FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.


February 7, 2001                                              01-05



RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

________ PRODUCT: Glenís Markets and Ashcraftís Markets brands of brownies, produced between August 22, 2000 and September 14, 2000, of the following types: a) Plain Brownies Giant. Recall #F-177-1. b) Walnut Brownies Giant. Recall # F-178-1. c) Peanut Butter Brownies Giant. Recall #F-179-1. d) Fudge Brownies 8"SQ. Recall #F-180-1. e) Fudge Nut Brownies 8"SQ. Recall #F-181-1. f) Peanut Butter Fudge 8"SQ. Recall #F-182-1. g) M&M Brownies Giant. Recall #F-183-1. All packages contain one large brownie covered with plastic wrap. Giant brownies are 26 oz. and all others are 20 oz. CODE: All brownies with sell by dates from 8/27/00 to 9/19/00. MANUFACTURER: 15 Glenís Markets and 8 Ashcraftís Markets all owned by Spartan Stores, Inc., through its subsidiary, Spartan Retail. Brownies were baked and sold at retail in each store. No wholesale distribution occurred. RECALLED BY: Spartan Stores, Inc. Grand Rapids, MI., by E-mail on September 14, 2000 and a follow-up call the same day. Firm-initiated recall complete. The firm obtained assistance and coordinated the recall with the Michigan Department of Agriculture, Food and Dairy Division. DISTRIBUTION: Northern Michigan. QUANTITY: Approximately 3,000 packages of brownies (one brownie per package) were produced during the 19-day period up to September 14, 2000. Approximately 225 packages of brownies were remaining on store shelves as of September 14, 2000. REASON: The brownies contain undeclared sweetened condensed milk. ________ PRODUCT: Kellogg Frosted Flakes Cereal - 20 oz. (20-oz. cereal per carton/ 14 cartons per case). F-184-1. CODE: Better if Used Date of Oct 03 2001 KMA101. MANUFACTURER: Kellogg Company, Memphis, TN. RECALLED BY: Kellogg Company, Battle Creek, MI, by letter on January 2, 2000. Firm- initiated recall complete. DISTRIBUTION: United States and Bahamas. QUANTITY: 864 cases of Frosted Flakes Cereal (20-oz. Cereal per carton/ 14 cartons per case). REASON: Undeclared almonds and wheat. Just Right Cereal, which contains almonds and wheat, was mixed with Frosted Flakes Cereal and packed in Frosted Flakes cartons. ________ PRODUCT: a) F-194-1 Negrita Mazamorra Naranja (Orange Flavored Dessert Mix) b) F-195-1 Negrita Mazamorra Nueva Mandarina (Mandarin Flavored Dessert Mix) c) F-196-1 Negrita Mazamorra Durazno (Peach Flavored Dessert Mix) CODE: None. MANUFACTURER: ASA Alimentos S.A. Jr., Lima 5, Peru. RECALLED BY: Peruvian Import Co., Inc., Passaic, NJ, Importer/Distributor, by letter via driver on September 3, 1999. Completed recall resulted from sample analysis and fllow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION: New York and New Jersey. QUANTITY: a)708 units Orange Flavored; b)Mandarin,543 units; c)Peach, 924 units. REASON: The productsí labels list "certified colors" as an ingredient but do not list the specific colors. The orange flavor dessert mix contained FD&C Yellow No. 5 and FD&C Yellow No. 6; the mandarin flavor dessert mix contained FD&C Yellow No. 5 and FD&C Yellow No. 6; and the peach flavor dessert mix contained FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1 and FD&C Red No. 40. ________ PRODUCT: Nama Udon brand Japanese Style U-don Noodles in flexible plastic packages, net wt. 7 oz. Product of Korea. Firm on label - Imported by: The Fair Trading Co., Ltd. Scarborough, Ontario Canada MIV5C7. Recall #F-198-1. CODE: All products on the market at the time the recall was initiated. MANUFACTURER: Korea RECALLED BY: Summit Import Corporation, New York, NY, (Importer/Distributor) by letter on September 12, 2000. Completed recall resulted from sample analysis and fllow-up by the New York State Department of Agriculture and Markets. Completed recall resulted from sample analysis and fllow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION: NY, FL, MO and CT. QUANTITY: 30 cases (30-7oz packages per case). REASON: The product was produced under insanitary conditions whereby it may have been rendered injurious to health. The product is not shelf-stable (requires refrigeration). ________ PRODUCT: a) Yolk Juice Bun packed in rigid plastic containers w/cellophane overwrap, net wt. 240 grams. Made in China. Recall #F-202-1. b)Peach Shaped Bun packed in rigid plastic containers w/cellophane overwrap, net wt. 350 grams. Made in China. Recall #F-203-1. Firm on labels - Guangzhou Restaurant Enterprises Group Likofu Food Co. Ltd. CODE: All codes including Q/(GZ)GZJJ4. MANUFACTURER: Guangzhou Restaurant Enterprises Group Likofu Food Co. Ltd.Guangzhou, China. RECALLED BY: East Park Trading Inc., Brooklyn, NY (Importer & distributor), by telephone on 6/8/00. Completed recall resulted from sample analysis and follow- up by the New York State Department of Agriculture and Markets. DISTRIBUTION: New York, NY. QUANTITY: Yolk Juice Buns: 100 cases (24 - 240 gram packages per case) were distributed; Peach Shaped Buns: 9 cases (28 - 350 gram packages per case) were distributed. REASON: Both products contain the unapproved color additive Ponceau 4R. In addition, the Yolk Juice Bun contains the uncertified color additive tartrazine (certifiable as FD&C Yellow No. 5). ________ PRODUCT: Loquat Slice in flexible plastic packages, net wt. 3.5 oz. (98 g), 50 packages per case. Ingredients: Sugar, Salt, Loquat. Product of China. Recall #F-204-1. CODE: Product bears barcode 998118 823938 & no other coding. MANUFACTURER: Shan Dong Zhaoyuan Huatuan Fruit Co., Shan Dong City, China. RECALLED BY: Strong America Ltd., Brooklyn, NY (Importer & distributor),by letter on May 10, 2000. Completed recall resulted from sample analysis and follow- up by the New York State Dept. of Agriculture & Markets (NYSDAM). DISTRIBUTION: NY, CT, MA, NJ, IL, OH, PA, and Washington DC. QUANTITY: 15 cases (50 - 3.5 oz. packages per case) . REASON: The product contains Ponceau 4R , an unapproved color additive. ________ PRODUCT: Acme All Natural Hickory Smoked Eastern Nova Salmon Cured with Honey and Citrus Fruit. Product is vacuum packed in film bag w/fiberboard support, net wt. 4 oz., 12 - 4 oz. packages per box. Recall #F-205-1. CODE: June 24 2000. MANUFACTURER: Acme Smoked Fish Corporation, Brooklyn, NY . RECALLED BY: Manufacturer, by letter, dated 5/22/00. Completed recall resulted from sample analysis and follow-up by by the New York State Department of Agriculture and Markets. DISTRIBUTION : New York State. QUANTITY: 50 boxes (12 - 4 oz. packages per box); 9 packages were reported returned by the firm and destroyed. REASON: The product contains undeclared nitrites at a level that has not determined to be safe (21 CFR 172.175).

