January 31, 2001 01-04RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT: Products: Jade Pharmacy brand Meridian Circulation Tablets, Meridian Circulation Liquid, and Quell Fire Tablets, labeled as manufactured by East Earth Herb, Inc., Eugene, OR. Recall #F-191/193-1. CODES: (refer to lot numbers listed below): F-191-1 LOT EXP. DATE Meridian Circulation tablets #2404 9/01 Meridian Circulation tablets #2952 5/03 Meridian Circulation tablets #3506 12/04 F-192-1 Meridian Circulation liquid #9609097 11/01 Meridian Circulation liquid #9707062 9/02 Meridian Circulation liquid #9804021 6/03 Meridian Circulation liquid #9907026 9/04 F-193-1 Quell Fire tablets #2079 4/01 Quell Fire tablets #2623 4/02 Quell Fire tablets #2832 11/02 Quell Fire tablets #3012 8/03 Quell Fire tablets #3140 11/03 Quell Fire tablets #3553 4/04 The firm listed the following on their recall letter and press release; however, none of this lot was distributed: Quell Fire tablets #3830 7/05. MANUFACTURER: East Earth Herb, Inc., Eugene, OR. RECALLED BY: Manufacturer, by telephone on 11/21/00 and 11/22/00, followed by a letter. FDA initiated-recall ongoing. DISTRIBUTION: To distributors and licensed health practitioners nationally and to Canada, Belgium and Australia. QUANTITY: Meridian Circulation tabs: 1455/50 tab btls, 272/150 tab btls, 268/300 tab btls, 576/75 tab btls; Meridian Circulation liquid 3326/1 oz. btls, 113/2 oz. btls, 45/4 oz. Btls; and Quell Fire: 1499/50 tab btls, 237/150 tab btls, 813/300 tab btls, 468/75 tab btls. REASON: The products contain aristolochic acid, a potent carcinogen and nephrotoxin.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
PRODUCT: Yellow Corn Flour masa to make taco shells, tortillas, tortilla chips, corn chips, and taquitos.. Labeling for all bags are stated in part, "***Minsa***STONE GROUND CORN MASA***Instant Corn Masa Floour***MINSA CORPORATION P.O. BOX 484, MULESHOE, TEXAS 79347***"For each of the following products the product number is hand written on bags that is used for varioous products and the additional labeling is stated in part, Taco 1, 6992 "***TACO SHELL #1***" Tortilla 2Y, 6993 "***TORTILLA***" Tortilla 2Y0, 6994 "***TORTILLA***" Corn Chip 8, 6995 "***CORN CHIP***" Tortilla Chip 1Y,6998 "***TORTILLA CHIP 1Y***" Taco 6F, 6999 "***TACO #6F***" Taco 6NF, 7000 "***TACO SHELL***" Taquito 7001 "***TAQUITO***" Tortilla Chip 1Y, 7007 "***TORTILLA CHIP 1Y***" Tortilla Chip 6Y, 7008 "***TORTILLA CHIP***" Tortilla Chip 5S, 7009 "***TORTILLA CHIP***" Corn Chip 6, 7010 "***CORN CHIP***" Tortilla 3Y 7012 "***TORTILLA***" Tortilla 3YS, 7013 "***TORTILLA 3YS***" Taco 1 7014 "***TACO SHELL #1***" Taco 6NF 7016 "***TACO SHELL***" Taco 6NF 7017 "***TACO SHELL***". Recall #F-185-1. CODE: The following codes of Yellow corn flour are being recalled: Taco 1, 6992; Tortilla 2Y, 6993; Tortilla 2Y0, 6994; Corn Chip 8, 6995; Tortilla Chip 1Y, 6998; Taco 6F, 6999; Taco 6NF, 7000; Taquito 1, 7001; Tortilla Chip 1Y, 7007; Tortilla Chip 6, 7008; Tortilla Chip 55, 7009; Corn Chip 6, 7010; Tortilla 3Y, 7012; Tortilla 3YS, 7013; Taco 1, 7014; Taco 6NF, 7016; and Taco 6NF, 7017. MANUFACTURER: Minsa Corporation, Muleshoe, TX . RECALLED BY: Manufacturer, by letter on November 6, 2000. Firm initiated recall complete. DISTRIBUTION: Nationwide. QUANTITY: 56,045 x 50 lb. bags of the 17 various corn mix products. REASON: Yellow corn flour tested positive for StarLink. ________ PRODUCT: Wing Kee Lung China brand Mixed Fruit Flavored Candy. Recall #F-186-1. CODE: Product bears barcode #7 37035 09001 9 & no other coding.. MANUFACTURER: Unknown. RECALLED BY: Strong America Ltd., Brooklyn, NY, (Distributor) by letter on October 2, 2000. Firm-initiated recall, complete. Problem identified by New York State Division of Agriculture and Markets. DISTRIBUTION: New York and Massachusetts. QUANTITY: 4 CASES (12 16 OZ. PACKAGES PER CASE). REASON: The product contained unapproved and uncertified color additives. _________ PRODUCT: Vastland brand Salted Beancurd Cracker(TM) packed in rigid plastic containers with plastic overwrap, net wt. 150 grams. Made in China. Recall # F-187-1. CODE: All codes including QB 1433.3 RECALLED BY: Strong America Limited, Brooklyn, NY (Importer & distributor) by letter dated October 2, 2000. Firm-initiated recall, complete. Problem identified by New York State Division of Agriculture and Markets. MANUFACTURER: Vastland Food Products Co., Ltd. Hong Kong, Kwai Chung, N. T., China. DISTRIBUTION: New York and Florida. QUANTITY: 20 cases (48 - 150 gram packages per case). REASON: Product contained uncertified color additives tartrazine and sunset yellow FCF. ________ PRODUCT: a) Red Bean and Rice Jelly Ice Bar. Recall #F-188-1; b) Super Plum Ice Bar. Recall # F-189-1. CODE: None. All product containing the unapproved color additive Ponceau 4R is under recall. MANUFACTURER: G-Jet Enterprise Co, Sunchung, Taiwan Rep.of China. RECALLED BY: Well Luck Co., Inc, Jersey City, NJ. by letter dated 10/9/2000. Firm- initiated recall, complete. Problem identified by New York State Division of Agriculture and Markets. DISTRIBUTION: Nationwide.. QUANTITY: 350 ctn x 6 bars of Ice Bar Red Bean; 200 ctn x 6 bar of Ice Bar Super plum REASON : Product contains an unpermitted color Ponceau 4R.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT: Plasma, Pheresis, Frozen. Recall #B-494-1. CODE: Units 26FF32524, 26FF32038. MANUFACTURER: The American National Red Cross, Mobile, AL. RECALLED BY: Manufacturer, by telephone on December 16, 1999 and by letter dated January 26, 2000. Firm initiated recall complete. DISTRIBUTION: Alabama. QUANTITY: Two Unit. REASON: Blood products, collected from a donor with a history of jaundice, were distributed. ________ PRODUCT: Red Blood Cells. Recall #B-507-1 CODE: Unit 28LJ08860 MANUFACTURER: American Red Cross Blood Services, Columbia, SC. RECALLED BY: Manufacturer, by letters dated November 16, 1999 and October 28, 1999. Firm Initiated Recall Complete. DISTRIBUTION: Georgia. QUANTITY: One unit. REASON: Blood product, which was mislabeled as CMV antibody negative, was distributed. ________ PRODUCT: Carticel Autologous Cultured Chondrocytes. Recall #B-536-1. CODE: Lot C90412 MANUFACTURER: Genzyme - Tissue Repair, Cambridge, MA RECALLED BY: Manufacturer, by telephone on November 16 and November 17, 2000, as well as by letter dated December 14, 2000. Firm initiated recall complete. DISTRIBUTION: Massachusetts. QUANTITY: 1 vial. REASON: Tissue repair product, contaminated with Staphylococcus species, was distributed. ________ PRODUCT: Red Blood Cells, Leukoreduced. Recall #B-552-1 . CODE: Unit FJ42324. MANUFACTURER: Healthcare Provider Services, Inc. Providence, RI. - dba: Rhode Island Blood Center. RECALLED BY: Manufacturer, by letter dated August 14, 2000. Firm initiated recall complete. DISTRIBUTION: Rhode