March 7, 2001 01-09
________ PRODUCT: German Chocolate Brownies. Recall # F-249-1; Peanut Butter Brownies - Giant. Recall #F-250-1; Cream Cheese Brownies. Recall #F-251-1; Peanut Butter Fudge Brownies- 8" SQ. Recall #F-252-1; M & M Brownies - Giant. Recall #F-253-1. CODE: Sell by dates from Nov. 1 to Nov. 11. MANUFACTURER: Glen’s Markets and Ashcraft Markets retail stores bakeries, northern Michigan RECALLED BY: Spartan Stores, Inc., Grand Rapids, MI, by fax on November 6, 2000. Firm-initiated recall complete. DISTRIBUTION: Northern Michigan. QUANTITY: 920 brownies of the various types. REASON: Brownies contain undeclared eggs. ________ PRODUCT: Apple Pie. Recall #F-254-1; Blackberry Pie. Recall #F-255-1; Blueberry Pie. Recall #F-256-1; Peach Pie. Recall #F-257-1; Cherry Pie. Recall #F-258-1; Razzleberry Pie. Recall #F-259-1; Strawberry-Rhubarb Pie. Recall #F-260-1. CODE: All pies that do not list eggs as an ingredient. MANUFACTURER: Western Country Pies, a Division of Edwards Fine Foods, Atlanta, GA. RECALLED BY: Manufacturer, by press release dated 12/8/00 and also established a Consumer Hot Line. Firm-initiated recall ongoing. DISTRIBUTION: AL, AZ, CA, COL, FL, ID, KS, LA, MO, NB, NM, NV, OK, OR, TN, TX, UT, WA, WY. QUANTITY: 463,400 total pies. REASON: The pies contain undeclared eggs. ________ PRODUCT: Red Wax Wedges of Cheddar Cheese. Recall #F-261-1. CODE: None. MANUFACTURER: Manufacturer of bulk cheese: Hill & Valley Cheese, Inc., Cashton, WI RECALLED BY: Bedford Cheese Store, Inc., Shelbyville, TN, by letter on November 6, 2000. Firm-initiated recall complete. DISTRIBUTION: Pell City, AL. QUANTITY: 18,000. REASON: The red wax wedges of cheddar cheese were manufactured using bulk cheese that Hill & Valley Cheese, Inc., Cashton, WI recalled due to potential Listeria monocytogenes contamination. ________ PRODUCT: Red Rind Cheddar Cheese Wedges. Recall #F-262-1. CODE: Product is not coded. The firm recalled product sold at retail on or after October 13, 2000. MANUFACTURER: Pioneer Cold Storage, Grenada, MS. Manufacturer of bulk cheese: Hill & Valley Cheese, Inc., Cashton, WI. RECALLED BY: Jitney Jungle Stores of America, Inc., Jackson, MS., by press release on November 4, 2000. Firm-initiated recall complete. DISTRIBUTION: LA, MS, AL, and FL. QUANTITY: 17,362.4 pounds of cheese. REASON: The product was manufactured using bulk cheese that Hill & Valley Cheese, Inc., Cashton, WI recalled due to potential Listeria monocytogenes contamination. ________ PRODUCT: Cole Slaw dressing in unlabeled plastic cups with plastic lids. Dressing is packed 12/16 oz. containers per case. Case labeling states "COLE SLAW DRESSING **". Recall #F-263-1. CODE: Cole Slaw Dressing: pull dates up to and including 121700. MANUFACTURER: Reser's Fine Foods, Inc., Beaverton, OR. RECALLED BY: Manufacturer, by telephone on 9/28/00. Firm-initiated recall complete. DISTRIBUTION: Oregon, Colorado, Arizona, and Idaho. QUANTITY: 2540 cases. REASON: Contains undeclared egg yolks. ________ PRODUCT: Bear Candy Smoked Salmon. Recall #F-265-1. CODE: “B118”and “B118X”ink stamped on individual packages. Packages are vacuum packed. MANUFACTURER: 2 Bear Ltd., Seattle, WA. RECALLED BY: Manufacturer, by telephone and mail on 9/22/00 and by press release 11/1/00. Firm-initiated recall completed. DISTRIBUTION: California. QUANTITY: 78 individual units weighing a total of 97 lbs. REASON: The product was contaminated with Listeriamonocytogenes. ________ PRODUCT: Weiss brand Gingerbread Assortment. Recall #F-266-1. CODE: All cookies in Christmas seasonal packaging. MANUFACTURER: Max Weiss GmBh, Nuernberg, Germany.. RECALLED BY: Stockmeyer, Inc., Lincoln Park, NJ, issued a press release on 12/8/2000. Firm-initiated recall completed. DISTRIBUTION: Nationwide. QUANTITY: 5725 cases. REASON: The product contains undeclared egg whites. ________ PRODUCT: Marshall’s Best Smoked Whitefish Salad. Recall #F-267- 1. CODE: 11777, expiration date 1/5/01. MANUFACTURER: Premier Smoked Fish, Inc., dba Hommarus/Marshall Smoked Fish, Inc., Bensalem, PA. RECALLED BY: Manufacturer, by press release and telephone on 12/15/00. Completed recall resulted from follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION: New York. QUANTITY: 5 lb tubs (600 lbs) and 30 cases of the 8 oz (2880 oz). REASON: The product was contaminated with Listeriamonocytogenes. _________ PRODUCTS: a) F-268-1 Colby and Monterey Jack Cheese (Colby Jack, Marble Jack) in chunks, slices, horn cut, or cubed: 1) County Line Colby Jack Cheese (Chunk), Net Wt. 8 oz. 2) County Line Colby Jack Cheese (Cubes), Net Wt. 8 oz. 3) County Line Marble Jack Cheese(Horn Cut),Net Wt. 1.5 lb. 4) County Line Colby Jack Cheese Slices, Net Wt. 1.5 lb. 5) County Line Colby Jack Cheese Slices, in random weight packages of about one pound. 6) Dorman's 100% Natural Colby Jack Cheese, two 5 pound labeled cubes packaged together 7) Lost Creek Farms Marble Jack (Horn Cut) random weight of about 1.5 lb.; 8) Lost Creek Farms Marble Jack (Cheese Slices), in random weight packages of about 7 - 10 oz. b) F-269-1 Football Platters: County Line Football Platters containing Colby Jack Cheese. c) F-270-1. Variety Pack: Dorman's 4/5 Lb. Variety Pack containing labeled 5 pound pakages of Colby Jack, Swiss, Pepper Jack, and Mild Cheddar cheeses. CODES: a) 1)sell by dates 12/24/00, 1/7/01, 1/13/01, and 1/16/01; 2)sell by dates 12/24/00, 1/20/01, and 1/28/01; 3)sell by date 3/24/01; 4)sell by dates 12/22/00, 12/24/00, 1/7/01, and 1/17/01; 5)sell by dates 12/20/00 and 12/25/00; 6)coded 0180 311m, 0188 111M, 0188 311M, and 0194 311m; 7)sell by date 3/24/01, distributed by Swissrose, Moonachie, NJ; 8)sell by date 12/25/00, distributed by Swissrose, Moonachie, NJ. b) purchased after 9/11/00; c) 0180 311m, 0194 311m and 0201 311m. MANUFACTURER: Hill & Valley Cheese, Inc., Cashton, WI. RECALLED BY: Swissrose International, Inc., Moonachie, NJ.,by letter dated 11/6/00. Firm-initated recall complete. DISTRIBUTION: Nationwide except in the far western U.S.; Two foreign accounts, Panama and Bermuda. QUANTITY: 70216 pounds. REASON: The cheeses were manufactured using bulk cheese that Hill & Valley Cheese, Inc., Cashton, WI recalled due to potential Listeria monocytogenes contamination.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT: Japanese Cucumber Dressing packaged in unlabeled 2.5 lb. poly bags, packed 8/2.5 lb. bags/case. Case labeling stated "JAPENESE CUCUMBER DRESSING". Recall #F-264-1. CODE: Japanese Cucumber Dressing: pull dates up to and including 101400. MANUFACTURER: Reser's Fine Foods, Inc., Beaverton, OR. RECALLED BY: Manufacturer, by telephone on 9/28/00. Firm-initiated recall complete. DISTRIBUTION: Idaho and Oregon. QUANTITY: 407 cases. REASON: Contains undeclared wheat. _________ PRODUCTS: a) Li'l Guy Trichips Bulk (CHTRBKCDM) containing Cinco De Mayo (CDM) chips which are red, white and green, packaged in unlabeled 5-lb. bags, 2 bags/case. Recall # F-272-1; b) Li'l Guy Trichips Red, White, Blue (CHTRBKRWB) containing red, white and blue chips (RWB) packaged in unlabeled 5-lb. bags, 2 bags/case. Recall # F-273-1; c. Li'l Guy Red Corn Tortillas - 6" (CT06RN) packaged in unlabeled bags containing 10-doz. tortillas, 6 bags/case. Recall # F-274-1. CODES: a) EXP 031001; b) EXP 030801; c) MFR 122900. MANUFACTURER: Sloan Acquisition, dba Li’l Guy Foods, Inc., Kansas City, MO. RECALLED BY: Manufacturer, by letter dated 1/8/01. Firm-initiated recall complete. DISTRIBUTION: Missouri. QUANTITY: a) 65.5 cases; b) 65 cases; c) 8 cases. REASON: The products do not bear ingredient statements and contain corn, FD&C Yellow No. 5 and FD&C Yellow No. 6. ________ PRODUCT: Wasabi Green Peas. Recall #F-275-1. CODE: None. MANUFACTURER: City Nut and Candy, Inc., Hollywood, FL. RECALLED BY: Manufacturer, by letter on 12/22/00. Completed recall resulted from follow-up by Florida Dept. of Agriculture and Consumer Services. DISTRIBUTION: Florida. QUANTITY: 30 packages. REASON: The product contains undeclared FD&C Yellow No. 5 and FD&C Blue No. 1. _________ PRODUCTS: Recall #F-276-1. Pasteurized Liquid Salt Yolks coded 273-0 and labeled as “Packed By: Crystal Lake Egg Products, Inc., Warsaw, IN” Recall #.F-277-1. Pasteurized Frozen Whole Eggs coded 273-0 a) Labeled as “Distributed By: Elias Brothers Restaurants, Inc., Warren, MI” b) Labeled as “Packed By: Crystal Lake Egg Products, Inc., Warsaw, IN” Recall #F-278-1. Pasteurized Frozen Egg Product (whole eggs, citric acid) coded 273-0 a) Labeled as “ Country Queen Scrambler” and “ Produced for Country Queen Foods, Brampton, Ont.” b)Labeled as “Da-Break” and “Distributed By: Armour Egg Products, Omaha, NE” CODE: a); b) and c) coded 273-0 MANUFACTURER: Crystal Lake Egg Products LLC, Warsaw, Indiana. RECALLED BY: Manufacturer, by telephone on 10/12/00. Firm-initiated recall complete. DISTRIBUTION: Michigan, Indiana, Ohio, Wisconsin, Kentucky and Brampton, Ontario, Canada. QUANTITY: 91,170 lbs. REASON: The products may be contaminated with Salmonella.