July 10, 2002 02-27
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
****CORRECTION**** Recall # F-421-2 on Enforcement Report 02-20 dated May 22, 2002 has the product “Portagen iron fortified nutritionally completepowder with medium chain triglycerides in 1 lb. cans” as being distributed in Hong Kong. The distribution should read: Nationwide, Australia and Spain.
_______________________ PRODUCT a) Nate's brand Rolled Tacos with Red Chile & Soy Cheese in 12 oz packages, 6 rolls per package. Recall # F-594-2. b) Nate’s Bean & Soy Cheese Rolled Tacos in 12 oz packages, 6 rolls per package. Recall # F-595-2. CODE (Elena’s food Specialties, Inc., does not place codes, lot numbers or manufacturer numbers on its products). RECALLING FIRM/MANUFACTURER Elena’s Food Specialties, Inc., South San Francisco, CA, by fax and letters on April 2, 2002. FDA initiated recall is complete. REASON The products contain undeclared milk protein, casein. VOLUME OF PRODUCT IN COMMERCE 4117 cases. DISTRIBUTION CA, IA, CO, VT and FL. _______________________ PRODUCT Sweet Rolls in clear plastic bag with labeling printed on bag stating in part "ANXUYEN BAKERY NET WT. 12 oz. ** Seatac, Washington. ** INGREDIENTS: ***". There are 12 sweet rolls per package. The labeling does not state the name of the product. Recall # F-596-2. CODE Product is not coded by the firm. RECALLING FIRM/MANUFACTURER Anxuyen Bakery, Seatac, WA, by visiting stores on June 5, 2002. FDA initiated recall is complete. REASON The product contained undeclared milk and eggs. VOLUME OF PRODUCT IN COMMERCE 90 pkgs/week. DISTRIBUTION WA. _______________________ PRODUCT April Hill Theme Cookie Cutouts, frozen cookie dough packaged in 5.99-lb. cartonboard cartons, 3 cartons/case, 72 Ready to Bake Shaped Cookies per case. The cartons are labeled with a sticker indicating the seasonal theme for the cookies contained in the carton, either a) Holiday Trees, Bells and Stars. Recall # F-597-2; b) Harvest Pumpkins and Apples. Recall # F-598-2. The responsible firm on the label is The Earthgrains Company, St. Louis, MO. CODE All codes on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Recalling Firm: Sara Lee Bakery Group, St. Louis, MO, by telephone on December 18, 2001. Manufacturer: Grocer's Baking Company, Inc., Grand Rapids, MI. Firm initiated recall is complete. REASON The product contained undeclared eggs. VOLUME OF PRODUCT IN COMMERCE a) 36,300/3/5.99-lb. carton cases Holiday theme; b) 3,577/3/5.99-lb. carton cases Harvest theme. DISTRIBUTION MI and OH. _______________________ PRODUCT EL Cotorro brand Coconut (CoCo Quemado) Macaroons Net Weight 4 oz. - four pack and 24 oz. - family pack; Packed in clear non flexible plastic containers. Recall # F-606-2. CODE El Cotorro brand Coconut (Coco Quemado) Macaroons: Unexpired codes are: 01.14.02, 01.30.02, 02.07.02, 02.13.02, 02.19.02, 02.22.02, 02.26.02, 02.28.02. RECALLING FIRM/MANUFACTURER Anita Bakery Products, Medley, FL, by letter on January 25, 2002. State initiated recall is complete. REASON Coconut Macaroons contain undeclared egg whites. VOLUME OF PRODUCT IN COMMERCE 600. DISTRIBUTION FL. _______________________ PRODUCT Melissa's brand Crystalized Ginger, NET WT. 3 OZ. in cellophane packets. Ingredients: Ginger, Cane Sugar. Recall # F-610-2. CODE Lot Number 156-69-606. RECALLING FIRM/MANUFACTURER Melissa's/World Variety Produce, Vernon, CA, by telephone and press release and fax on December 6, 2001. State initiated recall is complete. REASON Product contains 294 PPM sulfites that were not declared on the label. VOLUME OF PRODUCT IN COMMERCE 709 cases; 12/3 oz. packages/case. DISTRIBUTION Nationwide and Canada. _______________________ PRODUCT Wholly Healthy Two Crust Pies a) Apple - 8" Retail Apple UPC 0-74677-08110, 8" B&S Apple UPC 0-74677-08010, and 10" B&S Apple UPC 0-74677-10110. Recall # F-612-2; b) Blueberry - 8" Retail Blueberry UPC 0-74677-08112, 8" B&S Blueberry UPC 0-74677-08012, and 10" B&S Blueberry UPC 0-74677-10112. Recall # F-613-2; c) Cherry - 8" Retail Cherry UPC 0-74677-08113, 8" B&S Cherry UPC 0-74677-08013, and 10" B&S