February 21, 2001 01-07RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_________ PRODUCT: Recall #F-190-1. Enriched Long Grain Rice in flexible plastic bags, as follows: A. "FAME" brand in 5 # sizes; labeled in part: "***FAME***Long Grain Fancy ENRICHED RICE Naturally Low in Sodium***DISTRIBUTED BY NASH FINCH COMPANY***MINNEAPOLIS, MINNESOTA ***" There are six, 5# bags per brown shipping case. The brown shipping case reads in part: "***FE 6/5# LG 50% RICE***CODE 42431***FAME***". B. "GOOD DAY" brand in 5# and 20# sizes; labeled in part: "***GOOD DAY ENRICHED LONG GRAIN RICE***PACKED FOR ALBERTSON'S, INC. BOISE, IDAHO 83726***" There are six, 5# bags per brown shipping case. The brown shipping case reads in part: ***GD 8/5# 50% BROKEN RICE***CODE 48406***GOOD DAY***". The 20# bags are sold without being placed in shipping cases. C. "Our Family" brand in 1# sizes; labeled in part: "***Our Family***Long Grain ENRICHED RICE***DISTRIBUTED BY NASH FINCH COMPANY***MINNEAPOLIS, MINNESOTA 55435***" There are 24, 1# bags per brown shipping case. The brown shipping case reads in part: "***24/1# LONG GRAIN RICE***CODE 46800***OUR FAMILY***". CODE: A. "FAME" brand code reads for two dates in either two formats: "Best by Oct0601" or "Best by 100601". B. "GOOD DAY" brand code for the 5# bags were packed on two different days. The code for each day reads respectively: "100301" or "100601" "GOOD DAY" brand code for the 20# bag reads: "100301" C. "Our Family" brand code reads for two different dates in two different formats: "Best by OCT0501" or "Best by 100501" and "Best by OCT0601" or "Best by 100601" MANUFACTURER: C & F Foods, Inc., Sikeston, MO. RECALLED BY: C & F Foods, Inc., City of Industry, CA., by press releases via television, radio, print, and by fax on 12/12/00. Firm-initiated recall ongoing. DISTRIBUTION: OK, SD, TX. QUANTITY: "FAME " brand, 539 cases, 6-5 pound bags. "GOOD DAY" brand, 4020 - 20 pound bags total (not in cases) "GOOD DAY" brand, 811 cases, 8 - 5 pound bags. "Our Family" brand, 392 cases, 24-1 pound bags. REASON: The product may contain pieces of glass. ________ PRODUCT: Pasteurized Liquid Egg Product F-S Blend P. Recall #F-232-1. CODE: Lot 3210. MANUFACTURER: Echo Lake Farm Produce Co., Inc., Burlington, WI. RECALLED BY: Manufacturer, by telephone Firm-Initiated recall complete. DISTRIBUTION: Mason City, OH. QUANTITY: 9629 pounds in 5 totes. REASON: The product was found contaminated with Salmonella enteritidis. ________ PRODUCT: Oriental Delight brand frozen egg rolls: F-233-1 Shrimp and Pork Egg Rolls 60/3oz/carton (item no. 100603) and 100/2oz/carton (item no.) 102100 F-234-1 Shrimp Egg Rolls 60/3oz/carton (item no. 200603) F-235-1 Vegetable Egg Rolls 60/3oz/carton (item no. 300603) F-236-1 Petite Shrimp Egg Rolls 200/0.5oz/carton (item no. 205200) F-237-1 Petite Vegetable Egg Rolls 200/0.5oz/carton (item no. 305200) CODE: Any and all Lot Numbers with the following product codes: 100603,200603, 300603, 102100, 205200, and 305200. The firm maintains that a six digit ink stamp code is supposed to be appled to each carton. This may/may not be done, and if done, the six digit code may be a pack date, a ship date, or a getting ready to ship date. MANUFACTURER: Gourmet Foods International, Nashville, TN. RECALLED BY: Manufacturer, by FAX on 12/22/00. FDA-initiated recall ongoing. DISTRIBUTION: Charlotte, NC and Lexington, SC. QUANTITY: 460 cases of the various products. REASON: The products contain undeclared FD&C Yellow No. 5 and FD&C Yellow No. 6. ________ PRODUCT: Clayware, PROVENCAL GREEN BOWLS AND BAKING DISHES: a)F-238-1 #40272S SMALL BOWL 7" diameter b)F-239-1 #40272M MEDIUM BOWL 9 7/8 " diameter c)F-240-1 #40272L LARGE BOWL 13" diameter d)F-241-1 #40274S SMALL BAKING DISH 7 3/8" W x 10 7/8" L x 2" H e)F-242-1 #40274M MEDIUM BAKING DISH 8 5/8" W x 13" L x 2 3/8" H CODE: All product on the market at the time the recall was initiated.; a)#40272S SMALL BOWL 7" diameter b)#40272M MEDIUM BOWL 9 7/8 " diameter c)#40272L LARGE BOWL 13" diameter d)#40274S SMALL BAKING DISH 7 3/8" W x 10 7/8" L x 2" H e)#40274M MEDIUM BAKING DISH 8 5/8" W x 13" L x 2 3/8" H MANUFACTURER: Pauline Ala SA, Cedex, France. Recalling Firm: Rue de France, Middletown, RI., by letter on 1/22/01 via US Mail to all catalog sales customers who purchased the product. Firm-initiated recall ongoing. DISTRIBUTION: Sold through Rue De France Catalog Sales directly to the consumer. QUANTITY: 968 units. REASON: The products contain excessive levels of leachable lead. ________ PRODUCT: Driver's sponge cake. Net Weight 54 ounces each packaged in cardboard boxes. Sold by the case, 4 units per case. Recall #F-243-1. CODE: No lot number or expiration date is used. All manufacturing dates would be affected. MANUFACTURER: Clayborn's Bakery, Lebanon, TN. RECALLED BY: Manufacturer, by telephone on 1/12/01. Firm Initiated recall ongoing. DISTRIBUTION: Lebanon, TN. QUANTITY: 9/6/00-12/13/00, 215 cases (860 cakes), consignee is currently holding 3 cases. REASON: The product contains undeclared FD&C Yellow No. 6. ________ PRODUCT: Americaís Choice Honey Roasted Peanuts, 12 oz. Cans. Recall #F-244-1. CODE: Sell by: 10/13/01N UPC: 7 54807 51875. MANUFACTURER: Trophy Nut Co., Tipp City, OH. RECALLED BY: A&P Corporate, Montvale, NJ., by e-mailed on 11/15/2000. Firm- initiated recall complete. DISTRIBUTION: Detroit, MI, Wauwatosa, WI, North Bergen, NJ, Edison, NJ, Central Islip, NY and Baltimore, MD. QUANTITY: 350 cases containing 12 cans per case. REASON: Some cans actually contain mixed nuts instead of peanuts. ________ PRODUCT: Mama Lupe's Fresh Corn Tortillas in 25-oz. packages, 24 corn tortillas per package, 24 packages per case. The responsible firm on the label is Tortilla King, Inc., Moundridge, KS. Recall #F-245-1. CODE: Expiration date JAN 22 or earlier. MANUFACTURER: Tortilla