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT: Colonial Kitchen Bacon Bits. Recall #F-271-1. CODE: 08K3080, 06W3060, 09K3110, 09W3110, 08W3080, 08K3090, 09K3150, 09W3150. MANUFACTURER: Feaster Foods, Omaha, NE. RECALLED BY: Dollar Tree Stores, Inc., Chesapeake, VA. By phone on/about 12/5/2000. Completed recall resulted from follow-up by the New York State Agriculture and Markets. DISTRIBUTION: PA, IL, MS, and VA. QUANTITY: 42552 bottles. REASON: The product contains undeclared FD&C Red No. 40 and it not identified as an imitation bacon product. RECALLS AND FIELD CORRECTIONS: DRUGS - - CLASS I ________ PRODUCT: Cydec Drops - Antihistamine/Decongestant, 1 fl. Oz. (30 mL) with dropper. Recall #D-049-1. CODE: Lot nos. 02950 and 03110. MANUFACTURER: Great Southern Laboratories, Houston, TX. RECALLED BY: Manufacturer, by fax letter dated 1/9/01. Firm- initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: Lot 02950 - 6,135; Lot 03110 - unknown at this time. REASON: Incorrect dosage instructions: Side panel labeling incorrectly declares measurement in "teaspoons" rather than correct "ML".RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT: (OTC) Anso Comfort™ Capsules, Extract of Hainanensis Merr Leaf, 200 mg, 60 capsules per bottle. Recall #D- 100-1. CODE: Lot 0H0041, Sept 2003 and Lot 9422, Exp 7-2002. MANUFACTURER: Numeridian, Inc., Arcadia, CA. RECALLED BY: Manufacturer, by letter on 2/5/01. Firm-initiated recall ongoing. DISTRIBUTION: AK, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, PA, RI, SC, TN, TX, UT, VA, WA, and WI. Foreign distribution was to China (Shanghai), and Canada (BC and Ontario). QUANTITY: Lot OH0041, 6420 bottles; Lot 9422, unknown. REASON: Product contains the undeclared prescription drug- chlordiazdepoxide.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT: Red Blood Cells. Recall #B-734-1. CODE: (8 units), unit numbers FH84451, FH84453, FH84454, FH84455, FH84456, FH84457, FH84458, and FH84459. MANUFACTURER: Sacramento Medical Foundation Blood Center, Sacramento, CA. RECALLED BY: Manufacturer, by letter on March 30, 1999. Firm- initiated recall complete. DISTRIBUTION: California. QUANTITY: 8 units. REASON: Blood products, incorrectly tested for syphilis, were distributed. ________ PRODUCT: Red Blood Cells, Leukocytes Removed. Recall #B-735-1 CODE: Unit number 10612-5944. MANUFACTURER: Blood Systems, Inc., Scottsdale, AZ. RECALLED BY: Manufacturer, by letter dated February 9, 2000. Firm- initiated recall complete. DISTRIBUTION: Arizona QUANTITY: One unit. REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. ________ PRODUCT: Red Blood Cells, Leukocytes Removed, B-736-1. CODE: Unit number 10620-4935 MANUFACTURER: Blood Systems, Inc. Scottsdale, AZ. RECALLED BY: Manufacturer, by telephone on March 17, 2000, and by letter dated April 13, 2000. Firm-initiated recall complete. DISTRIBUTION: Arizona. QUANTITY: One unit. REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. ________ PRODUCTS: a) Red Blood Cells. Recall #B-737-1; b) Platelets. Recall #B-738-1. CODES: a) unit number 10622-3985; b) unit number 10622-3985. MANUFACTURER: Blood Systems, Inc. Scottsdale, AZ. RECALLED BY: Manufacturer, by telephone on June 3, 2000. Firm- initiated recall complete. DISTRIBUTION: Arizona. QUANTITY: Two units. REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. ________ PRODUCT: a)Red Blood Cells. Recall #B-739-1; b)Red Blood Cells, Leukocytes Removed. Recall #B-740-1. CODE: a) unit number 10615-2253; b) unit number 10618-8126. MANUFACTURER: Blood Systems, Inc. Chandler, AZ. RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by letter on April 19, 2000. Firm-initiated recall complete. DISTRIBUTION: Arizona. QUANTITY: Two units. REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. ________ PRODUCT: Red Blood Cells. Recall #B-741-1. CODE: Unit #36256-3931. MANUFACTURER: Blood Systems, Inc., Ventura, CA. RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by letter, on December 9, 1999. Firm-initiated recall complete. DISTRIBUTION: California. QUANTITY: One unit. REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. ________ PRODUCT: Red Blood Cells. Recall #B-742-1. CODES: Unit #36255-0787; 36255-6676, and 36257-9676. MANUFACTURER: Blood Systems, Inc., Ventura, CA. RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by letter, on June 7, 2000. Firm-initiated recall complete. DISTRIBUTION: California. QUANTITY: 3 units. REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. ________ PRODUCT: Red Blood Cells, Leukocytes Removed. Recall #B-743-1. CODES: Unit #10613-5544 and 10616-8082. MANUFACTURER: Blood Systems, Inc., Glendale, AZ. RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by letter, on March 28, 2000. Firm-initiated recall complete. DISTRIBUTION: Arizona. QUANTITY: 2 units. REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. ________ PRODUCT: Platelets. Recall #B-745-1. CODES: Unit 54KH37752. MANUFACTURER: American National Red Cross, Puerto Rico Region, Rio Piedras, PR. RECALLED BY: American Red Cross Blood Services, Puerto Rico Region, San Juan, PR., by letter on August 11, 1998. Firm- initiated recall complete. DISTRIBUTION: Puerto Rico and California. QUANTITY: One unit. REASON: Blood products, prepared from the same donation as Staphylococcus epidermidis contaminated Red Blood Cells, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-747-1; b) Platelets. Recall #B-748-1. CODES: a) Units 18FQ47824 and 18FW00212; b)Unit 18FW00212. MANUFACTURER: American Red Cross Blood Services, Great Lakes Region, Lansing, MI. RECALLED BY: Manufacturer, by letter on February 11, 2000. Firm- initiated recall complete. DISTRIBUTION: Massachusetts and Michigan. QUANTITY: Three units. REASON: Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-749-1; b) Platelets. Recall #B-750-1. CODES: a) and b) Unit 38FC64398. MANUFACTURER: American Red Cross Blood Services, Fort Wayne, IN. RECALLED BY: Manufacturer, by letter on November 16, 2000. Firm- initiated recall complete. DISTRIBUTION: Indiana. QUANTITY: Two units. REASON: Blood products, collected from a donor who traveled to an area designated as endemic for malarial, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-751-1; b) Platelets. Recall #B-752-1. CODES: a) and b) Unit 2273219. MANUFACTURER: Inland Northwest Blood Center, Spokane, WA. RECALLED BY: Manufacturer, by letter dated August 28, 2000. Firm- initiated recall complete. DISTRIBUTION: Tennessee and Washington. QUANTITY: Two units. REASON: Blood products, collected from a donor who traveled to an area designated as endemic for malarial, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-759-1; b) Fresh Frozen Plasma. Recall #B-760-1. CODES: a) and b) Unit LN71298. MANUFACTURER: NBAH Blood Center, New Brunswick, NJ. RECALLED BY: Manufacturer, by letter dated July 30, 1998. Firm- initiated recall complete. DISTRIBUTION: New Jersey. QUANTITY: Two units. REASON: Blood products, collected from an unsuitable donor due to an accidental needlestick during the previous twelve months, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-761-1; b) Ctyoprecipitated AHF. Recall #B-762-1; c) Recovered Plasma. Recall #B-763-1. CODES: a); b) and c) Units FO3394 and FO3592. MANUFACTURER: Community Blood Center of Greater Kansas City,Topeka, KA. RECALLED BY: Community Blood Center of Greater Kansas City, Kansas City, MO., by letters on April 9, 1999, or April 14, 1999. Firm- initiated recall complete. DISTRIBUTION: Kansas and Missouri and the Recovered Plasma were distributed in Switzerland. QUANTITY: Six 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: Red Blood Cells. Recall #B-764-1. CODES: Unit 0303653. MANUFACTURER: Community Blood Center of Greater Kansas City, Kansas City, MO., RECALLED BY: Manufacturer, by letter on June 9, 1999. Firm- initiated recall complete. DISTRIBUTION: Kansas. QUANTITY: One unit. REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria was distributed ________ PRODUCT: Red Blood Cells, Leukocytes Removed. Recall #B-765-1. CODES: Unit 29FJ40438. MANUFACTURER: The American National Red Cross, Mid-Atlantic Region, Norfolk, VA. RECALLED BY: Manufacturer, by letters dated October 26, and November 13, 2000. Firm-initiated recall complete. DISTRIBUTION: North Carolina. QUANTITY: One unit. REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. ________ PRODUCT: Red Blood Cells, Leukocytes Removed. Recall #B-766-1. CODES: Unit 04KK29395. MANUFACTURER: The American National Red Cross, New England Region, Dedham, MA. RECALLED BY: Manufacturer, by letter dated September 7, 2000. Firm- initiated recall complete. DISTRIBUTION: Massachusetts. QUANTITY: One unit. REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. ________ PRODUCT: Red Blood Cells, Deglycerolized. Recall #B-777-1. CODES: Unit 3568673. MANUFACTURER: LifeSource, Glenview, IL. RECALLED BY: Manufacturer, by telephone on April 6, 2000. Firm- initiated recall complete. DISTRIBUTION: Illinois. QUANTITY: One unit. REASON: Blood product, deglycerolized with an expired reagent, was distributed. ________ PRODUCT: Red Blood Cells. Recall #B-780-1. CODES: Unit V36436. MANUFACTURER: Sacramento Medical Foundation Blood Center, Sacramento, CA. RECALLED BY: Manufacturer, by fax dated February 24, 1999. Firm- initiated recall complete. DISTRIBUTION: Tennessee. QUANTITY: One unit. REASON: Blood product, collected from a donor whose arm preparation was not documented, was distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-781-1; b) Recovered Plasma. Recall #B-782-1. CODES: a) and b)Unit 38L42585. MANUFACTURER: American Red Cross Blood Services, Fort Wayne, IN. RECALLED BY: Manufacturer, by letter dated April 20, 1999. Firm- initiated recall complete. DISTRIBUTION: Indiana and California. QUANTITY: Two units. REASON: Blood products, drawn from an unsuitable donor who immigrated from a high risk country, was distributed. ________ PRODUCT: Source Plasma. Recall #B-790-1. CODE: Unit numbers 03831489, 01951868, 04798248, 04757337, 04751724, 02288055, 01401271, 02046334, 02042176, 00133920, 00440325, 99186289, 99180577, 99217495, 99298456, and 99293192. MANUFACTURER: North American Biologicals, Inc., Evansville, IN. RECALLED BY: North American Biologicals, Inc.,Boca Raton, FL ., by letter on August 28, 1998. Firm-initiated recall complete. DISTRIBUTION: California. QUANTITY: 16 units. REASON: Blood products, collected from an unsuitable donor due to previous positive testing for syphilis, were distributed. ________ PRODUCT: a) Platelets. Recall #B-791-1; b) Plasma. Recall #B- 792-1. CODE: a) and b)Unit number 53FC95002. MANUFACTURER: The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD. RECALLED BY: Manufacturer, by facsimile on August 23, 2000, and by letter on August 25, 2000. Firm-initiated recall complete. DISTRIBUTION: Maryland. QUANTITY: 2 units. REASON: Blood products, corresponding to a unit of Red Blood Cells possibly contaminated with Streptococcus sanguis, were distributed. ________ PRODUCT: a)Red Blood Cells. Recall #B-793-1; b)Platelets. Recall #B-794-1; c)Platelets, Irradiated Recall #B-795-1; d)Fresh Frozen Plasma Recall #B-796-1; CODE: a)(3 units), unit numbers KN48174, KH56048, and KL47155 b)(2 units), unit numbers KH56048 and KL47155; c)(1 unit), unit number KN48174; d)(3 units), unit numbers KN48174, KH56048, and KL47155. MANUFACTURER: Virginia Blood Services, Richmond, VA. RECALLED BY: Manufacturer, by letters on August 25, 2000, and September 20, 2000. Firm-initiated recall complete. DISTRIBUTION: Virginia and Florida. QUANTITY: 9 UNITS. REASON: Blood products, collected from an ineligible donor due to a previous dura mater transplant, were distributed. _________ PRODUCTS: a)Red Blood Cells. Recall #B-797-1; b)Platelets. Recall #B-798-1; c)Recovered Plasma. Recall #B-799-1. CODE: a)(2 units), unit numbers 6602598 and 4808670; b)(1 unit), unit number 6602598; c)(2 units), unit numbers 6602598 and 4808670. MANUFACTURER: LifeSource, Glenview, IL. RECALLED BY: Manufacturer, by telephone on September 21, 2000. The Recovered Plasma by facsimile on September 21, 2000. Firm-initiated recall complete. DISTRIBUTION: a) and b) Illinois, c) Scotland. QUANTITY: 5 units. REASON: Blood products, collected from an unsuitable donor due to use of the medication Valtrex, were distributed. _________ PRODUCTS: a) Platelets. Recall #B-800-1; b) Fresh Frozen Plasma. Recall #B-801-1. CODE: a) unit number 36-37232; b) unit number 36-37232. MANUFACTURER: Michigan Community Blood Center, Grand Valley Blood Program, Grand Rapids, MI RECALLED BY: Manufacturer, by telephone on March 21, 2000. Firm-initiated recall complete. DISTRIBUTION: Michigan. QUANTITY: Two units. REASON: Blood products, collected from a donor who should have been deferred due to use of the medication Androstendiol, were distributed. _________ PRODUCTS: a) Red Blood Cells. Recall #B-802-1; b) Platelets. Recall #B-803-1; c) Recovered Plasma. Recall #B-804-1. CODES: a) (6 units), unit numbers M08-06224, M08-22174, M08- 27203, C00-93531, C00-93654, and W16-12358; b)(5 units), unit numbers T43308, M08-22174, C00-93531, C00-93654, and W16-12358; c)(2 units), unit numbers M08-06224 and W16-12358. MANUFACTURER: Community Blood Council of New Jersey, Trenton, NJ. RECALLED BY: Manufacturer, by letters on various dates between 1996 and 2000. Firm-initiated recall complete. DISTRIBUTION: The recalled transfusable products in New Jersey. The recalled units of Recovered Plasma in Pennsylvania. QUANTITY: 13 units. REASON: Blood products, that were either: 1) labeled with the incorrect expiration date; or 2) collected from ineligible donors based on: a) behaviors that are known to increase the risk of infection with human immunodeficiency virus (HIV); b) previous reactive testing for syphilis; or c) travel to an area considered endemic for malaria, were distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-805-1; b) Recovered Plasma. Recall #B-806-1. CODES: a) and b)Unit 1995811. MANUFACTURER: New York Blood Center, Inc., New York, NY. RECALLED BY: Manufacturer, on or about June 4, 1999 and fax notification on 6/21/99. Firm-initiated recall complete. DISTRIBUTION: New Jersey and Switzerland. QUANTITY: Two units. REASON: Blood products, collected from a donor that disclosed previous reactive testing for antibody to hepatitis C virus (anti-HCV), were distributed.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT: Platelets, Pheresis, Leukoreduced. Recall #B-411-1. CODE: Unit 09FP18569. MANUFACTURER: American Red Cross Blood Services, Midwest Region, Omaha, NE. RECALLED BY: Manufacturer, by telephone on 11/14/97. Firm-initiated recall complete. DISTRIBUTION: Arizona. QUANTITY: One unit. REASON: Unlicensed blood product was distributed in interstate commerce. ________ PRODUCT: Cryoprecipated AHF. Recall #B-436-1. CODE: Unit 26160-6336. MANUFACTURER: Blood Systems Inc., Texarkana, TX. RECALLED BY: Blood Systems Inc., Scottsdale, AZ., by telephone on December 30, 1999 and by letter dated January 20, 2000. Firm-initiated recall complete. DISTRIBUTION: Texas. QUANTITY: One unit. REASON: Blood product, prepared from a unit of whole blood with an extended collection time, was distributed. ________ PRODUCT: Platelet, Pheresis. Recall #B-437-1. CODE: Unit 24FH23809. MANUFACTURER: American Red Cross Blood Services, River Valley Region, Louisville, KY. RECALLED BY: Manufacturer, by letter dated October 9, 2000. Firm- initiated recall complete. DISTRIBUTION: Indiana. QUANTITY: One unit. REASON: Unlicensed blood product was distributed in interstate commerce. ________ PRODUCT: Platelet, Pheresis. Recall #B-448-1. CODE: Unit 27P47477. MANUFACTURER: American National Red Cross, Greater Alleghenies Region, Johnstown, PA. RECALLED BY: Manufacturer, by telephone on March 20, 1999. Firm- initiated recall complete. DISTRIBUTION: Maryland. QUANTITY: One unit. REASON: Platelets Pheresis that were not properly agitated during storage were distributed. _________ PRODUCTS: a)Red Blood Cells. Recall #B-482-1; b)Platelets. Recall #B-483-1; c)Fresh Frozen Plasma. Recall #B-484-1; d)Cryoprecipitated AHF. Recall #B-485-1. CODES: a) units Q54609, M54112, H23835, M62096, G47010, Q71305, M70925, Q79230, G57316, N07355, and Q94010; b) units Q54609, M62096, Q71305; c) unit