Island. QUANTITY: One unit. REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. ________ PRODUCT: Source Plasma. Recall #B-554-1. CODE: Unit 11149651. MANUFACTURER: Sera-Tec Biologicals Limited Partnership, Richmond, KY. RECALLED BY: Sera-Tec Biologicals Limited Partnership, North Brunswick, NJ, by facsimile dated May 19, 1999. Firm initiated recall completed. DISTRIBUTION: California. QUANTITY: One unit. REASON: Blood product, that was not tested for the antibodies to the human immunodeficiency virus type1/2, and Hepatitis B surface antigen(HBsAg), Hepatitis C virus encoded antigen (anti-HCV), Hepatitis B core antigen (anti-HBc), and syphilis, was distributed. _________ PRODUCT: Red Blood Cells . Recall #B-556-1. CODE: Unit 42S79051 MANUFACTURER: American Red Cross Blood Services, Cleveland, OH . RECALLED BY: Manufacturer, by letter dated October 9, 2000. Firm initiated recall complete. DISTRIBUTION: Ohio QUANTITY: One unit. REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. ________ PRODUCT: Platelets Pheresis. Recall #B-541-1. CODE: Unit 0402922. MANUFACTURER: Siouxland Community Blood Bank, Sioux City, IA. RECALLED BY: Manufacturer, by letter dated August 11, 1998. Firm initiated recall complete. DISTRIBUTION: Iowa QUANTITY: One unit. REASON: Platelets Pheresis, which was collected from a donor who had taken Naprosyn on the day of donation, was distributed. ________ PRODUCT: a) Red Blood Cells. Recall # B-538-1; b) Recovered Plasma. Recall #B- 539-1. CODE: a) Unit C02749; b) Unit C02749 MANUFACTURER: Blood Centers of the Pacific, Burlingame, CA. RECALLED BY: Blood Centers of the Pacific San Francisco, CA , by letters dated May 13, 1998 or April 20, 1998. Firm initiated recall complete. DISTRIBUTION: California QUANTITY: Two units. REASON: Blood products, collected from a donor who had a tattoo within twelve months of donation, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-558-1; b) Platelets. Recall #B-559-1. CODE: a) Unit 16LS68704; b) Unit 16LS68704. MANUFACTURER: American Red Cross Blood Services, Columbus, OH. RECALLED BY: Manufacturer, by letters dated October 31, 2000. Firm initiated recall complete. DISTRIBUTION: Ohio. QUANTITY: Two units. REASON: Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed. ________ PRODUCT: Red Blood Cells. Recall #B-561-1. CODE: Unit H 11686 MANUFACTURER: Banco De Sangre Humacao, Incorporated, Humacao, PR. RECALLED BY: Manufacturer, by telephone on 11/28/00. Firm initiated recall complete. DISTRIBUTION: Puerto Rico. QUANTITY: One unit. REASON: Blood product, collected from a donor whose body temperature had not been documented, was distributed. ________ PRODUCT: Platelets. Recall #B-568-1. CODE: Unit 13P79685 MANUFACTURER: American Red Cross Blood Services, Detroit, MI. RECALLED BY: Manufacturer, by telephone on September 6, 2000, and by letter dated September 15, 2000. Firm Initiated Recall complete. DISTRIBUTION: Michigan. QUANTITY: One unit. REASON: Blood product, which had an unacceptable platelet count was distributed. _________ PRODUCT: a)Red Blood Cells. Recall # B-569-1; b)Platelets, Irradiated. Recall #B- 570-1. CODE: a)Unit M85118; b)Unit M85118. MANUFACTURER: Virginia Blood Services, Richmond, VA. RECALLED BY: Manufacturer, by telephone on September 15, 2000. Firm initiated recall complete. DISTRIBUTION: Virginia QUANTITY: Two units. REASON: Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed. ________ PRODUCT: Red Blood Cells, Leukoreduced. Recall #B-571-1. CODE: Unit 41738 MANUFACTURER: Virginia Blood Services, Richmond, VA. RECALLED BY: Manufacturer, by letter dated September 26, 2000. Firm initiated recall complete. DISTRIBUTION: Virginia. QUANTITY: One unit. REASON: Blood product, collected from a donor who reported having lived in an area designated as endemic for malaria, was distributed.