King, Inc., Moundridge, KS. RECALLED BY: Manufacturer, via telephone on 1/3/01. FDA Initiated recall complete. DISTRIBUTION: KS, OK, and MO. QUANTITY: Approximately 300 /24-count cases. REASON: The product contains undeclared FD&C Yellow No. 5, FD&C Yellow No. 6 and FD&C Red No. 40. ________ PRODUCT: Havista Chili Soy Bean Cheese, Chili Soya Cheese in 10.5 oz. glass jars. Recall #F-247-1. CODE: None. All product on the market at the time the recall was initiated was subject to recall. MANUFACTURER: Zhongshan Cereal & Oil Import & Export Co. of Guangdong, Guangdong, China. RECALLED BY: J. V. Trading Ltd., Glendale, NY, the importer sent a truck to the NJ distributor on 5/9/00, and on 5/16/00 and picked up the product on hand. FDA-initiated recall complete. DISTRIBUTION: New Jersey. QUANTITY: 200 cartons (36 x 250 g) and 384 cartons (24 x 454 g). REASON: The product is a low acid canned food without a registered manufacturer and scheduled process. ________ PRODUCT: Bakery Fresh Lemon Cookies, Net Wt 8.9 oz (252 g) Responsible firm on the label: Distributed by Petri Baking Products Silver Creek. Recall #F-248-1. CODE: Lot numbers are as follows: 00760, 00390, 10110, 12020, 01260, 01490, 11210, 12720, 02660, 02090, 11510, 02911, 01770, 02790, 12910, 01311, 00180, 10800, 10520, 02121, 02780, 12200, 11020 Code breakdown: 1st & 4th digit = month 2nd & 3rd digit = day 5th digit = year. MANUFACTURER: Petri Baking Products, Inc., Silver Creek, NY. RECALLED BY: Manufacturer, by letters dated 9/26/00 and 11/13/00. This ongoing recall was initiated and audited by the New York State Dept. of Agriculture & Markets. DISTRIBUTION IL, KS, MA, MD, MI, MS, NH, NJ, NY, OH, PA, and WV. QUANTITY: 6,681 cases x 18 units per case. REASON: The product contains undeclared FD&C Yellow No. 5 and FD&C Yellow No. 6.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT: Shawís Family Style Cut Green Beans, Frozen, 32 OZ. POLYBAG. Recall #F-246-1. CODE: SELL BY DATE: JUN 02 (036DAC2). MANUFACTURER: Comstock Michigan Fruit DV-CB, Brockport, NY. RECALLED BY: Shawís Supermarkets, Inc., East Bridgewater, MA, initiated a voluntary product withdrawal of this lot from their retail stores on 12/22/00. Firm-initiated recall complete. DISTRIBUTION: Shaw's Supermarkets in New England States: CT, MA, NH, ME, RI, VT. QUANTITY: Greater than 1122 bags exact amount unknown. REASON: The product may be contaminated with filth.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT: (Rx) Cytomel Liothyronine sodium tablets, 25 MCG, bottles of 100. Recall #D-090-1. CODE: Lot No. 549D16, Exp. 05/01. MANUFACTURER: Schering Canada, Inc., Pointe-Claire, Quebec H9R 1B4, Canada. RECALLED BY: Jones Pharma, Inc., St. Louis, MO, by letter on 1/19/01. Firm- initiated recall ongoing. DISTRIBUTION: Nationwide to wholesale distributors and physicians. QUANTITY: 23,748 bottles. REASON: Subpotency (@ 20 month of expiry). _________ PRODUCTS: Recall #D-101-138-1. (Rx) Adenosine Mono-Phosphate Injection, 25 mg/mL, 30 mL vial (Rx) Ascorbic Acid Injection, USP, 500 mg/mL, 50 mL vial (Rx) Adrenal Cortex Extract (ACE), 30 mL vial (Rx) Beet Ascorbic Acid Injection, USP, 500 mg/mL, 50 ml vial (Rx) Biotin Injection,10mg/mL, 30 mL vial (Rx) Dexpanthenol Injection, 250 mg/mL, 30 mL vial (Rx) DI-SOL Injection, USP brand of EDTA, 150 mg/mL, 100 mL vial (Rx) Echinacea Homeopathic Injection, 30 mL vial, 1:1 Mascerated (Rx) Edetate Disodium Injection, USP, 3 g/20mL(150mg/mL), 20 mL vial (Rx) Endocrine Injection, 30mL vial (Rx) Folic Acid Injection, 10 mg/mL, 30 mL vial (Rx) Germanium Sesg. (Sesguloxide), 15.5 mg/mL, 30 mL vial (Rx) (L) Glutathione Injection, 60mg/mL, 30 mL vial (Rx) HCL Injection, Diluted Hydrochloric Acid, 2 mg/mL, 100 mL vial (Rx) Human Chorionic Gonadotropin for Injection, USP, 10,000 units, 10 mL (Rx) Iron 59 Injection, (Ferrous Gluconate 5.9 mgÖ), 30 mL vial (Rx) Liver Injection Crude (Cyanocobalamin 2 mcg per mLÖ), 30 mL vial (Rx) Lypo-Vite Injection, ( cyancobalamin 100 mcg Ö) 30 mL vial (Rx) Magnesium Chloride Injection, 200 mg/mL, 50 mL vial (Rx) M.I.C. Injection, Each 2mL contains L-Methionine 50mg, Inositol 100mg, Choline Chloride 100 mg, Benzyl 1.5%, 50 mL vial (Rx) Procaine Hydrochloride Injection, USP, 2%, 100 mL vial (Rx) Pyridoxine HCL (B-6) Injection, 100 mg/mL, 30 mL vial (Rx) Sodium Thiosalicylic Injection, 100 mL/mL, 30 mL vial (Rx) Superoxide Dismutase (S.O.D.) 10 mg/mL, 30 mL vial (Rx) L-Taurine Injection, 50mg/mL, 100 mL vial (Rx) Thiamine HCL Injection, (B-1) 100mg/mL, 30 mL vial (Rx) Vitamin B-12 5000 Injection, 5000mg/mL Cyanocobalamin USP, 100mL vial (Rx) Thymus Extract Injection, 10 mg/mL, 30 mL vial (Rx) Choline Chloride Injection, 30 mL vial (Rx) Diphenhydramine Injection, 30 mL vial (Rx) Glycyrrhizen Injection, 30mL vial (Rx) Chlorpheniramine Injection (Rx) Hydrogen Peroxide Injection, 11cc per 100mL vial (Rx) Hydroxocobalamin Injection, 30 mL vial (Rx) MIC with Folic Acid Injection, 50 mL vial (Rx) Niacin Injection, 30 mL vial (Rx) Pangamic Acid Injection, 500 mg/mL, 30 mL vial (Rx) Riboflavin Injection, 30 mL CODES: All lot numbers and codes, strengths, sizes and expiration dates. MANUFACTURER: Phyne Pharmaceuticals, Inc., Scottsdale, AR. RECALLED BY: Manufacturer, by letter dated January 25, 2001. Firm-initiated recall ongoing. DISTRIBUTION: STATES OF AK, AL AR, AZ, CA, CO, CT, WASH DC, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, PUERTO RICO, CANADA, EUROPE. QUANTITY: Undetermined. REASON: Current good manufacturing practice deviations including, but not limited to, lack of assurance of sterility.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT: a) ACYCLOVIR FOR INJECTION 500 MG, 10 ML VIAL, NDC 59911-2465-02, RX. Recall #D-084-1. b) ACYCLOVIR FOR INJECTION 1 GRAM, 10 ML VIAL, NDC 59911-2466-02, RX. Recall #D-085-1. CODE: a) Lot No. 425-001, Exp. Date 2/01; Lot No. 425-419 Exp. Date 4/01; Lot No. 464-769 Exp. Date 7/01; b) Lot No. 425-020 Exp. Date 1/01; Lot No. 425-420 Exp. Date 1/01; Lot No. 426-039 Exp. Date 1/01. MANUFACTURER: Lederle Parenterals, Inc., Carolina, PR. RECALLED BY: Wyeth-Ayerst Laboratories, Philadelphia, PA, by letter on 12/27/00. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: Approximately 13,121 units. REASON: Discoloration. ________ PRODUCT: (RX)Dilantin Capsules, KAPSEALS (Extended Phenytoin Sodium Capsules, USP)100mg, 100 and 1000 units bottles.39F,. Recall #D-086-1. CODE: LOT NO. 10039F, EXP. Date 2/01; Lot No. 00299F, Exp. Date 8/01. MANUFACTURER: Warner Lambert (Parke-Davis), Fajardo, PR. RECALLED BY: PFIZER Inc., New York, NY., on 12/20/00 VIA UPS Ground-Tracking Service. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide, 18 bottles to South Africa and Thailand of LOT 10039F. QUANTITY: 4,032 bottles of lot 10039F and 40,464 bottles of lot 00299F. REASON: Dissolution Failure. ________ PRODUCT: Levsinex 0.375 mg (Hyoscyamine Sulfate USP 0.375 mg), 100 (extended release)Timecaps Capsules per bottle. Recall #D-091-1. CODES: OEO2119 (expiration date 1-02) OHO3126 (expiration date 4-02) OHO3170 (expiration date 5-02) MANUFACTURER: Schwarz Pharma, Inc., Seymour, IN . RECALLED BY: RightPak, Inc., Madison, WI, by e-mail on 1/11/01. Firm- initiated recall ongoing. DISTRIBUTION: Nationwide and Puerto Rico. QUANTITY: 1,409 bottles. REASON: Product packaged with incorrect insert, providing incorrect description of capsules. ________ PRODUCT: Children's Advil(tm)Suspension, brand of Ibuprofen, Grape flavored, 100 mg/5 ml, packaged in 4 ounce plastic bottle, 36 bottles/case, indicated for pain relief and fever reduction. Recall #D-092-1. CODES: Lot No. 99231. MANUFACTURER: Whitehall Robins Healthcare, Richmond, VA. RECALLED BY: Whitehall Robins Healthcare, Richmond, VA., by letter on 1/19/01. Firm- initiated recall ongoing. DISTRIBUTION: VA, PA, NJ,CT,RI,MD, NY,DE,WV,NC,NH,SC and PR. QUANTITY: 8,640 bottles. REASON: Some of the OTC product may be subpotent. ________ PRODUCT: a)(?) PremarinÆ tablets (conjugated estrogens tablets), 1.25mg, 1,000 count. Recall #D-093-1. b)(?) PremarinÆ tablets (conjugated estrogens tablets), 2.5mg, 100 count bottles. Recall #D-094-1. CODE: a) LOT NOS. 00344, Exp. Date: 08/03; and 01065, Exp. Date: 02/04; b) LOT NOS. 00430, Exp. Date: 10/03. MANUFACTURER: Ayerst Laboratories, Div. Of Wyeth-Ayerst Pharmaceuticals, Inc., Rouses Point, NY. And Wyeth Pharmaceuticals Co., Guayama, Puerto Rico. RECALLED BY: McKesson HBOC, Memphis, TN., by intranet on October 23, 2000 and December 13, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Ninety wholesalers within the United States. QUANTITY: a) Lot 00344: 1,198 bottles; Lot 01065: 2,388 bottles. b) Lot 00430: 2,932 bottles. REASON: Manufacturerís dissolution failure.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCTS: a) Red Blood Cells. Recall #B-530-1; b) Platelets. Recall #B-531-1; c) Fresh Frozen Plasma. Recall #B-532-1. CODE: a) Unit 09FH26777; b) Unit 09FH26777; c) Unit 09FH26777. MANUFACTURER: American Red Cross Services, Midwest Region, Omaha, NE. RECALLED BY: Manufacturer by letters dated February 4, 1998. Firm-initiated recall complete. DISTRIBUTION: Nebraska and Idaho. QUANTITY: Three units. REASON: Blood products, collected from a donor taking the drug Lupron, were distributed. ________ PRODUCTS: Red Blood Cells. Recall #B-579-1. CODE: Unit J11373. MANUFACTURER: Sacramento Medical Foundation Blood Center, Sacramento, CA. RECALLED BY: Manufacturer by telephone on June 22, 1999. Firm-initiated recall complete. DISTRIBUTION: California. QUANTITY: One units. REASON: Blood product, which was incorrectly tested for syphilis, was distributed. ________ PRODUCTS: Red Blood Cells. Recall #B-598-1. CODE: Unit 02FG37273. MANUFACTURER: American Red Cross Blood Services, Central Plains Region, Whichita, KS. RECALLED BY: Manufacturer by telephone on October 24, 1997. Firm-initiated recall complete. DISTRIBUTION: Kansas. QUANTITY: One units. REASON: Blood product, collected from a donor whose hemoglobin/hematocrit had not been documented, was distributed. ________ PRODUCTS: Platelets. Recall #B-599-1. CODE: Unit 02FC18816. MANUFACTURER: American Red Cross Blood Services, Central Plains Region, Whichita, KS. RECALLED BY: Manufacturer by telephone on February 24, 1997 and by letter dated February 27, 1997. Firm-initiated recall complete. DISTRIBUTION: Kansas. QUANTITY: One units. REASON: Blood product, which had an unacceptable platelet count, was distributed. ________ PRODUCTS: Platelets, Pheresis, Leukoreduced. Recall #B-600-1. CODE: Unit 02P46286. MANUFACTURER: American Red Cross Blood Services, Central Plains Region, Whichita, KS. RECALLED BY: Manufacturer by telephone on September 22, 1999 and by letter dated November 5, 1999. Firm-initiated recall complete. DISTRIBUTION: Kansas. QUANTITY: One units. REASON: Blood product, which had an unacceptable platelet count, was distributed. ________ PRODUCTS: Platelets, Pheresis, Irradiated. Recall #B-601-1. CODE: Unit 02P37088. MANUFACTURER: American Red Cross Blood Services, Central Plains Region, Whichita, KS. RECALLED BY: Manufacturer by telephone on December 8, 1997. Firm-initiated recall complete. DISTRIBUTION: Kansas. QUANTITY: One units. REASON: Blood product, which had an unacceptable platelet count, was labeled as a licensed product, and distributed. ________ PRODUCTS: a) Red Blood Cells. Recall #B-604-1; b) Platelets. Recall #B-605-1. CODE: a) Unit Y32453; b) Unit Y32453. MANUFACTURER: Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL. RECALLED BY: Manufacturer by letters dated November 2, 2000. Firm-initiated recall complete. DISTRIBUTION: Illinois. QUANTITY: Two units. REASON: Blood product, collected from a donor who had traveled to an area designated as endemic for malaria, was distributed. ________ PRODUCTS: Red Blood Cells. Recall #B-606-1. CODE: Unit L03339. MANUFACTURER: Community Blood Center of Greater Kansas City, Topeka, KS. RECALLED BY: Manufacturer by letter dated November 3, 1998. Firm-initiated recall complete. DISTRIBUTION: Kansas. QUANTITY: One units. REASON: Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. ________ PRODUCTS: Red Blood Cells. Recall #B-607-1. CODE: Unit 54KM51871. MANUFACTURER: American Red Cross, Puerto Rico Region, Rio Piedras, PR. RECALLED BY: Manufacturer by letter dated October 22, 1998. Firm-initiated recall complete. DISTRIBUTION: Puerto Rico. QUANTITY: One unit. REASON: Blood product, collected from a donor who had traveled to an area designated as endemic for malaria, was distributed. ________ PRODUCTS: a) Red Blood Cells. Recall #B-608-1; b) Red Blood Cells, Leukoreduced. Recall #B-609-1; c) Fresh Frozen Plasma. Recall #B-610-1; d) Cryoprecipitated AHF. Recall #B-611-1; e) Platelets. Recall #B-612-1; f) Recovered Plasma. Recall #B-613-1. CODE: a) Units K03299, K05228, K07629, K16798, K21014, K24351; b) Unit K09593; c) Units K03299, K16798, K21014; d) Unit K24351; e) Unit K09593; f) Units K05228, K07629, K09593, K24351. MANUFACTURER: Community Blood Center of Greater Kansas City, Topeka, KS. RECALLED BY: Community Blood Center of Greater Kansas City, Kansas City, MO, by letter dated July 19, 1999, July 20, 1999 or by facsimile on July 23, 1999. Firm-initiated recall complete. DISTRIBUTION: Kansas, Missouri, Arkansas, New Jersey, California and Switzerland. QUANTITY: 16 units. REASON: Blood products, collected from a donor who provided a history of hepatitis, were distributed. ________ PRODUCTS: a) Red Blood Cells. Recall #B-614-1; b) Fresh Frozen Plasma. Recall #B-615-1. CODE: a) Unit 02FC39166; b) Unit 02FC39166. MANUFACTURER: American Red Cross Blood Services, Central Plains Region, Whichita, KS. RECALLED BY: Manufacturer, by telephone on May 27, 1998. Firm-initiated recall complete. DISTRIBUTION: Kansas. QUANTITY: Two units. REASON: Blood products, collected from a donor with a history of having tested positive for hepatitis C, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-618-1; b) Recovered Plasma. Recall #B-619-1. CODE: a) Unit 35V36133 b) Unit 35V36133. MANUFACTURER: American Red Cross, Appalachian Region Blood Services, Roanoke, VA. RECALLED BY: Manufacturer, by letter dated July 6, 2000. Firm-initiated recall complete. DISTRIBUTION: Puerto Rico. QUANTITY: Two units. REASON: Blood products, collected from a donor with a history of jaundice, were distributed. ________ PRODUCT: Red Blood Cells. Recall #B-620-1. CODE: Unit R11448. MANUFACTURER: Tacoma-Pierce County Blood Bank, dba: Cascade Regional Blood Services, Tacoma, WA. RECALLED BY: Manufacturer, by letter dated September 7, 2000. Firm-initiated recall complete. DISTRIBUTION: Washington. QUANTITY: One unit. REASON: Blood product, collected from a donor who reported having lived in an area designated as endemic for malaria, was distributed. ________ PRODUCT: Red Blood Cells Leukoreduced . Recall #B-621-1. CODE: Unit 29KM06208. MANUFACTURER: American Red Cross Blood Services, Mid-Atlantic Region, Norfolk, VA. RECALLED by: Manufacturer, by letter dated October 18, 2000. Firm-initiated recall complete. DISTRIBUTION: Virginia. QUANTITY: One unit. REASON: Blood product, collected from a donor who had traveled to an area designated as endemic for malaria, was distributed. ________ PRODUCT: a) Red Blood Cells, Leukoreduced. Recall #B-624-1; b) Platelets. Recall #B-625-1. c) Fresh Frozen Plasma. Recall #B-626-1. CODE: a) Unit 36R67504; b) Unit 36R67504; c) Unit 36R67504 MANUFACTURER: American Red Cross Blood Services, South Carolina Region, Columbia, SC. RECALLED BY: Manufacturer, by letters dated February 22, 2000. One consignee was also notified by telephone on February 10. 2000. Firm-initiated recall complete. DISTRIBUTION: South Carolina. QUANTITY: Three units. REASON: Blood products, collected from a donor who had undergone a splenectomy, were distributed. ________ PRODUCT: Allergenic Extract, Tuna, for Scratch, Prick or Puncture Testing. Recall #B-627-1. CODE: Lot B18J3824 Expires 10/23/2001. MANUFACTURER: Hollister-Stier Laboratories LLC, Spokane, WA. RECALLED BY: Manufacturer, by letters dated October 3, 2000. Firm-initiated recall complete. DISTRIBUTION: The United States and in Israel, England, United Kingdom, United Arab Emirates, Italy, Hong Kong, Portugal, Republic of South Africa and Canada, QUANTITY: 573 vials. REASON: Sterility of the product can not be assured due to questions raised during a review of the sterility test results. ________ PRODUCT: a) Allergenic Extract, Pork, for Scratch, Prick or Puncture Testing. Recall #B-628-1. b) Allergenic Extract, Beef, for Scratch, Prick or Puncture Testing. Recall #B-629-1. CODE: a) Lots G20D9653, G20D9653C; b) Lot B30D9633C. MANUFACTURER: Hollister-Stier Laboratories LLC, Spokane, WA. RECALLED BY: Manufacturer, by telephone on September 20, 2000, and by letters dated September 21, 2000. Firm-initiated recall complete. DISTRIBUTION: The United States, Canada and Australia. QUANTITY: a) 93 vials; b) 9 vials distributed. REASON: Sterility of the product can not be assured due to questions raised during a review of the sterility test results. __ PRODUCT: a) Red Blood Cells. Recall #B-630-1; b) Red Blood Cells, Leukoreduced . Recall #B-631-1; c) Platelets. Recall #B-632-1; d) Recovered Plasma. Recall #B-633-1. CODE: a) Unit 39G99294; b) Unit 39G10915; c) Units 39G99294, 39G10915; d) Units 39G99294, 39G10915. MANUFACTURER: American Red Cross, Greater Alleghenies Region, Huntington, WV. RECALLED BY: Manufacturer, by telephone and letter on July 17, 2000. DISTRIBUTION: Ohio, Kentucky, and West Virginia, by telephone and letter on July 17, 2000. QUANTITY: 6 units. REASON: Blood products