M62096; d) unit H23835. MANUFACTURER: Carolina-Georgia Blood Center, Inc.Greenville, SC. RECALLED BY: Manufacturer, by telephone or letter on June 18, 1998 or June 19, 1998. Six non-respondents were sent second notices dated June 24, 1999, and two of these consignees were sent a third notification dated November 10, 2000. Firm-initiated recall complete. DISTRIBUTION: SC, TN, TX, and OH. QUANTITY: 16 units. REASON: Blood products, collected from a donor with a history of hemochromatosis, were distributed. _________ PRODUCTS: a)Red Blood Cells. Recall #B-499-1; b)Fresh Frozen Plasma. Recall #B-500-1; CODES: a) and b) Unit V65783, V67912. MANUFACTURER: Mississippi Valley Regional Blood Center, Davenport, IA. RECALLED BY: Manufacturer, by facsimile on June 24, 1999 and letters dated July 1, 1999. Firm-initiated recall complete. DISTRIBUTION: Iowa, Louisiana, Illinois and Colorado. QUANTITY: Four units. REASON: Blood products, collected from a donor who had been taking the drug Bactrim, were distributed. ________ PRODUCT: Red Blood Cells, Leukocytes Reduced. Recall #B-504-1. CODE: Unit 09FH27167. MANUFACTURER: American Red Cross Blood Services, Midwest Region, Omaha, NE. RECALLED BY: Manufacturer, by telephone on November 23, 1997. Firm- initiated recall complete. DISTRIBUTION: Nebraska. QUANTITY: One unit. REASON: Blood product, that failed the red cell recovery ratio, was distributed. ________ PRODUCT: Red Blood Cells. Recall #B-506-1. CODE: Unit 36LP16540. MANUFACTURER: American Red Cross Blood Services, South Carolina Region, Columbia, SC. RECALLED BY: Manufacturer, by letters dated January 13, 2000 and February 23, 2000. Firm-initiated recall complete. DISTRIBUTION: South Carolina. QUANTITY: One unit. REASON: Blood product, collected from a donor who had previously tested reactive for syphilis, was distributed. ________ PRODUCT: Platelets. Recall #B-510-1. CODE: Units 42F47899, 42F47900. MANUFACTURER: American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH. RECALLED BY: Manufacturer, by telephone on 11/6/2000. Firm- initiated recall complete. DISTRIBUTION: Ohio. QUANTITY: Two units. REASON: Blood products, collected in expired blood collection bags, were distributed. ________ PRODUCT: a)Red Blood Cells. Recall #B-516-1; b)Recovered Plasma. Recall #B-517-1. CODES: a)and b)Unit 5126936. MANUFACTURER: Central Texas Regional Blood & Tissue Center, Austin, TX. RECALLED BY: Manufacturer, by letter dated June 27, 2000. Firm- initiated recall complete. DISTRIBUTION: Texas and Florida. QUANTITY: Two units. REASON: Blood products, which tested negative for the antibody to the human immunodeficiency virus, (HIV-1/2), but were collected from a donor who previously tested repeatedly reactive for HIV-1, Western Blot negative, were distributed. ________ PRODUCT: Red Blood Cells. Recall #B-544-1. CODES: Unit 26KH44690. MANUFACTURER: American Red Cross Blood Services, Gulf Coast Region, Mobile, AL. RECALLED BY: Manufacturer, by phone on April 14, 2000 and by letter dated April 27, 2000. Firm-initiated recall complete. DISTRIBUTION: The ARC Alabama Region. QUANTITY: One unit. REASON: Blood product, which may have been exposed to unacceptable shipping temperature, was distributed. ________ PRODUCT: a)Red Blood Cells, Leukoreduced. Recall #B-545-1; b)Recovered Plasma. Recall #B-546-1. CODES: a)Units 02FG72677, 02FG72678, 02FG72679, 02FG72681, 02FG72682, 02FG72683, 02FG72684, 02FG72685, 02FG72687, 02FG72688, 02FG72689, 02FG72690, 02FG72691, 02FG72692, 02FG72693, 02FG72694, 02FG72696, 02FG72697, 02FG72698, 02FG72699, 02FG72701, 02FG72702, 02FG72703, 02FG72704, 02FG72705, 02FG72707, 02FG72708, 02FG72709, 02FG72710, 02FG72711, 02FG72712, 02FG72713, 02FG72714, 02FG72715, 02FG72716, 02FG72717, 02FG72718. b)Units 02FG72677, 02FG72678, 02FG72679, 02FG72680, 02FG72681, 02FG72682, 02FG72683, 02FG72684, 02FG72685, 02FG72687, 02FG72688, 02FG72689, 02FG72690, 02FG72691, 02FG72692, 02FG72693, 02FG72694, 02FG72695, 02FG72696, 02FG72697, 02FG72698, 02FG72699, 02FG72701, 02FG72702, 02FG72703, 02FG72704, 02FG72705, 02FG72707, 02FG72708, 02FG72709, 02FG72710, 02FG72711, 02FG72712, 02FG72713, 02FG72714, 02FG72715, 02FG72716, 02FG72717, 02FG72718. MANUFACTURER: American Red Cross Blood Services, Central Plains Region, Wichita, KS. RECALLED BY: Manufacturer, by telephone on July 20 & 21, 1999, and by letters dated July 21, 1999. Firm-initiated recall complete. DISTRIBUTION: Kansas and California. QUANTITY: a)37 units; b)39 units. REASON: Blood products, collected in expired blood collection bags, were distributed. ________ PRODUCT: Red Blood Cells. Recall #B-550-1. CODE: Units FH59098 and V29929. MANUFACTURER: Sacramento Medical Foundation Blood Center, Sacramento, CA. RECALLED BY: Manufacturer, by visits on June 4, 1998. Firm- initiated recall complete. DISTRIBUTION: California. QUANTITY: Two units. REASON: Blood products, incorrectly tested for hepatitis B surface antigen (HbsAg), were distributed. ________ PRODUCT: Fresh Frozen Plasma. Recall #B-572-1. CODES: Units 09P31195(2FP), 09P31198(3FP), 09P31198(4FP). MANUFACTURER: The American National Red Cross, Central Plains Region, Wichita, KS. RECALLED BY: Manufacturer, by telephone on September 9, 1996, and by letter dated September 12, 1996. Firm-initiated recall complete. DISTRIBUTION: Nebraska. QUANTITY: Three units. REASON: Fresh Frozen Plasma that was stored in an unmonitored freezer was distributed. ________ PRODUCT: Red Blood Cells. Recall #B-577-1. CODES: Unit T07087. MANUFACTURER: Virginia Blood Services, Richmond, VA. RECALLED BY: Manufacturer, by telephone on 7/27/00. Firm-initiated recall complete. DISTRIBUTION: Virginia. QUANTITY: One unit. REASON: Blood product, collected from a donor who had an elevated body temperature, was distributed. ________ PRODUCT: CPDA-1 Whole Blood. Recall #B-580-1. CODE: Unit 2730879. MANUFACTURER: Houchin Blood Services, Bakersfield, CA. RECALLED BY: Manufacturer, by visit on December 21, 1999. Firm- initiated recall complete. DISTRIBUTION: California. QUANTITY: One unit. REASON: Blood product, which was incorrectly labeled with an extended expiration date, was distributed. ________ PRODUCT: Red Blood Cells. Recall #B-582-1. CODE: Unit 26KH00479. MANUFACTURER: American Red Cross Blood Services, Gulf Coast Region, Mobile, AL. RECALLED BY: Manufacturer, by letter dated February 18, 1999. Firm- initiated recall complete. DISTRIBUTION: Alabama. QUANTITY: One unit. REASON: Blood product, which was labeled with an extended expiration date, was distributed. ________ PRODUCT: Fresh Frozen Plasma. Recall #B-589-1. CODES: unit numbers 13C97537, 13C97538, 13C97542, 13C97547, 13C97548, 13C97551, 13C97552, 13C97558, 13C97559, 13C97568, 13C97569, 13FG78372, 13FG79981, 13FG79994, 13FG79997, 13FG79998, 13FG80000, 13FG80010, 13FG80004, 13FG80005, 13FG80008, 13FG80009, 13FG80011, 13FH46477, 13FH56993, 13FH56998, 13FH57745, 13FH57749, 13FH57748, 13FH57760, 13FH57841, 13FH57848, 13FH57855, 13FH57857, 13FH57860, 13FH57862, 13FH57863, 13FH57864, 13FH57865, 13FH57867, 13FH57870, 13FH57871, 13FH57874, 13FH57878, 13FJ42109, 13FJ42158, 13FJ42160, 13FJ46280, 13FJ46471, 13FJ46474, 13FJ46475, 13FJ46480, 13FJ46484, 13FJ46487, 13FJ46488, 13FJ46490, 13FL82059, 13FL85199, 13FL86435, 13FL87416, 13FL89197, 13FL89201, 13FL89205, 13FL89206, 13FL89208, 13FM42534, 13FM42537, 13FR15813, 13FR15818, 13FR15863, 13FR15865, 13FR15871, 13FR15873, 13FR15869, 13FR15870, 13FR15875, 13FR15876, 13FR15872, 13FR15878, 13FR15880, 13FR15883, 13FY39834, 13FY43871, 13FY43915, 13FY43921, 13GC67120, 13GC67126, 13GC67134, 13GC67154, 13GC67155, 13GC67348, 13GC67361, 13GC67362, 13GC67363, 13GC67400, 13GC67403, 13GC67405, 13GC67407, 13GC67408, 13GC67412, 13GC67421, 13GC67423, 13GC67424, 13GC67427, 13GC67431, 13GC67434, 13GC67435, 13GC67436, 13GC67442, 13GC67443, 13GC67446, 13GC67448, 13GC67451, 13GC67453, 13GC67463, 13GC67467, 13GC67468, 13GC67469, 13GC67472, 13GC67474, 13GC67475, 13GC67477, 13GC67479, 13GC67481, 13GC67486, 13GM29009, 13GM30176, 13GM33205, 13GM33222, 13GM33234, 13GM33247, 13GM33312, 13GM33284, 13GM33288, 13GM33294, 13GM33477, 13GM33489, 13GM33544, 13GM33546, 13GM33547, 13GM33552, 13GM33553, 13GM33554, 13GM33559, 13GM33563, 13GM33564, 13GM33567, 13GM33569, 13GM33493, 13GQ16680, 13GQ20985, 13GQ20991, 13GQ21000, 13GQ21003, 13GQ21005, 13GQ21007, 13GQ21008, 13GQ21010, 13GQ21011, 13GQ21014, 13GX17577, 13GX17580, 13GX17596, 13GX17770, 13GX17774, 13GX17597, 13GX17660, 13GX17671, 