Cherry UPC 0-74677-10113. Recall # F-614-2; d) Apple Cranberry - 8" B&S Apple Cranberry UPC 0-74677-08060 and 10" B&S Apple Cranberry UPC 0-74677-10160. Recall # F-615-2; e) Harvest Berry 8" B&S Harvest Berry UPC 0-74677-08069 and 10" B&S Harvest Berry UPC 0-74677-10169. Recall # F-616-2; f) Mince 8" B&S Mince UPC 0-74677-08021. Recall # F-617-2; g) Peach 8" B&S Peach UPC 0-74677-08022 and 10" B&S Peach UPC 0-74677-10122. Recall # F-618-2; h) Strawberry Rhubarb 8" B&S Strawberry Rhubarb UPC 0-74677- 08034 and 10" B&S Strawberry Rhubarb UPC 0-74677-10134. Recall # F-619-2. CODE UPC 0-74377 - 08110 -- 8" Retail Apple 28 oz 08112 -- 8" Retail Blueberry 28 oz 08113 -- 8" Retail Cherry 28 oz 08010 -- 8" B&S Apple 28 oz 08060 -- 8" B&S Apple Cranberry 28 oz 08012 -- 8" B&S Blueberry 28 oz 08013 -- 8" B&S Cherry 28 oz 08069 -- 8" B&S Harvest Berry 28 oz 08021 -- 8" B&S Mince 28 oz 08022 -- 8" B&S Peach 28 oz 08034 -- 8" B&S Strawberry Rhubarb 28 oz 10110 -- 10" B&S Apple 53 oz 10160 -- 10" B&S Apple Cranberry 53 oz 10112 -- 10" B&S Blueberry 53 oz 10113 -- 10" B&S Cherry 53 oz 10169 -- 10" B&S Harvest Berry 53 oz 10122 -- 10" B&S Peach 53 oz 10134 -- 10" B&S Strawberry Rhubarb 53 oz. RECALLING FIRM/MANUFACTURER Recalling Firm: The Run-A-Ton Group, Inc., Morristown, NJ, by press release on May 1, 2002 and letter on May 2, 2002. Manufacturer: Specialty Bakers, Oehme Bakery Division, Lititz, PA. Firm initiated recall is complete. REASON Wholly Healthy Two Crust Pies contain undeclared egg ingredient. VOLUME OF PRODUCT IN COMMERCE 6,441 cases (38,646 units) DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
______________________ PRODUCT Choconuts brand GUM-DROPS in rigid plastic containers (tubs) of varying weights. Firm on label: Choconuts, Brooklyn, NY. Recall # F-477-2. CODE All products on the market at the time of the recall, including "Packed On 8/20", "Sell By 11/17". RECALLING FIRM/MANUFACTURER Asmar Nut Roasting dba Choconuts Inc. Brooklyn, NY. New York State Department of Agriculture and Markets visited the firm on 9/26/01 and sent a letter to the firm on 10/3/01. State initiated recall is complete. REASON The product contained undeclared FD&C Yellow #5 & #6, Blue #1 and Red #3. VOLUME OF PRODUCT IN COMMERCE 63 units. DISTRIBUTION NY. _______________________ PRODUCT a) Big Bunny Bites - Peanut Butter. Recall # F-587-2. b) Big Bunny Bites - Fudge Filled. Recall # F-588-2. The products are an Easter item. The products are peanut butter filled chocolate eggs and fudge filled chocolate eggs. The products are sold in a 1 oz "count good" (individual egg), 4 oz box (4 pack) and 8 oz box (8 pack). CODE Catalog Numbers: 00005, 00006, 00100, 00200, 12112, 13526, 13527, 13891, 13892, 14169, 14514, 14515, 15434, 16548, 42002, 42003, 42006, 42019, 42020, 42022, 42023, 42025, 78100, 78160, 78170, and 79200. UPC numbers 041269420031, 041269420062, 041269420024, 041269000066, and 041269000059. RECALLING FIRM/MANUFACTURER R. M. Palmer Company, West Reading, PA, by telephone on March 5 and 6, 2002. Firm initiated recall is complete. REASON Easter candy contains plastic shavings (foreign object). VOLUME OF PRODUCT IN COMMERCE 796,218 pounds. DISTRIBUTION Nationwide. _______________________ PRODUCT Golden Key Chocolate brand Honey Cake, packed in uncoded, foil trays with clear plastic covers. Ingredients: Flour, Sugar, Honey, Oil, Vanilla, Sugar. Recall # F-589-2. CODE Uncoded. RECALLING FIRM/MANUFACTURER Recalling Firm: Sweet Delight of Brooklyn, Inc. (dba Golden Key Chocolate), Brooklyn, NY, by phone, letter and sign beginning January 15, 2002. Manufacturer: Sweet Delight of Brooklyn, Inc., Brooklyn, NY. State initiated recall is complete. REASON The product contained undeclared almonds, which were visible. VOLUME OF PRODUCT IN COMMERCE 30 units. DISTRIBUTION NY. _______________________ PRODUCT Mandel Bread packed in clear rigid plastic containers, net wt. 0.88 lb. Recall # F-590-2. CODE All "SELL BY" dates on the market at the time of the recall initiation, including "SELL BY 01/24/02". Barcode # 2 00277 50325 3. RECALLING FIRM/MANUFACTURER