collected from a donor who engaged in high risk behaviors. ________ PRODUCT: Platelets Pheresis, Leukocytes Removed. Recall # B-638-1. CODE: Unit 00-79401 (split unit). MANUFACTURER: Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, MI. RECALLED BY: Manufacturer, by telephone on April 13, 1999. Firm-initiated recall complete. DISTRIBUTION: Michigan. QUANTITY: One unit (split unit). REASON: Platelets with a decreased platelet count were distributed. ________ PRODUCT: Platelets. Recall #B-639-1. CODES: (661 units), unit numbers 30-04881, 30-04882, 30-04883, 30-04884, 30-04885, 30-04886, 30-04887, 30-04889, 30-04890, 30-04891, 30-04893, 30-04894, 30-04895, 30-04896, 30-04897, 30-04898, 30-04899, 30-04900, 30-04901, 30-04902, 30-04903, 30-04904, 30-04905, 30-04906, 30-04907, 30-04908, 30-04909, 30-04910, 30-04911, 30-04912, 30-04914, 30-04915, 30-04916, 30-04917, 30-04918, 30-04921, 30-04923, 30-04924, 30-04925, 30-04926, 30-04927, 30-04929, 30-04930, 30-04932, 30-04933, 30-04934, 30-04936, 30-04939, 30-04942, 30-04943, 30-04944, 30-04947, 30-04948, 30-04950, 30-04951, 30-04952, 30-04953, 30-04954, 30-04958, 30-04959, 30-04961, 30-04962, 30-04963, 30-04965, 30-04966, 30-04967, 30-04968, 30-04969, 30-04970, 30-04971, 30-04972, 30-04974, 30-04975, 30-04976, 34-36396, 34-36398, 34-36399, 34-36400, 34-36401, 34-36402, 34-36403, 34-36404, 34-36406, 34-36408, 34-36409, 34-36410, 34-36412, 34-36413, 34-36416, 34-36417, 34-36418, 34-36419, 34-36420, 34-36421, 34-36422, 34-36423, 34-36424, 34-36426, 34-36427, 34-36428, 34-36429, 34-36430, 34-36431, 34-36432, 34-36434, 34-36436, 34-36438, 34-36439, 34-36440, 34-36441, 34-36442, 34-36443, 34-36444, 34-36445, 34-36446, 34-36447, 34-36448, 34-36449, 34-36450, 34-36451, 34-36452, 34-36453, 34-36454, 34-36455, 34-36456, 34-36457, 34-36458, 34-36459, 34-36460, 34-36461, 34-36462, 34-36463, 34-36468, 34-36469, 34-36470, 34-36471, 34-36472, 34-36474, 34-36475, 34-36477, 34-36478, 34-36479, 34-36480, 34-36482, 34-36483, 34-36484, 34-36485, 34-36486, 34-36487, 34-36488, 34-36489, 34-36490, 34-36491, 34-36492, 34-36493, 34-36494, 34-36495, 34-36498, 34-36499, 34-36500, 34-36501, 34-36503, 34-36504, 34-36505, 34-36506, 34-36508, 34-36510, 34-36513, 34-36515, 34-36516, 34-36517, 34-36518, 34-36521, 34-36522, 34-36524, 34-36525, 34-36529, 34-36530, 34-36537, 36-16027, 36-16028, 36-16029, 36-16030, 36-16031, 36-16032, 36-16033, 36-16034, 36-16036, 36-16038, 36-16040, 36-16041, 36-16042, 36-16043, 36-16044, 36-16045, 36-16047, 36-16048, 36-16049, 36-16050, 36-16051, 36-16052, 36-16054, 36-16055, 36-16056, 36-16057, 36-16058, 36-16059, 36-16060, 36-16061, 36-16062, 36-16063, 36-16066, 36-16067, 36-16068, 36-16071, 36-16072, 36-16076, 36-16078, 36-16079, 36-16080, 36-16081, 36-16082, 36-16083, 36-16084, 36-16086, 36-16087, 36-16088, 36-16090, 36-16092, 36-16094, 36-16095, 36-16097, 36-16098, 36-16099, 36-16102, 36-16103, 36-16104, 36-16106, 36-16108, 36-16109, 36-16111, 36-16113, 36-16115, 36-16116, 36-16117, 36-16118, 36-16119, 36-16120, 36-16121, 36-16122, 36-16123, 36-16124, 36-16125, 36-16126, 36-16127, 36-16128, 36-16129, 36-16130, 36-16131, 36-16132, 36-16133, 36-16134, 36-16138, 36-16139, 36-16140, 36-16141, 36-16142, 36-16144, 36-16146, 36-16147, 36-16148, 36-16149, 36-16150, 36-16152, 36-16153, 36-16154, 36-16155, 36-16156, 36-16157, 36-16158, 36-16159, 36-16160, 36-16161, 36-16162, 36-16163, 36-16165, 36-16166, 36-16167, 36-16169, 36-16170, 36-16172, 36-16173, 36-16174, 36-16175, 36-16176, 36-16177, 36-16178, 36-16181, 36-16182, 36-16183, 36-16184, 36-16185, 36-16186, 36-16188, 36-16189, 36-16191, 36-16192, 36-16193, 36-16194, 36-16196, 36-16197, 36-16198, 36-16200, 36-16201, 36-16203, 36-16204, 36-16207, 36-16208, 36-16209, 36-16214, 36-16215, 36-16216, 36-16217, 36-16219, 36-16221, 36-16223, 36-16224, 36-16225, 36-16229, 36-16233, 36-16236, 36-16237, 36-16238, 36-16239, 36-16240, 36-16241, 36-16243, 36-16244, 36-16245, 36-16246, 36-16249, 36-16325, 36-16326, 36-16327, 36-16328, 36-16329, 36-16330, 38-21461, 38-21468, 38-21469, 38-21471, 38-21472, 38-21473, 38-21474, 38-21475, 38-21476, 38-21477, 38-21478, 38-21480, 38-21481, 38-21483, 38-21484, 38-21485, 38-21486, 38-21487, 38-21488, 38-21503, 38-21504, 38-21505, 38-21506, 38-21508, 38-21510, 38-21512, 38-21513, 38-21514, 38-21516, 38-21521, 38-21522, 38-21523, 38-21524, 38-21527, 38-21529, 38-21530, 38-21531, 38-21533, 38-21534, 38-21535, 38-21537, 38-21538, 38-21539, 38-21540, 38-21541, 38-21542, 38-21543, 38-21544, 38-21545, 38-21546, 38-21549, 38-21553, 38-21556, 38-21462, 38-21463, 38-21566, 38-21567, 38-21568, 38-21569, 38-21570, 38-21571, 38-21572, 38-21573, 38-21574, 38-21576, 38-21577, 38-21578, 38-21579, 38-21580, 38-21581, 38-21583, 38-21584, 38-21585, 38-21586, 38-21587, 38-21588, 38-21589, 38-21590, 38-21592, 38-21594, 38-21595, 38-21596, 38-21597, 38-21598, 38-21599, 38-21600, 38-21601, 38-21604, 38-21606, 42-05087, 42-05088, 42-05089, 42-05090, 62-24668, 62-24669, 62-24670, 62-24672, 62-24673, 62-24674, 62-24675, 62-24676, 62-24678, 62-24679, 62-24680, 62-24681, 62-24682, 62-24683, 62-24684, 62-24685, 62-24687, 62-24688, 62-24692, 62-24694, 62-24695, 62-24696, 62-24697, 62-24700, 62-24703, 62-24706, 62-24709, 62-24710, 62-24711, 62-24713, 62-24714, 62-24715, 62-24719, 62-24742, 62-24743, 63-24745, 62-24748, 62-24749, 62-24750, 62-24751, 62-24753, 62-24755, 62-24758, 62-24759, 62-24760, 62-24761, 62-24763, 62-24764, 62-24766, 62-24767, 62-24769, 62-24770, 62-24776, 62-24780, 62-24781, 62-24783, 62-24785, 62-24786, 62-24791, 62-24813, 62-24814, 62-24818, 62-24819, 62-24821, 62-24823, 62-24824, 62-24825, 62-24826, 62-24827, 62-24829, 62-24831, 62-24832, 62-24834, 62-24835, 62-24836, 62-24837, 62-24838, 62-24839, 62-24840, 62-24841, 62-24843, 62-24844, 62-24846, 62-24848, 62-24849, 62-24850, 62-24851, 62-24852, 62-24853, 62-24854, 62-24856, 62-24857, 62-24862, 62-24863, 