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

________ PRODUCT: Redbug Brand, Dried Shrimp in 1 lb. Packages. Recall #F-197-1. CODE: No Codes. MANUFACTURER: Blum & Bergeron, INC., Houma, LA. RECALLED BY: Asia Trans & Co., INC., Kailua-Kona, HI., by telephone on 1/02/01. FDA- initiated recall ongoing. DISTRIBUTION: Island of Hawaii. QUANTITY: 100 LBS. REASON: Product contains undeclared FD&C Red #40. ________ PRODUCT: Pathmark brand Raspberry Seltzer, 2 Liter PET bottles. Recall #F-199-1. CODE: 27MAR01 CWP MANUFACTURER: Premium Beverages Packers, Wyomissing, PA. RECALLED BY: Cott Beverages USA, Inc., Tampa, FL, by e-mail on January 5, 2001 and a letter on January 8, 2001. Firm-initiated recall is complete. DISTRIBUTION: New Jersey. QUANTITY: 210 cases. REASON: Bottles labeled as "Raspberry Seltzer" actually contained a second product, "Raspberry Clear Essence." The "Raspberry Clear Essence" product contains citric acid, potassium benzoate (a preservative), aspartame, and ascorbic acid which are not listed on the "Raspberry Seltzer" label. Additionally, the label of the "Raspberry Seltzer" does not warn phenylketonurics that the product contains phenylalanine. _________ PRODUCTS: a) Safeway brand drinking water, one gallon (3.78L) clear plastic bottle with blue plastic cap, labeled in part: "SAFEWAY DRINKING drinking water *** 1 GALLON (3.78) *** DISTRIBUTED BY SAFEWAY INC. P.O. BOX 99, PLEASANTON, CA 94566-0009 PRODUCT OF U.S.A. ***". Recall # F-200-1. b) Safeway brand purified water, 1 gallon (3.78L) clear plastic bottle with red plastic cap, labeled in part: "SAFEWAY PURIFIED purified water *** 1 GALLON (3.78L) *** DISTRIBUTED BY SAFEWAY INC. HEAD OFFICE: OAKLAND, CA 94660 PRODUCT OF U.S.A. ***".Recall #F-201-1. CODE: Both products were identified with the code that reads ---"BEST BEFORE FEB 4" MANUFACTURER: Safeway Bottled Water Division, Tempe, Arizona. RECALLED BY: Safeway Inc., Pleasanton, California, by e-mail, on August 15, 2000. Firm-initiated recall complete. DISTRIBUTION: Arizona and New Mexico. QUANTITY: The firm shipped 7,560 cases of purified water and 23,100 cases of drinking water. All products are sold in cases of six gallon bottles each. REASON: The products are unfit for food since they contain particulate matter.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

PRODUCT: TegretolÆ (carbamazepine USP), 200 mg tablets, in bottles of 100 and 1,000 tablets. This Rx product is indicated for use as an anticonvulsant associated with epilepsy. 100 tablets: NDC 0083-0027-30, #6505-00-232- 5046. 1000 tablets: NDC 0083-0027-40, #6505-00-408-8915 EXTENSION TO D-059-1. CODE: LOT NOS. Initial lots recalled on 9/18/00: 150B2289 (10/2002), 155B2289 (10/2002), 121B9991 (4/2002), 128B1120 (6/2002), 137B1238 (6/2002), 144B1825 (8/2002), 156B3063 (10/2002), 158B3063 (10/2002), 170D4247 (1/2003), 1T237018 (9/2001). *** ADDITIONAL LOTS included in recall expansion of 11/17/00: 179D5121 (EXP. 2/2003) in bottles of 100s 179D5216 (EXP. 2/2003) in bottles of 1000s. MANUFACTURER: Novartis Pharmaceutical Corp. (Suffern, NY). RECALLED BY: Manufacturer, by letters on 9/18.00. and 11/27/00 (expansion). Firm- initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: A total of 172,586 bottles (150,223 bottles of 100s and 22,363 bottles of 1000s) for the 10 initial lots of recalled TegretolÆ 200 mg were distributed (by lot) as follows: Lot #150B2289: 3784 bottles of 1000s Lot #155B2289: 3787 bottles of 1000s Lot #121B9991: 3641 bottles of 1000s Lot #128B1120: 36,734 bottles of 100s Lot #137B1238: 3750 bottles of 1000s Lot #144B1825: 3756 bottles of 1000s Lot #156B3063: 37,444 bottles of 100s Lot #158B3063: 38,137 bottles of 100s Lot #170D4247: 37,908 bottles of 100s Lot #1T237018: 3645 bottles of 1000s *** Additional 2 lots: Lot #179D5216: 2689 bottles of 1000s were distributed between 9/11/00 and 10/23/00 Lot #179D5121: 11,047 bottles of 100s were distributed between 4/26/00 and 5/5/00. REASON: Dissolution failure. _______ PRODUCT: Pancrelipase 16,000 ECM Capsules, in 100 count bottles. Indicated for use for patients with pancreatic enzyme deficiency. NDC is 53489-322-01. Recall # D-081-1. CODE: Lot 40629 exp. 12/00. MANUFACTURER: Mutual Pharmaceutical Company, Inc., Philadelphia, PA. RECALLED BY: Manufacturer, by letter on October 10, 2000. FDA initiated recall complete. DISTRIBUTION: Nationwide. QUANTITY: 3,125 bottles. REASON: Dissolution failure. ________ PRODUCT: ZERIT Capsules (Stavudine), 40 mg capsules, 60 capsules per bottle, NDC #0003-1967-01. Recall #D-082-1 CODE: Lot #MCS08, EXP MAR 2002. Bristol-Myers Squibb Immunology A Bristol- Myers Squibb Company. MANUFACTURER: Bristol-Myers Squibb, Princeton, NJ. RECALLED BY: R & S Sales, Inc., Fountain Run, KY, by letter on October 30, 2000. Firm-initiated recall ongoing. DISTRIBUTION: NY, CA, KY, MN, WI, IL, CT, LA, PA, SC, TX and MI. QUANTITY: 3,756 bottles. REASON: The product has been relabeled with an extended expiration date. ________ PRODUCT: (OTC) Femgest ô Progesterone Cream, 2 oz (57 g) jars and 1.5 teaspoon units in pink sample blister packages. Recall #D-083-1. CODE: 2 oz. Jars: LOT NOS. 13410, 13449, 13576, & 13559; Product No.5717. Sample blister packs: Lot No.13410; Product No. 5616. MANUFACTURER: Home Health, Bohemia, NY. (A subsidiary of NBTY, Inc.). RECALLED BY: NBTY, Inc., Bohemia, NY, by telephone on 11/30/00 and a follow up "Urgent Recall" letter on 12/8/00. Firm-ititiated recall ongoing. DISTRIBUTION: NY, NJ,MA, CT, NH, MD, MI, IN,GA, FL, TX, AZ, IA, WI, UT, CO, MO, OR, WA, CA. QUANTITY: Approximately 30,000/2 ounce jars and 50,000 blister packs. REASON: Mold contamination.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

