December 12, 2001 01-49
RECALLS AND FIELD CORRECTIONS: FOODS CLASS I
_______________________ PRODUCT F-065-2/F-069-2 1. Chill-Ripe 2/5 lb. institutional boxes of Beer Battered Onion Rings, product #257925, Recall # F-065-2. 2. Chill-Ripe 2/5 lb. institutional boxes of Beer Battered Onion Rings, product #257927, Recall # F-066-2; 3. Pocahontas 2/5 lb. institutional boxes of Beer Battered Onion Rings, product #257926, Recall # F-067-2; 4. Chill-Ripe 6/2 lb. institutional boxes of Pre-Cooked Breaded Onion Rings, Recall # F-068-2; 5. Chill-Ripe 4/2 lb. institutional boxes of Pre-Cooked Steak Cut Onion Rings, Recall # F-069-2. CODE All lot numbers on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Recalling Firm: Agrilink Foods, Inc., Rochester, NY, by fax on 9/21/01. Manufacturer: Agrilink Foods, Inc., Montezuma, GA. Firm initiated recall is complete. REASON Labeling does not indicate the presence of eggs in the ingredient statement. VOLUME OF PRODUCT IN COMMERCE 26,645 cases. DISTRIBUTION Nationwide. _________________ PRODUCT Albertson's Pasta Ribbons 16 oz packages. The product is sold in 16 ounce poly packages. There are 12 packages per shipping case, UPC Number 41163 47343, Recall # F-070-2. CODE 'Best By MAR 29 03' or 'Best By APR 27 03'. RECALLING FIRM/MANUFACTURER Recalling Firm: New World Pasta Company Harrisburg, PA, via telephone and email on 9/14/01. Manufacturer: New World Pasta Company Fresno, CA. Firm initiated recall is ongoing. REASON Undeclared egg yolks. VOLUME OF PRODUCT IN COMMERCE 336 cases. DISTRIBUTION CA. _______________________ PRODUCT Garelick Farms Mint Cookie Ice Cream 1/2 Gallon Round Containers, UPC 30255-66116, Recall # F-071-2. CODE Code Date: "072402" RECALLING FIRM/MANUFACTURER Recalling Firm: Garelick Farms, Franklin, MA, by letter on 9/7/01. Manufacturer: Brighams Ice Cream, Arlington, MA. Firm initiated recall is complete. REASON Ice cream may contain peanuts or pieces of peanuts. VOLUME OF PRODUCT IN COMMERCE 992 half gallons. DISTRIBUTION CT, NH, MA, ME, RI, VT. _______________________ PRODUCT Janiecy's brand Tzatziki in 8 oz. and 24 oz. plastic containers. Affixed label states in part "Tzatziki Janiecy's Creamy Cucumber Garlic Sauce **”, Recall # F-075-2. CODE Use by 11/22/01. RECALLING FIRM/MANUFACTURER NorStar Specialty Foods, Inc., Seattle, WA, via telephone on 10/10/01. Firm initiated recall is complete. REASON Contaminated with Listeria monocytogenes. VOLUME OF PRODUCT IN COMMERCE 7,152/24 oz., 636/8 oz. DISTRIBUTION WA, OR, CA, AZ, NM, UT, CO, NV, TX. _______________________ PRODUCT Liuzzi Brand Cheeses: Fresh Ricotta Cheese packaged in 1 lb. and 3 lb. white plastic containers; and 1 lb. and 3 lb. tin containers, Recall # F-076-2; Fresh Mozzarella Cheese packaged in 1 lb. and 3 lb. white plastic containers, Recall # F-077-2; Fresh Basket Cheese packaged in a white basket and poly plastic bag, Recall # F-078-2; Impastata 10 lbs. For Restaurant Use, Recall # F-079-2. CODE: All product manufactured and distributed prior to 5/2/01. RECALLING FIRM/MANUFACTURER Caseificio Moderno, Inc., d.b.a. Liuzzi Cheese Co., North Haven, CT, by letter on 5/04/01. Firm initiated recall is complete. REASON Product associated with an outbreak of Salmonella. VOLUME OF PRODUCT IN COMMERCE Approximately 3,069 lbs. DISTRIBUTION NY, CT, MA, RI and NJ. _______________________ PRODUCT Hughson Nut brand, Almonds from California, Natural Whole Almonds packaged in bulk 50 lb. cardboard boxes, Recall # F-080-2. CODES Lots distributed domestically: D3214, D3215, D3223, D3227; D3231, D3233, D3236, D3240; D3237, D3214, D3248, D3237; D3249, D3253, D3237, D3263. ***D3217*** Lots distributed internationally (excluding Canada): D3256, D3221, D3251; D3252, D3213, D3246; D3220. Lots distributed in Canada: D3208, D3222; D3250, D3219; D3141, D3112; 3225, 3232; 3241, 3257. RECALLING FIRM/MANUFACTURER Hughson Nut, Inc., Hughson, CA, by fax on 5/7/01 and by phone on 7/13/01. Firm initiated recall complete. REASON The product is contaminated with Salmonella Enteritidis. VOLUME OF PRODUCT IN COMMERCE 29,000 lbs. DISTRIBUTION CA, WI, IL,OH, NJ and MA. _______________________ PRODUCT Sweet goods and mixes: a) Cowboy Cookie Mix 24 oz, Recall # F-081-2; b) Cowboy Cookies 2 oz, Recall # F-082-2; c) Double Chocolate "Moose" Brownie Mix 16 oz, Recall # F-083-2; d) Chocolate Bear Claws 2.7 oz, Recall # F-084-2; e) Dark Chocolate Bars 3 oz & 4 oz, Recall # F-085-2; f) Double Chocolate "Moose" Brownies 72 brownies, Recall # F-086-2; g) Double Dipped Chocolate Cookies 2 & 12 pack , Recall # F-087-2. CODE Products are not coded. RECALLING FIRM/MANUFACTURER Paula's Edibles Billings, MT, by telephone on 6/29/01. Firm initiated recall is complete. REASON a) Undeclared peanuts; b) Undeclared peanuts; c) Undeclared milk; d) Undeclared milk; e) Undeclared almonds and milk; f) Undeclared milk; g) Undeclared milk. VOLUME OF PRODUCT IN COMMERCE 34 pkgs of mixes, 192 pkgs cookies, 144 choc bars. DISTRIBUTION MT.RECALLS AND FIELD CORRECTIONS: FOODS CLASS III
_______________________ PRODUCT F-088-2 Chocolate Dipped Cinnamon Bears 6 oz , Recall # F-088-2. CODE Products are not coded. RECALLING FIRM/MANUFACTURER Paula's Edibles Billings, MT, by telephone on 6/29/01. Firm initiated recall is complete. REASON Undeclared FD&C Red No. 40. VOLUME OF PRODUCT IN COMMERCE 48 Pkgs cinnamon bears. DISTRIBUTION MT.RECALLS AND FIELD CORRECTIONS: DRUGS CLASS I
_______________________ PRODUCT Tiratricol, bulk powder, in 250 gram or 1000 gram containers, Recall # D-046-2. CODE All lots. RECALLING FIRM/MANUFACTURER Recalling Firm: Integrity Chemicals International, Sarasota, FL, by fax on 8/3/01. Manufacturer: Unknown. Importer: Tolbiac S.R.L., Buenos Aires, Argentina. Firm initiated recall is complete. REASON Unapproved new drug. VOLUME OF PRODUCT IN COMMERCE 1750 grams. DISTRIBUTION CA and MN. _______________________ PRODUCT T3 Pro-Thyroid Technology, 90 capsules, Tiratricol, 1000 mcg, Product was packaged 12 bottles to a case. Recall Number(s): D-047-2. CODE All codes are recalled. RECALLING FIRM/MANUFACTURER Recalling Firm: Global Enterprises College Station, TX by letter on 9/18/01. Manufacturer: Golden Desert Manufacturing Phoenix, AZ. Firm initiated recall is complete. REASON Unapproved new drug. VOLUME OF PRODUCT IN COMMERCE 8253 bottles of 90. DISTRIBUTION TX. _______________________ PRODUCT BIOPHARM T-Cuts Capsules, Trycan 100 mgs (pharmaceutical grade Tiratricol), 90 count bottles, Recall # D-048-2. CODE Lot #2276 exp. 6/03. RECALLING FIRM/MANUFACTURER Recalling Firm: ATF Fitness Products, Inc., Oakmont, PA, by press release on 7/27/01. Manufacturer: GDM, Inc Phoenix, AZ. Firm initiated recall is ongoing. REASON Unapproved new drug. VOLUME OF PRODUCT IN COMMERCE 400 units. DISTRIBUTION CA, VA, WV, NM, IN, SC, WA, NC, LA and Canada.RECALLS AND FIELD CORRECTIONS: DRUGS CLASS II
_______________________ PRODUCT Equate Allergy Medication Decongestant Caplets in 24 caplet blister cartons. The product contains Diphenhydramine Hydrochloride 25 mg and Pseudoephedrine Hydrochloride 60 mg., Recall D-040-2. CODE Lot No. 1GB0825, 1GB1041, 1GB1042. RECALLING FIRM/MANUFACTURER Recalling Firm: Leiner Health Products, Inc., Carson, CA, by letter on 10/12/01. Manufacturer: Leiner Health Products, Inc., Fort Mill, SC. Firm initiated recall is ongoing. REASON Misbranding; directions for use may lead to a doubling of the dosage. VOLUME OF PRODUCT IN COMMERCE 45,504/24 caplet cartons. DISTRIBUTION Nationwide. _______________________ PRODUCT Rescriptor 200 mg tablets (delavirdine mesylate tablets), NDC 0009- 7576-01, Bottles of 180 tablets, Recall # D-041-2. CODE Lot no. 17DSJ Exp. date 11/01. RECALLING FIRM/MANUFACTURER Recalling Firm: Pfizer Inc., New York, NY, by letter on 10/26/01. Manufacturer: Pharmacai & UpJohn Barceloneta, Puerto Rico. Firm initiated recall is ongoing. REASON Lowered therapeutic effectiveness. VOLUME OF PRODUCT IN COMMERCE 1,949 bottles. DISTRIBUTION Nationwide. _______________________ PRODUCT Meperidine HCL Injection, USP, 25,50,75 and 100 mg/mL-1 mL Dosette vials. Wyeth Ayerst, ESI Lederle, Recall # D-042-2; Recall # D-043-2; Recall # D-044-2; Recall # D-045-2. Labeled Products: Meperidine HCl Injection, USP 25 mg/ml, 25 x 1 mL DOSETTE vial; Meperidine HCl Injection, USP 50 mg/ml, 25 x 1 mL DOSETTE vial; Meperidine HCl Injection, USP 75 mg/ml, 25 x 1 mL DOSETTE vial; Meperidine HCl Injection, USP 100 mg/ml, 25 x 1 mL DOSETTE vial. Labeled Products: Meperidine HCl Injection, USP 25 mg/ml, 25 x 1 mL DOSETTE vial; Meperidine HCl Injection, USP 50 mg/ml, 25 x 1 mL DOSETTE vial; Meperidine HCl Injection, USP 75 mg/ml, 25 x 1 mL DOSETTE vial; Meperidine HCl Injection, USP 100 mg/ml, 25 x 1 mL DOSETTE vial. CODES: All lots (Baxter, ESI Lederle labels) within expiry of Mepridine HCL Injection, 25mg/ml, 50mg/ml, 75mg/ml, 100mg/ml. ESI Lots: 25 mg/mL: Lot 010095 EXP 10/01; Lot 010127 EXP 10/01; Lot 030093 EXP 12/01; Lot 030097 EXP 12/01; Lot 040048 EXP 1/02; Lot 110135 EXP 8/02; Lot 021175 EXP 11/02; Lot 041010 EXP 1/03; Lot 051087 EXP 2/03; Lot 081004 EXP 5/03; Lot 071173 EXP 4/03; Lot 040106 EXP 1/02; Lot 110065 EXP 8/02; Lot 071125 EXP 4/03; Lot 060032 EXP 3/02; Lot 010151 EXP 10/01. 50 mg/mL: Lot 010053 EXP 10/01; Lot 010061 EXP 10/02; Lot 020119 EXP 11/01; Lot 030090 EXP 12/01; Lot 030099 EXP 12/01; Lot 030185 EXP 12/01; Lot 030083 EXP 12/01; Lot 050148 EXP 2/02; Lot 050112 EXP 2/02; Lot 040050 EXP 1/02; Lot 040035 EXP 1/02; Lot 070072 EXP 4/02; Lot 110110 EXP 8/02; Lot 120066 EXP 9/02; Lot 050142 EXP 2/02; Lot 021073 EXP 11/02; Lot 031112 EXP12/02; Lot 051089 EXP 2/03; Lot 041167 EXP 1/03; Lot 041131 EXP 1/03. 75 mg/mL: Lot 031087 EXP 9/02; Lot 050014 EXP 11/01; Lot 050017 EXP 11/01; Lot 090093 EXP 3/02; Lot 061009 EXP 12/02; Lot 071160 EXP 1/03. 100 mg/mL: Lot 051074 EXP 11/02; Lot 040149 EXP 10/01; Lot 060136 EXP 12/02; Lot 100061 EXP 4/02; Lot 100063 EXP 4/02; Lot 110004 EXP 5/02; Lot 021080 EXP 8/02; Lot 051018 EXP 11/02; Lot 081137 EXP 2/03. Baxter Lots: 25 mg/mL: Lot 040103 EXP 1/02; Lot 060038 EXP 3/02; Lot 080115 EXP 5/02; Lot 031114 EXP 12/02; Lot 081167 EXP 5/03. 50 mg/mL: Lot 020116 EXP 11/01; Lot 030088 EXP 12/01; Lot 040159 EXP 1/02; Lot 060085 EXP 3/02; Lot 060040 EXP 3/02; Lot 060087 EXP 3/02; Lot 070125 EXP 4/02; Lot 080075 EXP 5/02; Lot 080137 EXP 5/02; Lot 090147 EXP 6/02; Lot 090057 EXP 6/02; Lot 110107 EXP 8/02; Lot 011064 EXP 10/02; Lot 021078 EXP11/02; Lot 031079 EXP 12/02; Lot 051076 EXP 2/03; Lot 041002 EXP 1/03; Lot 041014 EXP 1/03; Lot 051132 EXP 2/03. 75 mg/Ml Lot 080077 EXP 2/02; Lot 031093 EXP 9/02. 100 mg/mL: Lot 080182 EXP 2/02. RECALLING FIRM/MANUFACTURER Wyeth Ayerst ESI Lederle, Cherry Hill, NJ, by letter on 10/15/2001. Firm initiated recall ongoing. REASON Particulates (clear crystals). VOLUME OF PRODUCT IN COMMERCE 581,240 packs. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: BIOLOGICS CLASS II
_______________________ PRODUCT Red Blood Cells, Leukocyte Reduced, Recall # B-0185-2. CODE Unit 24KH65881. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Louisville, KY, by telephone June 14 and by letter dated May 2, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who reported living in an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION KY. _______________________ PRODUCT Red Blood Cells, Recall # B-0186-2. CODE Unit 03FW70999. RECALLING FIRM/MANUFACTURER American Red Cross, Atlanta, GA, by letters dated Dec. 6 and 22, 1999. Firm initiated recall is complete. REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION GA. _______________________ PRODUCT Red Blood Cells, Recall # B-0187-2. CODE Unit 12R07885. RECALLING FIRM/MANUFACTURER American Red Cross, Charlotte, NC, by letter dated June 5, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION TN. _______________________ PRODUCT Red Blood Cells, Recall # B-0188-2. CODE Unit 03LF11270. RECALLING FIRM/MANUFACTURER American Red Cross, Atlanta, GA, by letter dated Oct. 9, 2000. Firm initiated recall is complete. REASON Blood product, collected from a donor who reported living in an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION GA. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0191-2. CODE Unit 03GL56010. RECALLING FIRM/MANUFACTURER American Red Cross, Atlanta, GA, by telephone Oct.20, and by letter dated Oct. 23, 2000. Firm initiated recall is complete. REASON Red Blood Cells, collected from a donor whose hemoglobin level was not documented, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION GA. _______________________ PRODUCT a)Red Blood Cells, Recall # B-0195-2; b)Platelets, Recall # B-0196-2; c)Fresh Frozen Plasma, Recall # B-0197-2; d)Recovered Plasma, Recall # B-0198-2. CODE a) Units 03T54633, 03GG03351, 03GG05098, 03GG08739 03R67492; b) Units 03T54633, 03GG03351, 03GG05098, 03R67492; c) Unit 03R67492; d) Units 03T54633, 03GG03351, 03GG05098, 03GG08739. RECALLING FIRM/MANUFACTURER American Red Cross, Atlanta, GA, by letters dated Aug. 21, and September 20, 2000. Firm initiated recall is complete. REASON Blood products, collected from donors whose HBsAg confirmatory test result required reclassification, were distributed. VOLUME OF PRODUCT IN COMMERCE 14 units. DISTRIBUTION GA, VA and CA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0199-2; b) Red Blood Cells Leukoreduced, Recall # B-0200-2. CODE a) Units 21GL60594, 21GL60595, 21GL60596, 21GL60599, 21GL60600, 21GL60602, 21GL60605, 21GL60606, 21GL60607, 21GL60608, 21GL60610, 21GL60613, 21GL60616, 21GL60617, 21GL60618, 21GL60620, 21GL60626, 21GL60630, 21GL60631, 21GL60632, 21GL60633, 21GL60635, 21GL60636; b) Units 21GL60625, 21GL60627. RECALLING FIRM/MANUFACTURER American Red Cross, Portland, OR, by telephone on March 7, and by letter dated March 13, 2001. Firm initiated recall is complete. REASON Blood products, tested with improperly handled sample tubes, were distributed. VOLUME OF PRODUCT IN COMMERCE 25 units. DISTRIBUTION OR and WA. _______________________ PRODUCT Fresh Frozen Plasma, Recall # B-0235-2. CODE Units 03GF67389 and 03GF67379. RECALLING FIRM/MANUFACTURER American Red Cross, Atlanta GA, by telephone on Jan. 2 and 9, and by letter dated Mar 1, 2001. Firm initiated recall is complete. REASON Blood products, improperly collected due to an inadequate arm scrub, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION GA. _______________________ PRODUCT Source Plasma Units, Recall # B-0238-2. CODE G-23463-009, G-22789-009,G-22518-009, G-23686-009 G-24317-009, G-24521-009, G-25092-009, T-61417-009, T-61480-009, T-61510-009, T-61667-009, T-61707-009, T-61794-009, T-61828-009, T-61933-009, T-62019-009, T-62232-009, T-62372-009, T-62451-009, T-62639-009, T-62749-009, T-62932-009, T-63125-009, T-63268-009, T-63442-009, T-63987-009, T-64090-009, T-64284-009, T-64385-009, T-64586-009, T-64694-009, T-64902-009, T-64999-009, T-65203-009, T-65340-009, T-65484-009, T-65589-009, T-65747-009, T-65846-009, T-65998-009, T-66094-009, T-66248-009, T-66322-009, T-66482-009, T-66548-009, T-66706-009, T-66762-009, T-66930-009, T-66982-009, T-67129-009, T-67263-009, T-67324-009, T-67449-009, T-67950-009, T-68033-009, T-68135-009, T-68178-009, T-68281-009, G-45655-009, G-45980-009, G-46498-009, G-46699-009, G-47500-009, G-47710-009, G-48107-009, G-48292-009, G-52270-009, G-52425-009, G-52844-009, G-53012-009, G-53605-009, G-54062-009, G-54213-009, G-55115-009, G-55665-009, G-55849-009, G-56255-009, G-56452-009, G-56850-009, G-57062-009, G-57525-009, G-57770-009. RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA, by facsimile dated Feb.13 and June 5, 2001. Manufacturer: Alpha Therapeutic Corporation, Tacoma, WA. Firm initiated recall is complete. REASON Blood products, collected from a donor who engaged in high risks behaviors, were distributed. VOLUME OF PRODUCT IN COMMERCE 82 units. DISTRIBUTION NC, CA and the United Kingdom, Spain and Italy. _______________________ PRODUCT a) Platelets, Pheresis, Leukocytes Reduced, Recall # B-0266-2; b) Platelets, Pheresis, Irradiated, Recall # B-0267-2. CODE a) Unit 7223028 (Bag 1 and 2); b) Unit 1602761 (Bag 1 and 2). RECALLING FIRM/MANUFACTURER Recalling Firm: New York Blood Center, New York, NY, by letter dated May 21, 2001. Manufacturer: New York Blood Center/Long Island Blood Service, A Division of New York Blood Center, Inc.,Melville, NY. Firm initiated recall is complete. REASON Blood products, which had unacceptable platelet counts, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION NY. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0273-2. CODE Unit 42FW79542. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Cleveland, OH, by telephone on April 5 and by letter dated April 10, 2001. Firm initiated recall is complete. REASON Blood product, which had a hematocrit value that was greater than 80%, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OH. _________________ PRODUCT a) Red Blood Cells, Recall # B-0279-2; b) Fresh Frozen Plasma, Recall # B-0280-2. CODE a) Unit 0482950, 0439270; b) Unit 0482950. RECALLING FIRM/MANUFACTURER Hoxworth Blood Center , University of Cincinnati Medical Center, Cincinnati, OH, by letter dated Feb. 21, or March 30, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor taking the drug Remeron, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION KY and OH. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0298-2; b) Recovered Plasma, Recall # B-0299-2. CODE a) Unit S78769; b) Unit S78769. RECALLING FIRM/MANUFACTURER Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA, by letter dated July 21, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor who had skin piercing performed within 12 months of donation, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units DISTRIBUTION CA. ______________________ PRODUCT Source Plasma, Recall # B-0305-2. CODE Unit 41634714. RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Memphis, TN, by fax dated Aug. 23, 2000. Firm initiated recall is complete. REASON Blood product, collected from a donor who had a tattoo within twelve months of donation, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Source Plasma, Recall # B-0319-2. CODE Unit 10175071,10171653. RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Memphis, TN, by fax dated March 9, 1999. Firm initiated recall is complete. REASON Blood products, which tested negative for antibody to hepatitis C virus (anti-HCV), but collected from a donor that previously tested repeatedly reactive, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _______________________ PRODUCT Platelets Pheresis, Leukocytes Removed, Recall # B-0335-2. CODE Unit FF81688. RECALLING FIRM/MANUFACTURER Blood Bank of the Redwoods, Santa Rosa, CA, by letter dated July 29, 1998. Firm initiated recall is complete. REASON Blood product, not tested for Auszyme (HBsAg), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Source Plasma, Recall # B-0338-2. CODE Units G-33919-096, G-38476-096, G-38902-096, G-39805-096, G-40228- 096, G-41258-096, G-41684-096, G-42843-096, G-43173-096, G-44343-096, G-44700-096, G-47401-096, G-47789-096, G-48943-096, G-49931-096, G- 54483-096, G-54851-096, G-63603-096, G-63913-096, G-65750-096, G- 66052-096, G-67139-096, G-71234-096, G-71602-096, G-74597-096, G- 75678-096, G-76152-096. RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA, by fax dated Jan. 25, 2000. Manufacturer: Alpha Therapeutic Corporation, Bakersfield, CA. Firm initiated recall is complete. REASON Source Plasmas, collected from an ineligible donor, were distributed. VOLUME OF PRODUCT IN COMMERCE 27 units. DISTRIBUTION NC. _______________________ PRODUCT Source Plasma, for Further Manufacturing, Recall # B-0339-2. CODE Units 6070AM, 6557AM. RECALLING FIRM/MANUFACTURER Southern Plasma Corporation, Tallahassee, FL, by fax on Dec. 17, 1997. Firm initiated recall is complete. REASON Blood products, collected from a donor who tested positive for syphilis, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION NC. _______________________ PRODUCT Platelets, Recall # B-0343-2. CODE Unit 1812785. RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Lexington, KY, by letter dated Aug. 22, 2001. Firm initiated recall is complete. REASON Platelets, collected from a donor who had taken an aspirin product within 36 hours of donation, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION KY. _______________________ PRODUCT a) Red Blood Cells, Leukocyte Reduced, Recall # B-0344-2; b) Fresh Frozen Plasma, Recall # B-0345-2. CODE a) Unit 07FK47364; b) Unit 07FK47364. RECALLING FIRM/MANUFACTURER American National Red, Tucson, AZ, by letter dated Feb. 21, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who previously tested reactive for HBsAg, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION AZ. _____________________ PRODUCT Red Blood Cells, Recall # B-0355-2. CODE Unit 02FM22363. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Wichita, KS, by telephone on Nov. 29, 2000. Firm initiated recall is complete. REASON Blood product, not properly quarantined after receiving information concerning post donation illness, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION KS. _______________________ PRODUCT Red Blood Cells, Leukocytes Removed, Recall # B-0356-2. CODE Unit 02W33212. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Wichita, KS, by telephone on March 10, and by letter dated March 15, 2000. Firm initiated recall is complete. REASON Blood product, collected from a donor who had no hematocrit check performed, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION KS. _______________________ PRODUCT Recovered Plasma, Recall #B-0357-2. CODE Units 1560655, 1106942, 1472777. RECALLING FIRM/MANUFACTURER New York Blood Center, New York, NY, by fax dated August 10, 2000. Firm initiated recall is complete. REASON Blood products, collected from unsuitable donors, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION Switzerland. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B-0364-2. CODE Unit 36259-2826. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on August 17, 2000, and by letter dated September 13, 2000. Manufacturer: Blood Systems, Inc., Ventura, CA. Firm initiated recall is complete. REASON Blood product, that was labeled leukoreduced but was not tested to determine the white blood cell count as required in the firm's standard operating procedures, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0366-2; b) Platelets, Recall # B-0367-2; c) Fresh Frozen Plasma, Recall # B-0368-2. CODE a) Unit numbers 10624-0348 and 21379-0172; b) Unit number 10624-0348; c) Unit number 10624-0348. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ, by telephone Jan. 4 and 5, and by letter dated Jan. 11, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for the antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from donors that previously tested repeatedly reactive for anti-HIV-1/2, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION AZ and ND. _______________________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Recall # B-0369-2. CODE Unit numbers 0579882-1, 0579882-2, 0561024, and 0550107. RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter dated March 5, 2001. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION OH. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0370-2; b) Platelets, Recall # B-0371-2. CODE a) and b) Unit number 0586270. RECALLING FIRM/MANUFACTURER University of Cincinnati Medical Center, Cincinnati, OH, by letter dated June 12, 2001. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION OH. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0372-2; b) Platelets, Recall # B-0373-2. CODE a) and b) Unit number 2102816. RECALLING FIRM/MANUFACTURER LifeShare, Inc., Elyria, OH, by letter dated August 8, 2001. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION OH. _______________________ PRODUCT Corneas, Recall # B-0374-2. CODE Donor Identification OS 2001-03-2005 and OD 2001-03-2006. RECALLING FIRM/MANUFACTURER Recalling Firm: Heartland Lions Eye Bank, Columbia, MO, by telephone on 5/30/01. Manufacturer: Central Illinois Lions Eye Bank, Springfield, IL. Firm initiated recall is complete. REASON Corneas, collected from a donor who was diagnosed with suspected, but unconfirmed, Creutzfeld-Jakob Disease (CJD), were distributed for transplant. VOLUME OF PRODUCT IN COMMERCE 2 corneas. DISTRIBUTION KA and MO. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0378-2; b) Red Blood Cells, Washed, Irradiated, Recall # B—379-2. CODE a) Units 2713222, 3950690; b) Unit 2732718. RECALLING FIRM/MANUFACTURER Houchin Blood Services, Bakersfield, CA, by telephone on September 13, and by letter dated September 20, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor who was taking Evista, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION CA. _______________________ PRODUCT Source Plasma, Recall # B-0383-2. CODE Units 10712566, 10632376, 08047090, 10640333, 08286284, 10630405, 08285003, 10637227, 08282347, 10635964, 08281180, 10633502, 08048486. RECALLING FIRM/MANUFACTURER Recalling Firm: Sera-Tec Biologicals, North Brunswick, NJ, by letter dated May 7, 1999. Manufacturer: Sera-Tec Biologicals, Clearwater, FL. Firm initiated recall is complete. REASON Blood products, collected from a donor who previously tested HCV reactive in PCR testing, were distributed. VOLUME OF PRODUCT IN COMMERCE 13 units. DISTRIBUTION CA. _______________________ PRODUCT Fresh Frozen Plasma, Recall # B-0384-2. CODE Unit GX34662. RECALLING FIRM/MANUFACTURER Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA, by letter dated March 21, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor taking the drug Lupron, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Platelets Pheresis, Recall # B-0385-2. CODE Unit numbers 26161-9057, 26161-9055, 26161-9048, 26161-9037, 26161-9024, 26161-9021, 26161-8910, 26161-8905, 26161-8868, 26161-8805, 26161-8785, 26161-8755, 26161-8701, 26162-6974, 26162-6910, 26162-6883, 26162-6803, 26162-6707, 26164-5704, 26162-4817, 26162-4787, 26162-480,26162-4769, 26162-4715, 26161-4710, 26160-2890, and 26165-2748; the following unit numbers were distributed as two split products 26161-9063, 26161-8982, 26161-8917, 26161-8869, 26161-8815, 26162-6862,26162-6839, 26162-6819, 26162-4837, 26162-4810, 26162-4707, 26158-4648, 26165-2756, 26165-2755, 26165-2741, and 26165-2738. RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Fort Smith, AR, by letters dated December 14, 2000, and October 16, 2001. Firm initiated recall is complete. REASON Platelets with a platelet count outside the manufacturer’s specifications were distributed. VOLUME OF PRODUCT IN COMMERCE 59 units. DISTRIBUTION MS, AR, TX and OK. _______________________ PRODUCT a)Red Blood Cells, Recall # B-0386-2; b) Recovered Plasma, Recall # B-0387-2. CODE a) Units 49GR03327, 49LH18661, and 49LH27047; b) Unit 49GR03327. RECALLING FIRM/MANUFACTURER The American national Red Cross, Tulsa, OK, by letters dated July 14, 1998, August 19, 1998, and April 20, 2001. REASON Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible due to a reported history of previous reactive testing for anti-HCV, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION MA, TX, CA, OK. _______________________ PRODUCT a) Red Blood Cells, Irradiated, Recall # B-0431-2; b) Recovered Plasma, Recall # B-0432-2. CODE a) and b) Unit 0540807. RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH, by letter dated November 20, 2000. Firm initiated recall is complete. REASON Blood products, not quarantined after receiving post donation information related to a tick bite, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION OH and FL. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0433-2; b) Cryoprecipitate AHF, Recall # B-0434-2; c) Recovered Plasma, Recall # B-0435-2. CODE a), b) and c) Unit 7841008. RECALLING FIRM/MANUFACTURER Carter Blood Care, Bedford, TX, by letters dated July 9, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who was taking Proscar, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION TX and Switzerland. _______________________ PRODUCT a) Red Blood Cells, Recall # B-436-2; b) Platelets, Recall # B-437-2; c) Fresh Frozen Plasma, Recall # B-438-2. CODE a), b) and c) Unit 7841796. RECALLING FIRM/MANUFACTURER Carter Blood Care, Bedford, TX, by letter dated July 20, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor whose hemoglobin was not determined, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION TX. _______________________ PRODUCT Platelets Pheresis, Recall # B-0440-2. CODE (2 split units), unit number 11LS19735. RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, St. Louis, MO, by telephone on March 8, and by letter dated March 15, 2000. Manufacturer: American Red Cross Blood Services, Crestwood, MO. Firm initiated recall is complete. REASON Blood product, labeled with the incorrect expiration date, was distributed. VOLUME OF PRODUCT IN COMMERCE 2 split units. DISTRIBUTION MO. _______________________ PRODUCT Red Blood Cells, Recall # B-0444-2. CODE Unit 4197826. RECALLING FIRM/MANUFACTURER Blood Bank of Alaska, Inc., Anchorage, AK, by letter dated May 30, 2001. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AK. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0447-2; b) Cryoprecipitate AHF, Recall # B-0448-2; c) Recovered Plasma, Recall # B-0449-2. CODE a), b) and c) Unit 7837167. RECALLING FIRM/MANUFACTURER Carter Blood Care, Bedford, TX, by letters dated August 28 or 29, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who reported sexual contact with her spouse who had hepatitis, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION TX and Switzerland. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0523-2; b) Fresh Frozen Plasma, Recall # B-0524-2. CODE a) and b) Unit 1632203. RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by fax dated Oct. 3, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor who lived in the United Kingdom for greater than 6 months between 1980-1996, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION TX and WI.RECALLS AND FIELD CORRECTIONS: BIOLOGICS CLASS III
_______________________ PRODUCT Serum, for Further Manufacturing of Non-Injectable Products, Recall # B-0322-2. CODE Unit TT44953. RECALLING FIRM/MANUFACTURER Interstate Blood Bank, Inc.(IBBI), Memphis, TN, by letter dated May 7, 2001. Firm initiated recall is complete. REASON Blood product, which tested negative for viral markers, but was collected from a donor whose health history was inadequately determined, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION PA. _______________________ PRODUCT Platelet Pheresis Irradiated, Recall # B-0341-2. CODE Units 007FP09023 (split product), 007FP09025, 007FP09026 (part 1), 007FP09029 (split product). RECALLING FIRM/MANUFACTURER American National Red Cross, Arizona Region, Tucson, AZ, by telephone on Feb. 15, 2001. Firm initiated recall is complete. REASON Platelets, not stored under continuous agitation, were distributed. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION AZ. _______________________ PRODUCT Liquid Plasma, Recall # B-0342-2. CODE Unit FF80880. RECALLING FIRM/MANUFACTURER Blood Bank of the Redwoods, Santa Rosa, CA, by telephone on July 15, 1998. Firm initiated recall is complete. REASON Liquid Plasma, labeled with an incorrect expiration date, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Recovered Plasma, Recall # B-0358-2 . CODE Units 2834288 and 1105481. RECALLING FIRM/MANUFACTURER New York Blood Center (Center West), New York, NY, by facsimile dated August 10, 2000 Firm initiated recall is complete. REASON Blood products, collected from unsuitable donors, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION Switzerland. _______________________ PRODUCT Source Plasma, Recall # B-0363-2. CODE Units N56918-018 and N56959-018. RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA, by letter dated June 2, 1999. Manufacturer: Alpha Therapeutic Corporation, Fresno, CA. Firm initiated recall is complete. REASON Source Plasma, that was exposed to unacceptable storage temperatures and was not properly relabeled as Source Plasma, Salvaged, was distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated, Recall # B-0365-2. CODE Unit 10620-9557. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on March 13, 2000. Manufacturer: Blood Systems, Inc., Scottsdale, AZ. Firm initiated recall is complete. REASON Blood product, labeled with the incorrect anticoagulant, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AZ. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0375-2; b) Platelets, Recall # B-0376-2; c) Fresh Frozen Plasma, Recall # B-0377-2. CODE a) 2133714, 2132904; b) 2133714, 2132904; C) 2133714, 2132904. RECALLING FIRM/MANUFACTURER LifeShare, Inc., Elyria, OH, by letters dated Aug. 8, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who was taking the antibiotic, Keflex, were distributed. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION OH. _______________________ PRODUCT Recovered Plasma, B-0380-2. CODE Units 2732718, 3950690, 2713222. RECALLING FIRM/MANUFACTURER Houchin Blood Services, Bakersfield, CA, by telephone on September 13, 2000, and by letter dated September 20, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor who was taking Evista, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0381-2; b) Fresh Frozen Plasma, Recall # B-0382-2. CODE a) and b) 1637930. RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center (CKBC), Lexington, KY, by letter dated Aug. 22, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who was taking Sulfasalazine, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION KY. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0388-2; b) Cryoprecipitated AHF, Recall # B-0389-2; c) Fresh Frozen Plasma, Recall # B-0390-2; d) Recovered Plasma, Recall # B-0391-2. CODE a) Unit numbers 7892623, 7837690, 7827137, and 7827420; b) Unit number 7827137; c) Unit number 7827420; d) Unit numbers 7892623, 7837690, and 7827137. RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX, by letters dated June 26 and Aug. 21, 2001. Firm initiated recall is complete. REASON Blood products, collected from donors whose arm inspection was either not documented or was noted to be unacceptable, were distributed. VOLUME OF PRODUCT IN COMMERCE 9 units. DISTRIBUTION TX and Switzerland. _______________________ PRODUCT Short Ragweed Allergenic Extract, Recall # B-0439-2. CODE Lot number 7O9F22380. RECALLING FIRM/MANUFACTURER ALK-Abello, Round Rock, TX, by telephone on or about May 18, 1999. Firm initiated recall is complete. REASON Allergenic extract was distributed labeled with the incorrect expiration date. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AK, CT, IL, TX, MD, MA, MN, TN and FL. _______________________ PRODUCT Source Plasma, Recall # B-0441-2. CODE Unit 0083827. RECALLING FIRM/MANUFACTURER DCI Biologicals Carbondale, Inc., Carbondale, IL, by letter on Sept. 10, 2001. Firm initiated recall is complete. REASON Blood product, untested for viral markers, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NC. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0442-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-0443-2. CODE a) Units E22201, E22236, G04397, G04401, G04412, K31631, L34892, L34904, L34905, L34907, L34909, L34910, L34911, L34924, L34928, L34931, L34937, L34938, L34943, L34945, L34948, L34952, L34954, L34955, L34958, L34959, L34960, L34963, L34964, L34966, L34968, L34973, L34974, L34975, L34977, L34980, L34982, L34988, L34990, L34991, L34992, L34998, L34999, L35020, L35051, L35052, L35062, L35065, L35070, L35076, L35079, L35080, and L35081; b) Units G04366, L34884, L34893, L34895, L34897, L34898, L34899, L34900, L34903, L34906, L34908, L34919, L34920, L34921, L34922, L34926, L34927, L34929, L34930, L34935, L34940, L34942, L34944, L34961, L34969, L34979, L34984, L34985, L34996, L35000, and L35001. RECALLING FIRM/MANUFACTURER Central Illinois Community Blood Bank, Springfield, IL, 1998, by telephone and letter on Aug. 9, 2001. Firm initiated recall is complete. REASON Blood products, subjected to incorrect storage temperatures, were distributed. VOLUME OF PRODUCT IN COMMERCE 84 units. DISTRIBUTION IL. _______________________ PRODUCT Platelets, Recall # B-0453-2. CODE Unit 10632-9138. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on Oct. 24, 2000. Manufacturer: United Blood Services, Scottsdale, AZ. Firm initiated recall is complete. REASON Platelets, shipped at an unacceptable temperature, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AZ. _______________________ PRODUCT Red Blood Cells, Recall # B-0457-2. CODE Unit 7050978. RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL, by telephone on March 31, 2001. Firm initiated recall is complete. REASON Blood product, collected from an ineligible donor due to medication with an antibiotic in the previous 72 hours, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IL. _______________________ PRODUCT Red Blood Cells, Recall # B-0458-2. CODE Unit 9004553. RECALLING FIRM/MANUFACTURER Blood Bank of Alaska, Inc., Anchorage, AK, by letter dated April 16, 2001. Firm initiated recall is 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 AK. _______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-0521-2. CODE Unit 10717-4411. RECALLING FIRM/MANUFACTURER United Blood Services, Scottsdale, AZ, by telephone on Sept. 18, 2001. Firm initiated recall is complete. REASON Blood product, labeled with an extended expiration date, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AZ. _______________________ PRODUCT Platelets, For use in Maufacturing Non-Injectables, B-0525-2. CODE Unit 1632203. RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by fax dated Oct. 3, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor who lived in the United Kingdom for greater than 6 months between 1980-1996, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 units. DISTRIBUTION TX and WI.RECALLS AND FIELD CORRECTIONS: DEVICES CLASS II
_______________________ PRODUCT Femoral Heads, Recall # Z-0312-2; Recall # Z-0313-2. CODE: B. Howmedica„Zirconia Femoral Head (K920577 and K946026), Product Numbers Product Description MFG Date or Last Date 6284-3-126 Zirconia Head 26mm STD * 6284-3-128 Zirconia Head 28mm STD Sept 1998 6284-3-132 Zirconia Head 32mm STD March 1995 6284-3-226 Zirconia Head 26mm,+5mm * 6284-3-228 Zirconia Head 28mm,+5mm Feb 1996 6284-3-232 Zirconia Head 32mm,+5mm March 1995 C. V40 Zirconia Femoral Heads (K952418) include: (5-year expiration from date of manufacture) MFG Date or Product Numbers Product Description Last Date 6264-6-028 V40 Zirconia Fem Head 28mm,-4mm * 6264-6-122 V40 Zirconia Fem Head 22mm STD * 6264-6-128 V40 Zirconia Fem Head 28mm STD August 1997 6264-6-222 V40 Zirconia Fem Head 22mm,+3mm * 6264-6-228 V40 Zirconia Fem Head 28mm,+4mm August 1997 6264-6-328 V40 Zirconia Fem Head 28mm,+8mm * 6264-6-428 V40 Zirconia Fem Head 28mm,+12mm * B. Howmedica„µ Zirconia Femoral Head (K920577 and K946026) include: (5-year expiration from date of manufacture) Product Numbers Product Description MFG Date or Last Date 6284-3-126 Zirconia Head 26mm STD * 6284-3-128 Zirconia Head 28mm STD Sept 1998 6284-3-132 Zirconia Head 32mm STD March 1995 6284-3-226 Zirconia Head 26mm,+5mm * 6284-3-228 Zirconia Head 28mm,+5mm Feb 1996 6284-3-232 Zirconia Head 32mm,+5mm March 1995 C. V40 Zirconia Femoral Heads (K952418) include: (5-year expiration from date of manufacture) MFG Date or Product Numbers Product Description Last Date 6264-6-028 V40 Zirconia Fem Head 28mm,-4mm * 6264-6-122 V40 Zirconia Fem Head 22mm STD * 6264-6-128 V40 Zirconia Fem Head 28mm STD August 1997 6264-6-222 V40 Zirconia Fem Head 22mm,+3mm * 6264-6-228 V40 Zirconia Fem Head 28mm,+4mm August 1997 6264-6-328 V40 Zirconia Fem Head 28mm,+8mm * 6264-6-428 V40 Zirconia Fem Head 28mm,+12mm * RECALLING FIRM/MANUFACTURER Recalling Firm: Howmedica Osteonics Corp., Allendale, Corp., NJ. by letters dated 8/16,22,23/2001. Manufacturer: Morgan Matroc Ltd., Rugby, Warwichshire, United Kingdom, CV213Q. Firm initiated recall is ongoing. REASON Potential breakage of ceramic femoral heads. VOLUME OF PRODUCT IN COMMERCE 271 units. DISTRIBUTION Nationwide _______________________ PRODUCT All GEM Analyzers including: a) Recall # Z-0314-2, GEM 6 Plus Model 2300; b) Recall # Z-0315-2, GEM Premier Model 5300; c) Recall # Z-0316-2, GEM Stat Model 4300; d) Recall # Z-0317-2, GEM Premier Plus Model 5500; e) Recall # Z-0318-2. GEM Premier 3000 Model 5700. CODE: All codes. RECALLING FIRM/MANUFACTURER Recalling Firm: Instrumentation Laboratory Co., Lexington, MA, by letter on 10/03/01. Manufacturer: Instrumentation Laboratory Co., Orangeburg, NY. Firm initiated recall is ongoing. REASON Thiopental sodium, an anesthetic agent, may interfere with Na+, K+ and Cl- reading. VOLUME OF PRODUCT IN COMMERCE 1,997. DISTRIBUTION Nationwide. _______________________ PRODUCT Roche Elecsys Model 1010 Analyzers, Catalog # 1705253, Recall # Z-0319-2. CODE All units. RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnoistics Corp., Indianapolis, IN, by letter on 11/9/01. Manufacturer: Tegimenta RD Instrument Center Switzerland. Firm initiated recall is ongoing. REASON Electrical short may cause fire in the sample incubation chamber. VOLUME OF PRODUCT IN COMMERCE 223 units. DISTRIBUTION Nationwide. _______________________ PRODUCT CryoValve Allograft, a) Recall # Z-0320-2, Model Number AV00; b) Recall # Z-0321-2, Model Number PV00. CODE a) Serial Number 6010989; b) Serial Number 6010997. RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA, by letter on November 1, 2001. Firm initiated recall is complete. REASON Donor did not meet current guidelines regarding serodilution of plasma. VOLUME OF PRODUCT IN COMMERCE 2 valves. DISTRIBUTION LA and Canada. _______________________ PRODUCT CryoValve Allograft, a) Z-0322-2, Model Number AV00; b) Z-0323-2, Model Number PV00. CODE a) Serial Number 6964281; b) Serial Number 6964303. RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA, by letter on November 1, 2001. Firm initiated recall is complete. REASON Donor did not meet current guidelines regarding serodilution of plasma. VOLUME OF PRODUCT IN COMMERCE 2 items. DISTRIBUTION PA.RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II
_______________________ PRODUCT 43 CHDS Teat Dip (Chlorhexidine) sold in: - 15 gallon containers; and - 1 gallon jugs (4 per case), Recall # V-008-2; CODE 43 CHDS: Lot # TTZW, Exp. June 2002 Lot # PRPL11, Exp. August 2002 RECALLING FIRM/MANUFACTURER Benbow Chemical Packaging, Inc. Syracuse, NY, by telephone on 10/5/01. FDA initiated recall is ongoing. REASON Noncompliance with GMPs. VOLUME OF PRODUCT IN COMMERCE 600 one gallon; 22 five gallon; 9 fifteen gallon containers. DISTRIBUTION NY. _______________________ PRODUCT a) Pig Starter feeds in 50 lb. paper sacks labeled in part: b) "Country Blend Pig Creep & Starter 20% ***Medicated*** Active Drug in Ingredient", Recall # V-011-2. c) "Hawaiian grain Pig Starter Medicated W/CSP ***Medicated***,” Recall # V-012-2. d) "Sweet Pig Starter CSP ***Medicated***, Recall # V-013-2. e) Land O Lakes Top Wean CSP Complete Pig Starter Pellet. ***Medicated***, Recall # V-014-2. CODE a) Country Blend Creep & Starter - 1249RIV3. b) Hawaiian Grain Pig Starter Medicated with CSP - 1256RIV2. c) Albers Sweet Pig Starter CSP - 1275RIV3. d) Land O'Lakes Top Wean CSP - 1250RIV1, 1270RIV3. RECALLING FIRM/MANUFACTURER Land O'Lakes Farmland Feed LLC Portland, OR, by telephone on 10/3/01. Firm initiated recall is ongoing. REASON Products are subpotent for CSP 250. VOLUME OF PRODUCT IN COMMERCE 71/50# bags of Country Blend Pig Creep & Starter, 72/50# bags of Hawaiian Grain PIg Starter Medicated with CSP, 9/50# bags of Albers Sweet Pig Starter CSP, 815/50# bags of Land O'Lakes Top Wean CSP . DISTRIBUTION HI, WA, OR, ID, CA, AKRECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS III
_______________________ PRODUCT a) Double Dip Iodine Teat Dip, 1 gallon jugs/4 per case, Recall # V-009-2; b) Double Dip 2 Iodine Teat Dip, 1 gallon jugs/4 per case, Recall # V-010-2; CODE a) Double dip: Lot#PYLY 13, Exp. 8/2002 b) Double dip: Lot 3 PSER 16, Exp. 8/2002. RECALLING FIRM/MANUFACTURER Benbow Chemical Packaging, Inc., Syracuse, NY, by telephone on 10/5/01. REASON Net weight not displayed on immediate containers. VOLUME OF PRODUCT IN COMMERCE 600 gallons. DISTRIBUTION NY.END OF ENFORCEMENT REPORT FOR DECEMBER 12, 2001 ####
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