62-24865, 62-24866, 62-24869, 62-24870, 62-24871, 62-24874, 62-24878, 62-24879, 62-24880, 62-24884, 62-24885, 62-24892, 62-24893, 62-24894, 62-24895, 62-24896, 62-24897, 62-24898, 62-24899, 62-24900, 62-24904, 62-24905, 62-24909, 62-24910, 62-24912, 62-24913, 62-24914, 62-24919, 62-24929, 62-24961, 63-02646, 63-02653, 63-02656, 63-02662, 63-02663, 63-02664, 63-02668, 63-02672, 63-02675, 63-02676, 63-02677, 63-02678, 63-02679, 63-02680, 63-02682, 63-02683, 63-02684, 63-02691, 63-02694, 63-02695, 63-02697, 63-02699, 63-02700, 63-02701, 63-02704, 63-02705, 63-02706, 63-02707, 63-02709, 63-02712, 87-05678, 87-05679, 87-05681, 87-05683, 87-05686, 87-05687, 87-05689, 87-05690, 87-05691, 87-05692, 87-05695, 87-05696, 87-05697, 87-05698, 87-05699, 87-05700, 87-05701, 87-05703, 87-05704, 87-05705, 87-05706, 87-05707, 87-05708, 87-05709, 87-05710, 87-05711, 87-05713, 87-05717, 87-05718, 87-05721, 87-05724, 87-05725, 87-05726, 87-05727, 87-05728, 87-05729, 87-05731, 87-05732, 87-05734, 87-05735, 87-05736, 87-05737, 87-05738, 87-05739, 87-05740, 87-05741, 87-05742, 87-05746, 87-05747, 87-05748, 87-05750, 87-05753, 87-05754, 87-05755, 87-05756, 87-05757, 87-05758, 87-05760, 87-05762, 87-05766, 87-05768, 87-05769, 87-05770, 87-05772, 87-05773, 87-05774, and 87-05788 MANUFACTURER: Michigan Community Blood Centers, Saginaw Valley Blood Program, Saginaw, MI. RECALLED BY: Manufacturer, by letter dated June 26, 1997. Firm-initiated recall complete. DISTRIBUTION: Michigan. QUANTITY: 661 units. REASON: Platelets with a decreased platelet count were distributed. ________ PRODUCT: Platelets Pheresis, Recall #B-642-1. CODE:.Unit 13P80714. MANUFACTURER: The American National Red Cross, Southeastern Michigan Region, Detroit, MI. RECALLED BY: Manufacturer, by telephone on November 10, 2000. Firm-initiated recall complete. DISTRIBUTION: Michigan. QUANTITY: One unit. REASON: Platelets with a decreased platelet count were distributed. _________ PRODUCTS: a) Red Blood Cells. Recall #B-647-1; b) Cryoprecipitated AHF. Recall #B-648-1; c) Recovered Plasma. Recall #B-649-1. CODE: a) units J31046 and J31774; b) unit J31774; c) units J31046 and J31774. MANUFACTURER: Mississippi Valley Regional Blood Center, Davenport, IA. RECALLED BY: Manufacturer, by telephone and letter on April 28, 1999, and by letter dated May 5, 1999. DISTRIBUTION: New York,and Illinois, and the recalled units of Recovered Plasma were distributed to a manufacturer in Switzerland. QUANTITY: Five units. REASON: Blood products, collected from a donor who should have been deferred due to use of the medication Arthrotec, were distributed. _________ PRODUCTS: a) Whole Blood. Recall # B-654-1; b) Red Blood Cells. Recall #B-655-1; c) Platelets. Recall #B-656-1; d) Platelets Pheresis. Recall #B-657-1; e) Fresh Frozen Plasma. Recall #B-658-1. CODE: a) (1 unit), unit number W83606; b) (19 units), unit numbers S04072, M30948, W11477, W40907, W40910. W40911, W40916, W40936, W40954, W83604, W63605, W83698, W83611, W83612, W83613, W83616, R31096, W83610, and C20775; c) (4 units), unit numbers S04072, M30948, W40916, and W40936 d) (17 units), unit numbers C04160, C04169, C04173, C04176 (split unit), W63943, W63945 (split unit), W63946, W63949 (split unit), W63951 (split unit), W63952 (split unit), and W63953 (split unit); e) (2 units), unit numbers S04072 and W40936. MANUFACTURER: Virginia Blood Services, Richmond, VA. RECALLED BY: Manufacturer, by letter dated July 7, 2000. Firm-initiated recall complete. DISTRIBUTION: Virginia. QUANTITY: 43 Units. REASON: Blood products, incorrectly tested for antibodies to human immunodeficiency virus types 1 and 2 (anti-HIV- 1/2), were distributed. _________ PRODUCTS: a) Recall #B-659-1. Red Blood Cells; b) Recall #B-660-1 Red Blood Cells, Washed; c) Recall #B-661-1 Red Blood Cells, Leukocytes Removed; d) Recall#B-662-1 Platelets; e) Recall #B-663-1 Fresh Frozen Plasma; f) Recall #B-664-1 Cryoprecipitated AHF; g) Recall #B-665-1 Red Blood Cells for Further Manufacture; h) Recall #B-666-1 Plasma for Research; i) Recall #B-667-1 Platelets for Research; j) Recall #B-668-1 Recovered Plasma. CODE: a)Red Blood Cells (55 units), unit numbers 13V83920, 13Y96600, 13FT17497, 13Y04038, 13K40845, 13V22529, 13X81276, 13K27348, 13X79486, 13GZ20461, 13V80156, 13FN12829, 13GZ21786, 13FJ29329, 13FL70009, 13FL68305, 13GZ29631, 13FL78920, 13GQ22400, 13FN44055, 13X85831, 13H24374, 13K37167, 13M37585, 13FG03516, 13H55192, 13T65594, 13FY10318, 13FH39024, 13Y05308, 13H80153, 13H44347, 13M26782, 13C69182, 13H70731, 13J90716, 13E59743, 13K41257, 13G75682, 13Q29515, 13FC65290, 13Y86229, 13M38562, 13V84357, 13M15247, 13V00626, 13J90910, 13V96443, 13E78693, 13FC95243, 13FH57226, 13G47282, 13M25845, 13FC87774 and 13K26624; b) Red Blood Cells, Washed (1 unit), unit number 13E42281; c)Red Blood Cells, Leukocytes Removed (4 units), unit numbers 13FJ52467, 13FN49947, 13GC25756, and 13FG34540 d) Platelets (40 units), unit numbers 13X81276, 13K27348, 13X79486, 13GZ20461, 13FN12829, 13FJ29329, 13FL68305, 13GZ29631, 13FL78920, 13GQ22400, 13FN44055, 13FJ52467, 13FN49947, 13X85831, 13H24374, 13K37167, 13M37585, 13FG03516, 13H55192, 13T65594, 13GC25756, 13FH39024, 13Y05308, 13H80153, 13FG34540, 13C69182, 13H70731, 13E59743, 13G75682, 13Q29515, 13FC65290, 13Y86229, 13M38562, 13V84357, 13V00626, 13J90910, 13V96443, 13FC95243, 13FH57226, and 13G47282; e) Fresh Frozen Plasma (17 units), unit numbers 13GZ20461, 13FN12829, 13FJ29329, 13GZ29631, 13FL78920, 13GQ22400, 13H24374, 13T65594, 13GC25756, 13FY10318, 13FH39024, 13Y05308, 13FG34540, 13G75682, 13J90910, 13E78693 and 13FC95243; f) Cryoprecipitated AHF (6 units), unit numbers 13K37167, 13FG03516, 13H55192, 13H80153, 13V96443 and 13G47282; g)Red Blood Cells for Further Manufacture (1 unit), unit number 13H96061 h) Plasma for Research (1 unit), unit number: 13GZ23302; i) Platelets for Research (3 