February 19, 2003 03-08
_____________________________ PRODUCT Shahzada (TM) Raisins, Net Wt. 200 g, 7 oz, packaged in a plastic bag. Recall # F-181-3. CODE None. RECALLING FIRM/MANUFACTURER Recall Firm: Advance Food International, Inc., Maspeth, NY, by press release and letter on
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
February 21, 2002. Manufacturer: Zaiga Food Industries Karachi, Pakistan. State initiated recall is complete. REASON The product contained undeclared sulfites. VOLUME OF PRODUCT IN COMMERCE 365 units. DISTRIBUTION NY. _____________________________ PRODUCT Gold Nosh brand TU B'Shvat Fruits (a mixture of dried fruit and nuts) packed in clear, rigid
plastic container w/lid, 16 oz. Barcode # 44664 00337. Recall # F-183-3. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Gold Nut Corporation, Brooklyn, NY, by Safety Alert and telephone on February 4, 2002. State
initiated recall is complete. REASON The product contained undeclared sulfites. VOLUME OF PRODUCT IN COMMERCE 150 containers. DISTRIBUTION NY. _____________________________ PRODUCT Kellogg brand Pop-tarts, frosted brown sugar cinnamon, 14 ounce package of 8. Recall # F-185-3. CODE Best if used before dates of SEP 23 03 CT, OCT 27 03 CP, OCT 28 03 CP, NOV 06 03 CT, NOV 07 03 CT, NOV 08 03 CT, NOV 23 03 CP, NOV 24 03 CP, NOV 25 03 CP, NOV 26 03 CP and NOV 27 03 CP. RECALLING FIRM/MANUFACTURER Kellogg Co., Battle Creek, MI, by press release on December 6, 2002. Firm initiated recall is ongoing. REASON The product contained undeclared egg. VOLUME OF PRODUCT IN COMMERCE 730,000 packages. DISTRIBUTION Nationwide. _____________________________ PRODUCT Imperial Savoury Snacks brand "CHIN CHIN", Weight 14 oz., packaged in a clear, plastic bag with a blue, yellow & red colored logo. Recall # F-201-3. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Recalling Firm: Advance Food International, Inc., Maspeth, NY, by press release and letter on March 12, 2002. Manufacturer: Imperial Snack Foods Limited Wolverhampton, England. State initiated recall is complete. REASON The product contained undeclared ingredients including cashews, almonds and raisins. VOLUME OF PRODUCT IN COMMERCE 260.5 units. DISTRIBUTION NY, CT, MA, NC, and VA. _____________________________ PRODUCT Fructs Lycll Herb (CAU KY TU), packed in a rigid plastic container, NET WT 12 oz. (340 G +/- 5G), Product of China. Barcode # 64460 10437. Recall # F-202-3. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Recalling Firm: Ho's Trading, Inc., Brooklyn, NY., by press release on August 20, 2002 and by letters, dated December 22, 2002. Manufacturer: Zhao Wu Chen Sheng Li Humen Wan Jiang Dong Guan Guang Dong, China. State initiated recall is complete. REASON The product contained undeclared sulfites. VOLUME OF PRODUCT IN COMMERCE 101 cases (50 - 12 oz. Packages per case). DISTRIBUTION Nationwide. _____________________________ PRODUCT Navabhojan Mango Bar brand Dehydrated Mango Pulp, Net Contents 200g (7.1 oz.). Product of India. Recall # F-203-3. CODE Batch No: Juhe 2001, Date of Packing: Sept 2002. RECALLING FIRM/MANUFACTURER Recalling Firm: Peekay International, Inc., Maspeth, NY, by press release and letter on April 3, 2002. Manufacturer: Malabar Fruit Products, Kerala, S. India. State initiated recall is complete. REASON The product contained undeclared sulfites. VOLUME OF PRODUCT IN COMMERCE Undetermined. DISTRIBUTION NY, NJ, CT, MA, PA, VA, NC, GA, and FL. _____________________________ PRODUCT Sungarden Sprouts, alfalfa (alfalfa and clover), in 4 ounce clear plastic container with snap closure lids. Recall # F-204-3. CODE 11/12. RECALLING FIRM/MANUFACTURER Sungarden Sprout Co., Division of International Specialty & Supply, LLC, Cookeville, TN, by press release and telephone on November 8, 2002. State initiated recall is complete. REASON The Georgia Department of Agriculture found the product to be contaminated with Listeria monocytogenes. VOLUME OF PRODUCT IN COMMERCE 6780 containers. DISTRIBUTION AL, TN, GA, and KY. _____________________________ PRODUCT Turkey sandwiches. All sandwiches are labeled with the firm's name and address. Sandwiches are either packed into modified atmosphere packaging (standard sandwiches) or cryovac (hoagie style sandwiches). LUNCH BOX SANDWICH brand: TURKEY. Recall # F-207-3; SMOKED TURKEY. Recall # F-208-3; HALF CLUB. Recall # F-209-3; TURKEY Deli Wedge. Recall # F-210-3. DASHBOARD Deli brand: The Commuter TURKEY SUB. Recall # F-211-3; LONG HAUL. Recall # F-212-3; TURKEY EURO PITA LITE STYLE. Recall # F-213-3. Jumbo Foods label: TURKEY PITA. Recall # F-214-3; TURKEY CROISSANT. Recall # F-215-3; TURKEY BAGEL. Recall # F-216-3; TURKEY HOAGIE. Recall # F-217-3; SMOKED TURKEY ON SOURDOUGH. Recall # F-218-3. CODE Product with a date code of 10/14 through 11/1. Each date is preceeded with the letter A, B, C, D, E or with the number 1, 2, 3, 4, 5. The A and 1 represent Monday production, B and 2 represent Tuesday production, etc. The letters represent product produced on one line, and the numbers represent product manufactured on a different line. For example: E101802 5 10/18 represent sandwiches produced on Friday, 9/20/02 and coded with a pull date of 10/18/02. RECALLING FIRM/MANUFACTURER Jumbo Foods, Inc., Mukilteo, WA, by telephone on October 14, 2002. Firm initiated recall is complete. REASON Sandwiches were manufactured using turkey recalled by Wampler Foods due to Listeria monocytogenes contamination. VOLUME OF PRODUCT IN COMMERCE 100,000/week. DISTRIBUTION AZ, CA, ID, NM, NV, OR, UT, WA and WY. _____________________________ PRODUCT a) Walker's Sour Cream and Cheddar Penne Pasta Salad packaged 2/5-lb. plastic containers per case. Recall # F-219-3; b) K.C. Masterpiece Cole Slaw packaged 2/10-lb. plastic containers per case. Recall # F-220-3; c) Walker's Jalapeno Cheese and Pimento Spread packaged 2/5-lb. plastic containers per case. Recall # F-221-3; d) Back Yard Burgers Home Style Creamy Cole Slaw packaged 2/10-lb. plastic containers per case. Recall # F-222-3. CODE The products are coded with the following expiration dates: a) 4/02/02 thru 5/07/02; b) 4/02/02 thru 5/07/02; c) 6/21/02 thru 7/21/02; d) 4/02/02 thru 5/08/02. RECALLING FIRM/MANUFACTURER Walker Food Products Co., Inc. North Kansas City, MO., by telephone on March 21-22, 2002, by fax on April 9, 2002 and by fax and telephone on April 10, 2002 and April 16, 2002. FDA initiated recall is complete. REASON The products contained undeclared eggs. VOLUME OF PRODUCT IN COMMERCE a) 115/2/5-lb. container cases; b) 200/2/10-lb. container cases; c) 106/2/5-lb. container cases; d) 72/2/10-lb. container cases. DISTRIBUTION MO, KS, and IA.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_____________________________ PRODUCT E. Wedel brand Czekoladowa Mieszanka Wedlowska (Assorted Chocolate Candies) Net Weight: 260g (9.17 oz), packed in cellophane packages. Product of Poland. Barcode # 76841 01247. Recall # F-182-3. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Recalling Firm: Adamba Imports International, Inc., Brooklyn, NY, by telephone on/about October 3, 2001. Manufacturer: Cadbury Wedel Sp.Z, Warsaw, Poland. State initiated recall is complete. REASON The product contained Ponceau 4R (E124), an unapproved color additive, and sunset yellow FCF (E110, certifiable as FD&C Yellow #6). VOLUME OF PRODUCT IN COMMERCE 50 cases (10 - 260 g packages per case). DISTRIBUTION NY, NJ, and MA. _____________________________ PRODUCT Shneider's brand Tubble Gum Tutti, net wt. 35 g, packaged in a rigid plastic tube. Barcode # 532340 000442. Recall # F-184-3. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Recalling Firm: Paskesz Candy, Inc., Brooklyn, NY, by letter dated May 1, 2002. Manufacturer: Moral Mamtak 1988 Ltd., 20 Jerusalem, Israel. State initiated recall is complete. REASON The product contained Ponceau 4R (E124), an unapproved color. VOLUME OF PRODUCT IN COMMERCE 252 cases 9 (6 boxes with 36 -35 gram tubes each per case). DISTRIBUTION NY. _____________________________ PRODUCT Re-Vita Liqua Health. Lemon-Lime Flavored Dietary Supplement labeled in part: 'Nutrients From Nature Liqua Health All in One Nutritional Assurance; The product is sold in 32 oz. plastic bottles, 16 oz. plastic bottles and 5 fl. oz. packets (packets further packaged in plastic bags with 10, 60, or 600 of these packets per bag). Each individual packet is labeled in part: 'Re-Vita Liqua Health (Lemon-Lime) Not For Individual Sale. See Master Packaging For Nutritional Information.' Recall # F-188-3. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Re-Vita Manufacturing Co., Inc., Orange Park, FL., by letter on December 13, 202. FDA initiated recall is ongoing. REASON The product contained an undeclared color, FD&C Yellow No. 5. VOLUME OF PRODUCT IN COMMERCE To be determined. DISTRIBUTION To be determined. _____________________________ PRODUCT Re-Vita Liqua Health. Butternut flavor Dietary Supplement labeled in part: 'Nutrients From Nature Liqua Spirulina Energy Booster. The product is sold in 32 oz. plastic bottles, 16 oz. plastic bottles and 5 fl. oz. packets (packets further packaged in plastic bags with 10, 60, or 600 of these packets per bag). Each individual packet is labeled in part: 'Re-Vita Liqua Spirulina (Butternut) Not For Individual Sale. See Master Packaging For Nutritional Information.' Recall # F-190-3. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Re-Vita Manufacturing Co., Inc., Orange Park, FL., by letter on December 13, 202. FDA initiated recall is ongoing. REASON The product contained an undeclared color, FD&C Yellow No. 5. VOLUME OF PRODUCT IN COMMERCE To be determined. DISTRIBUTION To be determined. _____________________________ PRODUCT Re-Vita Liqua Health. Lemon-Lime Flavored Dietary Supplement labeled in part: 'Nutrients From Nature Liqua Spirulina Energy Booster. The product is sold in 32 oz. plastic bottles, 16 oz. plastic bottles and 5 fl. oz. packets (packets further packaged in plastic bags with 10, 60, or 600 of these packets per bag). Each individual packet is labeled in part: 'Re-Vita Liqua spirulina (Lemon-Lime) Not For Individual Sale. See Master Packaging For Nutritional Information.' Recall # F-192-3. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Re-Vita Manufacturing Co., Inc., Orange Park, FL., by letter on December 13, 202. FDA initiated recall is ongoing. REASON The product contained an undeclared color, FD&C Yellow No. 5. VOLUME OF PRODUCT IN COMMERCE To be determined. DISTRIBUTION To be determined. _____________________________ PRODUCT a) Snowflake Chocolates Handmade in Vermont: in 1 Lb., 2 Lb., and 1/2 Lb. boxes specifically containing 2-4 pieces of lemon and orange creams with milk/dark chocolate ,wintergreen patties with dark chocolate and any chocolate with sugar decorations. Recall # F-193-3; b) Snowflake Chocolate Wintergreen Patties packaged in 7.5 ounce clear tube. Recall # F-194-3. CODE Product shipped prior to October 1, 2002. RECALLING FIRM/MANUFACTURER Snowflake Chocolates, Jericho, VT, by letter on/about October 10, 2002. Firm initiated recall is complete. REASON The product label did not declare colors - FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Red No. 40, and FD&C Red No. 3. VOLUME OF PRODUCT IN COMMERCE 535 lbs. DISTRIBUTION Nationwide. _____________________________ PRODUCT Saltwater taffy sold in 25 lb. cases, to be sold at retail in bulk bins. Flavors include: a) Black Licorice. Recall # F-196-3; b) Wicky-Wacky Licorice. Recall # F-197-3; c) Licorice Swirl. Recall # F-198-3; d) Mocha. Recall # F-199-3; e) Mixed flavors of taffy in 1/2 lb. bags/25 lb. cases. Recall # F-200-3; CODE Products are not coded. RECALLING FIRM/MANUFACTURER The Candy Basket, Inc., Portland, OR., by on site visit and letter on July 29, 2002. FDA initiated recall is complete. REASON The products contained undeclared colors - FD&C Yellow No. 6, FD&C Red No. 40, FD&C Red No. 3, FD&C Blue No. 1, and FD&C Blue No. 2 aluminum lake. VOLUME OF PRODUCT IN COMMERCE Approx. 10/25 lb. cases per week. DISTRIBUTION CA, OR, and WA. _____________________________ PRODUCT a) Ball's Blue Cheese Potato Salad packaged in 2/5-lb. or 2/10-lb. plastic containers per case. Recall # F-223-2; b) Walker's Tuna Salad packaged 2/5-lb. plastic containers per case. Recall # F-224-2. CODE The products are coded with the following expiration dates: a) and b) 4/02/02 thru 5/07/02. RECALLING FIRM/MANUFACTURER Walker Food Products Co., Inc. North Kansas City, MO., by telephone on March 21-22, 2002, by fax on April 9, 2002 and by fax and telephone on April 10, 2002 and April 16, 2002. FDA initiated recall is complete. REASON The products did not list subingredients of mayonnaise. VOLUME OF PRODUCT IN COMMERCE a) 15/2/5-lb. container cases; b) 83/2/5-lb. container cases. DISTRIBUTION MO, KS, and IA.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
_____________________________ PRODUCT Re-Vita Liqua Health. Berry Flavored Dietary Supplement labeled in part: 'Nutrients From Nature Liqua Health All in One Nutritional Assurance; The product is sold in 32 oz. plastic bottles, 16 oz. plastic bottles and 5 fl. oz. packets (packets further packaged in plastic bags with 10, 60, or 600 of these packets per bag). Each individual packet is labeled in part: 'Re-Vita Liqua Health (Berry) Not For Individual Sale. Recall # F-186-3. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Re-Vita Manufacturing Co., Inc., Orange Park, FL, by letter on December 13,2002. FDA initiated recall ongoing. REASON The product contained an undeclared color, FDC Red #40. VOLUME OF PRODUCT IN COMMERCE To be determined. DISTRIBUTION To be determined. _____________________________ PRODUCT Re-Vita Liqua Health. Grape Flavored Dietary Supplement labeled in part: 'Nutrients From Nature Liqua Health All in One Nutritional Assurance. The product is sold in 32 oz. plastic bottles, 16 oz. plastic bottles and 5 fl. oz. packets (packets further packaged in plastic bags with 10, 60, or 600 of these packets per bag). Each individual packet is labeled in part: 'Re-Vita Liqua Health (Grape) Not For Individual Sale. Recall # F-187-3. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Re-Vita Manufacturing Co., Inc., Orange Park, FL, by letter on December 13,2002. FDA initiated recall is ongoing. REASON The product contained an undeclared color, FDC Red #40. VOLUME OF PRODUCT IN COMMERCE To be determined. DISTRIBUTION To be determined. _____________________________ PRODUCT Re-Vita Liqua Health. Berry Flavored Dietary Supplement labeled in part: 'Nutrients From Nature LIQUA Spirulina Energy Booster. The product is sold in 32 oz. plastic bottles, 16 oz. plastic bottles and 5 fl. oz. packets (packets further packaged in plastic bags with 10, 60, or 600 of these packets per bag). Each individual packet is labeled in part: 'Re-Vita Liqua Spirulina (Berry) Not For Individual Sale. Recall # F-189-3. CODE All codes are involved that do not list the referenced color. RECALLING FIRM/MANUFACTURER Re-Vita Manufacturing Co., Inc., Orange Park, FL, by letter on December 13,2002. FDA initiated recall ongoing. REASON Undeclared FDC Red #40. VOLUME OF PRODUCT IN COMMERCE To be determined. DISTRIBUTION To be determined. _____________________________ PRODUCT Re-Vita Liqua Health. Grape flavor Dietary Supplement labeled in part: 'Nutrients From Nature Liqua Spirulina Energy Booster. The product is sold in 32 oz. plastic bottles, 16 oz. plastic bottles and 5 fl. oz. packets (packets further packaged in plastic bags with 10, 60, or 600 of these packets per bag). Each individual packet is labeled in part: 'Re-Vita Liqua Spirulina (Grape) Not For Individual Sale. Recall # F-191-3. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Re-Vita Manufacturing Co., Inc., Orange Park, FL, by letter on December 13,2002. FDA initiated recall ongoing. REASON The product contained an undeclared color, FDC Red #40. VOLUME OF PRODUCT IN COMMERCE To be determined. DISTRIBUTION To be determined. _____________________________ PRODUCT Walker's Potato Salad with Egg packaged 2/5-lb. or 2/10-lb. plastic containers per case. Recall # F-225-2. CODE Walker's Potato Salad with Egg - 4/02/02 thru 5/07/02. RECALLING FIRM/MANUFACTURER Walker Food Products Co., Inc. North Kansas City, MO., by telephone on March 21-22, 2002, by fax on April 9, 2002 and by fax and telephone on April 10, 2002 and April 16, 2002. FDA initiated recall is complete. REASON The product did not bear a complete ingredient statement. VOLUME OF PRODUCT IN COMMERCE 662/2/10-lb. container cases. DISTRIBUTION MO, KS, and IA.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_____________________________ PRODUCT Nature-Throid NT-2, (Thyroid, U.S.P), 129.6 mg, 100 tablet bottles, Rx only. Recall # D-117-3. CODE Lot B036N Expiration date 03/05. RECALLING FIRM/MANUFACTURER RSJ, Inc., Phoenix, AZ., by telephone and letter on December 3, 2002. Firm initiated recall ongoing. REASON Mislabeled bottles labeled to contain Nature-Throid NT-2 (129.6mg) actually contains Nature-Throid NT-1 (65mg). VOLUME OF PRODUCT IN COMMERCE 360 bottles. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_____________________________ PRODUCT Red Blood Cells, Leukoreduced. Recall # B-0315-3. CODE Unit 107244286 RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Ventura, CA, by telephone on January 22, 2002, and by letter dated February 19, 2002. Firm initiated recall complete. REASON Blood product, which were below the firm's specification for product volume, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AZ. _____________________________ PRODUCT a) Red Blood Cells. Recall # B-0423-3; b) Recovered Plasma. Recall # B-0424-3. CODE a) and b) Unit M16406. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Inc., Richmond, VA, by letter dated September 23, 2002 and by facsimile dated October 21, 2002. Firm initiated recall complete. REASON Blood products, collected from a donor who had not completed a nvCJD increased risk question, was distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION VA. _____________________________ PRODUCT a) Red Blood Cells. B-0426-3; b) Platelets. B-0427-3; c) Fresh Frozen Plasma. B-0428-3. CODE a), b) and c) Unit R45594. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA, by telephone on August 6, 2002. Firm initiated recall complete. REASON Blood products, collected from an ineligible donor who had not completed their blood donation record, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION VA. _____________________________ PRODUCT a) Red Blood Cells. Recall # B-0436-3; b) Red Blood Cells, Leukocytes Reduced. Recall # B-0437-3; c) Platelets. Recall # B-0438-3; d) Recovered Plasma. Recall # B-0439-3. CODE a) and c) Unit 6630591; b) Unit 0025169; d) Unit 0025169, 6630591. RECALLING FIRM/MANUFACTURER Suncoast Communities Blood Bank, Inc., Sarasota, Fl., by facsimile transmission dated December 28, 2001. Firm initiated recall complete. REASON Blood products, collected from a donor with a history of hepatitis, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION FL. _____________________________ PRODUCT a) Red Blood Cells. Recall # B-0440-3; b) Platelets. Recall # B-0441-3; c) Fresh Frozen Plasma. Recall # B-0442-3. CODE a), b) and c) Unit 0058522. RECALLING FIRM/MANUFACTURER Suncoast Communities Blood Bank, Inc., Sarasota, FL, by telephone on February 15, 2000. Firm initiated recall complete. REASON Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt Jakob Disease (nvCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION FL. _____________________________ PRODUCT a) Plasma, Frozen within 24 hours. Recall # B-0443-3; b) Recovered Plasma. Recall #B-0444-3 CODE a) Unit 53G53811; b) Unit 53FL05939. RECALLING FIRM/MANUFACTURER American Red Cross, Chesapeake Region, Baltimore, MD, by letter dated April 5, 2002. Firm initiated recall complete. REASON Blood products, collected from a donor who was at increased risk for new variant Cretzfeldtr Jakob Disease (nvCJD), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION DC. _____________________________ PRODUCT Plasma, Frozen within 24 hours. Recall # B-0445-3. CODE Unit 53FM54177. RECALLING FIRM/MANUFACTURER American Red Cross, Chesapeake Region, Baltimore, MD, by letter dated August 7, 2002. Firm initiated recall complete. REASON Blood product, collected from a donor who was at increased risk for new variant Cretzfeldtr Jakob Disease (nvCJD), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MD. _____________________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced. Recall # B-0451-3; b)Platelets, Leukocytes Reduced. Recall # B-0452-3. CODE a) and b) Unit 42FW97030. RECALLING FIRM/MANUFACTURER American Red Cross Blood Servicer, Cleveland, OH, by letter dated September 30, 2002. Firm initiated recall complete. REASON Blood products, collected from a donor who had traveled to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION OH. _____________________________ PRODUCT Recovered Plasma. Recall # B-0453-3. CODE Unit 42E38311. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Cleveland, OH., by a "Questionable Plasma Inquiry" on September 10, 2002. Firm initiated recall complete. REASON Blood product, collected from a donor who had traveled to the United Kingdom and Western Europe, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _____________________________ PRODUCT Source Plasma. Recall # B-0454-3. CODE 9UH330, 9ZE016, 9ZE472, 9ZE718, 9ZF409, 9ZG032, 9ZG277, 9ZG759, 9ZG993, 9ZH436, 9ZH605, 9ZI129, 9ZI381, 9ZI864, 94J665, 94J982, 94K372, 98K578, 98K895, 98L265, 98M230, 98M449, 98M992, BRBBJW, BRBCRM, BRBCZV BRBFLY, BRBFTD, BRJZTW, BRKBHB, BRKCQG, BRKDDS, BRKFDT, BRKFXQ, BRKGMP BRKHLQ, BRKHXN, BRKJWT, BRKKKK, BRKLJT, BRKMCG, BRKMVW, BRKNLF, BRKPMS, BRKQJT, BRKRJS, BRKSBY, BRKSYP, BRKTWN, BRKVCQ, BRKWSS, BRKXDC, BRKYHX, BRKYVV, BRKZYM, BRLBMS, BRLCRD, BRLCYW, BRLKRT, BRLLGP, BRLMHH, BRLMWZ, BRLNVV, BRMKKC, BRMLGS, BRMMBB, BRMQFL RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis Bio-Services, Inc., Knoxville, TN, by facsimile dated October 17,2002. Manufacturer: Aventis Bio-Services, Akron, OH. Firm initiated recall complete. REASON Blood products, that tested negative for viral markers, but were collected from a donor that subsequently admitted to multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV) and hepatitis B virus (HBV), were distributed. VOLUME OF PRODUCT IN COMMERCE 67 units. DISTRIBUTION IL. _____________________________ PRODUCT Human Cornea Tissues. Recall # B-0490-3. CODE Donor EB 02-08-09-A, Lot # 012971004. RECALLING FIRM/MANUFACTURER Cleveland Eye Bank, Inc., Cleveland, OH, by letter dated December 10,2002. Firm initiated recall complete. REASON Human tissue, collected from a donor who tested positive for heroin, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 tissues. DISTRIBUTION OH. _____________________________ PRODUCT a) Red Blood Cells. Recall # B-0498-3 b) Platelets. Recall # B-0499-3 c) Fresh Frozen Plasma. Recall # B-0500-3. CODE a), b) and c) Unit 0062411; RECALLING FIRM/MANUFACTURER Suncoast Communities Blood Bank, Inc., Sarasota, Fl, by letter dated March 11, 2002. Firm initiated recall complete. REASON Blood products, collected from a donor with a history of hepatitis, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION FL. _____________________________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall # B-0501-3. CODE Units 04GK51689, 04C45921. RECALLING FIRM/MANUFACTURER American Red Cross, New England Region, Dedham, MA, by letter dated October 4, 2002. Firm initiated recall complete. REASON Blood products, collected from a donor who had lived in an area designated as endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION NY and MA. _____________________________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall # B-0502-3. CODE Unit 04FK32434. RECALLING FIRM/MANUFACTURER American Red Cross, New England Region, Dedham, MA, by letter dated October 18, 2002. Firm initiated recall complete. REASON Blood product, collected from a donor who had lived in an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NY. _____________________________ PRODUCT Red Blood Cells. Recall # B-0524-3. CODE Unit G26573. RECALLING FIRM/MANUFACTURER Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, MI, by fax dated February 4, 2002. Firm initiated recall complete. REASON Blood product, collected from a donor whose body temperature had not been documented, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MI. _____________________________ PRODUCT Platelets. Recall # B-0527-3. CODE Unit 6144271. RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL, by telephone on October 2, 2002. Firm initiated recall complete. REASON Blood products, collected under conditions where the sterility may have been compromised, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IL. _____________________________ PRODUCT a) Red Blood Cells. Recall # B-0528-3; b) Recovered Plasma. Recall # B-0529-3. CODE a) and b) Unit 0553203. RECALLING FIRM/MANUFACTURER Blood Center of the Pacific, San Francisco, CA, by letter dated June 4, 2001. Firm initiated recall complete. REASON Blood products, collected from a donor who had a sexual partner who lived in a HIV Group O risk area, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _____________________________ PRODUCT Recovered Plasma. Recall # B-0530-3. CODE Unit 12FZ02883. RECALLING FIRM/MANUFACTURER The American National Red Cross, Carolinas Region, Charlotte, NC, by electronic mail on September 27, 2002. Firm initiated recall complete. REASON Blood product, collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _____________________________ PRODUCT Source Plasma. Recall # B-0554-3. CODE Units 01GMIA7880, 01GMIA8157, 01GMIA8938, 01GMIA9230, 01GMIA9961, 01GMIA0273, 01GMIA1037, 01GMIA1354, 01GMIA2108, and 01GMIA2425. RECALLING FIRM/MANUFACTURER BioLife Plasma Services, Walker, Mi, by letter dated July 5, 2001. Firm initiated recall complete. REASON Blood product, which was collected from a donor who admitted to engaging in multiple high risk behaviors, was distributed. VOLUME OF PRODUCT IN COMMERCE 10 units. DISTRIBUTION AL. _____________________________ PRODUCT a) Red Blood Cells. Recall # B-0555-3; b) Platelets Irradiated. Recall # B-0556-3. CODE a) Unit 0131789; b) Unit 0123134. RECALLING FIRM/MANUFACTURER Marquette General Hospital, Inc., Marquette, MI, by letters dated May 10, 2002. Firm initiated recall complete. REASON Blood products, which were collected from a donor who had traveled to a malaria endemic area, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MI. _____________________________ PRODUCT Source Plasma. Recall # B-0558-3. CODE units MSN000197, MSN000256, EG0017112, EG0017296, EG0017475, EG0017806, EG0018000, EG0018153, EG0018720, EG0018892, EG0019345, EG0019471, EG0020050, EG0020164, EG0020555, EG0020685, EG0020932, MSG000442, MSG000714, MSG000854, MSG001092, MSG001198, MSG001826, MSG002840, MSG003193, and MSG004934. RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Mesa, AZ., by facsimile on May 17, 2002. Firm initiated recall complete. REASON Blood product, which was collected from a donor who was previously deferred from donation for engaging in high risk behavior, was distributed. VOLUME OF PRODUCT IN COMMERCE 26 units. DISTRIBUTION AZ. _____________________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced. Recall # B-0559-3; b) Red Blood Cells for Further Manufacture. Recall # B-0560-3. CODE a) Unit 04KL69572; b) Unit 04KL66365. RECALLING FIRM/MANUFACTURER American Red Cross, New England Region, Dedham, MA, by letters dated October 11, 2002. Firm initiated recall complete. REASON Blood products, collected from a donor who had traveled to an area designated as endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION NJ and MA. _____________________________ PRODUCT a) Red Blood Cells. Recall # B-0561-3; b) Platelets, Irradiated. Recall # B-0562-3; c) Recovered Plasma. Recall # B-0563-3. CODE a), b) and c) Unit T19828. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Inc., Richmond, VA, by facsimile transmission dated August 8, 2002, and by letter dated September 4, 2002. Firm initiated recall complete. REASON Blood products, collected from a donor who had an accidental needle stick within the past 12 months, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION VA. _____________________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced. Recall # B-0568-3; b) Recovered Plasma. Recall # B-0569-3. CODE a) and b) Unit 42Q70469. RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH, by letter on July 11, 2002. Firm initiated recall is complete. REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION OH and CA. _____________________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced. Recall # B-0570-3; b) Recovered Plasma. Recall # B-0571-3. CODE a) Unit 03KM20283; b) Unit 03KM19620. RECALLING FIRM/MANUFACTURER The American National Red Cross, Southern Region, Atlanta, GA., by letter on March 26, 2002. Firm initiated recall is complete. REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION GA and CA. _____________________________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall # B-0572-3. CODE Unit 42F54014. RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH, by letter on November 12, 2002. Firm initiated recall complete. REASON Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OH. _____________________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced. Recall # B-0573-3; b) Recovered Plasma. Recall # B-0574-3. CODE a) and b) Unit 42K53062. RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH, by letter on October 25, 2002. Firm initiated recall complete. REASON Blood products, collected from an ineligible donor due to use of the drug Proscar, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION OH and CA. _____________________________ PRODUCT Recovered Plasma. Recall # B-0575-3. CODE Unit 38FK22135. RECALLING FIRM/MANUFACTURER The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by facsimile on September 19, 2002. Firm initiated recall complete. REASON Blood product, collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _____________________________ PRODUCT Plasma. Recall # B-0577-3. CODE Unit T01736. RECALLING FIRM/MANUFACTURER Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, MI, by facsimile on February 4, 2002. Firm initiated recall complete. REASON Blood product, collected from an ineligible donor due to use of the medication Lipitor, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MI. _____________________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced. Recall # B-0583-3; b) Platelets Pheresis, Leukocytes Reduced. Recall # B-0584-3; c) Platelets. Recall # B-0585-3; d) Fresh Frozen Plasma. Recall # B-0586-3; e) Recovered Plasma. Recall # B-0587-3. CODE a) Unit 7055376, 1908824, 1843547, and 1800188; b) Unit numbers 7056629, 7055951, and 7055376 (all units distributed as two split units); c) and d) Unit numbers 1843547, 1800188, and 2337261; e) Unit number 1908824. RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by facsimile in early June 2002. Firm initiated recall complete. REASON Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from a donor that previously tested repeatedly reactive for anti-HCV, were distributed. VOLUME OF PRODUCT IN COMMERCE a) 4 units; b) 6 units; c) 3 units; d) 3 units; e) 1 unit. DISTRIBUTION TX and FL. _____________________________ PRODUCT a) Red Blood Cells. Recall # B-0597-3; b) Platelets. Recall # B-0598-3. CODE a) and b) Unit 3008243. RECALLING FIRM/MANUFACTURER Walter L. Shepherd Community Blood Center, Inc., Augusta, GA, by letters dated February 6, 2002. Firm initiated recall complete. REASON Blood products, which were collected from a donor who emigrated from an area of high risk for the human immunodeficiency virus (HIV), were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION GA.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_____________________________ PRODUCT Red Blood Cells. Recall # B-0422-3. CODE Units R70499, R70494, R70496, R70498, R70488, R70501. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Inc., Richmond, VA, by telephone on September 23, 2002, and by letter dated September 27, 2002. Firm initiated recall as complete. REASON Blood products, collected from a donor whose temperature was inaccurately determined, were distributed. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION VA. _____________________________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall # B-0425-3. CODE Unit C53031. RECALLING FIRM/MANUFACTURER Virginia Blood Services, Inc., Richmond, VA., by telephone on September 11, 2002, and by letter dated October 22, 2002. Firm initiated recall complete. REASON Blood product, collected from a donor whose arm inspection was not accurately documented, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION VA. _____________________________ PRODUCT Red Blood Cells. Recall # B-0435-3. CODE M86662. RECALLING FIRM/MANUFACTURER Stanford Medical School Blood Center, Pal Alto, CA., by letter dated November 26, 2002. Firm initiated recall complete. REASON Blood product, which tested reactive for syphilis, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _____________________________ PRODUCT Red Blood Cells, Washed. Recall # B-0446-3. CODE Unit 53FP45116. RECALLING FIRM/MANUFACTURER American Red Cross, Chesapeake Region, Baltimore, MD, by letter dated July 11, 2002. Firm initiated recall complete. REASON Blood product, that failed the parameters for red cell recovery, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MD. _____________________________ PRODUCT a) Red Blood Cells. Recall # B-0493-3; b) Platelets. Recall # B-0494-3; c) Recovered Plasma. Recall # B-0495-3. CODE a), b) and c) Unit T03892. RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Traverse City, MI, by facsimile transmission and by letter dated February 4, 2002. Firm initiated recall complete. REASON Blood products, collected from a donor who had an elevated body temperature, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION MI. _____________________________ PRODUCT Red Blood Cells. Recall # B-0526-3. CODE Unit L02110. RECALLING FIRM/MANUFACTURER Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, MI., by telephone on May 14, 2002. Firm initiated recall complete. REASON Blood product, which was identified as possibly containing a clot, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION FL. _____________________________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall # B-0531-3. CODE Unit numbers 27LQ04302, 27LS03451, 27LS03453, 27LR11017, 27LR11024, 27LR11034, 27LR11036, 27LR11040, 27LR11046, 27LR11081, 27LW07205, 27LW07203, 27LW07199, 27LW07191, 27LR11097, 27LR11095, 27LR11094, 27LR11089, 27LR11088, 27LR11082, 27LR11084, 27LW07189, 27LW07186, 27LW07185, 27LW07183, 27LR11101, 27LR11107, 27LR11108, 27LT05565, 27LR11004, 27LR11015, 27LT05602, 27LR11010, 27LR11001, 27LR11000, 27LQ04305, 27LY04006, 27LY04001, 27LR11020, 27LR11025, 27LR11029, 27LR11030, 27LR11032, 27LR11039, 27LR11050, 27LR11056, 27LR11064, 27LR11066, 27LR11069, 27LR11070, 27LW07193, 27LR11111, 27LR11012, 27LR11006, 27LQ04317, 27LR11115, 27LR11120, 27LR11131, 27LR11142, 27LS03427, 27LW07214, 27LW07215, 27LW07224, 27LR11018, 27LR11071, 27LJ13123, 27LF31200, 27LF31198, 27LR11085, 27LW07187, 27LR11011, 27LR11005, 27LR11003, 27LY03945, 27LQ04323, 27LR11080, 27LR11086, 27LR11051, 27LS03429, 27LW07220, 27LW07184, 27LR11112, 27LF31184, 27LF31179, 27GL13598, 27LJ13151, 27LJ13125, 27LJ13153, 27GT48685, 27LJ13113, 27LF31202, 27LJ13148, 27LF31209, 27LR11022, 27LS03425, 27LT05600, 27LR11026, 27LW07212, 27LR11033, 27LR11052, 27LR11109, 27LS03440, 27LR11021, 27LR11098, 