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT: Platelets. Recall #B-503-1. CODE: Unit 28GG43867 MANUFACTURER: American Red Cross Blood Services, Savannah, GA. RECALLED BY: Manufacturer, by telephone on June 18, 1998. Firm initiated recall complete. DISTRIBUTION: South Carolina. QUANTITY: One unit. REASON: Blood product, prepared from a unit of Whole Blood with an extended collection time was distributed. ________ PRODUCT: Red Blood Cells. Recall # B-505-1. CODE: Unit L02710. MANUFACTURER: Sacramento Medical Foundation, Sacramento, CA.. RECALLED BY: Manufacturer, by facsimile dated March 23, 1998. Firm initiated recall complete. DISTRIBUTION: New Jersey. QUANTITY: One unit. REASON: Blood product, collected from a donor whose arm inspection And skin disease status had not been documented, was distributed. ________ PRODUCT: a) Red Blood Cells, Leukocytes Reduced. Recall #B-508-1; b) Recovered Plasma. Recall #B-509-1. CODE: a) Unit 26FS26444; b) Unit 26FS26444. MANUFACTURER: The American National Red Cross, Mobile, AL. RECALLED BY: Manufacturer, by letter dated November 17, 1999. Firm initiated recall complete. DISTRIBUTION: Alabama. QUANTITY: Two units. REASON: Blood products, which had an acceptable ALT, but was collected from a donor who had previously been deferred due to a history of having an elevated ALT, were distributed. ________ PRODUCT: Platelets. Recall # B-511-1. CODE: Unit 3603787 MANUFACTURER: Gulf Coast Regional Blood Center, Houston, Texas. RECALLED BY: Manufacturer, by facsimile on May 10, 1999. Firm Initiated Recall complete. DISTRIBUTION: Texas. QUANTITY: One unit. REASON: Blood product, prepared from a Whole Blood unit that lacked documentation for the collection time, was distributed. ________ PRODUCT: Fresh Frozen Plasma. Recall #B-512-1. CODE: Unit 26FK33468 MANUFACTURER: The American National Red Cross, Mobile, RECALLED BY: Manufacturer, by letter dated September 2, 1999. Firm Initiated Recall complete. DISTRIBUTION: Alabama QUANTITY: One unit. REASON: Blood product, prepared from a Whole Blood unit that had discrepant start and end times documented, was distributed. ________ PRODUCT: a)Platelets. Recall # B-513-1; b) Fresh Frozen Plasma. Recall # B-514-1. CODE: a)Units 09F52569, 09F52743, 09FG57383; b) Unit 09FG57383. MANUFACTURER: American Red Cross Blood Services, Omaha, NE. RECALLED BY: Manufacturer, by letters dated July 27, 1998. Firm initiated recall complete. DISTRIBUTION: Nebraska. QUANTITY: Four units. REASON: Blood product, prepared from units of Whole Blood that had discrepant start and end times documented, were distributed. ________ PRODUCT: a)Cryoprecipitated AHF. Recall #B-534-1; b)Recovered Plasma. Recall #B- 535-1 CODE: a)Unit 27V81089; b) Unit 27V81089. MANUFACTURER: American Red Cross Blood Services, Johnstown, PA. RECALLED BY: Manufacturer, by telephone on January 3, 1999. Firm Initiated Recall complete. DISTRIBUTION: Pennsylvania QUANTITY: Two units. REASON: Blood products, corresponding to a unit of Red Blood Cells That was positive for Serratia liquifaciens, were distributed. ________ PRODUCT: Red Blood Cells. Recall #B-537-1. CODE: Unit FR23551. MANUFACTURER: Sacramento Medical Foundation, Sacramento, CA . RECALLED BY: Manufacturer, by telephone on March 5, 1999. Firm initiated recall complete. DISTRIBUTION: California QUANTITY: One unit. REASON: Blood product, collected from a donor whose arm inspection And skin disease status had not been documented, was distributed.