________ PRODUCT: DILANTIN 100 MG KAPSEALS (EXTENDED PHENYTOIN SODIUM CAPSULES, USP). ANDA 84-349 NDC N 0071-0362-32, BOTTLES OF 1000'S NDC N 0071-0362-24, BOTTLES OF 100'S. Recall #D-086-1. CODE: LOT NO. EXP. DATE 10039F 2/01 00299F 8/01 MANUFACTURER; WARNER LAMBERT (PARKE-DAVIS)FAJARDO, PR. RECALLED BY: PFIZER INC., NEW YORK, NY.,on 12/20/00 via UPS Groung-Tracking Service. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide, South Africa and Thailand. QUANTITY: 4,032 Bottles of lot 10039F and 40,464 bottles of lot 00299F. REASON: Dissolution failure. _______ PRODUCT: TheraPatch Vapor nose & chin Cough Suppressant containing 14 strips; NDC# 51747-012-01; active ingredients: Camphor 4.7% and Menthol 2.6%; TheraPatch Vapor chest Cough Suppressant containing 7 patches; NDC# 51747-005-01; active ingredients: Camphor 4.7% and Menthol 2.6%; Triaminic Vapor Patch, Menthol Scent containing 6 patches per carton; NDC# 0067-0209-06; active ingredients: Camphor 4.7% and Menthol 2.6%; product is labeled as being distributed by Novartis Consumer Health,Inc., Summit, NJ The products are described on the TheraPatch labels as "Ointment on a breathable cloth patch" or "Ointment On A Breathable Adhesive Cloth Patch". Recall #D-087-089-1. CODE: All lots manufactured during the last 18 months. MANUFACTURER: LecTec Corporation , Edina, MN. RECALLED BY: Manufacturer, by letters, dated November 20, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 6043 cases of 24 retail packages per case of TheraPatch Vapor Chest; 1810 cases of 24 retail packages per case of TheraPatch Vapor nose/chin; 329 cases of 36 retail packages per case of TheraPatch Vapor nose/chin. REASON: Pouch seal failures (opening along top, sides and/or bottom).

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_______ PRODUCT: Platelets, Pheresis. Recall #B-540-1. CODE: Unit 0400601 MANUFACTURER: Siouxland Community Blood Bank, Sioux City, IA. RECALLED BY: Manufacturer, by telephone on July 2, 1998. Firm-initiated recall complete. DISTRIBUTION: Iowa. QUANTITY: One Unit. REASON: Blood product, which had an unacceptable platelet count, was distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-547-1; b) Fresh Frozen Plasma. Recall #B-548-1. CODE: a) Unit L53656; b) Unit L53656 MANUFACTURER: Virginia Blood Services, Richmond, VA. RECALLED BY: Manufacturer, by telephone on 10/3/00. Firm-initiated recall complete. DISTRIBUTION: Virginia. QUANTITY: 2 Units. REASON: Blood products, collected from a donor who had received an MMR vaccination, were distributed. ________ PRODUCT: Red Blood Cells, Leukoreduced. Recall #B-549-1. CODE: Unit 01KF49875. MANUFACTURER: American Red Cross Blood Services, New York-Penn Region, Rochester, NY. RECALLED BY: American Red Cross Blood Services, New York-Penn Region. West Henrietta, NY, by letters dated May 25, 2000 and June 20, 2000. Firm-initiated recall complete. DISTRIBUTION: New Jersey. 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-553-1. CODE: Units 81152018, 81126330, 79601610, 79297936, 79293679, 79291743 MANUFACTURER: Sera-Tec Biologicals Limited Partnership, Richmond, KY. RECALLED BY: Sera-Tec Biologicals Limited Partnership, North Brunswick, NJ., by letter dated February 24, 1998. Firm-initiated recall complete. DISTRIBUTION: California. QUANTITY: Six units. REASON: Blood products, collected from a donor who had been incarcerated, were distributed. ________ PRODUCT: Source Plasma. Recall #B-555-1. CODE: TO321233 MANUFACTURER: Sera-Tec Biologicals Limited Partnership, Toledo, OH. RECALLED BY: Sera-Tec Biologicals Limited Partnership, North Brunswick, NJ, by facsimile dated December 15, 1997. Firm-initiated recall complete. DISTRIBUTION: California. QUANTITY: One unit. REASON: Blood product, collected from a donor with an elevated ALT, Was distributed. ________ PRODUCT: Red Blood Cells, Leukoreduced. Recall #B-557-1. CODE: Unit 18223-8108 MANUFACTURER: United Blood Services, Casper Satellite Center, Casper, WY. RECALLED BY: Blood Systems, Inc., Scottsdale, AZ., by telephone on September 27, 2000 and by letter dated October 30, 2000. Firm-initiated recall complete. DISTRIBUTION: Wyoming. QUANTITY: One unit. REASON: Blood product, which had an unacceptable white blood cell count, was labeled as leukoreduced, and distributed. ________ PRODUCT: Red Blood Cells. Recall #B-560-1 CODE: Unit C44741. MANUFACTURER: Virginia Blood Services. Richmond, VA. RECALLED BY: Manufacturer, by telephone on October 31, 2000 and by letter dated November 16, 2000. Firm initiated recall complete. DISTRIBUTION: Virginia. QUANTITY: One unit. REASON: Blood product, collected from a donor who had been exposed to body fluids due to a human bite, was distributed. ________ PRODUCT: Platelets, Pheresis. Recall #B-562-1. CODE: Units E37576, E37475, E56630 MANUFACTURER: Sacramento Medical Foundation, Sacramento, CA. RECALLED BY: Manufacturer, by telephone on December 8, 1998. Firm-initiated recall complete. DISTRIBUTION: California QUANTITY: Three units. REASON: Blood products, which had high white cell counts, were labeled as leukoreduced, and distributed. ________ PRODUCT: Platelets. Recall #B-563-1. CODE: Unit 02FC37810. MANUFACTURER: American Red Cross Blood Services, Central Plains Region, Wichita, KS RECALLED BY: Manufacturer, by telephone on April 6, 1998, and by letter dated April 21. 