27LW07197, 27GM43305, 27LT05599, 27LR11065, 27LR11093, 27LT05591, 27LY04016, 27LJ13119, 27GT48691, 27LF31190, 27LF31189, 27GT48686, 27LT05597, 27LR11100, and 27LR11013 RECALLING FIRM/MANUFACTURER The American National Red Cross, Huntington, WV, by telephone on February 21, 2001, and by letters on March 2, 7, and 8, 2001, and April 9, 2001. Firm initiated recall complete. REASON Blood products, that were labeled leukoreduced but were manufactured with leukoreduction filters that were experiencing an increase in failed quality control testing due to an elevated white blood cell count, were distributed. VOLUME OF PRODUCT IN COMMERCE 119 units. DISTRIBUTION WV, OH, and KY. _____________________________ PRODUCT Source Plasma. Recall # B-0549-3. CODE Unit 60-FNCVGH-A. RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Springfield, IL, by facsimile on August 27, 2002. Firm initiated recall complete. REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IL. _____________________________ PRODUCT Red Blood Cells Leukocytes Removed. Recall # B-0553-3. CODE Unit 38FC89379. RECALLING FIRM/MANUFACTURER American National Red Cross, Fort Wayne, IN., by telephone on August 29, 2002. Firm initiated recall complete. REASON Blood product, which was leukoreduced greater than 5 days past the time of collection, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IN. _____________________________ PRODUCT Source Plasma. Recall # B-0557-3. CODE Units 0530318743, 0530318745, 0530318747, 0530318750, 0530318753, 0530318757, 0530318760, 0530318763, 0530318765, 0530318767, 0530318774, 0530318779, 0530318787, 0530318791, 0530318800, 0530318816, 0530318817, 0530318829, 0530318836, 0530318844, 0530318846, 0530318849, 0530318854, 0530318858, 0530318863, 0530318900, 0530318903, 0530318906, 0530318908, 0530318912, 0530318914, 0530318919, 0530318922, 0530318933, 0530318937, 0530318938, 0530318941, 0530318944, 0530318947, 0530318957, 0530318960, 0530318964, 0530318970, 0530318973, 0530318977, 0530318979, 0530318997, 0530319000, 0530319002, 0530319005, 0530319010, 0530319191, 0530319197, 0530319198, 0530319202, 0530319204, 0530319233, 0530319237, 0530319240, 0530319242, 0530319254, 0530319265, 0530319274, 0530319278, 0530319281, 0530319284, 0530319287, 0530319290, 0530319305, 0530319307, 0530319310, 0530319318, 0530319320, 0530319455, 0530319459, 0530319461, 0530319465, 0530319471, 0530319477, 0530319480, 0530319493, 0530319497, 0530319500, 0530319503, 0530319508, 0530319510, 0530319524, 0530319526, 0530319528, 0530319531, 0530319535, 0530319537, 0530319540, 0530319546, 0530319548, 0530319550, 0530319557, 0530319560, 0530319561, 0530319562, 0530319564, 0530319602, 0530319604, 0530319608, 0530319616, 0530319618, 0530319621, 0530319627, 0530319629, 0530319640, 0530319645, 0530319646, 0530319661, 0530319666, 0530319667, 0530319669, 0530319672, 0530319676, 0530319684, 0530319693, 0530319696, 0530319699, 0530319705, 0530319708, 0530319717, 0530319724, 0530319727, 0530319734, 0530319739, 0530319740, 0530319743, 0530319744, 0530319746, 0530319749, 0530319761, 0530319764, 0530319767, 0530319777, 0530319792, 0530319799, 0530319805, 0530319807, 0530319811, 0530319816, 0530319822, 0530319825, 0530319832, 0530319835, 0530319838, 0530319844, 0530320037, 0530320038, 0530320041, 0530320047, 0530320048, 0530320061, 0530320070, 0530320072, 0530320075, 0530320088, 0530320097, 0530320103, 0530320118, 0530320122, 0530320132, 0530320134, 0530320143, 0530320147, 0530320152, 0530320153, 0530320157, 0530320160, 0530320161, 0530320162, 0530320163, 0530320170, 0530320173, 0530320175, 0530320177, 0530320191, 0530320255, 0530320256, 0530320260, 0530320262, 0530320264, 0530320267, 0530320272, 0530320274, 0530320277, 0530320280, 0530320282, 0530320284, 0530320298, 0530320301, 0530320302, 0530320305, 0530320308, 0530320329, 0530320332, 0530320336, 0530320343, 0530320350, 0530320351, 0530320354, 0530320355, 0530320359, 0530320367, 0530320370, 0530320374, 0530320382, 0530320384, 0530320396, 0530320398, 0530320401, 0530320404, 0530320408, 0530320409, 0530320412, 0530320416, 0530320418, 0530320428, 0530320429, 0530320431, 0530320433, 0530320438, 0530320439, 0530320443, 0530320446, 0530320453, 0530320456, 0530320476, 0530320488, 0530320496, 0530320503, 0530320509, 0530320512, 0530320515, 0530320521, 0530320523, 0530320527, 0530320531, 0530320736, 0530320742, 0530320759, 0530320762, 0530320764, 0530320767, 0530320784, 0530320791, 0530320795, 0530320808, 0530320812, 0530320813, 0530320820, 0530320823, 0530320827, 0530320862, 0530320865, 0530320866, 0530320886, 0530320888, 0530320894, 0530320900, 0530320916, 0530320917, 0530320922, 0530320925, 0530320937, 0530320942, 0530320949, 0530320954, 0530321056, 0530321059, 0530321062, 0530321066, 0530321068, 0530321073, 0530321083, 0530321099, 0530321102, 0530321105, 0530321111, 0530321115, 0530321122, 0530321128, 0530321134, 0530321139, 0530321196, 0530321295, 0530321302, 0530321303, 0530321307, 0530321309, 0530321313, 0530321323, 0530321329, 0530321336, 0530321347, 0530321355, 0530321356, 0530321372, 0530321376, 0530321380, 0530321383, 0530321385, 0530321387, 0530321395, 0530321397, 0530321417, 0530321420, 0530321428, 0530321447, 0530321452, 0530321455, 0530321461, 0530321466, 0530321477, 0530321481, 0530321526, 0530321530, 0530321533, 0530321535, 0530321538, 0530321546, 0530321549, 0530321552, 0530321554, 0530321556, 0530321564, 0530321589, 0530321593, 0530321639, 0530321649, 0530321731, 0530321735, 0530321739, 0530321741, 0530321747, 0530321752, 0530321755, 0530321759, 0530321761, 0530321765, 0530321771, 0530321778, 0530321840, 0530321845, 0530321852, 0530321853, 0530321855, 0530321859, 0530321865, 0530321870, 0530321873, 0530321875, 0530321879, 0530321881, 0530321885, 0530321893, 0530321895, 0530321896, 0530321899, 0530321901, 0530321905, 0530321910, 0530321913, 0530321915, 0530321917, 0530321920, 0530321924, 0530321925, 0530321973, 0530321977, 0530321978, 0530321980, 0530321981, 0530321985, 0530321987, 0530321994, 0530321999, 0530322005, 0530322024, 0530322031, 0530322036, 0530322051, 0530322100, 0530322103, 0530322109, 0530322116, 0530322121, 0530322129, 0530322132, 0530322134, 0530322138, 0530322145, 0530322157, 0530322159, 0530322162, 0530322165, 0530322168, 0530322170, 0530322176, 0530322177, 0530322205, 0530322219, 0530322223, 0530322237, 0530322239, 0530322242, 0530322248, 0530322251, 0530322253, 0530322383, 0530322393, 0530322420, 0530322430, 0530322432, 0530322437, 0530322446, 0530322448, 0530322451, 0530322573, 0530322575, 0530322582, 0530322584, 0530322589, 0530322595, 0530322598, 0530322599, 0530322603, 0530322628, 0530322785, 0530322788, 0530322791, 0530322796, 0530322799, 0530322805, 0530322814, 0530322815, 0530322817, 0530322820, 0530322840, 0530322845, 0530322852, 0530322854, 0530323144, 0530323145, 0530323147, 0530323154, 0530323165, 0530323173, 0530323178, 0530323182, 0530323190, 0530323195, 0530323202, 0530323206, 0530323209, 0530323217, 0530323222, 0530323225, 0530323229, 0530323231, 0530323237, 0530323238, 0530323246, 0530323248, 0530323252, 0530323254, 0530323256, 0530323259, 0530323261, 0530323274, 0530323276, 0530323279, 0530323286, 0530323288, 0530323293, 