August 16, 2000 00-33RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Clover brand Dried Shrimp, in plastic bags, net weight 7.1 ounces and in bulk sold by the pound Recall #F-643-0. CODE None. MANUFACTURER Chue Eiw Mong Eak Ltd., Part., Bangkok, Thailand(bulk supplier). RECALLED BY C. Kenneth Imports Company, Inc., Bronx, New York, by letter dated September 7, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, New Jersey, Connecticut, Pennsylvania. QUANTITY 20 bulk cartons, 20 kilograms each, were distributed. REASON Product contained undeclared FD&C Yellow No. 6. ________ PRODUCT Mo Li Hua Haw Flake, in 255 gram (9-ounce) plastic packages. Recall #F-755-0. CODE None. MANUFACTURER Undetermined. Product of China. RECALLED BY Yick Cheung Trading Corporation, Brooklyn, New York, doing business as Good World Trading, Inc., by telephone and visit on October 8, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY 2 cases (48 packages per case were distributed). REASON Product contained the unapproved color additive ponceau R. ________ PRODUCT Lion brand Custard Powder, in 300g (10.5-ounce) metal cans. Recall #F-756-0. CODE All product on the market at the time of recall initiation. MANUFACTURER London Food Factory Production, Hong Kong. RECALLED BY Tai Wing Hong Importer, Inc., Brooklyn, New York, by letter dated August 12, 1999. Completed field correction resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION Florida, Pennsylvania, New Jersey, New York, Illinois, Maryland, Massachusetts. QUANTITY 11 cases (24 cans per case) were distributed. REASON Product contained the undeclared and uncertified color additives tartrazine (certifiable as FD&C Yellow No. 5) and sunset yellow FCF (certifiable as FD&C Yellow No. 6.) ________ PRODUCT Happiness Red brand Yung Chung Noodles, in 12-ounce (340g) flexible plastic packages. Recall #F-757-0. CODE None. MANUFACTURER Hun Win Luck Corporation, Taipei, Taiwan. RECALLED BY Tai Wing Hong Importer, Inc., Brooklyn, New York, by letter dated August 4, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION Michigan and New Jersey. QUANTITY Undetermined. REASON Product contained the undeclared and uncertified color additive tartrazine (certifiable as FD&C Yellow No. 5). ________ PRODUCT Cock brand Tapioca Pearl, in 14-ounce flexible plastic bags. Recall #F-760-0. CODE None. MANUFACTURER Thai World Import & Export Company, Ltd., Bangkok, Thailand. RECALLED BY Hong Thai Foods Corporation, Brooklyn, New York, by letter on December 21, 1998. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, Massachusetts, Connecticut, New Jersey, Florida, Pennsylvania, Virginia, Illinois. QUANTITY 50 cases (50 bags per case) were distributed. REASON The product contains the undeclared and uncertified color additives tartrazine (certifiable as FD&C Yellow No. 5) and brilliant blue FCF (certifiable as FD&C Blue No. 1); it also contains the unapproved color additive Ponceau 4R. ________ PRODUCT Nishi brand Juicy Jelly Cup, packaged in 28.21-ounce (800g) flexible plastic bags. Recall #F-764-0. CODE None. MANUFACTURER Nikka Goods Company, Ltd., Kobe, Japan. RECALLED BY Nishi Trading Company, Inc., Brooklyn, New York, by letter dated September 23, 1999. Firm-initiated recall complete. DISTRIBUTION New York, Massachusetts, North Carolina, Pennsylvania, Maryland, New Jersey, Georgia, Connecticut, Virginia. QUANTITY 225 cases (10 bags per case) were distributed. REASON Product contained undeclared FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Red No. 40. ________ PRODUCT CTF brand Pickled Banana Bud, in 15-ounce jars. Recall #F-765-0. CODE None. MANUFACTURER Combine Thai Foods Company, Ltd., Bangkok, Thailand. RECALLED BY BCN Trading Corporation, Brooklyn, New York, by letter dated March 9, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, Pennsylvania, Massachusetts, Connecticut, New Jersey, District of Columbia. QUANTITY 97 cases (24 jars per case) were distributed. REASON Product contained undeclared sulfites. ________ PRODUCT Various smoked tuna dip in plastic tubs: a) Original Recipe Smoked Tuna Dip, 5-pounds and 8-ounces; b) Skinny Dip Smoked Tuna Dip, 5-pounds and 8 ounces; c) Cajun Skinny Dip Smoked Tuna Dip, 6-pounds and 8-ounces. Recall #F- 766/768-0. CODE All unexpired products. MANUFACTURER Gulf Smoked Seafood, Inc., Pensacola, Florida. RECALLED BY Manufacturer, by telephone on May 10, 2000, by visit on May 11, 