13GX17680, 13GX17681, 13GX17688, 13GX17694, 13GX17707, 13GX17708, 13GX17775, 13GX17808, 13GX17809, 13GX17810, 50F69059, 50G59268, 50G60347, 50G60862, 50G65803, 50G65822, 50H02877, 50H03270, 50H03234, 50H03330, 50H06951, 50H06955, 50H06964, 50J57471, 50X09826, and 50F68964. MANUFACTURER: The American National Red Cross, Southeastern Michigan Region, Detroit, MI. RECALLED BY: Manufacturer, by telephone on April 19 and 20, 1999, and by letter dated August 5, 1999. Firm-initiated recall complete. DISTRIBUTION: Michigan. QUANTITY: 194 units. REASON: Blood products, subjected to elevated temperatures during storage, were distributed. ________ PRODUCT: Fresh Frozen Plasma. Recall #B-590-1. CODES: Unit numbers 02P38114, 02P37652, 02P36664, 02P37341, 02P36368, 02P36591, 02P36373, 02P36448, 02P36345, 02P36722, 02P36314, 02P36717, 02P37108, 02P38788 (divided unit), 02P35938, 02P37405, 02P38007, 02P38123, 02P35006, 02P35039, 02P35669, 02P35711, 02P35909, 02P36008, 02P36504, 02P36523, 02P36525, 02P36588, 02P36724, 02P36740, 02P36749, 02P36755, 02P36769, 02P36873, 02P36888, 02P36951, 02P36930, 02P36964, 02P36973, 02P36988, 02P37007, 02P37105, 02P37200, 02P37253, 02P37360, 02P37387, 02P37411, 02P37828, 02P38230, and 02P38369. MANUFACTURER: American National Red Cross, Central Plains Region, Wichita, KS. RECALLED BY: Manufacturer, by telephone and/or facsimile between April 20 and 24, 1998. In addition, follow-up letters dated April 29, 1998. Firm-initiated recall complete. DISTRIBUTION: Kansas, Michigan, Massachusetts, Oklahoma, New York, California, and Tennessee. QUANTITY: 50 units. REASON: Unlicensed blood products were labeled with the firm's license number and distributed. ________ PRODUCTS: a) Red Blood Cells. Recall #B-592-1; b) Recovered Plasma. Recall #B-593-1. CODES: a) and b)Unit 7858801. MANUFACTURER: LifeSource, Glenview, IL. RECALLED BY: Manufacturer, by telephone on September 7, 2000 and by facsimile dated September 16, 2000, September 20, 2000. Firm-initiated recall complete. DISTRIBUTION: a) Illinois; b) California. QUANTITY: Two units. REASON: Blood products, collected from a donor whose arm inspection and skin disease status had not been documented, were distributed. ________ PRODUCT: Red Blood Cells, Irradiated. Recall #B-596-1. CODE: Unit 0309536. MANUFACTURER: Community Blood Center of Greater Kansas City, Kansas City, MO. RECALLED BY: Manufacturer, by telephone on July 20, 1999. Firm- initiated recall complete. DISTRIBUTION: Missouri. QUANTITY: One unit. REASON: Blood product, labeled with an extended expiration date, was distributed. ________ PRODUCT: Red Blood Cells. Recall # B-597-1. CODE: Units 54KH43155, 54KH43156. MANUFACTURER: American Red Cross, Puerto Rico Region, Rio Piedras, PR. RECALLED BY: Manufacturer, by telephone on April 23, 1999 and by letters dated April 29, 1999. Firm-initiated recall complete. DISTRIBUTION: Puerto Rico. QUANTITY: Two units. REASON: Blood products, that were not separated from Whole Blood within eight hours of collection, were distributed. ________ PRODUCT: Platelets, Pheresis. Recall # B-602-1. CODE: Unit 02P22383. MANUFACTURER: American Red Cross Blood Services, Central Plains Region, Whichita, KS. RECALLED BY: Manufacturer, by telephone on February 21, 1997. Firm- initiated recall complete. DISTRIBUTION: Oklahoma. QUANTITY: One unit. REASON: Unlicensed blood product was distributed in interstate commerce. ________ PRODUCT: Platelets, Pheresis, Irradiated. Recall #B-603-1. CODE: Unit 02P36448. MANUFACTURER: American Red Cross Blood Services, Central Plains Region, Whichita, KS. RECALLED BY: Manufacturer, by telephone on October 28, 1997. Firm- initiated recall complete. DISTRIBUTION: Oklahoma. QUANTITY: One unit. REASON: Unlicensed blood product was distributed in interstate commerce. ________ PRODUCT: Red Blood Cells. Recall # B-622-1. CODE: Unit 26FL12573. MANUFACTURER: American Red Cross Blood Services, Gulf Coast Region, Mobile, AL. RECALLED BY: Manufacturer, by telephone on October 12, 1999 and by letter dated October 13, 1999. Firm-initiated recall complete. DISTRIBUTION: Mississippi. QUANTITY: One unit. REASON: Blood product, which was labeled with an extended expiration date, was distributed. ________ PRODUCT: Plasma, Cryoprecipitate Reduced. Recall #B-623-1. CODE: units 27GM15207, 27GM15208, 27GM15209, 27GM15211, 27GM15213, 27GM15215, 27GM15218, 27GM15219, 27GM15221, 27GM15225, 27GM15643, 27GM15645, 27GM15652, 27GM15662, 27GM15688, 27GM15689, 27GM15690, 27GM15693, 27GM15696, 27GM15713, 27GM15714, 27GM15718, 27GM15726, 27GM15739, 27GM15748, 27GM15758, 27GM15760, 27GM15769, 27GM15771, 27GM15781, 27GM15782, 27GM15784, 27GM15785, 27GM15789, 27GM15792, 27GM15808, 27GM15819, 27GM15822, 27GM15839, 27GP92687, 27GP93028, 27GR80528, 27GR80534, 27GR80537, 27GR80542, 27GR80549, 27GR80570, 27GR80636, 27GR80726, 27GR80731, 27GR80733, 27GR80736, 27GR80738, 27GR80739, 27GR80741, 27GR80743, 27GR80744, 27GS20225, 27GT16250, 27GT16261, 27GT16277, 27GT16279, 27GT16280, 27LE08747, 27LE08748, 27LF08586, 27LF08589, 27LF08592, 27LF08598, 27V88107, 27V88112, 27V88116, 27V88120, 27V88122, 27V88124, 27V88129, 27V88130, 27V88161, 27V88167, and 27V88168. MANUFACTURER: American Red Cross Blood Services, Greater Alleghenies Region, Johnstown, PA. RECALLED BY: Manufacturer, by telephone on August 20, 1999 and by letters dated August 26 and September 27, 1999. Firm- initiated recall complete. DISTRIBUTION: Massachusetts, Pennsylvania and West Virginia. QUANTITY: 80 units. REASON: Blood products, which were incorrectly labeled with extended expiration dates, were distributed. ________ PRODUCT: Plasma, Cryoprecipitate Reduced. Recall #B-640-1. CODES: Unit numbers 18FJ24760, 18FJ24773, 18FJ24774, 18FK30873, 18FK30876, 18FQ46716, 18FQ46727, 18FR37769, 18FR37770, 18FR37800, 18FR37801, 18FR37802, 18FR37808, 18FR37809, 18FT22210, 18FT22211, 18FT22212, 18FT22213, 18FT22217, 18FT22219, 18FT22220, 18FT22243 18FV10991, 18FX07997, 18FX07999, 18FX08000, 18FX08015, 18FX08026, 18FX08110, 18FX08119, 18FX08121, 18FX08122, 18S94572, 18S94617, 18S94641, 18S94643, 18S94676, 18S94906, 18S94907, 18S94909, 18S94910, 18S94913 and 18S94917. MANFUACTURER: The American National Red Cross, Great Lakes Region,Lansing, MI. RECALLED BY: Manufacturer, by telephone and letter on August 24, 1999. A follow-up letter dated October 7, 1999. Firm-initiated recall complete. DISTRIBUTION: Alabama, Maryland, Massachusetts, Michigan, and Ohio. QUANTITY: 43 units. REASON: Blood products, labeled with the incorrect expiration date, were distributed. ________ PRODUCT: Red Blood Cells, Divided. Recall #B-641-1. CODES: Unit numbers 38FC63255, 38FC63275,38FC63382, 38FC63450, 38FC63456 and 38FC63458. MANUFACTURER: The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN. RECALLED BY: Manufacturer, by telephone on August 25, 2000. Firm- initiated recall complete. DISTRIBUTION: Indiana. QUANTITY: 11units. REASON: Blood products, collected in an anticoagulant bag that had exceeded its expiration date, were distributed. _________ PRODUCTS: a)Red Blood Cells. Recall #B-645-1. b)Recovered Plasma. Recall #B-646-1. CODES: (a)(18 units), unit numbers 02FK03268, 02FK03269, 02FK03272, 02FK03273, 02FK03274, 02FK03275, 02FK03276, 02FK03277, 02FK03278, 02FK03281, 02FK03282, 02FK03283, 02FK03285, 02FK03286, 02FK03287, 02FK03288, 02FK03289, and 02FK03290 b)(18 units), unit numbers 02FK03268, 02FK03269, 02FK03272, 02FK03273, 02FK03274, 02FK03275, 02FK03276, 02FK03277, 02FK03278, 02FK03281, 02FK03282, 02FK03283, 02FK03285, 02FK03286, 02FK03287, 02FK03288, 02FK03289, and 02FK03290. MANUFACTURER: The American National Red Cross, Central Plains Region, Wichita, KS. RECALLED BY: Manufacturer, by telephone on May 24, 1999, and letter dated May 25, 1999. Firm-initiated recall complete. DISTRIBUTION: California, Oklahoma, and Kansas. Units of Recovered Plasma were distributed in California and New York. QUANTITY: 36 units. REASON: Blood products, collected in an anticoagulant bag that had exceeded its expiration date, were distributed. ________ PRODUCTS: a)Red Blood Cells, Leukocytes Removed. Recall # B-650-1; b)Red Blood Cells, Leukocytes Removed Irradiated. Recall #B-651-1; c)Fresh Frozen Plasma. Recall #B-652-1; d)Recovered Plasma. Recall #B-653-1. CODES: a) (27 units), unit numbers 02FH71866, 02FH71868, 02FH71869, 02FH71870, 02FH71871, 02FH71872, 02FH71873, 02FH71874, 02FH71875, 02FH71876, 02FH71877, 02FH71878, 02FH71879, 02FH71880, 