0530323313, 0530323319, 0530323321, 0530323326, 0530323333, 0530323337, 0530323340, 0530323446, 0530323458, 0530323467, 0530323474, 0530323475, 0530323476, 0530323501, 0530323505, 0530323506, 0530323508, 0530323542, 0530323546, 0530323553, 0530323556, 0530323559, 0530323588, 0530323591, 0530323596, 0530323635, 0530323636, 0530323640, 0530323642, 0530323645, 0530323649, 0530323652, 0530323658, 0530323659, 0530323663, 0530323697, 0530323700, 0530323706, 0530323710, 0530323712, 0530323717, 0530323720, 0530323729, 0530323732, 0530323737, 0530323739, 0530323743, 0530323842, 0530323847, 0530323855, 0530323856, 0530323863, 0530323867, 0530323868, 0530323872, 0530323902, 0530323910, 0530323915, 0530323920, 0530323922, 0530324145, 0530324150, 0530324154, 0530324156, 0530324165, 0530324168, 0530324172, 0530324190, 0530324194, 0530324197, 0530324200, 0530324202, 0530324208, 0530324217, 0530324222, 0530324227, 0530324247, 0530324251, 0530324257, 0530324263, 0530324267, 0530324269, 0530324271, 0530324274, 0530324277, 0530324279, 0530324282, 0530324290, 0530324306, 0530324308, 0530324309, 0530324314, 0530324322, 0530324327, 0530324332, 0530324336, 0530324515, 0530324519, 0530324561, 0530324565, 0530324568, 0530324569, 0530324572, 0530324576, 0530324594, 0530324614, 0530324615, 0530324618, 0530324621, 0530324628, 0530324633, 0530324635, 0530324638, 0530324646, 0530324656, 0530324678, 0530324705, 0530324708, 0530324717, 0530324721, 0530324727, 0530324730, 0530324750, 0530324827, 0530324835, 0530324840, 0530324847, 0530324850, 0530324853, 0530324857, 0530324861, 0530324865, 0530324875, 0530324896, 0530324900, 0530324926, 0530324930, 0530324980, 0530324984, 0530324985, 0530324987, 0530324989, 0530324994, 0530325005, 0530325018, 0530325025, 0530325028, 0530325030, 0530325033, 0530325037, 0530325046, 0530325048, 0530325065, 0530325119, 0530325128, 0530325129, 0530325133, 0530325137, 0530325151, 0530325153, 0530325290, 0530325292, 0530325294, 0530325300, 0530325302, 0530325306, 0530325309, 0530325311, 0530325314, 0530325321, 0530325323, 0530325327, 0530325331, 0530325333, 0530325334, 0530325339, 0530325341, 0530325343, 0530325344, 0530325346, 0530325347, 0530325356, 0530325359, 0530325365, 0530325370, 0530325371, 0530325375, 0530325392, 0530325402, 0530325403, 0530325411, 0530325414, 0530325416, 0530325420, 0530325424, 0530325427, 0530325435, 0530325436, 0530325438, 0530325444, 0530325498, 0530325499, 0530325502, 0530325505, 0530325509, 0530325510, 0530325521, 0530325541, 0530325542, 0530325546, 0530325547, 0530325557, 0530325559, 0530325560, 0530325562, 0530325564, 0530325567, 0530325576, 0530325590, 0530325593, 0530325599, 0530325607, 0530325610, 0530325611, 0530325616, 0530325618, 0530325621, 0530325624, 0530325628, 0530325631, 0530325640, 0530325642, 0530325650, 0530325657, 0530325661, 0530325663, 0530325687, 0530325692, 0530325696, 0530325698, 0530325711, 0530325718, 0530325722, 0530325725, 0530325728, 0530325730, 0530325737, 0530325778, 0530325781, 0530325783, 0530325786, 0530325787, 0530325790, 0530325799, 0530325805, 0530325808, 0530325820, 0530325826, 0530325829, 0530325839, 0530325840, 0530325845, 0530325850, 0530325851, 0530325856, 0530325861, 0530325882, 0530325884, 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0530328920. RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Lexington, KY, by telephone on November 1, 2002, and by letter dated November 20, 2002. Firm initiated recall complete. REASON Blood products, which were collected from donors who were not asked all the medical history questions during the donor screening process, were distributed. VOLUME OF PRODUCT IN COMMERCE 1,079 units. DISTRIBUTION NC. _____________________________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall # B-0576-3. CODE Unit 38H94395. RECALLING FIRM/MANUFACTURER The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN., by telephone on October 28, 2002. Firm initiated recall complete. REASON Blood product, collected using expired anticoagulant solution, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IN. _____________________________ PRODUCT Red Blood Cells. Recall # B-0582-3. CODE Unit 42FP89593. RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH, by telephone on July 24, 2002. Firm initiated recall complete. REASON Blood product, that tested positive for unexpected antibodies to red blood cell antigens, but was labeled negative for unexpected antibodies, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OH.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
_____________________________ PRODUCT a) Baxter Vented Buretrol Volumetric Pump Solution Set, 10 drops/mL; catalog 1C8384; 10 units per case. Recall # Z-0504-03; b) Baxter Interlink System Minivolume Extension Set; catalog 1C8412. Recall # Z-0505-03; c) Baxter Y-Type Minivolume Extension Set; catalog 1C8499. Recall # Z-0506-03; d) Baxter Interlink System Extension Set with 0.22 Micron Filter, catalog 1C8546. Recall # Z-0507-03; e) Baxter Interlink System Vented Buretrol Solution Set, 10 drops/mL; catalog 1C8560. Recall # Z-0508-03; f) Baxter Interlink System Minivolume Extension Set with 0.22 Micron Filter, catalog 1C8577. Recall # Z-0509-03; g) Baxter Interlink System Buretrol Solution Set, 10 drops/mL; catalog 1C8633. Recall # Z-0510-03; h) Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8516 and 1M8516Y. Recall # Z-0511-03; i) Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8522 and 1M8522Y. Recall # Z-0512-03; j) Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8527 and 1M85827Y. Recall # Z-0513-03; k) Baxter Auto Syringe Extension Set with 0.22 Micron Filter, catalog 1M8529. Recall # Z-0514-03; l) Baxter Minivolume T-Connector Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2C5683, 48 units per case. Recall # Z-0515-03; m) Baxter Minivolume Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2C5693, 48 units per case. Recall # Z-0516-03; n) Baxter Interlink System Microbore T-Connector Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2N3332, 200 units per case. Recall # Z-0517-03; o) Baxter Interlink System Microbore T-Connector Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2N3333, 200 units per case. Recall # Z-0518-03; p) Baxter Microbore 3-Lead Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2N3342, 50 units per case. Recall # Z-0519-03; q) Baxter 36" Micro-Volume Extension Set, catalog 2N3347. Recall # Z-0520-03; r) Baxter 60" Micro-Volume Extension Set, catalog 2N3350. Recall # Z-0521-03; s) Baxter Interlink System Minivolume Extension Set, catalog 1C8483. Recall # Z-0522-03; t) Baxter Interlink System Buretrol Solution Set, 60 drops/mL; catalog 1C8600. Recall # Z-0523-03. CODE All lots received prior to 10/23/2002. RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corp., Round Lake, IL., by letter dated October 17, 2002. Manufacturer: Baxter Healthcare Corp., Deerfield, IL. Firm initiated recall ongoing. REASON The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter. VOLUME OF PRODUCT IN COMMERCE a) 2,064 units; b) 679,968 units; c) 13,104 units; d) 0 units; e) 21,972 units; f) 1,920 units; g) 4,908 units; h) 16,860 units; i) 53,310 units; j) 0 units; k) 0 units; l) 198,816 units; m) 634,992 units; n) 47,000 units; o) 265,240 units; p) 130,040 units; q) 247,800 units; r) 630,140 units; s) 74,832 units; t) 9,072 units. DISTRIBUTION Nationwide and Internationally.