units), unit numbers 13Y96600, 13E78693 and 13K40845; j) Recovered Plasma (48 units), unit numbers 13V83920, 13E42281, 13Y96600, 13FT17497, 13Y04038, 13K40845, 13V22529, 13FG06138, 13H96061, 13X51690, 13FH30922, 13X81276, 13K27348, 13X79486, 13V80156, 13GZ21786, 13FL70009, 13FL68305, 13FG57209, 13FN44055, 13FJ52467, 13FN49947, 13X85831, 13K37167, 13M37585, 13FG03516, 13H55192, 13H80153, 13H44347, 13M26782, 13C69182, 13H70731, 13J90716, 13E59743, 13K41257, 13Q29515, 13FC65290, 13Y86229, 13M38562, 13V84357, 13M15247, 13V00626, 13V96443, 13FH57226, 13G47282, 13M25845, 13FC87774 and 13K26624. MANUFACTURER: The American National Red Cross, Southeastern Michigan Region, Detroit, MI. RECALLED BY: Manufacturer, by letters between March 10, 2000, and April 30, 2000. Firm-initiated recall complete. DISTRIBUTION: Michigan and California. QUANTITY: 128 units. REASON: Blood products, that tested negative for antibody to human immunodeficiency virus type 1 (anti-HIV-1), but were collected from donors that previously tested repeatedly reactive for anti-HIV-1, were distributed. _________ PRODUCTS: Red Blood Cells, Leukoreduced. Recall #B-690-1. CODE: Units 38FE61433, 38FE61446 MANUFACTURER: American Red Cross Great Lakes Region, Fort Wayne, IN. RECALLED BY: Manufacturer by telephone and letter on August 18, 2000. Firm- Initiated recall complete. DISTRIBUTION: Indiana. QUANTITY: 2 units. REASON: Blood products, collected in bags that had missing tabs that cover the sterile ports, were distributed. ________ PRODUCT: Source Plasma. Recall #B-702-1. CODE: (7 units), unit numbers 0420770632, 0420772753, 0420778169,0420809898, 0420810231, 0420810989, and 0420811732. MANUFACTURER: North American Biologicals, Inc., Lansing, MI. RECALLED BY: Manufacturer, by letter dated July 11, 1998. DISTRIBUTION: North Carolina. QUANTITY: 7 units. REASON: Blood products, that tested negative for antibody to human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor that previously tested repeatedly reactive for anti-HIV-1, were distributed. ________ PRODUCT: Source Plasma. Recall #B-703-1. CODE: Unit NF140138. MANUFACTURER: Sera-Tec Biologicals Limited Partnership, Clarksburg, WV. RECALLED BY: Sera-Tec Biologicals Limited Partnership, Harrisburg, PA, by letter dated August 25, 2000. Firm-initiated recall complete. DISTRIBUTION: North Carolina. QUANTITY: One unit. REASON: Blood product, collected from an unsuitable donor due to a history of illegal drug use, was distributed. ________ PRODUCT: Recovered Plasma. Recall #B-704-1. CODE: unit 1151239 MANUFACTURER: University of Texas, M.D. Anderson Cancer Center, Houston, TX. RECALLED BY: Manufacturer, by telephone and letter on September 28, 2000. Firm-initiated recall complete. DISTRIBUTION: Texas. QUANTITY: One unit. REASON: Blood product, collected from an unsuitable donor due to a history in intravenous drug use, was distributed. ________ PRODUCT: Source Plasma. Recall # B-705-1. CODE: unit number 0420710712. MANUFACTURER: North American Biologicals, Inc., Lansing, MI Problem: RECALLED BY: Manufacturer, by letter dated March 25, 1998. Firm-initiated recall complete. DISTRIBUTION: North Carolina. QUANTITY: One unit. REASON: Blood product, collected from an unsuitable donor due to a history of body piercing, was distributed. _________ PRODUCTS: a) Red Blood Cells. Recall # B-706-1; b) Platelets, Irradiated. Recall #B-707-1. CODES: a) unit number T55528; b) unit number T55528. MANUFACTURER: Virginia Blood Services, Richmond, VA. RECALLED BY: Manufacturer, by telephone on September 18, 2000. Firm-initiated recall complete. DISTRIBUTION: Virginia. QUANTITY: 2 units. REASON: Blood products, collected from an unsuitable donor due to an incomplete donor health screening concerning behavior found to increase the risk of infection with human immunodeficiency virus (HIV), were distributed.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_________ PRODUCTS: a) Platelets. Recall #B-643-1. b) Platelets Pheresis. Recall #B-644-1. CODES: a)(255 units), unit numbers 13FS75226, 13FY49502, 13FS75214, 13GQ27528, 13GQ27534, 13FS75225, 13FG84961, 13FG84962, 13FN47332, 13FN47333, 13FG84955, 13FC02533, 13FC02534, 13GQ27513, 13GM40055, 13GM40060, 13GM40064, 13GM40045, 13GM40049, 13FY49493, 13FY49496, 13GX24542, 13GX24543, 13GX24545, 13LG62563, 13GR12769, 13GR12770, 13GR12771, 13LG62569, 13GR12772, 13GR12774, 13GX24525, 13GX24529, 13GX24531, 13GX24534, 13GX24498, 13GX24500, 13GX24502, 13GX24503, 13GX24506, 13GX24507, 13GX24508, 13GX24486, 13GX24509, 13GX24512, 13GX24513, 13GX24487, 13GX24488, 13GX24489, 13GX24490, 13GX24494, 13GX24471, 13GX24472, 13GX24474, 13GX24497, 13GX24475, 13GX24476, 13GQ27514, 13GX24481, 13GQ27517, 13GR12738, 13GR12748, 13GC73434, 13GC73435, 13GC73436, 13GC73437, 13GC73438, 13GQ27519, 13GQ27521, 13GC73419, 13GC73422, 13GC73423, 13GC73424, 13GC73425, 13GC73426, 13GC73427, 13GC73428, 13FM49578, 13GC73429, 13FM49580, 13FR20847, 13FR20849, 13FR20850, 13FR20854, 13FJ52272, 13FJ52274, 13FC02555, 13FC02556, 13FC02560, 13FC02562, 13FC02544, 13FC02545, 13GX24587, 13GX24573, 13GX24576, 13GX24580, 13GX24581, 13GX24555, 13GX24556, 13GX24559, 13GX24560, 13GX24561, 13GX24565, 13GX24563, 13GM40089, 13GM40084, 13FY49517, 13FY49512, 13FM49585, 13FS75237, 13FS75240, 13FS75242, 13FS75243, 13FN47363, 13FN47356, 13FR20868, 13FN47359, 13FN47361, 13FN47348, 13FN47349, 13FN47351, 13FN47352, 13FL95284, 13FL95286, 13FL95287, 13FL95289, 13FL95290, 13FL95291, 13FM49582, 13FM49583, 13FL95271, 13FL95272, 13FL95273, 13FL95277, 13FL95278, 13FL95280, 13FL95281, 13FL95283, 13FN47373, 13W97692, 13W97696, 13W97689, 13W97690, 13T83658, 13GR12780, 13FS75258, 13LG62616, 13LG62634, 13LG62594, 13LG62595, 13LG62631, 13GR12817, 13FS75287, 13FS75290, 13GR12802, 13GR12807, 13FS75275, 13FS75279, 13FS75280, 13FN47403, 13FN47404, 13GR12756, 13GR12767, 13FG84964, 13FC02537, 13FC02535, 13GM40074, 