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT: Medtronic BioMedicus Adult Femoral Cannula: a) Bio-Medicus arterial percutanious cannula kits. Recall#Z-130-1; b) Bio-Medicus arterial percutanious cannula kits. Recall #Z-131-1; c)Bio-Medicus arterial percutanious cannula kits. Recall #Z-132-1; d)Bio-Medicus arterial percutanious cannula kits. Recall #Z-133-1; e) Bio-Medicus venous percutanious cannula kits. Recall #Z-134-1; f) Bio-Medicus venous percutanious cannula kits. Recall #Z-135-1; g) Bio-Medicus venous percutanious cannula kits. Recall #Z-136-1; h) Bio-Medicus venous percutanious cannula kits. Recall #Z-137-1; i) Bio-Medicus adult venous cannulae with introducer and 1/2 inch non- vented connector. Recall #Z-138-1 j) Bio-Medicus adult venous cannulae with introducer and 1/2 inch non- vented connector. Recall #Z-139-1 k) Bio-Medicus adult venous cannulae with introducer and 1/2 inch non- vented connector. Recall #Z-140-1 l) Bio-Medicus adult venous cannulae with introducer and 1/2 inch non- vented connector. Recall #Z-141-1 CODE: a) Product Code 96530-015; b) Product Code 96530-017; c) Product Code 96530-019; d) Product Code 96530-021; e) Product Code 96600-015; f) Product Code 96600-017; g) Product Code 96600-019; h) Product Code 96600-021; i) Product Code 96370-023; j) Product Code 96370-025; k) Product Code 96370-027; l) Product Code 96370-029. MANUFACTURER: Medtronic Sterile Systems, Inc., Grand Rapids, MI. RECALLED BY: Manufacturer, by letter, on September 25,2000. Firm initiated recall ongoing. DISTRIBUTION: US, Australia, Canada, Latin America, the Netherlands. QUANTITY: 345 units in the US, 17 internationally, also affected are 893 units that remain under Medtronic control, total 1347. REASON: Difficulty in inserting the recommended 0.038 inch guidewire into the tip end of the introducer. ________ PRODUCT: a)Zimmer Trilogy Acetabular System Eccentric Liner, 32mm I.D.,10 Degree Oblique Face for use with 70mm O.D. Shell, Catalog No. 00-6151-070-32. Recall #Z-174-1. b)Zimmer Trilogy Acetabular System Eccentric Liner, 32 mm I.D., 10 Degree Oblique Face for use with 72 mm O.D. Shell Catalog No. 00-6151-072-32, Recall #Z-175-1. CODE: a)Lot No. 35031200; b) Lot No. 35031300. MANUFACTURER: Zimmer, Inc., Warsaw, IN. RECALLED BY: Manufacturer, by letter, on October 26, 2000. Firm initiated recall ongoing. DISTRIBUTION: Ohio, Illinois, Michigan, California, Maryland, Oregon, Florida and Arizona. QUANTITY: 36 units manufactured, 32 units distributed (16 of each lot). REASON: 70 mm liner inside a 72 mm package. _______ PRODUCT: a)Sensolog III Pulse Generator, Model No. 2033. Z-176-1; b) Dialog II Pulse Generator, Model No. 2037. Recall # Z-177-1. CODE: Sensolog III model 2033 and Dialog II model 2037. All serial numbers. MANUFACTURER: Siemens-Elema AB Sweden. RECALLED BY: St. Jude Medical, Inc., Sylmar, CA. Sales reps will personally contact the physicians. Firm initiated recall ongoing. DISTRIBUTION: Bethesda