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
***CORRECTION***
Enforcement Report for February 12,2003, (03-07), the recall listing for Spinal 26 Gauge Quincke with Bupivacaine, Epinephrine, and Lidocaine, Recall # Z-0527-03 has Abbott Laboratories, Abbott Park, IL listed as the Recalling Firm/Manufacturer, the correct Recalling Firm/Manufacturer is Abbott Laboratories, Laurinburg, NC. ____________________________ PRODUCT X-Cel MB-700 A/C Podiatry X-Ray System. Recall # Z-0424-03. CODE Model Number: MB-700 A/C. RECALLING FIRM/MANUFACTURER X-Cel X-Ray Corporation, Crystal Lake, IL, by technician visit beginning February 13, 2003. Firm initiated recall ongoing. REASON The X-Ray system contained a defective X-Ray tube shield. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION Nationwide. ____________________________ PRODUCT a) Venus Eye Sphere 12 mm (Sterile). Recall # Z-0528-03; b) Venus Eye Sphere 14 mm (sterile). Recall # Z-0529-03; c) Venus Eye Sphere 16 mm (sterile). Recall # Z-0530-03; d) Venus Eye Sphere 18 mm (sterile). Recall # Z-0531-03; e) Venus Eye Sphere 20 mm (sterile). Recall # Z-0532-03; f) Venus Eye Sphere 22 mm (sterile). Recall # Z-0533-03; g) Conformer Small (sterile). Recall # Z-0534-03; h) Conformer Medium (sterile. Recall # Z-0535-03; i) Conformer Large (sterile). Recall # Z-0536-03; j) Conformer Small with holes (sterile). Recall # Z-0537-03; k) Conformer Medium with holes (sterile). Recall # Z-0538-03; l) Conformer Large with holes (sterile). Recall # Z- 0539-03; m) Venus Eye sphere 10 mm (Sterile). Recall # Z-0540-03. CODE a) Model Number 14151, lot number 8284; b) Model Number 14152, lot number 8447; c) Model number 14153, lot numbrt 8159; d) Model number 14154, lot number 8447; e) Model number 14155, lot number 8404; f) Model number 14156, lot number 8447; g) Model number 14164, lot number 8264B; h) Model number 14165, lot number 1187; i) Model number 14166, lot number 1218; j) Model number 14167, lot number 1233; k) Model number 14168, lot number 1234; l) Model number 14169, lot number 1235; m) Model number 14150, lot number 7381. RECALLING FIRM/MANUFACTURER Gulden Ophthalmics, Elkins Park, PA., by letters on November 29, 2002. Firm initiated recall ongoing. REASON Lack of sterility assurance. VOLUME OF PRODUCT IN COMMERCE 1096 units. DISTRIBUTION Nationwide and New Zealand. ____________________________ PRODUCT Coulter LH 700 Series Hematology Analyzers. Recall # Z-0541-03. CODE All lots. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA., by letters on January 10, 2003. Firm initiated recall is ongoing. REASON Biohazard situation exists for users. VOLUME OF PRODUCT IN COMMERCE 210. DISTRIBUTION Nationwide and Canada. ____________________________ PRODUCT Lifepak 12 defibrillator/monitor is a portable battery operated, complete acute cardiac care response system with both manual and semi-automatic defibrillation operation. Recall # Z-0542-03. CODE All LIFEPAK 12 units are affected. RECALLING FIRM/MANUFACTURER Medtronic Physio Control Corp., Redmond, WA, by letter, on January 27, 2003. Firm initiated recall is ongoing. REASON Impact and damage to the high voltage connectors results in poor or no electrical contact from the cable to the LIFEPAk 12 unit. VOLUME OF PRODUCT IN COMMERCE 46,042. DISTRIBUTION Nationwide and Internationally. _____________________________ PRODUCT Synchron LX20 and LX20 Pro. Recall # Z-0545-03. CODE All serial numbers. RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA., by letter on December 16, 2002. Firm initiated recall is ongoing. REASON The disk that controls the home position of the sample wheel comes loose preventing a proper home sequence. VOLUME OF PRODUCT IN COMMERCE 1001. DISTRIBUTION Canada and Nationwide. ____________________________ PRODUCT Radiopaque bone cement, 40 gram. Product number 424800. Recall # Z-0546-03. CODE All lots. RECALLING FIRM/MANUFACTURER Biomet, Inc., Warsaw, IN., by letter on January 21, 2003. Firm initiated recall is ongoing. REASON There may be cracks in the blister pack overwrap for the glass ampoule containing the liquid monomer. VOLUME OF PRODUCT IN COMMERCE 301,226 units. DISTRIBUTION Nationwide. ____________________________ PRODUCT Zoll AED Plus Defibrillator (Automatic External Defibrillator). Recall # Z-0548-03. CODE Serial Numbers: X02F000812 through X02K007486. RECALLING FIRM/MANUFACTURER Zoll Medical Corp., Burlington, MA., by letter on December 17, 2002. Firm initiated recall is ongoing. REASON Defibrillator may fail to function due to false detection of safety fault condition. VOLUME OF PRODUCT IN COMMERCE 5,597 units. DISTRIBUTION Nationwide. ____________________________ PRODUCT a) Boston Scientific/Microvasive Rapid Exchange retrieval Balloon/8.5 mm balloon, Catalog #4544. Recall # Z-0551-03; b) Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/11.5 mm balloon, Catalog #4545. Recall # Z-0552-03. c) Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/15.5 mm balloon, Catalog #4546. Recall # Z-0553-03. CODE a) Lot Number: 5173906; b) Lot Numbers: 5175575 5185073 5185074 5185075 5193211 5193212 5193213 5193920 5196902; c) Lot Number: 5184800. RECALLING FIRM/MANUFACTURER Boston Scientific Corp., Natick, MA., by letter dated January 27, 2003, and mailed January 29,2003. Firm initiated recall is ongoing. REASON Breach in sterile barrier may compromise sterility. VOLUME OF PRODUCT IN COMMERCE a) 22 units; b) 255 units; c) 30 units. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_____________________________ PRODUCT 25 Gauge Hydrodissection Cannula 1" (25 mm) with U-Shaped Flattened End. Recall # Z-0543/Z-0544-03. CODE Model Number of Device: 3425, Catalog Number: 3425, Lot Number: MK10190 exp 11/2006. RECALLING FIRM/MANUFACTURER Surgical Specialties Corp., Reading, PA., via fax on November 8, 2002 and December 10, 2002 and via email on November 5, and November 12, 2002. Firm initiated recall is complete. REASON The wrong product in the box. VOLUME OF PRODUCT IN COMMERCE 211 units. DISTRIBUTION CA, Spain and Australia. ____________________________ PRODUCT a) Ascension PIP, Prosthesis, finger, semi-constrained, pyrolytic carbon, uncemented. The Ascension PIP received Humanitarian Device Exemption approval on March 22, 2002, under HDE number H010005. Recall # Z-0549-03; b) Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal. Recall # Z-0550-03. CODE a) Removal domestically of literature Document: LC-04-207- 001. b) Brochure intended for international distribution, Document: LC-04-107-011. RECALLING FIRM/MANUFACTURER Ascension Orthopedics, Inc., Austin, TX., by e-mail and telephone on October 31, 2002 and November 1, 2002. Firm initiated recall is ongoing. REASON Brochures approved for international distribution only were distributed domestically. VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION Nationwide.END OF ENFORCEMENT REPORT FOR FEBRUARY 19, 2003 ####
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