Appetizing Plus, Inc., Brooklyn, NY, by press release and letters on January 7, 2002. State initiated recall is complete. REASON The product contained undeclared almonds, which were visible. VOLUME OF PRODUCT IN COMMERCE 40 units (weekly). DISTRIBUTION NY. _______________________ PRODUCT Reeds brand Crystallized Ginger, 3.5 oz. Recall # F-593-3. CODE All lots. RECALLING FIRM/MANUFACTURER Reeds, Inc., Los Angeles, CA, by letter on February 13, 2002. State initiated recall is ongoing. REASON Undeclared sulfite, 64 ppm. VOLUME OF PRODUCT IN COMMERCE Undetermined. DISTRIBUTION NH, CA, OH, IA, WI, TX, UT, IL, OR, CO, NJ and FL. _______________________ PRODUCT a) El Cotorro brand Torticas Sugar Cookies, 15 oz. family pack. Recall # F-608-2; b) El Cotorro brand Pan de Maiz Sweet Corn Bread, 12 oz., family pack. Recall # F-609-2. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Anita Bakery Products, Medley, FL, by letter on January 25, 2002. State initiated recall is complete. REASON Sugar Cookies and Sweet Corn Bread contain FD&C Yellow No. 6. VOLUME OF PRODUCT IN COMMERCE 600. DISTRIBUTION FL. ______________________ PRODUCT Lemon Hamantash. Recall # F-622-2. CODE Use by dates: Nov 5, Nov 6, and Nov 7. RECALLING FIRM/MANUFACTURER Irene's Bakery & Gourmet Kitchen, Philadelphia, PA, by telephone on October 22, 2001. Firm initiated recall is complete. REASON Contained undeclared FD&C Yellow No. 5. VOLUME OF PRODUCT IN COMMERCE 120 units. DISTRIBUTION PA and NJ.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
_______________________ PRODUCT Chef-Boyardee Brand of the following: a) Cheese Pizza Kits. Recall # F-475-2; b) Pepperoni Pizza Kits. Recall # F-476-2. CODE Cheese Pizza Kits HW Code UCS Code Product description UPC code Unit Size 00059 6414404247 1/PL CB Chse Pizza 6414404271 31.85 oz 02752 6414404342 Twin cheese Pizza Kit 6414404342 31.85 oz 02754 6414404344 Single Cheese Pizza Kit 6414404343 14 7/8oz Pepperoni Pizza Kits HW Code UCS Code Product description UPC code Unit Size 02699 6414404273 2 Pepperoni Pizza Kit 6414404273 33.6 oz. 02751 6414404340 Single Pepperoni Pizza Kit 6414404340 16 5/8oz RECALLING FIRM/MANUFACTURER Recalling Firm: ConAgra Grocery Products, Irvine, CA, by letter between November 21, 2001 and November 26, 2001. Firm initiated recall is complete. REASON The product was manufactured under conditions whereby it may have been contaminated with filth. VOLUME OF PRODUCT IN COMMERCE Not supplied. DISTRIBUTION Nationwide and Barbados and the Bahamas. _______________________ PRODUCT Canada Dry Ginger Ale in 67.6 fl. oz. PET bottles, packaged 8 bottles per case. Recall # F-478-2. CODE Product Code JUN1002MDB. RECALLING FIRM/MANUFACTURER Coca-Cola Enterprises, Inc., Atlanta, GA, by letters dated March 21, 2002. Firm initiated recall is complete. REASON The product contains undeclared quinine, resulting in an off- taste. VOLUME OF PRODUCT IN COMMERCE 2532 cases. DISTRIBUTION IL. _______________________ PRODUCT a) H&G (headed and gutted) fresh whole Mahi-Mahi 10/15 (size) - NICA Brand, product of Nicaragua. 100 Lbs. Master Carton. Recall # F-591-2. b) Fresh large Mahi fillets packed in unlabeled plastic bags in variable weights. Recall # F-592-2. CODE Products were not labeled and coded. Products were distributed between 10/30/01 and 11/02/01. RECALLING FIRM/MANUFACTURER Stavis Seafoods, Inc., Boston, MA, by fax on December 17, 2001. Firm initiated recall is complete. REASON Product is decomposed. VOLUME OF PRODUCT IN COMMERCE 458 lbs. - H&G fresh mahi and 559.5 lbs. - fresh large mahi fillets. DISTRIBUTION CT, MA, ME, MN, NH, NJ, NY, PA, and VT. _______________________ PRODUCT El Cotorro brand Masareal de Guayaba Guava Sandwich, 8.5 oz and 20 oz. Recall # F-607-2. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Anita Bakery Products, Medley, FL, by letter on January 25, 2002. State initiated recall complete. REASON Undeclared FD&C Red No. 40. VOLUME OF PRODUCT IN COMMERCE 600. DISTRIBUTION FL. _______________________ PRODUCT World's Best Cheesecake, ready to eat, packaged in a corrugated box, net weight 2 lbs, and Mrs. Martin's brand, New York Style, Cream Cheese Cake, ready to eat, packaged in a corrugated box, 2 cakes per box, net wt 4 lbs. Recall # F-620-2. CODE 02121 thru 02166. RECALLING FIRM/MANUFACTURER World's Best Cheesecake, Ashland, VA, by letter dated June 17, 2002. Firm initiated recall is ongoing. REASON The product does not bear a complete ingredient statement and does not list subingredients of ingredients. VOLUME OF PRODUCT IN COMMERCE 2520 units. DISTRIBUTION VA, NC and MD. _______________________ PRODUCT Frozen 3/8" diced onions in poly lined cardboard carton, net wt. 25 lbs., carton labeled in part "***25 lbs. NET WT. ** 3/8" I.Q.F. DICE ONIONS INGREDIENTS: Sweet Spanish Onions. TO BE SOLD AS A UNIT KEEP FROZEN GREAT AMERICAN APPETIZERS/ NAMPA, IDAHO & WAHOO, NEBRASKA" Recall # F-621-2. CODE Codes are 112601, 112701, and 112801. RECALLING FIRM/MANUFACTURER Great American Appetizers, Nampa, ID, by telephone on March 18, 2002. Firm initiated recall is ongoing. REASON Frozen diced onions contained plastic pieces. VOLUME OF PRODUCT IN COMMERCE 7,425 lbs. (297 bags). DISTRIBUTION IA. _______________________ PRODUCT a) Raspberry Hamantash. Recall # F-623-2; b) Raspberry Rugallah. Recall # F-624-2. CODE Use by dates: Nov 5, Nov 6, and Nov 7. RECALLING FIRM/MANUFACTURER Irene's Bakery & Gourmet Kitchen, Philadelphia, PA, by telephone on October 22, 2001. Firm initiated recall is complete. REASON Products did not bear complete ingredient statement. VOLUME OF PRODUCT IN COMMERCE 120 units. DISTRIBUTION PA and NJ.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________________ PRODUCT Intralipid 20%, (20% I.V. Fat Emulsion), For Intravenous Use, 500 mL bottles, Rx only, NDC 0336-0491-03. Recall # D-339-2. CODE Lot numbers MSI0205, NR66055, NR66056, NR66057, NR66058, NR66059, NR66062, NR66063. RECALLING FIRM/MANUFACTURER Fresenius Kabi, Clayton, NC, by letter dated May 16, 2002. Firm initiated recall is ongoing. REASON Particulates: bottles may contain dark tan to brown particulate matter. VOLUME OF PRODUCT IN COMMERCE 25,200 units. DISTRIBUTION NationwideRECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________ PRODUCT Premarin (conjugated estrogens tablets USP) 1.25 mg tablets, 100, 1000 and 5,000-tablet bottles. Recall # D-058-2. CODE NDC #: 0046-0866-91 (bottles of 1000) Lot #s: 9000353, exp. 11/04 and 9000681, exp. 11/04 RECALL EXTENDED ON 6/18/02 to the following 3 lots NDC #: 0046-0866-81 (bottles of 100) Lot #: 9000477, Exp. 1/05 Distribution dates: 6/12/00-8/17/01 Quantity distributed: 31,310 bottles NDC #: 0046-0866-91 (bottles of 1000) Lot #: 9000682, Exp. 1/05 Distribution dates: 7/10/00 - 5/2/01 Quantity distributed: 2,132 bottles NDC #: 0046-0866-95 (bottles of 5000) Lot #: 9000481, Exp. 1/05 Distribution dates: 7/6/00 - 3/13/01 Quantity distributed: 1,308 bottles. RECALLING FIRM/MANUFACTURER Recalling Firm: Wyeth-Ayerst Laboratories, Richmond, VA, by letters dated November 21, 2001. Manufacturer: Ayerst Laboratories, Inc., Rouses Point, NY. Firm initiated recall is ongoing. REASON Failure to meet dissolution specifications. VOLUME OF PRODUCT IN COMMERCE 34,750 bottles. DISTRIBUTION Nationwide. _______________________ PRODUCT Levoxyl Tablets (Levothyroxine Sodium Tablets, USP) 50 mcg (0.05 mg), Rx only, 100 and 1,000 tablet bottles, Daniels Pharmaceuticals, St. Petersburg, FL. Recall # D-345-2. Levoxyl Tablets (Levothyroxine Sodium Tablets, USP) 75 mcg (0.075 mg), Rx only, 100 and 1,000 tablet bottles, Daniels Pharmaceuticals, St. Petersburg, FL.Recall # D-346-2; Levoxyl Tablets (Levothyroxine Sodium Tablets, USP) 88 mcg (0.088 mg), Rx only, 100 and 1,000 tablet bottles, Daniels Pharmaceuticals, St. Petersburg, FL.Recall # D-347-2; Levoxyl Tablets (Levothyroxine Sodium Tablets, USP) 100 mcg (0.1 mg), Rx only, 100 and 1,000 tablet bottles, Daniels Pharmaceuticals, St. Petersburg, FL.Recall # D-348-2. CODE 50 mcg, 100 tablet bottle: Lot Nos. 6533, 6534, 6567, 6568, 6569, 6570 (exp 05/02); 6571 (Exp 06/02); 6623, 6624, 6626, 6627, 6628 (Exp 07/02); 6648, 6649, 6651, 6652, 6658, 6660 (Exp 08/02); 6732, 6736, 6737, 