. Firm initiated recall is ongoing. REASON Mammography film does not meet speed or sensitivity control limits. VOLUME OF PRODUCT IN COMMERCE 1906 boxes. DISTRIBUTION NJ, GA, TX, CA and IL.
END OF ENFORCEMENT REPORT FOR FEBRUARY 6, 2002 ####
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