1998. Firm-initiated recall complete. DISTRIBUTION: Texas. QUANTITY: One unit. REASON: Blood product, corresponding to a unit of Red Blood Cells, that was found to contain a clot, was distributed. ________ PRODUCT: a) Blood Cells, Recall #B-565-1; b)Recovered Plasma, Recall #B-566-1. CODE: a) Unit 39KJ38708; b)Unit 39KJ38708. MANUFACTURER: American Red Cross, Tri-State Region, Huntington, WV. RECALLED BY: Manufacturer, by letter dated July 19, 2000. DISTRIBUTION: West Virginia. QUANTITY: 2 units. REASON: Blood products, collected from a donor taking the drug Methotrexate, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-573-1; b) Platelets. Recall #B-574-1. CODE: a) Unit 13L97355; b) Unit 13L97355. MANUFACTURER: American Red Cross, Southeastern Region, Detroit, MI. RECALLED BY: Manufacturer, by letter on July 25, 2000. Firm initiated recall complete. DISTRIBUTION: Michigan. QUANTITY: 2 units. REASON: Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed. _________ PRODUCT: a)Red Blood Cells. Recall #B-583-1; b) Cryoprecipitated AHF. Recall #B-584-1. CODE: a) unit 2111086; b) unit 2111086. MANUFACTURER: Lifeshare, Inc., Elyria, OH. RECALLED BY: Lifeshare, Inc., Elyria, OH, by letter dated October 12, 2000. Firm- initiated recall complete. DISTRIBUTION: Ohio. QUANTITY: 2 units. REASON: Blood products, collected from an unsuitable donor due to an accidental needlestick during the previous twelve months, were distributed. ________ PRODUCT: Platelets, Pheresis, Leukocytes Reduced. Recall #B-585-1. CODE: units 0746710, 0755530, 0763970, and 0771667. MANUFACTURER: Bergen Community Regional Blood Center, Paramus, NJ. RECALLED BY: Manufacturer, by by letter dated March 6, 2000. Firm-initiated recall complete. DISTRIBUTION: New Jersey. QUANTITY: 4 units. REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. _________ PRODUCTS: a) Blood Cells. Recall #B-586-1; b) Platelets. Recall # B-587-1. CODE: a) Unit 33LL85708; b)unit 33LL85708. MANUFACTURER: The American National Red Cross, Connecticut Region, Farmington, CT. RECALLED BY: Manufacturer, by letters dated October 17, 2000, and December 5, 2000. Firm-initiated recall complete. DISTRIBUTION: New York and Connecticut. QUANTITY: 2 units. REASON: Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed. ________ PRODUCT: Red Blood Cells. Recall #B-588-1. CODE: Unit 0736630 MANUFACTURER: Bergen Community Regional Blood Center, Paramus, NJ RECALLED BY: Manufacturer, by letter dated June 3, 1999. Firm-initiated recall complete. DISTRIBUTION: New Jersey. QUANTITY: One unit. REASON: Blood product, collected from an unsuitable donor based on possible body piercing within the previous twelve months, was distributed. ________ PRODUCT: Platelets. Recall #B-591-1. CODES: (1625 units), unit numbers 1107000, 1107010, 1108643, 1108649, 1108673, 1108674, 1108675, 1108679, 1108682, 1108685, 1108686, 1108688, 1108693, 1108694, 1108696, 1108704, 1108706, 1108707, 1108714, 1108937, 1108938, 1108941, 1108942, 1109160, 1109239, 1109244, 1109247, 1109264, 1109273, 1109282, 1109283, 1109284, 1109291, 1109293, 1109298, 1109304, 1109307, 1109310, 1109312, 1109313, 1109314, 1109316, 1109354, 1109355, 1109356, 1109364, 1109366, 1109367, 1109374, 1109380, 1109395, 1109397, 1109400, 1109415, 1109417, 1109458, 1109459, 1109460, 1109462, 1109465, 1109468, 1109491, 1109492, 1109495, 1109496, 1109497, 1109498, 1109510, 1109553, 1109555, 1109557, 1109559, 1109562, 1109564, 1109565, 1109566, 1109570, 1109575, 1109576, 1109577, 1109579, 1109838, 1109840, 1109844, 1109846, 1109848, 1109858, 1109871, 1109877, 1109883, 1109894, 1109896, 1109899, 1109900, 1109950, 1109951, 1109952, 1109955, 1109962, 1109970, 1109979, 1109980, 1109981, 1109982, 1109984, 1109992, 1109994, 1109995, 1109998, 1110000, 1110004, 1110007, 1110008, 1110009, 1110010, 1110011, 1110012, 1110013, 1110014, 1110015, 1110017, 1110018, 1110019, 1110021, 1110023, 1110024, 1110029, 1110030, 1110031, 1110032, 1110033, 1110034, 1110035, 1110037, 1110039, 1110040, 1110041, 1110042, 1110043, 1110046, 1110047, 1110048, 1110049, 1110071, 1110106, 1110112, 1110113, 1110117, 1110122, 1110123, 1110124, 1110125, 1110126, 1110130, 1110140, 1110141, 1110142, 1110147, 1110149, 1110151, 1110153, 1110155, 1110157, 1110160, 1110162, 1110166, 1110167, 1110170, 1110172, 1110179, 1110180, 1110274, 1110275, 1110298, 1110301, 1110304, 1110334, 1110343, 1110352, 1110397, 1110605, 1110610, 1110611, 1110619, 1110657, 1110689, 1110697, 1110706, 1110719, 1110722, 1110741, 1110749, 1110754, 1110755, 1110759, 1110763, 1110769, 1111217, 1111222, 1111229, 1111235, 1111237, 1111238, 1111239, 1111240, 1111241, 1111243, 1111250, 1111252, 1111271, 1111272, 1111274, 1111278, 1111284, 1111643, 1111644, 1111646, 1111650, 1111651, 1111652, 1111653, 1111654, 1111655, 1111657, 1111660, 1111672, 1111675, 1111676, 1111681, 1111682, 1111683, 1111708, 1111713, 1111718, 1111719, 1111720, 1111733, 1111741, 1111744, 1111747, 1111759, 1111762, 1112227, 1112294, 1112336, 1112348, 1112350, 1112352, 1112364, 1112382, 1112425, 1112430, 1112446, 1112449, 1113385, 1113722, 1113781, 1113790, 1113795, 1113868, 1113869, 1113870, 1113911, 1113914, 1113918, 1113919, 1113949, 1113957, 1113983, 1113990, 1114636, 1114672, 1114684, 1114688, 1114699, 1114720, 1114723, 