13GC73431, 13GC73432, 13GQ27520, 13FR20857, 13FR20856, 13FM49569, 13GM40069, 13GM40061, 13FY49498, 13GX24540, 13LG62567, 13GR12750, 13GQ27515, 13GQ27518, 13GR12745, 13GR12749, 13GC73420, 13FR20855, 13FG84969, 13FC02554, 13GX24593, 13GX24574, 13GX24564, 13GX24579, 13LG62576, 13GM40099, 13GM40101, 13LG62630, 13FM49573, 13FM49575, 13FJ52268, 13FM49563, 13FM49564, 13FG84971, 13GM40059, 13GC73433, 13FM49566, 13FM49568, 13FM49570, 13FG84974, 13FG84975, 13FJ52264, 13FJ52266, 13FC02558, 13FC02561, 13FC02542, 13FG84968, 13FC02546, 13FC02547, 13FC02548, 13FC02549, 13GX24582, 13GX24588, 13GX24590, 13GM40051, 13GM40048, 13GX24535, 13GX24526, 13GX24492, 13GR12739, 13FM49561, 13FJ52275, 13GX24485, 13GX24493, 13GR12740, 13GM40088, 13GM40091, 13GM40098, 13GM40081, 13FS75251, 13FY49508, 13FR20858, 13T83683, 13LG62602, 13GQ27524, 13FL95308, 13FN47391, 13FN47399, 13FN47400, 13FN47395, 13GR12789, 13LG62626, 13LG62596, 13LG62597, 13L94706, 13W97716, 13P75541, and 13FR20865 b) (5 units), unit numbers 13P75530 (split unit), 13P75533, 13P75504, and 13P75542 MANUFACTURER: The American National Red Cross, Southeastern Michigan Region, Detroit, MI. RECALLED BY: Manufacturer, by telephone on November 8, 1999, and by letter dated November 18, 1999. DISTRIBUTION: Michigan. QUANTITY: a) Platelets - 255 units; b) Platelets Pheresis - 5 units. REASON: Platelets, exposed to unacceptable storage temperatures, were distributed.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT: Vitros Immunodiagnostic Products AFP Reagent; Z-208-1 - Catalog No. 680 0784 AFP Reagent; Z-209-1 - Catalog No. 680 0038 CA 125 II Reagent Pack; Z-210-1 - Catalog No. 680 0039 CA 15-3; Z-211-1 - Catalog No. 189 6836 CK-MB Reagent Pack; Z-212-1 - Catalog No. 107 4053 Cortisol Reagent Pack; Z-213-1 - Catalog No. 835 6636 Ferritin Reagent Pack; Z-214-1 - Catalog No. 138 7000 Free T4 Reagent Pack; Z-215-1 - Catalog No. 193 1922 FSH Reagent Pack; Z-216-1 - Catalog No. 135 0198 LH Reagent Pack; Z-217-1 - Catalog No. 680 0030 NTx Reagent Pack; Z-218-1 - Catalog No. 184 9743 Prolactin Reagent Pack; Z-219-1 - Catalog No. 680 0269 Total B-hCG Reagent Pack. CODE: (1) AFP, All lots below 5070; (2) CA 125 II, all lots below 120; (3) CA 15-3, all lots below 80; (4) CK-MB, all lots 101; (5) Cortisol, all lots below 81; (6) Ferritin, all lots below 112; (7) Free T4, all lots below 222; (8) FHS, all lots below 130; (9) LH, all lots below 101; (10) NTx, all lots below 100; (11) Prolactin, all lots below 102; (12) Total B-hCG, all lots below 140. MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Rochester, NY. RECALLED BY: Manufacturer, by letter on May 2, 2000. Corrected letters were sent on May 9, 2000, and letters with further revised instructions were sent on August 31, 2000. Firm- initiated recall ongoing. DISTRIBUTION: Nationwide to 157 clinic and hospital laboratories, 26 Federal Government accounts (Contract V797P-6565A), and to 18 OCD/J&J Affiliates worldwide. QUANTITY: 16,354 kits. REASON: Defective microtiter wells in the various reagent packs. Some wells were not coated with the binding agent (Streptavidin). ________ PRODUCT: Cryovalve Allograft; a) Z-236-1 - Model No. AV00, Serial No. 3874532; b) Z-237-1 - Model No. PV10, Serial No. 3874524. CODE: a) Model No. AV00, Serial No. 3874532; b) Model No. PV10, Serial No. 3874524; MANUFACTURER: Cryolife, Inc., Kennesaw, GA. RECALLED BY: Manufacturer, by letter on December 14, 2000 and by telephone on December 21, 2000. Firm-initiated recall complete. DISTRIBUTION: Pasadena, CA. And Omaha, NE. QUANTITY: 2 valves. REASON: Donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered. ________ PRODUCT: Cryovalve Allograft; a) Z-238-1 - Model No. AV00, Serial No. 3958221; b) Z-239-1 - Model No. PV00, Serial No. 3958248. CODE: a) Model No. AV00, Serial No. 3958221; b) Model No. PV00, Serial No. 3958248. MANUFACTURER: Cryolife, Inc., Kennesaw, GA. RECALLED BY: Manufacturer, by letter on December 13, 2000. Firm-initiated recall complete. DISTRIBUTION: Milwaukee, WI. And Denver, CO. QUANTITY: 2 valves. REASON: Donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered. ________ PRODUCT: Cryovalve Allograft, Model No. PV05, Serial No. 3945944. Recall #Z-240-1. CODE: Model No. PV05, Serial No. 3945944. MANUFACTURER: Cryolife, Inc., Kennesaw, GA. RECALLED BY: Manufacturer, by telephone and bisit by a CryoLife Technical Representative on Decemb 14, 2000 . Firm- initiated recall complete. DISTRIBUTION: Milwaukee, WI. QUANTITY: 1 valve. REASON: Donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered. ________ PRODUCT: Cryovalve Allograft, Model No. AV05, Serial No. 3945936. Recall #Z-241-1. CODE: Model No. AV05, Serial No. 3945936. MANUFACTURER: Cryolife, Inc., Kennesaw, GA. RECALLED BY: Manufacturer, by letter on December 15, 2000, and telephone on December 21, 2000. Firm-initiated recall complete. DISTRIBUTION: Cleveland, OH. QUANTITY: 1 valve. REASON: Donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered. ________ PRODUCT: Cryovalve Allograft, Model No. PV00, Serial No. 3946096. Recall #Z-242-1. CODE: Model No. PV00, Serial No. 3946096. MANUFACTURER: Cryolife, Inc., Kennesaw, GA. RECALLED BY: Manufacturer, by letter on January 2, 2001. Firm-initiated recall complete. DISTRIBUTION: Tampa, FL. QUANTITY: 1 valve. REASON: Donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_________ PRODUCT: Florestore Flowable Composite with Fluoride Light Cure. Recall #Z-224-1. CODE: Lot No. 407001C, Part No. 030381827. MANUFACTURER: Den-Mat Corp., Santa Maria, CA. RECALLED BY: Manufacturer, by telephone on June 26, 2000. Firm-initiated recall as complete. DISTRIBUTION: Canada. QUANTITY: 7 REASON: Lot failed the bond strength test prior to the expiration date of the product.END OF ENFORCEMENT REPORT FOR FEBRUARY 21, 2001 ####
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2001-FEB-21.