2000, and by letter. Firm-initiated field correction (relabeling) complete. DISRIBUTION Alabama and Florida. QUANTITY Approximately less than 50 units. REASON Products contained undeclared FD&C Yellow No. 5, sodium benzoate, and polysorbate 80. ________ PRODUCT Ping-Pong brand Jelly Juice Candy, in 1.76 ounce(50g) plastic bags. Recall #F-769-0. CODE None. MANUFACTURER Suzhou Guanda Food Company, Ltd., Tailiuxian Taicang Jiangsu, China. RECALLED BY Tai Wing Hong Importer, Inc., Brooklyn, New York, by letter dated August 4, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION Undetermined. QUANTITY 116 cases were distributed. REASON Product contained the undeclared and uncertified color additives tartrazine (certifiable as FD&C Yellow No. 5) and Allura Red AC (certifiable as FD&C Red No. 40). ________ PRODUCT a) Meiji brand Mixed Fruit Drop Candy, packaged in 6.7-ounce cans; b) Kani Chip brand Crab Crackers, packed in foil 2.47 ounces. Recall #F-770/771-0. CODE All product on the market at time of recall initiation. MANUFACTURER a) Toko Shoji Company, Ltd., Yokohama, Japan; b) Itoh Trading Company, Ltd., Mizunami City, Gifu pref Japan. RECALLED BY Hadson Toko Trading Company, Brooklyn, New York, by letter on December 24, 1998. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION a) New York, New Jersey, Massachusetts, Ohio, Illinois, Florida, Georgia, Michigan, Pennsylvania, Missouri; b) New York, Massachusetts, New Jersey, Pennsylvania, Illinois, Connecticut, Florida, Virginia, Rhode Island, Missouri. QUANTITY a) 48 cases (40 cans per case); b) 76 cases (20 packages per case) were distributed. REASON Products contained monascus, an unapproved color additive. ________ PRODUCT Hanmi Pickled Radish in Sweetened Brine, in 24.64-ounce (1.54-pound) plastic containers. Recall #F-772-0. CODE None. MANUFACTURER Samjin Trading Central, Seoul, Korea. RECALLED BY Samjin America, Inc., Brooklyn, New York, by telephone on June 14, 1999, and by letter. Completed recall resulted from follow-up investigation by New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY Approximately 100 cases (14 packages per case) were distributed. REASON Product contained undeclared tartrazine (certifiable as FD&C Yellow No. 5). The product also contains undeclared Aspartame and the product label does not bear the required warning statement for Aspartame. ________ PRODUCT EarthGrains Potato Premium Bread, in 24-ounce plastic bags. Recall #F- 773-0. CODE Best if purchased by dates of April 23 through May 11. MANUFACTURER Earthgrains Baking Companies, Inc., Stockton, California. RECALLED BY Earthgrains Baking Companies, Inc., St. Louis, Missouri, by letter hand delivered on May 5 and 6, 2000. Firm-initiated recall complete. DISTRIBUTION California, Arizona, Nevada. QUANTITY Approximately 12,000 loaves were distributed. REASON Bread contained undeclared whey and nonfat milk. ________ PRODUCT Schwebel's brand Onion Bagels, packaged in 15-ounce plastic bags. Recall #F-776-0. CODE All Sell-By dates from JUN 26 through JUL 29. UPC Code: 71319-00863. MANUFACTURER Kravitz Bagels, Inc., North Jackson, Ohio. RECALLED BY Schwebel Baking Company, Youngstown, Ohio, by telephone on July 24, 2000, and by letter on July 25, 2000. Firm-initiated recall complete. DISTRIBUTION Ohio, Pennsylvania, New York. QUANTITY 12,643 packages were distributed. REASON Product contains undeclared FD&C Yellow No. 5 and FD&C Red No. 40. ________ PRODUCT Pickled Plum, packaged in 2.5 kg flexible plastic containers. Recall #F- 777-0. CODE None. MANUFACTURER Guangdong Jiangmen Foreign Trade Development Corporation, Guangdong, China. RECALLED BY 282 International Trading, Inc., Brooklyn, New York, by visit on April 11, 2000. Completed recall resulted from an inspection by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY 16 cases (6 packages per case) were distributed. REASON Product contained sodium saccharin which is not permitted for use in this type of product. ________ PRODUCT Anjar brand Pomegranate Syrup (Grenadine), in 20-ounce containers. Recall #F-778-0. CODE None. MANUFACTURER Domanco SARL, Anjar-Bekaa, Lebanon. RECALLED BY Baroody Imports, Clifton, New Jersey, by mail on March 24, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New Jersey, New York, Connecticut, Rhode Island, Massachusetts, Pennsylvania, Ohio, Virginia, North Carolina. QUANTITY 50 cases (24 units per case) were distributed. REASON Product containes Ponceau 4R an unpermitted color additive whose safety has not been established.