02FH71881, 02FH71882, 02FH71883, 02FH71885, 02FH71887, 02FH71888, 02FH71889, 02FH71890, 02FH71891, 02FH71892, 02FH71893, 02FH71895, and 02FH71896; b)(1 unit), unit number 02FH71886; c)(1 unit), unit number 02FH71878; d)(26 units), unit numbers 02FH71866, 02FH71868, 02FH71869, 02FH71870, 02FH71871, 02FH71872, 02FH71873, 02FH71874, 02FH71875, 02FH71876, 02FH71877, 02FH71879, 02FH71880, 02FH71881, 02FH71882, 02FH71885, 02FH71886, 02FH71887, 02FH71888, 02FH71889, 02FH71890, 02FH71891, 02FH71892, 02FH71893, 02FH71895, and 02FH71896. MANUFACTURER: The American National Red Cross, Central Plains Region, Wichita, KS. RECALLED BY: Manufacturer, of the transfusable products by telephone on December 23, 1999, and by follow-up letter dated January 3, 2000. The Recovered plasma by facsimile on December 30, 1999. Firm-initiated recall complete. DISTRIBUTION: The recalled transfusable products were distributed to Massachusetts, California, Oklahoma, and Kansas. Units of Recovered Plasma were distributed to California and New York. QUANTITY: 55 units. REASON: Blood products, collected in an anticoagulant bag that had exceeded its expiration date, were distributed. ________ PRODUCT: Red Blood Cells, Irradiated. Recall #B-675-1. CODE: Unit 54KF55912 MANUFACTURER: American Red Cross Blood Services, Puerto Rico Region, Rio Piedras, PR. RECALLED BY: American Red Cross Blood Services, Puerto Rico Region, San Juan, PR., by telephone on February 3, 1997. Firm- initiated recall complete. DISTRIBUTION: Puerto Rico. QUANTITY: One unit. REASON: Blood product, labeled with an extended expiration date, was distributed. ________ PRODUCT: Leukoreduced Red Blood Cells. Recall #B-693-1. CODES: Units 54KW05242, 54KW05243 MANUFACTURER: American National Red Cross, Puerto Rico Region, Rio Piedras, PR. RECALLED BY: American Red Cross, Puerto Rico Region, San Juan, PR , by telephone on November 16, 1998, and by letter on December 1, 1998. Firm-initiated recall complete. DISTRIBUTION: Puerto Rico. QUANTITY: Two units. REASON: Leukoreduced Red Blood Cells that failed red cell recovery ratio, were distributed. ________ PRODUCT: Recovered Plasma, for use in Manufacturing Non- Injectable Products. Recall #B-699-1. CODE: Unit 0991587. MANUFACTURER: University of Texas M.D., Anderson Cancer Center, Houston, TX. RECALLED BY: Manufacturer, by letter dated January 5, 1999 and fax on March 19, 1999. Firm-initiated recall complete. DISTRIBUTION: Texas. QUANTITY: One unit. REASON: Blood product, which tested repeatedly reactive for the antibody To the Hepatitis B core antigen (anti-HBc), was distributed. ________ PRODUCT: Red Blood Cells. Recall #B-708-1. CODE: Unit numbers 01GE22364, 01GE22430, 01GG42374, 01GG42434, 01GW39410, 01GY41016, 01LT23726, and 01GY40929 MANUFACTURER: The American National Red Cross, New York -Penn Region, Syracuse, NY. RECALLED BY: The American National Red Cross, New York -Penn Region, West Henrietta, NY., by letter dated May 4, 2000. Firm-initiated recall complete. DISTRIBUTION: New York. QUANTITY: 8 units. REASON: Blood products exposed to unacceptable shipping temperatures were distributed. _________ PRODUCTS: a) Whole Blood. Recall #B-709-1. b) Red Blood Cells, Leukocytes Removed. Recall #B-710-1. c) Red Blood Cells, Leukocytes Removed Irradiated. Recall #B-711-1. CODES: a) (46 units) 21R60571, 21R57336, 21R56020, 21R56015, 21R57313, 21R61775, 21R61797, 21R57302, 21R57280, 21R60784, 21R57314, 21R56212, 21R56194, 21R56179, 21R56180, 21R61353, 21R61361, 21R51989, 21R53976, 21R53972, 21R49921, 21R54382, 21R60559, 21R60555, 21R60581, 21R60563, 21R59241, 21R59253, 21FR11125, 21FR09355, 21FR10396, 21FR10410, 21FR10403, 21R60787, 21R61043, 21R61037, 21R60561, 21R60930, 21FR11005, 21R54373, 21R53967, 21R56168, 21R61021, 21R56006, 21R61345, and 21R54377; b) (10 units), unit numbers 21KM16313, 21GE19202, 21KJ42609, 21KK33599, 21KM16298, 21KJ42645, 21KK33771, 21KJ42648, 21KL25470, and 21GW30772; c) (1 unit), unit number 21R60795 MANUFACTURER: The American National Red Cross, Pacific Northwest Region, Portland, OR. RECALLED BY: Manufacturer, by telephone on September 22, 26, and 27, 2000 and by follow-up letter dated October 10, 2000. Firm-initiated recall complete. DISTRIBUTION: California, Oregon, and Washington. QUANTITY: a) 46 units; b) 10 units, and c) one unit. REASON: Blood products stored at unacceptable temperatures were distributed. _________ PRODUCT: Pooled Plasma, Solvent/Detergent Treated, PLAS+?SD. Recall #B-712-1. CODES: Lot numbers FX90605, FX00906, GX90526, FW90507, FZ90607, and FZ90510. MANUFACTURER: American Red Cross Plasma Services Arlington, VA. RECALLED BY: Manufacturer, by letter dated December 8, 2000. Firm- initiated recall complete. DISTRIBUTION: 40 states, District of Columbia, and Puerto Rico, Quebec, and the Virgin Islands. QUANTITY: 6 lots. REASON: Blood products, stored to unacceptable storage temperatures, were distributed. _________ PRODUCTS: a) Red Blood Cells, Irradiated. Recall #B-713-1; b)Platelet Pheresis, Irradiated. Recall #B-714-1. CODES: a)(3 units), unit numbers 54KM42206, 54KG51559, and 54KG51538; b) (2 units), unit numbers 54KP06426 and 12T22861. MANUFACTURER: The American National Red Cross, Puerto Rico Region, Rio Piedras, PR. RECALLED BY: Manufacturer, by telephone on July 30, 1997, and by letter dated August 5, 1997. Firm-initiated recall complete. DISTRIBUTION: Puerto Rico. QUANTITY: 5 units. REASON: Irradiated blood products that were possibly out of controlled storage for more than 30 minutes were distributed. ________ PRODUCT: Fresh Frozen Plasma. Rcall #B-715-1. CODES: (608 units), unit numbers 3448550, 3462951, 3462952, 3462953, 3462954, 3462955, 3462956, 3462957, 3462958, 3462959, 3462960, 3462961, 3462962, 3462963, 3462964, 3462965, 3462966, 3462967, 3462968, 3452969, 3462970, 3519422, 3519439, 3519481, 3519537, 3519554, 3519567, 3519610, 3519619, 3551892, 3523209, 3554584, 3557465, 3557743, 3565868, 3565869, 3565883, 3565890, 3565973, 3565983, 3565990, 3566018, 3566032, 3566066, 3566971, 3566078, 3567510, 3567536, 3571861, 3571882, 3571906, 3571915, 3571931, 3571974, 3571983, 3571992, 3572014, 3572015, 3572026, 3572051, 3572054, 3572060, 3576494, 3577700, 3579557, 3579567, 3579570, 3579593, 3579612, 3579613, 3579617, 3579624, 3580714, 3580726, 3580733, 3580735, 3580739, 3580743, 3580744, 3580745, 3580747, 3580749, 3580750, 3580758, 3580762, 3580764, 3580765, 3580766, 3580767, 3580773, 3580778, 3580783, 3580923, 3580925, 3584494, 3584517, 3609238, 3609239, 3609243, 3609244, 3609257, 3609267, 3609269, 3609282, 3609288, 3609291, 3609296, 3609308, 3609315, 3609332, 3609342, 3609900, 3610555, 3610558, 3610589, 3610590, 3610592, 3610596, 3610606, 3610614, 3610618, 3610621, 3610622, 3610626, 3610645, 3610652, 3610689, 3610690, 3610695, 3610700, 3610702, 3610708, 3610723, 3610745, 3610747, 3610758, 3610760, 3610764, 3610788, 3610792, 3610821, 3610847, 3611538, 3611541, 3611551, 3611556, 3611561, 3611563, 3611567, 3611568, 3611577, 3611579, 3611582, 3611583, 3611587, 3611589, 3611592, 3611594, 3611598, 3611603, 3611605, 3611607, 3611612, 3611618, 3611629, 3611647, 3611648, 3611654, 3611662, 3611722, 3611735, 3613143, 3613154, 3613251, 3613259, 3613287, 3613296, 3613352, 3613355, 3613359, 3613381, 3613412, 3613424, 3613428, 3613477, 3613488, 3613495, 3613505, 3613506, 3613519, 3613528, 3613541, 3618975, 3619713, 3619745, 3619746, 3619781, 3619782, 3619802, 3619804, 3619806, 3619809, 3619811, 3619816, 3619819, 3619825, 3619828, 3619840, 3619842, 3619844, 3619845, 3619846, 3622543, 3623184, 3623205, 3623213, 3623218, 3623225, 3623232, 3623238, 3623240, 3623271, 3623277, 3623304, 3623321, 3623356, 3523358, 3623359, 3623380, 3523384, 3623385, 3623390, 3523407, 3623421, 3623429, 3623437, 3623438, 3626170, 3626175, 3626181, 3626182, 3626190, 3626191, 3626192, 3626193, 3526195, 3626196, 3626201, 3626202, 3626203, 3626205, 3626207, 3626208, 3626212, 3626213, 3626215, 3626219, 3626221, 3626224, 3626231, 3626234, 3626238, 3626241, 3626244, 3626247, 3626249, 3626352, 3626357, 3626361, 3626364, 3626369, 3626372, 3626376, 3626380, 3626381, 3626386, 3626392, 3626393, 3626394, 3626395, 3626397, 3626402, 3626403, 3626404, 3626412, 3626424, 3626429, 3626442, 3626443, 3626449, 3636207, 3638757, 3638770, 3638774, 3638796, 3638812, 3638816, 3638819, 3638829, 3638866, 3638870, 3638882, 3638894, 3638898, 3638917, 3638922, 3638929, 3638934, 3638940, 3638959, 3638970, 3638981, 3639006, 3639040, 