6738, 6740 (Exp. 10/02); 6771, 6772, 6795, 6796, 6797 (Exp 11/02); 50 mcg, 1000 tablet bottle: Lot Nos. 6572, 6573 (Exp 06/02); 6650, 6659, 6661, 6662 (Exp 08/02); 6733, 6735, (Exp 10/02); 6773 (Exp 11/02); 75 mcg, 100 tablet bottle: Lot Nos. 6542, 6543, 6574, 6576 (Exp 06/02); 6633 (Exp 07/02); 6634, 6635, 6636, 6637 (Exp 08/02); 6694, 6695, 6696, 6698, 6699, 6701, 6702, 6703, (Exp 09/02); 6753, 6754, 6755, 6756 (Exp 10/02); 75 mcg, 1000 tablet bottle: Lot Nos. 6578 (Exp 07/02); 6638 (Exp 08/02); 6697, 6700 (Exp 09/02); 6807 (Exp 11/02); 88 mcg, 100 tablet bottle: Lot Nos. 6538, 6539, (Exp 05/02); 6593 (Exp 06/02); 6646 (Exp 07/02); 6668, 6669, 6670 (Exp 08/02); 6769, 6770, 6802, 6803 (Exp 11/02); 88 mcg, 1000 tablet bottle: Lot Nos. 6538 (Exp 05/02); 6668 (Exp 08/02); 6802 (Exp 11/02) 100 mcg, 100 tablet bottle: Lot Nos. 6555, 6556, 6557, 6562, 6563, 6564 (Exp 05/02); 6603, 6604, 6605, 6606 (Exp 06/02); 6645, 6716, 6718, 6722 (Exp 09/02); 6726, 6727, 6728, 6729 (Exp 10/02); 6764 (Exp 11/02); 100 mcg, 1000 tablet bottle: Lot Nos. 6613, 6614, 6615, 6616, 6617, 6618, 6631, 6632 (Exp 07/02); 6642, 6643, 6644, 6717, 6719, 6723 (Exp 09/02); 6724, 6725, 6761, 6762 (Exp 10/02); 6763 (Exp 11/02). RECALLING FIRM/MANUFACTURER Recalling Firm: King Pharmaceuticals, Inc., Bristol, TN, by letter on May 10, 2002. Manufacturer: King Pharmaceuticals, Inc., St. Petersburg, FL. Firm initiated recall is ongoing. REASON Lack of assurance product will maintain potency throughout its labeled expiration date. VOLUME OF PRODUCT IN COMMERCE 2,885,015 units. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Pulmicort Turbuhaler (budesonide inhalation powder) 200 mcg 60 Metered Doses For Oral Inhalation, Rx Only, Professional Sample. Recall # D-349-2. CODE Lot Numbers: CK1524, CK1527, CK1539, CK1547- Exp. Date Apr-03 CL1555, CL1560, CL1562, CL1564, CL1566-Exp. Date May-03 CM1589- Exp. Date Jun-03. RECALLING FIRM/MANUFACTURER Recalling Firm: Astrazeneca, Wilmington, DE, by letter on June 10, 2002. Manufacturer: Astrazeneca Liquid Production, Sodertalje, Sweden Firm initiated recall is ongoing. REASON The turbuhaler may deliver a super-potent dose. VOLUME OF PRODUCT IN COMMERCE 200,000. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT Platelets, Pheresis, Leukoreduced, Recall # B-1517-2. CODE Units FJ68112-1, FR32706-1, FR32715-1, FR32715-2, FR32769-2, FW11391-1, FW11653-1, FW11653-2, KM30022-1, KM30022-2, KZ56547-1, KZ56547-2, KZ56547-3, KZ56611-1, KZ56611-2, KZ56621-1, LH56337-1, LH56337-2, LH56337-3, LH56347-1, LH56351-1, LH56354-1, LH56358-1, LH56390-1, LX99610-2, LX99617-1, LX99617-2 RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone on December 11, 13 and 14. 2000 or August 23, 2001 and by letter dated December 13 or 14, 2000. Firm initiated recall is complete. REASON Blood products, which had a low platelet count, were distributed. VOLUME OF PRODUCT IN COMMERCE 27 units. DISTRIBUTION WI. _______________________ PRODUCT Red Blood Cells Leukocytes Removed, Recall # B-1545-2. CODE Units 40GV24714 and 40GT35540. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Peoria, IL, by letters dated March 28, 2002. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who had lived in a malarial endemic area, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION- IL and VA. _______________________ PRODUCT Red Blood Cells Leukocytes Removed, Recall # B-1546-2. CODE Unit 40GV32117 and 40GL86809. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Peoria, IL, by letters dated April 8, 2002. Firm initiated recall is complete. REASON Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION IL and MO. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1555-2. CODE Unit number LP01938. RECALLING FIRM/MANUFACTURER San Diego Blood Bank, San Diego, CA, by telephone on February 19, 2002. Firm initiated recall is complete. REASON Blood product, collected from a donor that did not have a hemoglobin determination performed, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Red Blood Cells, Recall # B-1557-2. CODE Unit number 6799821. RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Monroe, LA, by telephone on May 16, 2001. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION LA. _______________________ PRODUCT Red Blood Cells, Recall # B-1558-2. CODE Unit numbers 1918812 and 1914241. RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport, LA, by letter on April 18, 2000. 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 LA.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Red Blood Cells, Leukoreduced, Recall # B-1521-2. CODE Units 32KN00524, 32KJ88267, 32KJ88269, 32KJ88270, 32KJ88271, 32KJ88272, 32KJ88273, 32KJ88274, 32KJ88275, 32KJ88276, 32KJ88278, 32KJ88280, 32KJ88281, 32KJ88282, 32KJ88283, 32KJ88286, 32KJ88288, 32KJ88291, 32KJ88293, 32KJ88294. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Badger-Hawkeye Region, Madison, WI, by telephone on October 16 or 18, 2001 and by letter dated October 25, 2001. Firm initiated recall is complete. REASON Blood products, which were not refrigerated within 8 hours of Whole Blood collection, were distributed. VOLUME OF PRODUCT IN COMMERCE 20 units. DISTRIBUTION CA, IL, MI, PA and WI. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1550-2; b) Platelets Pooled, Recall # B-1551-2; c) Recovered Plasma, Recall # B-1552-2. CODE a) Unit numbers FW23786 and LP37858; b) Pool numbers P13855 and P26369; c) Unit number LP37858. RECALLING FIRM/MANUFACTURER The Blood Center of Southeast Wisconsin, Inc., Milwaukee, WI, by telephone on December 6 and 13, 2001 and by letters dated November 14, 2001 and December 7, 2001. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor due to medication with antibiotics, were distributed. VOLUME OF PRODUCT IN COMMERCE 5 units. DISTRIBUTION WI and Switzerland. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1553-2. CODE Unit number LP41937. RECALLING FIRM/MANUFACTURER The Blood Center of Southeast Wisconsin, Inc., Milwaukee, WI, by telephone on January 5, 2002 and by letter dated January 7, 2002. Firm initiated recall is complete. REASON Blood product, collected from an ineligible donor due to a history of ulcerative colitis, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WI. _______________________ PRODUCT Source Plasma, Recall # B-1554-2. CODE Unit numbers 00MMNB9347, 00MMNB9348, 00MMNB9356, 00MMNB9386, 00MMNB9602, 00MMNB9862, 00MMNB9995, 00MMNC0675, 00MMNC0832, 00MMNC0899, 00MMNC1119, 00MMNC1153, 00MMNC1621, 00MMNC2183, 00MMNC3459, 00MMNC5207, 00MMNC6337, 00MMNC7267, 00MMNC7623, 00MMNC8122, 00MMNC8172, 00MMNC8262, 00MMNC8438, 00MMNC8447, 00MMNC8454, 00MMNC8469, 00MMNC8797, 00MMNC8975, 00MMNC9086, 00MMNC9130, 00MMNC9248, 00MMNC9253, 00MMNC9258, 00MMNC9279, 00MMNC9568, 00MMNC9992, 00MMND0075, 00MMND0414, 00MMND0982, 00MMND2390, 00MMND3453, and 00MMND4737. RECALLING FIRM/MANUFACTURER Recalling Firm: Community Bio-Resources, Inc., Hoover, AL, by fax on November 27, 2000. Manufacturer: Community Bio-Resources, Inc., Mankato, MN. Firm initiated recall is complete. REASON Blood products, collected from donors whose health history screening was inadequately performed for medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed. VOLUME OF PRODUCT IN COMMERCE 42 units. DISTRIBUTION MI and Austria. _______________________ PRODUCT Red Blood Cells, Recall # B-1556-2. CODE Unit number 6894702. RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport, LA, by telephone on December 4, 1999. Firm initiated recall is complete. REASON Blood product, labeled with an extended expiration date, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION LA. _______________________ PRODUCT Collagenase, Santyl Ointment, Recall # B-1564-2. CODE Lot 34901047. RECALLING FIRM/MANUFACTURER Advance Biofactures Corporation, a subsidiary of Biospecifics Technologies Corp., Lynbrook, NY, by letter dated August 11, 2001. Firm initiated recall is complete. REASON Drug product, which did not meet potency specifications (sub-potent), was distributed. VOLUME OF PRODUCT IN COMMERCE 26,314 units. DISTRIBUTION FL. _______________________ PRODUCT Collagenase, Santyl Ointment, Recall # B-1565-2. CODE Lot 00S030K010. RECALLING FIRM/MANUFACTURER Advance Biofactures Corporation, a subsidiary of Biospecifics Technologies Corp., Lynbrook, NY, by letter dated September 5, 2001. Firm initiated recall is complete. REASON Drug product, which did not meet potency specifications (sub-potent), was distributed. VOLUME OF PRODUCT IN COMMERCE 13,428. DISTRIBUTION FL.