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT Smilowitz Home Made Baking brand Sugar Free Raspberry Flaky Rugelech, in 7-ounce rigid plastic containers. Recall #F-759-0. CODE All codes before 1/29/00. MANUFACTURER Smilowitz Home Made Foods, Inc., Brooklyn, New York. RECALLED BY Manufacturer, by letter dated December 15, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, Maryland, Colorado, Missouri. QUANTITY Approximately 200 containers were distributed. REASON Product, labeled as "sugar free" is misbranded since it contains undeclared sugars. ________ PRODUCT Long life brand Instant Egg Noodles, in 14-ounce flexible plastic bags. Recall #F-761-0. CODE None. MANUFACTURER Fujian Cereals, Oils, & Foodstuffs, Fujian, China. RECALLED BY Hong Thai Foods Corporation, Brooklyn, New York, by letter dated December 30, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, Pennsylvania, Connecticut, New Jersey, Florida, Virginia, Massachusetts. QUANTITY 297 cases (50 packages per case) were distributed. REASON Product did not meet the standard of identity for noodles as specified in 21 CFR 139.150 because it did not contain the required amount of egg solids. ________ PRODUCT Wei Yuen brand Herbal Jelly, in 350-gram metal cans. Recall #F-774-0. CODE All can codes. MANUFACTURER Wah Yuen Trading Company, Hong Kong, China. RECALLED BY Tai Wing Hong Importer, Inc., Brooklyn, New York, by letter dated September 9, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, Florida, Pennsylvania, New Jersey, Ohio, Illinois. QUANTITY Approximately 1,100 cases (24 cans per case) were distributed. REASON Product contained undeclared Chrysanthemum and Mesona chinensis Benth, which are considered Generally as Safe. ________ PRODUCT Cortas brand Grape Vinegar, in 1-liter containers. Recall #F-779-0. CODE None. MANUFACTURER Cortas SAR, Lattakia, Syria. RECALLED BY Baroody Imports, Clifton, New Jersey, by mail on March 24, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New Jersey, New York, Connecticut, Rhode Island, Massachusetts, Pennsylvania, Ohio, Virginia, North Carolina. QUANTITY 102 cases (12 units per case) were distributed. REASON Product contained undeclared sulfites.RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II
________ PRODUCT Organic Essentials Silk Essence Shampoo, in 8-fluid ounce bottles. Recall #F-775-0. CODE 0B019556 and 0B029556. MANUFACTURER Stanford Personal Care Manufacturing, Inc., Santa Clarita, California. RECALLED BY FreeLife International LLC, Milford, Connecticut, by letter on June 23, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 5,414 bottles were distributed. REASON The shampoo is contaminated with Pseudomonas fluorescens.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT New Life Colostrum(tm) Cream (unscented moisturizing/repair skin cream), in 2-ounce jars. Recall #D-442-0. CODE Lot #A2106990 EXP 1/01. MANUFACTURER Vege-Kurl, Glendale, California. RECALLED BY Symbiotics, Inc., Sedona, Arizona, by telephone on or about May 27, 2000 through June 8, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Puerto Rico, Canada. QUANTITY Undetermined. REASON Microbial contamination - Pseudomonas putida and Tsukamurella paurometabolum. ________ PRODUCT Cortef(r) Oral Suspension (hydrocortisone cypionate) 10 mg/5mL, in 4 fluid ounce units. NDC #0009-0142-01. Recall #D-447-0. CODE Lot numbers: 62CAT, 63CAT, 64CAT, 23CRW, 24CRW, 04CJX, 05CJX, 19DAJ, 98DXA and 91DTM. MANUFACTURER Pharmacia Corporation, Kalamazoo, Michigan. RECALLED BY Manufacturer, by letter dated July 18, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Belgium, Canada, Chile, Ireland, United Kingdom, Uruguay. QUANTITY 144,357 bottles were distributed. REASON Product may not always be effective for the treatment of congenital adrenal hyperplasia.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT Orasone(tm) 5 Tablets (Prednisone Tablets, USP), 5 mg, in bottles of 1,000, Rx anti-inflammatory agent. Recall #D-445-0. CODE Lot #89335. MANUFACTURER Solvay Pharmaceuticals, Inc., Baudette, Minnesota. RECALLED BY Solvay Pharmaceuticals, Inc., Marietta, Georgia, by letter on June 26, 2000. Firm-initiated recall ongoing. DISTRIBUTION California, Colorado, Connecticut, Minnesota, Missouri, New York, North Dakota, Ohio, South Dakota, Tennessee. QUANTITY 3,765 bottles were distributed. REASON Dissolution failure (18 month stability). ________ PRODUCT Marquee brand Menthol Sore Throat Spray (Pehnol 1.4%), OTC, in 6-fluid ounce bottles. Recall #D-446-0. CODE Lot #9JV0178 EXP 8/01. MANUFACTURER Perrigo Company, Allegan, Michigan. RECALLED BY Manufacturer, by telephone on January 28, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 10,452 bottles were distributed. REASON Product is missing the tamper resistant protection.