3640853, 3640854, 3640862, 3640866, 3640872, 3640873, 3640885, 3645877, 3645881, 3645882, 3645883, 3645884, 3645889, 3645891, 3645899, 3645903, 3645914, 3645917, 3645927, 3645931, 3645937, 3645945, 3645947, 3646624, 3646627, 3646630, 3646643, 3646647, 3646653, 3646654, 3646662, 3646664, 3646666, 3646672, 3646673, 3646678, 3646682, 3647917, 3647987, 3648258, 3649310, 3649327, 3649366, 3649370, 3649372, 3649374, 3649387, 3649466, 3649486, 3649487, 3651194, 3651370, 3651379, 3651383, 3651391, 3651397, 3651404, 3651427, 3651436, 3651442, 3651448, 3651458, 3651483, 3651384, 3651511, 3651516, 3651530, 3651538, 3651553, 3651556, 3651561, 3651566, 3651571, 3651576, 3651580, 3651586, 3651599, 3651613, 3651619, 3651642, 3654052, 3654076, 3654081, 3654082, 3654084, 3654090, 3654100, 3654101, 3654105, 3654108, 3654111, 3654130, 3654140, 3654155, 3654164, 3654204, 3654206, 3654225, 3654228, 3654230, 3654243, 3654255, 3654271, 3657203, 3657205, 3657209, 3657211, 3657220, 3657242, 3659799, 3659808, 3659821, 3659854, 3659874, 3659878, 3659886, 3659889, 3659904, 3659911, 3659924, 3659927, 3659946, 3659948, 3659952, 3659954, 3659964, 3659967, 3659970, 3659977, 3659998, 3660001, 3660010, 3660019, 3660026, 3661556, 3661563, 3661610, 3661617, 3661618, 3661629, 3661636, 3661639, 3661640, 3661645, 3661647, 3661652, 3661656, 3661665, 3661680, 3661681, 3661688, 3681119, 3681123, 3681126, 3681147, 3681150, 3681152, 3681160, 3681173, 3681177, 3681181, 3681184, 3681199, 3684057, 3684981, 3685193, 3685195, 3685551, 3685552, 3685553, 3685554, 3685555, 3685556, 3685557, 3685558, 3685560, 3685561, 3685562, 3685563, 3685564, 3665565, 3686666, 3685568, 3685569, 3685570, 3685571, 3686672, 3685573, 3685574, 3685575, 3685576, 3685577, 3685578, 3685579, 3685580, 3685581, 3685582, 3685583, 3685584, 3685585, 3685586, 3685587, 3685588, 3687074, 3687132, 3687155, 3687156, 3687159, 3687160, 3687164, 3688633, 3688683, 3691500, 3691502, 3691503, 3691509, 3691511, 3691518, 3691521, 3691524, 3691526, 3691535, 3691536, 3691538, 3691543, 3691546, 3702518, 3704129, 3705685, 3707656, 3707657, 3707659, 3707660, 3707668, 3707671, 3707682, 3707685, 3707687, 3707697, 3707698, 3707703, 3707714, 3707721, 3707722, 3707728, 3707729, 3707734, 3707749, 3713774, 3713775, 3717357, 3717358, 3717363, 3717364, 3717374, 3718260, 3726509, 3726510, 3726511, 3726512, 3726513, 3726515, 3726516, 3726517, 3726518, 3726519, 3726520, 3726521, 3726522, 3725551, 3726552, 3727762, 3727765, 3727769, 3727770, 3727776, 3727797, 3727803, 3727808, 3727811, 3747863, 3751412, 3781402, 3781461, 3784875, 3785145, 3803763, 3803765, 3803778, 3803780, 3803783, 3803785, 3803796, and 3803802. MANUFACTURER: Gulf Coast Regional Blood Center, Houston, TX. RECALLED BY: Manufaacturer, by telephone and letter on February 18, 2000. Firm-initiated recall complete. DISTRIBUTION: Texas and Louisiana. QUANTITY: 608 units. REASON: Blood products, collected using the incorrect anticoagulant, were distributed. ________ PRODUCT: Platelets. Recall #B-717-1. CODE: Unit 53GE48943. MANUFACTURER: American Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD. RECALLED BY: Manufaacturer, by telephone on October 4, 2000. Firm- initiated recall complete. DISTRIBUTION: Washington, D.C. QUANTITY: One unit. REASON: Blood product, that had an extended rest time, was distributed. ________ PRODUCT: Red Blood Cells. Recall #B-718-1. CODE: 38FE64248, 38FE64243, 38FE64245, 38FE64255, 38FE64260, 38FE64232, 38FE64238, 38FE64239, 38FE64242, 38FE64246, 38FE64254, 38FE642437 38FE64256, 38FE64257, 38FE64250, 38FE64241, 38FE64249. 38FE64251. 38FE64259, 38FE64234; 38FE64244, 38FE64258. MANUFACTURER: American Red Cross Blood Services. RECALLED BY: Manufacturer, by telephone on September 18, 2000. Firm-initiated recall complete. DISTRIBUTION: Indiana and Ohio. QUANTITY: 22 units. REASON: Blood products, collected in an anticoagulant bags that may have exceeded their expiration date, were distributed. ________ PRODUCT: Hib TITER? Haemophilus b Conjugate Vaccine. Recall #B- 719-1. CODE: lot number 613803A (shipper control number 471-912). MANUFACTURER: Wyeth-Ayerst Pharmaceuticals, Pearl River, NY. RECALLED BY: Wyeth-Ayerst Laboratories, Philadelphia, PA, BY VISIT ON August 22, 2000 and by letter on August 30, 2000. Firm-initiated recall complete. DISTRIBUTION: Nationwide. QUANTITY: One lot. REASON: Vaccine that was shipped without a freeze indicator and may have been subjected to unacceptable temperatures during shipment was distributed. ________ PRODUCT: Red Blood Cells, Irradiated. Recall #B-723-1. CODE: Unit number 36257-9831. MANUFACTURER: Blood Systems, Inc., Ventura, CA. RECALLED BY: Blood Systems, Inc., Scottsdale, AZ., by telephone on February 17, 2000, and by letter dated March 3, 2000. Firm-initiated recall complete. DISTRIBUTION: California. QUANTITY: One unit. REASON: Blood product, labeled with the incorrect expiration date, was distributed. ________ PRODUCT: Red Blood Cells. Recall #B-724-1. CODE: Unit number 36257-3184. MANUFACTURER: Blood Systems, Inc.,Ventura, CA.. RECALLED BY: Blood Systems, Inc., Scottsdale, AZ., by telephone on December 9, 1999. Firm-initiated recall complete. DISTRIBUTION: California. QUANTITY: One unit. REASON: Blood product, labeled with the incorrect expiration date, was distributed. ________ PRODUCT: Red Blood Cells, Luekocytes Removed. Recall #B-725-1. CODE: Unit number 10620-2448. MANUFACTURER: Blood Systems, Inc.,Chandler, AZ. RECALLED BY: Blood Systems, Inc., Scottsdale, AZ., by telephone on February 29, 2000. Firm-initiated recall complete. DISTRIBUTION: Arizona. QUANTITY: One unit. REASON: Blood product, labeled with the incorrect expiration date, was distributed _________ PRODUCTS: a) Platelets. Recall #B-726-1; b) Platelet Pheresis. Recall #B-727-1. CODES: a) (18 units), unit numbers 12H95752, 53FF28155, 54KH23605, 12P89844, 53GE15603, 53Z13966, 53GE15599, 12H95722, 54KH23849, 12H96157, 54KR17682, 54KH23858, 54KF52058, 54KK21283, 54KS17283, 54KF52057, 12R61503, and 54KF52061 b) (2 units), unit numbers 53LT51653 and 54KP05374. MANUFACTURER: The American National Red Cross, Puerto Rico Region, Rio Piedras, PR. RECALLED BY: Manufacturer, by telephone on October 18,1996 and by letter dated October 28, 1996. Firm-initiated recall complete. DISTRIBUTION: Puerto Rico. QUANTITY: 20 units. REASON: Blood products that were out of controlled storage for more than 30 minutes were distributed. ________ PRODUCT: Platelets. Recall #B-728-1. CODE: Unit number 54KJ33161. MANUFACTURER: The American National Red Cross, Puerto Rico Region, Rio Piedras, PR. RECALLED BY: Manufacturer, by letter dated September 2, 1998. Firm- initiated recall complete. DISTRIBUTION: Puerto Rico. QUANTITY: One unit. REASON: Blood product, stored at an unacceptable temperature, was distributed. ________ PRODUCT: a) Platelets. Recall #B-729-1. b) Platelets, Irradiated. Recall #B-730-1. CODE: a) (72 units), unit numbers 54KH38532, 54KH38537, 54KM53012, 54KF79246, 54KF79249, 54KF79250, 54KF79251, 54KF79252, 54KF79253, 54KF79256, 54KF79266, 54KG64104, 54KG64108, 54KG64109, 54KG64110, 54KG64111, 54KG64112, 54KG64115, 54KG64117, 54KG64118, 54KG64119, 54KG64120, 54KG64137, 54KG64139, 54KG64140, 54KG64141, 54KJ33159, 54KJ33160, 54KJ33163, 54KJ33164, 54KJ33180, 54KJ33184, 54KJ33185, 54KJ33186, 54KJ33187, 54KJ33190, 54KJ33191, 54KJ33193, 54KK30471, 54KK30472, 54KK30477, 54KK30478, 54KK30479, 54KK30480, 54KK30481, 54KK30484, 54KK30485, 54KK30486, 54KK30448, 54KK30489, 54KK30490, 54KK30493, 54KK30498, 54KK30499, 54KM52997, 54KM52998, 54KM52999, 54KM53003, 54KR24490, 54KR24491, 54KR24493, 54KR24494, 54KS25112, 54KS25113, 54KS25114, 54KS25115, 54KS25116, 54KS25117, 54KS25118, 54KS25119, 54KS25120, and 54KM53010 b) (13 units), unit numbers 54KH38538, 54KS25121, 54KK30487, 54KJ33165, 54KJ33171, 54KJ33175, 54KJ33177, 54KG64122, 54KG64106, 54KG64107, 54KF79259, 54KF79261, and 54KF79255 MANUFACTURER: The American National Red Cross, Puerto Rico Region, Rio Piedras, PR. RECALLED BY: Manufacturer, by telephone on August 28, 1998, and by letter dated September 2, 1998. Firm-initiated recall complete. DISTRIBUTION: Puerto Rico. QUANTITY: 85 units. REASON: Blood products, stored at an unacceptable temperature, were distributed. ________ PRODUCT: Recovered Plasma. Recall #B-731-1. CODES: (53 units), unit numbers 54KC10417, 54KC10419, 54KC10420, 54KC10422, 54KC10423, 54KC10424, 54KF90674, 54KG72961, 54KG72962, 54KG72963, 54KG72964, 54KG72969, 