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________ PRODUCT Breathing bag and the bleed valve assemblies, as follows: a) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees, 2L. Part no. 4312 b) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees, latex-free, 2L [with Norman mask elbow and Washington tee]. Part no. 15609. c) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees, latex-free, 2L. [with Norman mask elbow, Washington tee and an extra gas sampling line]. Part no. 15609A. d) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees, latex-free, 2L, [with Norman mask elbow]. Part no. 4322-30. e) MMS (Meridian Medical Systems) brand Modified Jackson Rees, latex-free, 2L. Part no. 4222-30. f) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees, 1L. Part nos. 4311 and 4321 g) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees, latex-free, 1L. Part no. 4321-30 h) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees, latex-free, 1/2L. Part No. 4325-30-50. i) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees. Part no. 4211 j) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees., 1L bag [with fresh gas elbow]. Part no. KS4160 k) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees, 3L bag [with fresh gas elbow]. Part no. KS4180 l) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees, 1/2L bag. Part no. KS4230 m) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees, 1L bag. Part no. KS4610 n) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees, 3L bag. Part no. KS4630 o) MMS (Meridian Medical Systems) brand Circuit-Modified Jackson Rees, 3L bag and an extra 72 inch hose. Part no. KS4830 p) Meridian Medical Systems brand Circuit-Modified Jackson Rees. latex-free, 1L bag. Part no. 4221-30 q) Hudson Respiratory Care brand anesthesia breathing circuit, modified Jackson-Rees Circuit, .5 liter bag w/valve. Cat. No. 354006 r) Hudson Respiratory Care brand anesthesia breathing circuit, modified Jackson-Rees Circuit, 1 liter bag w/valve. Cat. No 354007 s) Hudson Respiratory Care brand breathing circuit, nonconductive modified Jackson-Rees (with Norman fresh gas elbow and gas scavenging valve), 3L. Cat. no. 7145 t) MMS (Meridian Medical Systems) brand breathing bag- 1L latex w/bleed valve. Part no. 3501-36B u) MMS (Meridian Medical Systems) brand breathing bag w/bleed valve, latex-free, 1/2L bag. Part No. 3525-36B30 v) Trident Medical International brand breathing bag with bleed valve-2L, latex-free. Ref. no. T3522-36B30. w) Trident Medical International brand circuit-MJR, 1L bag. Ref. no. T4211. x) Trident Medical International brand circuit-MJR, latex-free, .5L bag. Ref. no. T4315-30. y) Trident Medical International brand circuit-MJR, latex-free, 1L bag. Ref. no. T4311-30. z) A+CC (Anesthesia & Critical Care Products) brand circuit- modified Jackson Rees, 3L bag. Part no. AC15479. aa) A+CC (Anesthesia & Critical Care Products) brand circuit- modified Jackson Rees, 2L bags. Part nos. AC16112 bb) A+CC (Anesthesia & Critical Care Products) brand circuit- modified Jackson Rees, 2L bags [with Washington T and 72 inch fresh gas line]. Part no. AC4222. cc) A+CC (Anesthesia & Critical Care Products) brand circuit- modified Jackson Rees, 1L bag [and an extra 100 inch hose]. Part no. AC4312. dd) A+CC (Anesthesia & Critical Care Products) brand circuit- modified Jackson Rees, 3L. Part no. AC15479. ee) A+CC (Anesthesia & Critical Care Products) brand circuit- modified Jackson Rees. Part no. AC16112 and AC4222. ff) A+CC (Anesthesia & Critical Care Products) brand circuit- modified Jackson Rees, 2L bag [with extra 100 inch hose]. Part no. AC4312. gg) Anesthesia Service Inc. brand circuit-modified Jackson Rees, 3L bag. Part no. ASI4213. hh) DRE (DRE Medical) brand circuit- modified