1114727, 1114745, 1114757, 1114777, 1114785, 1114801, 1114802, 1114803, 1114808, 1114810, 1114811, 1114812, 1114813, 1114816, 1114817, 1114828, 1114830, 1114831, 1114832, 1114833, 1114838, 1114855, 1114862, 1114863, 1114871, 1114876, 1114877, 1114878, 1114884, 1114895, 1114898, 1114900, 1114945, 1114947, 1114952, 1114964, 1115050, 1115062, 1115064, 1115065, 1115066, 1115067, 1115069, 1115070, 1115072, 1115074, 1115076, 1115078, 1115079, 1115080, 1115081, 1115082, 1115083, 1115084, 1115883, 1115885, 1115886, 1115887, 1115890, 1115891, 1115894, 1115895, 1115899, 1115904, 1115906, 1115907, 1115910, 1115911, 1115912, 1115913, 1115914, 1115915, 1115917, 1115922, 1115923, 1115924, 1115926, 1115928, 1115929, 1115930, 1115939, 1116051, 1116055, 1116064, 1116093, 1116094, 1116104, 1116111, 1116114, 1116117, 1116119, 3027294, 3027296, 3027297, 3027300, 3027301, 3027303, 3027305, 3027307, 3027308, 3027310, 3027311, 3027536, 3027538, 3027540, 3027543, 3027546, 3027549, 3027550, 3027551, 3027552, 3027558, 3027668, 3027669, 3027670, 3027671, 3027673, 3027674, 3027675, 3027678, 3027681, 3027682, 3027684, 3027686, 3027687, 3027688, 3027689, 3027690, 3027691, 3027692, 3027693, 3027694, 3027695, 3027696, 3027785, 3027786, 3027787, 3027789, 3027791, 3027792, 3027794, 3027797, 3027954, 3028002, 3028003, 3028004, 3028005, 3028006, 3028009, 3028010, 3028012, 3028014, 3028016, 3028019, 3028020, 3028022, 3028024, 3028026, 3028030, 3028032, 3028033, 3028034, 3028041, 3028072, 3028074, 3028075, 3028076, 3028078, 3028079, 3028080, 3028081, 3028082, 3028087, 3028090, 3028091, 3028093, 3028094, 3028157, 3028161, 3028163, 3028166, 3028167, 3028169, 3028178, 3028179, 3028182, 3028183, 3028184, 3028185, 3028187, 3028188, 3028190, 3028193, 3028195, 3028196, 3028197, 3028198, 3028199, 3028200, 3028205, 3028207, 3028210, 3028211, 3028215, 3028218, 3028223, 3028224, 3028225, 3028226, 3028227, 3028230, 3028232, 3028235, 3028237, 3028238, 3028239, 3028242, 3028243, 3028245, 3028246, 3028247, 3029483, 3029484, 3029485, 3029486, 3029488, 3029491, 3029494, 3029495, 3029499, 3029504, 3029598, 3029599, 3029600, 3029651, 3029652, 3029653, 3029657, 3029659, 3029660, 3029663, 3029664, 3029666, 3029669, 3029670, 3029723, 3029724, 3029725, 3029801, 3029802, 3029803, 3029804, 3029805, 3029806, 3029807, 3029811, 3029863, 3029868, 3029871, 3029874, 3029877, 3029878, 3029880, 3029881, 3029882, 3029883, 3029884, 3029885, 3029889, 3029892, 3029893, 3029894, 3029895, 3030271, 3030272, 3030275, 3030276, 3030278, 3030279, 3030280, 3030281, 3030282, 3030283, 3030284, 3030285, 3030288, 3030289, 3030413, 3030414, 3030423, 3030427, 3030428, 3030429, 3030430, 3030432, 3030433, 3030435, 3030437, 3030439, 3030441, 3030443, 3516710, 3516712, 3516715, 3516717, 3516719, 3516721, 3516722, 3516723, 3516725, 3516726, 3516727, 3516728, 3516729, 3516731, 3516732, 3516733, 3516734, 3516735, 3516736, 3516737, 3516741, 3516748, 3516750, 3516754, 3516757, 3516758, 3516759, 3516760, 3516762, 3516763, 3516765, 3516766, 3516767, 3516769, 3516770, 3516773, 3516776, 3516777, 3516780, 3516792, 3516809, 3516810, 3516811, 3516812, 3516813, 3516815, 3516816, 3516818, 3516819, 3516821, 3516824, 3516825, 3516845, 3516846, 3516856, 3516887, 3516907, 3516909, 3517389, 3517390, 3517391, 3517392, 3517394, 3517395, 3517396, 3517397, 3517398, 3517399, 3517401, 3517402, 3517403, 3517404, 3517405, 3517407, 3517416, 3517419, 3517420, 3517421, 3517422, 3517423, 3517424, 3517425, 3517426, 3517434, 3517436, 3517437, 3517438, 3517439, 3517441, 3517445, 3517446, 3517447, 3517449, 3517452, 3517454, 3517455, 3517456, 3517484, 3517485, 3517487, 3517488, 3517489, 3517491, 3517492, 3517493, 3517494, 3517495, 3517496, 3517497, 3517498, 3517500, 3517501, 3517502, 3517503, 3517505, 3517506, 3517507, 3517508, 3517509, 3517510, 3517511, 3517513, 3517514, 3517516, 3517518, 3517519, 3517520, 3517521, 3517522, 3517523, 3517524, 3517525, 3517568, 3517569, 3517571, 3517573, 3517574, 3517575, 3517576, 3517578, 3517581, 3517582, 3517585, 3517586, 3517596, 3517598, 4062563, 4062564, 4062565, 4062566, 4062567, 4062568, 4062570, 4062571, 4062572, 4062573, 4062574, 4062575, 4062577, 4062578, 4062579, 4062580, 4062581, 4062582, 4062583, 4062584, 4062585, 4062586, 4062587, 4062588, 4062589, 4062590, 4062591, 4062594, 4062595, 4062597, 4062598, 4062599, 4062600, 4062601, 4062602, 4062603, 4062604, 4062605, 4062606, 4062607, 4062608, 4062609, 4062610, 4062611, 4062612, 4062613, 4062615, 4062617, 4062618, 4062620, 4062628, 4062643, 4062648, 4062649, 4062650, 4062654, 4062655, 4062657, 4062658, 4062659, 4062660, 4062665, 4062666, 4062667, 4062670, 4062671, 4062672, 4062673, 4062675, 4062677, 4062678, 4062679, 4062688, 4062689, 4062690, 4062691, 4062692, 4062693, 4062696, 4062697, 4062699, 4062700, 4062701, 4062702, 4062703, 4062704, 4062705, 4062708, 4062709, 4062710, 4062711, 4062712, 4062715, 4062717, 4062718, 4062720, 4062722, 4062723, 4062725, 4062727, 4062728, 4062730, 4062731, 4062801, 4062804, 4062805, 4062806, 4062808, 4062809, 4062810, 4062811, 4062815, 4062819, 4062827, 4062830, 4062832, 4062833, 4062837, 4062838, 4062839, 4062844, 4062852, 4062856, 4062860, 4062865, 4062869, 4062872, 4062873, 4062874, 4062875, 4062877, 4062880, 4062883, 4062884, 4062885, 4062886, 4062889, 4062891, 4062892, 4062897, 4062899, 4062900, 4062903, 4062905, 4062908, 4062910, 4062913, 4062914, 4062916, 4062919, 4062920, 4062923, 4062930, 4062931, 4062932, 4062939, 4062940, 4062942, 