54KG72972, 54KG72973, 54KG72975, 54KG72976, 54KG72979, 54KG72984, 54KG72985, 54KG72986, 54KG72987, 54KG72988, 54KG72989, 54KG72990, 54KG72991, 54KG72992, 54KG72993, 54KG72996, 54KG72998, 54KG72999, 54KG73003, 54KG73005, 54KG73006, 54KH45799, 54KH45800, 54KH45801, 54KH45803, 54KH45805, 54KH45806, 54KH45814, 54KH45816, 54KH45817, 54KH45819, 54KH45822, 54KH45823, 54KM59305, 54KM59307, 54KM59310, 54KM59311, 54KM59316, 54KM59317, 54KR28125, and 54KR29129. MANUFACTURER: The American National Red Cross, Puerto Rico Region, Rio Piedras, PR. RECALLED BY: Manufacturer, by letter on July 8, 1999. Firm-initiated recall complete. DISTRIBUTION: California. QUANTITY: 53 units. REASON: Blood products, stored at an unacceptable temperature, were distributed. ________ PRODUCT: Recovered Plasma. Recall #B-746-1. CODES: Unit 54KH37752. MANUFACTURER: American National Red Cross, Puerto Rico Region, Rio Piedras, PR. RECALLED BY: American Red Cross Blood Services, Puerto Rico Region, San Juan, PR., by letter on August 11, 1998. Firm- initiated recall complete. DISTRIBUTION: Puerto Rico and California. QUANTITY: One unit. REASON: Blood products, prepared from the same donation as Staphylococcus epidermidis contaminated Red Blood Cells, were distributed. _________ PRODUCTS: a) Platelets. Recall #B-753-1. b) Platelet Pheresis Leukoreduced. Recall #B-754-1. CODES: a) Units: 0289518, 0289519, 0289520, 0289524, 0289526, 0289533, 0289536, 0289544, 0289549, 0289550, 0289601, 0289602, 0289605, 0289606, 0289609, 0289610, 0289611, 0289613, 0289614, 0289615, 0289617, 0289618 and 0289619. b) Units: 0289502A, 0289502B, 0289504, 0289516B, 0289527, 0289534B1, 0289534B2, 0289543A, 0289556, 0289558, 0289559B, 0289560, 0289566 and 0289578. MANUFACTURER: Inland Northwest Blood Center, Spokane, WA. RECALLED BY: Manufacturer, by letters dated January 28, 1999 and February 1, 1999. Firm-initiated recall complete. DISTRIBUTION: Washington. QUANTITY: 37 units. REASON: Platelets, not stored under continuous agitation, were distributed. ________ PRODUCT: Red Blood Cells. Recall B-755-1. CODE: Unit number 33GK06202. MANUFACTURER: The American National Red Cross, Connecticut Region, Farmington, CT. RECALLED BY: Manufacturer, by telephone on November 4, 2000. Firm- initiated recall complete. DISTRIBUTION: Connecticut. QUANTITY: One unit. REASON: Blood product, that tested positive for the C antigen, but was labeled as C antigen negative, was distributed. ________ PRODUCT: a) Red Blood Cells. Recall #B-757-1; b) Recovered Plasma. Recall #B-758-1. CODE: a) and b) unit number 2176517. MANUFACTURER: Community Blood Center of Greater Kansas City, Kansas City, MO. RECALLED BY: Manufacturer, by letter dated November 22, 1999. Firm- initiated recall complete. DISTRIBUTION: Kansas and California. QUANTITY: Two units. REASON: Blood products, collected from an ineligible donor due to a history of a tissue transplant within twelve months of donation, were distributed. ________ PRODUCTS: a) Cryoprecipitated AHF. Recall #B-788-1; b) Fresh Frozen Plasma. Recall #B-789-1. CODES: a)(98 units), unit numbers C 31927, L 00195, L 00196, L 01986, L 03695, L 25001, L 25002, L 28199, L 51287, L 51397, M 02381, M 04226, M 04622, M 04625, M 05533, M 05663, M 06472, M 25150, M 25155, M 25157, M 25951, M 25953, M 28219, M 50761, M 51376, M 53300, M 54620, M 54781, M 55260, M 56789, M 57946, M 57947, M 57949, M 57951, M 78771, M 78772, M 79086, S 02212, S 02448, S 02463, S 02500, S 02665, S 02667, S 23506, T 00586, T 00587, T 00589, T 50209, T 50210, T 50246, T 50324, T 51264, T 51265, T 51971, T 80456, T 80457, T 80459, T 80511, T 80512, T 80514, T 80883, T 82763, T 83000, T 83278, T 83433, T 83434, T 83648, T 83650, T 83651, T 83780, T 83781, T 83782, T 83874, T 83900, W 01478, W 01847, W 05663, W 07744, W 07747, W 07750, W 30550, W 31623, W 31669, W 35026, W 35261, W 35458, W 35493, W 35494, W 35658, W 35659, W 36936, W 37507, W 37509, W 39533, W 40361, W 81632, W 81681, and W 84274; b) (1 unit), unit number S 23172. MANUFACTURER: Virginia Blood Services, Richmond, VA. RECALLED BY: Manufacturer, by telephone on October 18 and 19, 2000 and November 14, 2000, and by letter dated November 14, 2000. Firm-initiated recall complete. DISTRIBUTION: Virginia. QUANTITY: 99 units. REASON: Blood products, prepared more that eight hours after collection of the corresponding unit of Whole Blood, were distributed.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT: Vitros ECi Immunodiagnostic System. Recall #Z-248-1. CODE: Serial Numbers: 30000001 thru 30001276; R3100151; R3100153; R3100154. MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Rochester, NY. RECALLED BY: Manufacturer, by Federal Express letter on August 9, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide, and 26 Federal government customers (Government Contract GS-24f-124c) QUANTITY: Domestic - 222 units; International - 729 units. REASON: Sample processing on the system may cause incorrect results. ________ PRODUCT: ELA/Angeion Lyra Implantable Cardioverter Defibrillators. Z-251-Model No. 2020; Z-252-Model No. 2021; Z-253-Model No. 2022. CODES: Model No. 2020; Model No. 2021; Model No. 2022. MANUFACTURER: Angeion Corporation, St. Paul, MN. RECALLED BY: Manufacturer, by letter on February 2, 2001. Firm- initiated recall ongoing. DISTRIBUTION: Nationwide, and in Europe and South America. QUANTITY: 494. REASON: The device may fail to provide pacing or defibrillation therapy. _______ PRODUCT: Bioelectrical Discharger: Recall #Z-273-1 - Model No. ZQ1; Recall #Z-274-1 - Model No. ZQ2. CODE: Model No. ZQ1; Model No. ZQ2. All units distributed between September 1 and December 1, 2000. MANUFACTURER: Z’ Strong International, Inc., El Monte, CA. RECALLED BY: Manufacturer, by letter on January 4, 2001. Firm- initiated recall ongoing. DISTRIBUTION: Nationwide and the U.S. Virgin Islands. QUANTITY: 725 devices. REASON: Inappropriate medical claims.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT: Vitros 250 Chemistry Systems with Software Versions 6.x (6.0,6.01, 6.02, etc). Recall #Z-249-1. CODES: Catalog #8132086. Vitros 250 Chemistry System serial numbers less than 2501494. MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Rochester, NY. RECALLED BY: Manufacturer, by letter on June 28, 2000. Firm- initiated recall ongoing. DISTRIBUTION: Nationwide and worldwide. There are 209 Federal government accounts under government contract #GS-24f- 1243c. QUANTITY: 1,780 - domestic; and approx. 2,700 - international. REASON: Test results may be mis-reported as 0.0 for any analyte including CK-MB, acetaminophen, iron, lithium, and salicylate. ________ PRODUCT: Carbamazepine (CRBM) slides; 5x18 slides. Recall #Z- 250-1. CODES: Lot Nos. 3904-0004-4318 through 3904-0004-4320, 3904-0004-5274 through 3004-0004-5277, 33904-0004-7709 and 3904-0004-7710, 3905-0005-7707, 3905-0005-0255 through 3905-0005-0257, 3905-0005-2161 through 3905-0005-2163, 3905-0005-4196 and 3905-0005- 4197, 3905-0005-4249 through 3905-0005-4251, 3906-0006-7694 through 3906-7696; MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Rochester, NY. RECALLED BY: Manufacturer, by telephone and letter dated September 29, 2000. A second letter was issued on October 13, 2000. Firm-initiated recall complete. DISTRIBUTION: Nationwide and worldwide, and 16 Federal government consignees under government contract V797P-6565A. QUANTITY: 2,194 packs - domestic; and 1,387 packs- international. REASON: The CRBM slides were labeled with wrong expiration date. ________ PRODUCT: Vitros ECi Immunodiagnostic Systems: Recall #Z-275-1.- Catalog No. 8633893; Recall #Z-276-1 - Catalog No. 6801059. CODES: Lot Nos. 30000001 thru 30001276, and R3100151 thru R3100158. MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Rochester, NY. RECALLED BY: Manufacturer, by letter on September 12, 2000. Firm- initiated recall ongoing. DISTRIBUTION: Nationwide and worldwide, and 25 Federal government accounts who purchased under government contract GS- 24f-1243c. QUANTITY: 222 domestic and 717 International. REASON: The DRD pump assembly is out of specification, and could result in deliver of excess fluid. "Correction: The Enforcement Report for November 22, 2000 (Recall Number Z-030-1) incorrectly listed the address of Medical Data Electronics as Arleta, GA. The address is Arleta, California.END OF ENFORCEMENT REPORT FOR MARCH 7, 2001
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