Naval Hospital in Bethesda, MD, VA facilities in AL, FL, GA, IA, ND, SC, TN. To physicians nationwide. QUANTITY: 367 active implants in US, plus 123 lost to follow-up. REASON: A corrosion bridge forms across the feedthrough inside the battery resulting in a sudden decrease of cellvoltage. ________ PRODUCT: Cryovalve Allograft, a) Recall #Z-178-1. b) Recall #Z-179-1. CODE: a) Model No. AVOO, Serial Nos. 3803473, 6280099. b) Model No. PVOO, Serial No. 3803465. MANUFACTURER: Cryolife, Inc., Kennesaw, GA. RECALLED BY: Manufacturer, by letter, on November 7, 2000. Firm initiated recall complete. DISTRIBUTION: Portland, Or; Roslyn, NY, and Boston, MA. QUANTITY: 3 valves. REASON: Did not meet the current guidelines regarding serodilution of plasma because of the amount of transfused/ infused fluids administered. ________ PRODUCT: TheraSeed Palladium 103 (Pd-103) Seeds. Recall #Z-180-1 CODE: Model 200, Lot 0039D. MANUFACTURER: Theragenics Corp., Norcross, GA. RECALLED BY: Manufacturer, by Facsimile on September 29, 2000 and via telephone on October 3, 2000. Firm initiated recall ongoing. DISTRIBUTION: CO, FL, IA, KY, LA, NJ, NY, PA, SD, TN, WA. QUANTITY: 13 REASON: Improperly labeled Pd-103 sources may lead to inappropriate exposure of the patient to radiation with the potential for a misadministration of radiation therapy. ________ PRODUCT: ION Implanted Femoral Bearing Head. Recall No. Z-181-1. CODE: Lot 58486201. MANUFACTURER: Howmedica Osteonics Corp, Allendale, NJ RECALLED BY: Manufacturer, by letter, on December 8, 2000. Firminitiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 12 REASON: Package labeled as a 06-2800, Lot 58486201, Osteonics C-Taper + 0 Head actually contained a 06-28056201,Oseonics C-Taper + 5 Head.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT: Roche Creatinine Mira, Catalog No.3033414. Recall #Z-071-1. CODE: Lot No. A12071, Exp. September 2002. MANUFACTURER: Raichem, division of Hemagen, San Diego, CA. RECALLED BY: Roche Diagnostics Corporation, Indianapolis, IN., by letter, on December 20, 2000. Firm initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 2550 pieces. REASON: Package insert, contained in the kit, was printed with an incorrect reagent volume for COBAS MIRA analyzers using software Version 8735.RECALLS AND FIELD CORRECTIONS: VETERINARY MED -- CLASS II
________ PRODUCT: Cardoxin LS (Digoxin Veterinary Elixir), Oral Liquid, 0.05mg Digoxin/ml, 2 fl. oz. Recall #V-009-1. CODE: Lot #1421(Exp.09/00); Lot #1893 (Exp. 04/01); Lot #2573 (Exp. 02/02). MANUFACTURER: Evsco Pharmaceuticals, Affiliate of IGI, Inc., Buena, NJ. RECALLED BY: Manufacturer, by fax on September 8, 2000. Follow-up fax sent 60 days later to all non-responding accounts. Firm-initiated recall completed. DISTRIBUTION: United States, Canada, Puerto Rico, and Greece. QUANTITY: 5,204 dozen. REASON: Product is subpotent. ________ PRODUCT: IN Diet Supplement for Cats. Recall #V-010-1. CODE: All codes. MANUFACTURER: ALC Inovators, Inc., Milford, CT. RECALLED BY: Manufacturer, by letter via certified mail on July 5, 2000. Firm- initiated recall completed. DISTRIBUTION: Connecticut, Massachusetts, New York, New Jersey, Pennsylvania, Virginia, and Wisconsin. QUANTITY: 114/24 x 11 oz cases and 107/12 x 1 lb. 8oz. Cases. REASON: Product tested positive for Salmonella.END OF ENFORCEMENT REPORT FOR JANUARY 31, 2000. ####
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