4062943, 4062949, 4062950, 4062952, 4062953, 4062955, 4062956, 4062957, 4062958, 4063006, 4063010, 4063012, 4063013, 4063016, 4063017, 4063018, 4063019, 4063022, 4063023, 4063026, 4063028, 4063031, 4063032, 4063033, 4063034, 4063036, 4063037, 4063039, 4063040, 4063041, 4063042, 4063045, 4063047, 4063050, 4063051, 4063052, 4063053, 4063060, 4063062, 4063065, 4063066, 4063068, 4063069, 4063071, 4063072, 4063073, 4063076, 4063079, 4063082, 4063084, 4063085, 4063087, 4063088, 4063089, 4063091, 4063093, 4063094, 4063097, 4063102, 4063103, 4063111, 4063114, 4063115, 4063116, 4063117, 4063121, 4063122, 4063124, 4063126, 4063128, 4063129, 4063131, 4063139, 4063140, 4063151, 4063152, 4063154, 4063156, 4063158, 4063159, 4063161, 4063163, 4063164, 4063166, 4063167, 4063173, 4063176, 4063179, 4063180, 4063181, 4063183, 4063189, 4063190, 4063193, 4063194, 4063195, 4063196, 4063198, 4063201, 4063202, 4063204, 4063207, 4063208, 4063210, 4063211, 4063213, 4063214, 4063215, 4063216, 4063217, 4063220, 4063221, 4063228, 4063230, 4063231, 4063233, 4063300, 4063309, 4063314, 4063320, 4063322, 4063323, 4063326, 4063328, 4063330, 4063333, 4063337, 4063338, 4063339, 4063340, 4063341, 4063342, 4063354, 4063357, 4063359, 4063364, 4063369, 4063371, 4063756, 4063759, 4063760, 4063761, 4063762, 4063767, 4063769, 4063770, 4063774, 4063775, 4063776, 4063780, 4063782, 4063879, 4063882, 4063889, 4063897, 4063898, 4063901, 4063904, 4063905, 4063906, 4063910, 4065389, 4065390, 4065391, 4065392, 4065396, 4065397, 4065398, 4065399, 4065401, 4065402, 4065403, 4065406, 4065407, 4065409, 4065410, 4065413, 4065414, 4065415, 4065416, 4065418, 4065419, 4065420, 4065422, 4065424, 4065425, 4065426, 4065427, 4065428, 4065429, 4065430, 4065431, 4065432, 4065433, 4065434, 4065435, 4065438, 4065439, 4065444, 4065445, 4065446, 4065447, 4065448, 4065449, 4065450, 4065451, 4065453, 4065454, 4065455, 4065457, 4065459, 4065460, 4065462, 4065463, 4065464, 4065465, 4065466, 4065468, 4065469, 4065470, 4065474, 4065475, 4065477, 4065478, 4065483, 4065484, 4065488, 4065489, 4065490, 4065491, 4065492, 4065496, 4065498, 4065500, 4065501, 4065502, 4065504, 4065505, 4065506, 4065507, 4065508, 4065509, 4065511, 4065512, 4065514, 4065515, 4065516, 4065517, 4065520, 4065521, 4065522, 4065547, 4065549, 4065550, 4065553, 4065554, 4065555, 4065557, 4065558, 4065560, 4065561, 4065563, 4065564, 4065565, 4065566, 4065567, 4065568, 4065569, 4065570, 4065574, 4065575, 4065576, 4065577, 4065580, 4065581, 4065582, 4065583, 4065585, 4065588, 4065589, 4065591, 4065592, 4065593, 4065595, 4065598, 4065599, 4065600, 4065601, 4065602, 4065604, 4065605, 4065606, 4065607, 4065608, 4065612, 4065613, 4065614, 4065616, 4065617, 4065618, 4065619, 4065622, 4065624, 4065627, 4065629, 4065630, 4065631, 4065632, 4065635, 4065636, 4065638, 4065640, 4065641, 4065643, 4065646, 4065647, 4065648, 4065651, 4065652, 4065656, 4065657, 4065658, 4065662, 4065663, 4065665, 4065668, 4065669, 4065670, 4065671, 4065672, 4065673, 4065676, 4065677, 4065678, 4065679, 4065680, 4065681, 4065682, 4065683, 4065684, 4065686, 4065687, 4065688, 4065689, 4065691, 4065694, 4065696, 4065697, 4065698, 4065699, 4065702, 4065703, 4065706, 4065708, 4065710, 4065713, 4065714, 4065716, 4065719, 4065720, 4065724, 4065727, 4065728, 4065730, 4065731, 4065732, 4065737, 4065739, 4065740, 4065741, 4065742, 4065743, 4065744, 4065745, 4065746, 4065747, 4065748, 4065749, 4065751, 4065752, 4065753, 4065757, 4065758, 4065759, 4065760, 4065761, 4065762, 4065763, 4065764, 4065765, 4065767, 4065768, 4065769, 4065770, 4065771, 4065777, 4065779, 4065780, 4065782, 4065785, 4065786, 4065787, 4065790, 4065792, 4065793, 4065794, 4065795, 4065796, 4065798, 4065799, 4065800, 4065801, 4065810, 4065812, 4065816, 4065818, 4065821, 4065822, 4065823, 4065824, 4065825, 4065827, 4065829, 4065830, 4065831, 4065832, 4065836, 4065837, 4065838, 4065841, 4065842, 4065843, 4065844, 4065845, 4065847, 4065848, 4065849, 4065850, 4065852, 4065854, 4065855, 4065856, 4065861, 4065862, 4065863, 4065865, 4065868, 4065869, 4065870, 4065871, 4065874, 4065876, 4065877, 4065878, 4065879, 4065881, 4065882, 4065883, 4065884, 4065885, 4065887, 4065889, 4065891, 4065892, 4065894, 4065895, 4065896, 4065899, 4065901, 4065902, 4065903, 4065904, 4065905, 4065906, 4065907, 4065909, 4065910, 4065911, 4065912, 4065913, 4065915, 4065916, 4065918, 4065920, 4065921, 4065925, 4065927, 4065929, 4065932, 4065933, 4065934, 4065935, 4065936, 4065937, 4065938, 4065939, 4065941, 4065942, 4065943, 4065944, 4065945, 4065946, 4065948, 4065951, 4065952, 4065953, 4065954, 4065957, 4065968, 4065969, 4065976, 4065979, 4065982, 4066004, 4066006, 4066007, 4066010, 4066011, 4066013, 4066015, 4066018, 4066027, 4066028, 4066029, 4066031, 4066039, 4066041, 4066042, 4066043, 4066076, 4066077, 4066078, 4066083, 4066084, 4066085, 4066087, 4066091, 4066092, 4066096, 4066098, 4066099, 4066100, 4066101, 4066103, 4066104, 4066105, 4066107, 4066108, 4066118, 4066119, 4066181, 4066187, 4066193, 4066197, 4066201, 4066205, 4066209, 4066210, 4066212, 4066275, 4066276, 4066277, 4066280, 4066285, 4066286, 4066288, 4066289, 4066291, 4066292, 4066293, 4066294, 4066295, 4066296, 4066300, 4066302, 4066303, 4066306, 4066307, 4066309, 4066313, 4066314, 4066316, 4066321, 4066322, 4066323, 4066324, 4066325, 4066326, 4066329, 4066331, 4066334, 4066567, 4066569, 4066597, 4066612, 4066640, 4066642, 4067255, 4067265, 4067269, 4067270, 4067272, 4067273, 4067280, 4067304, 