Jackson Ree, 1L bag. Part No. DRE4321. ii) DRE (DRE Medical) brand circuit- modified Jackson Rees, .5L bag. Part No. DRE4325. jj) Metro (Metropolitan Medical Inc.) brand circuit- modified Jackson Rees, 3L bag. Part No. MMI4323. Recall # Z-1137-2. CODE all lots manufactured between 9/1/00 thru 10/30/01. Part 15609; lots 193830900, 196110900, 199631000 and 208261000 Part 15609A; lots 190180800, 190540800 and 204391000 Part 4222-30; lot 209031000 Part 4311; lot 277640601 Part 4321; lots 224661200, 255090301 and 298640801 Part KS4160; lot 298240801 Part KS4180; lot 309301001 Part KS4230; lot 296270801 Part KS4610; lots 302110901 and 298960801 Part KS4630; lot 313441001 Part KS4830; lot 223551200 Part 4312; lot 199761000 Part 4211; lot 233270101 Part 4221-30; lot 221101200 Part 4322-30; lots 191510801, 193580800, 197500900, 203491000, 212131100, 209661100, 211841100, 215021100, 219691200, 221831200, 236210101, 224680101, 253190301, 257750401, 242950201, 267520501, 267810501, 282990601, 286070701, 292150701, 295180801, 295950801, 299790801, 301810901, 305680901, 308440901, 313541001, 311781001 and 315831001 Part 4325-30-50; lots 191520800, 194150900, 197510900, 202751000, 203501000, 212141100, 215031100, 222391200, 224691200, 224701200, 226800101, 233470101, 254130301, 269070501, 264460404, 261040401, 274120501, 283000601, 290050701, 301820901, 309461001 and 314371001 Part 4321-30; lots 191950800, 194140900, 195810900, 197490900, 199771000, 203481000, 209651100, 211831100, 212121100, 215011100, 219681200, 218211100, 224671200, 226780101, 233460101, 236200101, 241250201, 242940201, 248050301, 254120301, 263010401, 267800601, 269060501, 258980401, 264450401, 274110501, 282980601, 285570701, 287440701, 287420701, 288760701, 292140701, 295170801, 297040801, 299780801, 301800901, 305220901, 310461001, 307380901, 311771001 and 313531001 Part 354006; lots 196580900, 201441000, 228720101, 258210401, 306510901, 307180901 and 309051001 Part 354007; lots 185590700, 183780700, 190300800, 201451000, 225641200, 229740101, 278130601, 297750801, 297790801 and 306520901 Part 7145; lots 185170700, 185560700, 191300800, 201941000, 306590901 and 308500901 Part 3501-36B; lot 294750801 Part 3525-36B30; lots 259800401, 266030501, 262210401, 268990501, 282810601, 297270801, 303290901 and 308410901 Part T3522-36B30; lot 301360900 Part T4211; lots 285890701 and 312130700 Part T4311-30; lots 193490800 and 196060900 Part T4315-30; lot 50390301 Part AC15479; lots 221371200, 221381200, 212761100, 208771000, 220041200 and 267720501 Part AC16112; lots 306190901 and 192870800 Part AC4222; lot 192830800, 197580900, 197760900, 211711100 and 310251001 Part AC4312; lot 302060901 Part ASI4213; lots 201991000, 206601000, 210941100, 234730101 and 244570201 Part DRE4321; lot 231020101 Part DRE4325; lot 228500101 and 2310301010 Part MMI4323; lot 310641001. RECALLING FIRM/MANUFACTURER Meridian Medical Systems, Inc., Indianapolis, IN, by letter dated May 1, 2002. Firm initiated recall is ongoing. REASON A rubber breathing bag tip may be inside of the breathing bag. VOLUME OF PRODUCT IN COMMERCE 734 cases (20 bags per case). DISTRIBUTION CA, CO, FL, IN, KS, KY, MO, OK, OR, PA and VA.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________ PRODUCT CryoValve Allograft - Heart valve. Recall # Z-1123-2. CODE Serial No. 6773739, Model No. PV00. RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA, by visit on April 5, 2002. Firm initiated recall is complete. REASON Aortic valve donor was associated with alleged case of Endocarditis. VOLUME OF PRODUCT IN COMMERCE One valve. DISTRIBUTION CA. _______________________ PRODUCT Depuy brand self-centering bi-polar head, 28MM ID, 45 MM OD. Recall # Z- 1138-2. CODE Part 1035-45-000, lot WB1DR1. RECALLING FIRM/MANUFACTURER DePuy Orthopaedics, Inc., Warsaw, IN, by telephone on April 16, 2002. Firm initiated recall is complete. REASON Incorrect components included in two packages from this lot. VOLUME OF PRODUCT IN COMMERCE 2. DISTRIBUTION NJ and PA.END OF ENFORCEMENT REPORT FOR JULY 10, 2002
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