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT Red Blood Cells. Recall #B-952-0. CODE Unit #03GK49002. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by telephone on August 19, 1999. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY 1 unit was distributed. REASON Blood product, which was positive for the Jka antigen, was distributed for a patient with a history of anti-Jka. ________ PRODUCT Platelets, Pheresis. Recall #B-967-0. CODE Unit #12W38812. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated February 1, 2000. Firm-initiated recall complete. DISTRIBUTION South Carolina. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported a history of Sarcoidosis. ________ PRODUCT Platelets, Pheresis. Recall #B-968-0. CODE Unit #42KF02679. MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by telephone on May 4, 2000, and by letter May 10, 2000. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit was distributed. REASON Blood product was collected in a manner that may have compromised the sterility of the units. _______ PRODUCT a) Red Blood Cells; b) Red Blood Cells Leukocytes Reduced; c) Platelets. Recall #B-980/982-0. CODE Unit Numbers: a) 1634-4733; b-c) 16344-0998. MANUFACTURER Blood Systems, Inc., Meridian, Mississippi. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on February 8, 1999, and by letter dated March 3, 1999. Firm-initiated recall complete. DISTRIBUTION Mississippi. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Carticel (Autologous Cultured Chondrocytes). Recall #B-983-0. CODE Lot C92930. MANUFACTURER Genzyme Tissue Repair, Cambridge, Massachusetts. RECALLED BY Manufacturer, by telephone on May 22, 2000, and by letters on May 22 and 24, 2000. Firm-initiated recall complete. DISTRIBUTION Germany. QUANTITY 1 unit was distributed. REASON Tissue repair product was contaminated with Staphylococcus hominis subspecies hominis. ________ PRODUCT Platelets. Recall #B-984-0. CODE Unit #16352-6254. MANUFACTURER Blood Systems, Inc., Merdian, Mississippi. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on February 28, 2000, and by letter dated March 22, 2000. Firm-initiated recall complete. DISTRIBUTION Mississippi. QUANTITY 1 unit was distributed. REASON Platelets were prepared from a unit collected from a donor who had taken aspirin within three days of donation. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Plasma; e) Recovered Plasma. Recall #B-986/990-0. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled. MANUFACTURER Department of the Navy, National Naval Medical Center, Bethesda, Maryland. RECALLED BY Manufacturer, by telephone starting in May 1994, by fax in June 1994, and by letters on November 12, 1999 and June 12, 2000. Firm-initiated recall ongoing. DISTRIBUTION California, District of Columbia, Georgia, Maryland, New Jersey, New Mexico. QUANTITY a) 424 units; b) 21 units; c) 32 units; d) 4 units; e) 389 units were distributed. REASON Blood products were collected from donors who had not been questioned about mucus membrane exposure to blood or body fluids. ________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall #B-991-0. CODE Unit Numbers: 12441-1646 and 12441-7104. MANUFACTURER United Blood Services, Albuquerque, New Mexico. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated May 10, 2000. Firm-initiated recall complete. DISTRIBUTION New Mexico. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-992-0. CODE Unit #49FJ72273. MANUFACTURER American Red Cross Blood Services, Wichita, Falls, Texas. RECALLED BY American Red Cross Blood Services, Tulsa, Oklahoma, by letter dated September 7, 1999. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall #B-999-0. CODE Unit #4806281. MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo, Texas. RECALLED BY Manufacturer, by letter dated May 8, 2000. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had body piercing within 12 months of donation. ________ PRODUCT Platelets, Pheresis. Recall #B-1012-0. CODE Unit #7035107 (split unit). MANUFACTURER South Texas Blood and Tissue Center, San Antonio, Texas. RECALLED BY Manufacturer, by fax on February 22, 2000. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 split unit was distributed. REASON Blood products, which were not leukoreduced, were distributed, labeled as leukoreduced. ________ PRODUCT Platelets, Pheresis. Recall #B-1014-0. CODE Unit #02P45742. MANUFACTURER American Red Cross Blood Services, Wichita, Kansas. RECALLED BY Manufacturer, by telephone on August 16, 1999. Firm-initiated recall complete. DISTRIBUTION Kansas. QUANTITY 1 unit was distributed. REASON Blood product, which was not tested for CMV antibodies, was distributed, labeled CMV negative. ________ PRODUCT Red Blood Cells. Recall #B-1015-0. CODE Unit Numbers: 02FC60049 and 02FC60050. MANUFACTURER American Red Cross Blood Services, Wichita, Kansas. RECALLED BY Manufacturer, by telephone on July 14, 1999. Firm-initiated recall complete. DISTRIBUTION Kansas. QUANTITY 2 units were distributed. REASON Blood products which tested CMV positive, were distributed labeled CMV negative. ________ PRODUCT Red Blood Cells. Recall #B-1016-0. CODE Unit Numbers: 12441-1647 and 12441-7109. MANUFACTURER United Blood Services, Albuquerque, New Mexico. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated May 10, 2000. Firm-initiated recall complete. DISTRIBUTION New Mexico. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-1017-0. CODE Unit #02FH60145. MANUFACTURER American Red Cross Blood Services, Wichita, Kansas. RECALLED BY Manufacturer, by letter dated October 5, 1999. Firm-initiated recall complete. DISTRIBUTION Kansas. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-1018-0. CODE Unit #02FC64884. MANUFACTURER American Red Cross Blood Services, Wichita, Kansas. RECALLED BY Manufacturer, by letter dated January 3, 2000. Firm-initiated recall complete. DISTRIBUTION Kansas. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria. _______ PRODUCT Red Blood Cells. Recall #B-1019-0. CODE Unit #02FJ51330. MANUFACTURER American Red Cross Blood Services, Wichita, Kansas. RECALLED BY Manufacturer, by letter dated January 12, 2000. Firm-initiated recall complete. DISTRIBUTION Kansas. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT Red Blood Cells. Recall #B-985-0. CODE Unit #16345-9990. MANUFACTURER Blood Systems, Inc., Meridian, Mississippi. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on March 26, 1999. Firm-initiated recall complete. DISTRIBUTION Mississippi. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. ________ PRODUCT Red Blood Cells, Leukoreduced. Recall #B-1013-0. CODE Unit #02FG76856. MANUFACTURER American Red Cross Blood Services, Wichita, Kansas. RECALLED BY Manufacturer, by telephone on October 27, 1999. Firm-initiated recall complete. DISTRIBUTION Kansas. QUANTITY 1 unit was distributed. REASON Blood product, which did not met the criteria for red blood cell recovery after leukoreduction, was distributed, labeled as leukoreduced.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT Abbott Multiconstituent Calibrator, List #IE65-01, for in-vitro diagnostic use. Recall #Z-878-0. CODE Lot #55765M100 EXP 01/10/01. MANUFACTURER MAS, Inc., Camarillo, California. RECALLED BY Abbott Laboratories, Inc., South Pasadena, California, by letter June 14, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Puerto Rico. QUANTITY 1,621 kits were distributed. REASON A shift in control values on Creatinine assay. ________ PRODUCT Abbott A-GENT Uric Acid Standard Kit, for in-vitro diagnostic use. Recall #Z-879-0. CODE Catalog #06008-02, Lot #61015HWOO EXP 11/30/00 and Lot #61070H00 EXP 11/30/00. MANUFACTURER CASCO/NERL Company, East Providence, Rhode Island. RECALLED BY Abbott Laboratories, South Pasadena, California, by letter on June 20, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Germany, St. Martin, Mexico, Venezuela, Taiwan, Dominican Republic, Colombia, Jamaica, San Salvador, Argentina, Hong Kong, Italy, Korea, Singapore, Japan, Canada, Bahamas, Brazil, West Indies, Honduras, Cayman Islands, Paraguay, Uruguay. QUANTITY 404 kits were distributed. REASON The standard labeled 6mg/dL is recovering at approximately 5mg/dL. Use of these Standards on the spectrum instrument will result in a calibration failure.END OF ENFORCEMENT REPORT FOR AUGUST 16, 2000.
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