8015219, 8506139, 8506140, 8506142, 8506145, 8506148, 8506151, 8506160, 8506162, 8506164, 8506165, 8506166, 8506168, 8506171, 8506172, 8506174, 8506176, 8506180, 8506181, 8506182, 8506184, 8506185, 8506186, 8506187, 8506188, 8506189, 8506190, 8506191, 8506192, 8506193, 8506194, 8506195, 8506196, 8506197, 8506198, 8506199, 8506202, 8506203, 8506204, 8506207, 8506208, 8506210, 8506211, 8506212, 8506213, 8506214, 8506215, 8506217, 8506271, 8506274, 8506280, 8506285, 8506286, 8506287, 8506288, 8506295, 8506296, 8506302, 8506304, 8506305, 8506306, 8506308, 8506321, 8506327, 8506329, 8506330, 8506331, 8506338, 8506342, 8506343, 8506344, 8506345, 8506346, 8506347, 8506349, 8506352, 8506353, 8506357, 8506359, 8506360, 8506363, 8506364, 8506365, 8506368, 8506369, 8506373, 8506374, 8506376, 8506378, 8506379, 8506380, 8506381, 8506382, 8506383, 8506387, 8506389, 8506390, 8506392, 8506393, 8506396, 8506397, 8506401, 8506404, 8506405, 8506406, 8506409, 8506410, 8506436, 8506441, 8506443, 8506445, 8506449, 8506450, 8506452, 8506453, 8506455, 8506456, 8506458, 8506459, 8506460, 8506461, 8506462, 8506463, 8506465, 8506504, 8506515, 8506521, 8506528, 8506531, 8506533, 8506535, 8506538, 8506540, 8506543, 8506984, 8506985, 8506986, and 8506987 NOTE: Some of the Platelet units noted above were pooled and distributed under pool numbers 5671, 5672, 5673, 5674, 5677, 5678, 5679, 5680, 5682, 5701, 5703, 5704, 5705, 5706, 5707, and 5708 MANUFACTURER: Community Blood Center, Dayton, OH. RECALLED BY: Manufacturer, by letter on September 27,2000. Recall #B-591-1. DISTRIBUTION: Ohio and Indiana. QUANTITY: 1625 units. REASON: Platelets, labeled with an extended expiration date, were distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

________ PRODUCT: Red Blood Cells, Leukoreduced. Recall #B-551-1. CODE: Unit 35V41922 MANUFACTURER: American Red Cross, Appalachian Region Blood Services, Roanoke, VA. RECALLED BY: Manufacturer, by letters dated October 13, 2000 and October 24, 2000. Firm-initiated recall complete. DISTRIBUTION: West Virginia. QUANTITY: One unit. REASON: Blood product, collected from a donor with a history of Idiopathic Thrombocytopenic Purpura, was distributed. ________ PRODUCT: Platelets. Recall #B-564-1. CODE: Unit 02FG37195. MANUFACTURER: American Red Cross Blood Services, Central Plains Region, Wichita, KS. RECALLED BY: Manufacturer, by telephone on October 21, 1997 and by letter dated October 30, 1997. Firm-initiated recall complete. DISTRIBUTION: Kansas. QUANTITY: One unit. REASON: Blood product, collected from a donor who developed a hematoma during the collection process, was distributed. ________ PRODUCT: Red Blood Cells. Recall #B-567-1. CODE: Units 009LL27273, 009LL27274, 009LL27275, 009LL27276, 009LL27277 MANUFACTURER: American Red Cross Blood Services, Midwest Region, Omaha, NE . RECALLED BY: Manufacturer, by telephone on December 13, 1996. Firm-initiated recall complete. DISTRIBUTION: Iowa and Nebraska. QUANTITY: Five units. REASON: Blood products, for which temperature after shipment was not recorded upon receipt, were distributed. __________ PRODUCT: Platelets. Recall #B-575-1. CODES: Unit 29KJ07094 MANUFACTURER: American Red Cross Blood Services, Mid-Atlantic Region, Norfolk, VA. RECALLED BY: Manufacturer, by letter dated July 26, 2000. Firm-initiated recall compete. DISTRIBUTION: Connecticut. QUANTITY: One unit. REASON: Blood product, prepared from a unit of Whole Blood with an extended collection time, was distributed. ________ PRODUCT: Cryoprecipitate AHF. Recall #B-576-1 CODE: Unit 29FW37328 MANUFACTURER: American Red Cross Blood Services, Mid-Atlantic Region Norfolk, VA. RECALLED BY: Manufacturer, by letter dated July 26, 2000. Firm-initiated recall complete. DISTRIBUTION: Virginia. 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-578-1. CODE: Unit 0422027. MANUFACTURER: Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati,Ohio. RECALLED BY: Manufacturer, by letter dated September 1, 2000. Firm-initiated recall complete. DISTRIBUTION: Ohio. QUANTITY: One unit. REASON: Blood product, that was not quarantined after receiving information concerning a post donation illness, was distributed. ________ PRODUCT: Source Plasma. Recall #B-581-1. CODE: Unit 93291415 MANUFACTURER: Sera-Tec Biologicals, Norfolk, VA. RECALLED BY: Sera-Tec Biologicals, Harrisburg, PA., by letter dated January 27, 1998. Firm-initiated recall complete. DISTRIBUTION: North Carolina. QUANTITY: One unit. REASON: Blood product, which had an acceptable ALT, but was collected from a donor who previously had an elevated ALT on two separate occasions, was distributed.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

________ PRODUCT: Gelfoam Sterile Powder, 1 g jar; Gelfoam Sterile Sponge, Dental Pack - Size 4, Gelfoam Sterile Sponge, Size 2 cm and Size 12-7 mm. Recall No. Z-182-1 CODE: All lots. MANUFACTURER: Pharmacia Corporation, Kalamazoo, MI. RECALLED BY: Manufacturer, by letter on November 17, 2000. Firm initiated recall ongoing. DISTRIBUTION: United States, Canada, United Kingdom, Japan, Aruba, Barbados, Bermuda, Curacao, Grand Cayman, Haiti, Jamaica, Puerto Rico, St. Lucia, Singapore, Ireland, Australia, Belgium, Egypt, Saudi Arabia, Jordan, Korea, New Zealand, Taiwan, Chile, Panama, Costa Rica, Brazil, and Cyprus. QUANTITY: 1,505,802 units were distributed between 10/95 and 10/00. REASON: Aluminum shavings or fragments from the lid liner of the jar.


RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

________
PRODUCT:	
Model  Smoothlase Alexandrite Laser System.  
Recall #Z-104-1.
CODE:	
Serial Nos. 019 thru 023, 025-026, 028-029.
MANUFACTURER:
Cooper Surgical of Shelton, CT.
RECALLED BY:
Manufacturer, by certification labels on April 24, 2000 .  Firm-initiated 
recall ongoing.
DISTRIBUTION:
NY, CA, VA, NJ, AR, ID and IL.
QUANTITY:
9 units
REASON:	
Lasers lacked certain required procedures and labels.
_________
PRODUCT:
I Stat Systems a)I Stat CG-4+, Catalog No. 220500, Recall # Z-184-1; and 
b) Abbott Laboratories, Catalog Nos. 7G02-01, 7G02-02.  Recall #Z-185-1.
CODE:
Abbott Lot Nos. P00263.00275, P00280.
MANUFACTURER:
I-Stat Corp., Windsor, NJ.
RECALLED BY:
Manufacturer, by telephone and Federal Express letter on 12/15/2000.  
Firm-initiated recall ongoing.
DISTRIBUTION:
Ohio, Tenn., Florida, Washington, D.C., Iowa, and Hong Kong, Singapore, 
Japan, and Australia
QUANTITY:
9100 cartridges.
REASON:
The calibration fluid contained in most if not all cartridges in the 
three affected lots, has a low and out of specification concentration of 
lactic acid used to calibrate the lactate test. 
_______
PRODUCT:
Rugged EZ-Pro 2, Model No. 6091 Ambulance Cots.  
Recall #Z-187-1.
CODE:
All cots manufactured in the period August 14, 1999 to February 15, 2000.  
The first four numbers of the serial number are 9908 through 9912, and 
0001 and 0002. 
MANUFACTURER:
Stryker Medical, Kalamazoo, MI.       
RECALLED BY:
Manufacturer, by field correction notice dated August 21, 2000.  Firm-
initiated recall ongoing.
DISTRIBUTION:
United States and Canada, Naval Medical Clinic Portsmouth, NH, and 
Elmendorf AFB, AK.
QUANTITY:
172.
REASON:
The device lock pin may not properly engage and therefore the cot may 
drop to the next lower level while transporting patients. 
________
PRODUCT:
Clearview Easy hCG Pregnancy Test. Recall #Z-192-1.
CODE:
Lot Nos. CE0029A, CE0031/1A, CE0033A.
MANUFACTURER:
Carter Wallace Inc., Cranbury, NJ.
RECALLED BY:
Manufacturer, by telephone on August 15, 2000.  Firm-initiated recall 
ongoing.
DISTRIBUTION:
Nationwide.
QUANTITY:
805 kits.
REASON:
Contaminant in a batch of pouching foil, which may affect the performance 
of this product.  
________
PRODUCT:   
Whisperflow 2-60 CPAP Generator (with Criterion 60 
Pressure/Oxygen Monitor).  Recsll #Z-194-1.
CODE:
Serial numbers: 0526000711-01 through 0526000711-09
                0526000809-01 through 0526000809-12
		0526000814-01 through 0526000814-12
MANUFACTURER:
Caradyne, Ltd., Galway, Ireland.
RECALLED BY:
Engineered Medical Systems, Inc., Indianapolis, IN,
By letter on October 23, 2000.  Firm-initiated recall ongoing.
DISTRIBUTION:
Nationwide.
QUANTITY:
29
REASON:
The observed measured oxygen reading might be higher than that delivered 
to a patient.  

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

________ PRODUCT: Immulite 2000 Automated Immunoassay Analyzer Software Versions 1.6 and 1.61. Recall No. Z-183-1. CODE: None. MANUFACTURER: DPC Cirrus, Inc., Randolph, NJ RECALLED BY: Manufacturer, by facsimile and telephone on November 3, 2000 and November 6, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. There are 8 Government accounts. The product was shipped internationally to Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Pakistan, Poland, Portugal, Russia, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UK, Venezuela. QUANTITY: 962. REASON: Software code is incorrect for manual dilutions in the Batch Tests by Rack, which could cause incorrect calculation of results. ________ PRODUCT: LiquiChem Liquid Reagent LD), Catalog No. 139-121 (USA), S1203 (International). Recall #Z-186-1. CODE: Lot No. 030004. MANUFACTURER: Medical Analysis Systems, Inc., Camarillo, CA. RECALLED BY: Manufacturer, by facsimile on December 19, 2000. Firm-initiated recall ongoing. DISTRIBUTION: PA and MA, Internationally to Spain, England and Belgium. QUANTITY: 50 kits. REASON: Stability failure may not flag a lower LD-P result indicating a potential problem for the patient. ________ PRODUCT: Lyphochek Anemia Control, Catalog Item 500. Recall No. Z-193-1. CODE: Lot No. 43060. MANUFACTURER: Bio-Rad Laboratories, Inc., Irvine, CA RECALLED BY: Manufacturer, by certified letter on May 31, 2000. Firm-initiated recall complete. DISTRIBUTION: Nationwide, and Australia, Canada, France, Germany, Hong Kong, Italy, New Zealand, Sweden. Also U.S. Naval Medical Center Portsmouth VA and VA Medical Center Albuquerque NM. QUANTITY: 8,580 Vials distributed (6 per box for 1,430 boxes). REASON: Defective control may cause a slight increase in total variation (%CV and SD).
END OF ENFORCEMENT REPORT FOR FEBRUARY 7, 2001
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