September 25, 2002 02-38
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________ PRODUCT Zhongqiao Brand Conjac Coconut Jelly candy - Made in China. There is no firm name or address in English on the jar label or individual cups. a) Candies sold as jars of assorted flavors - grape, lychee, mango, orange, peach, and pineapple. Recall # F-762-2; b) Candies sold as jars of lychee flavor. Recall # F-763-2. The product is packaged in individual serving sized plastic cups with foil lids, with the product meant to be squeezed out of the cup directly into the mouth. The 16.7 gram individual serving cups are packaged in 1000 gram round plastic jars/6 jars per box, sold two boxes per case. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Recalling Firm: Hanmi, Inc., Chicago, IL, by letter dated July 12, 2002. Manufacturer: Zhongshan Foodstuffs Imp. & Exp. Co., Ltd. of Guangdong, China Zhongshan City, Guangdong, CN. Firm initiated recall is ongoing. REASON This candy is in violation of section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it is unfit for food due to the characteristics that result in a serious choking hazard. VOLUME OF PRODUCT IN COMMERCE 1,867 cases. DISTRIBUTION IL, IN, MO, IA, NE, MI, MN and KY. _______________________ PRODUCT Mozzarella Cheese, 20 lb. blocks. Recall # F-764-2. CODE Vats 7 and 8, 7/26/02 production. RECALLING FIRM/MANUFACTURER Cedar Valley Cheese, Belgium, WI, by telephone on August 5, 2002. Firm initiated recall is ongoing. REASON The cheese was contaminated with Listeria monocytogenes. VOLUME OF PRODUCT IN COMMERCE Cheese was shipped from vats 7, 8 and 9 and totaled 18,000 to 19,000 pounds with 10,729 pounds from vats 7 & 8. DISTRIBUTION IL. _______________________ PRODUCT Dried basil leaves sold under either Spice World brand or Roma brand. Recall # F-765-2. CODE The Spice World brand was coded with "0912" on the label. The Roma brand was not coded. The firm recalled product distributed between January 4, 2002, and May 23, 2002. RECALLING FIRM/MANUFACTURER Spice World Inc., Orlando, FL, by telephone on July 16, 2002 followed by letter and press release on July 17, 2002. Firm initiated recall is complete. REASON The product was contaminated with Salmonella. VOLUME OF PRODUCT IN COMMERCE 76 cases of 24/1 oz and 220/5 lb. and 310 1.5 lb. DISTRIBUTION FL. _______________________ PRODUCT a) Astor brand Sesame Seeds in 1 oz. plastic (poly) bottles and 2 oz. glass bottles. Recall # F-766-2; b) "Fischer's Greens Seasoning" in 29 oz. plastic bottles, which contain sesame seeds, minced onions, salt, dehydrated onions, sugar, paprika, turmeric, dextrose, red pepper, mustard, artificial flavor, yeast extracts, dehydrated garlic, and extract of paprika. Recall # F-767-2. CODE a) Astor brand Sesame Seeds in 1 oz. bottles - product number 1218; lot # 02-099, Sell by date of 5/15/04. Astor brand Sesame Seeds in 2 oz. bottles - product number 1784; lot # 02-099, Sell by dates of 2/27/04 to 5/15/04. b) "Fischer's Greens Seasoning" - product number 19108; lot # 02-099, Sell by dates of 3/20/04 to 05/08/04. RECALLING FIRM/MANUFACTURER Astor Products, Inc. (A Division of Winn Dixie Stores, Inc.), Jacksonville, FL, by e-mail on June 7, 2002. FDA initiated recall is ongoing. REASON The products were contaminated with Salmonella. VOLUME OF PRODUCT IN COMMERCE Total 2759 lbs. (73 cases of Sesame seeds in 1 oz. bottles, 108 cases of Sesame seeds in 2 oz. bottles, and 1435 cases of Greens Seasoning). DISTRIBUTION Nationwide. _______________________ PRODUCT Dried Oregano sold under either Spice Eagle brand or Roma brand. Recall # F-768-2. CODE The firm recalled all products shipped between Feb. 18, 2002 and May 9, 2002. RECALLING FIRM/MANUFACTURER Spice World Inc., Orlando, FL, by telephone and letter on June 12, 2002. Firm initiated recall is complete. REASON FDA's analysis revealed the presence of salmonella in a sample of dried oregano. VOLUME OF PRODUCT IN COMMERCE 1490 pounds. DISTRIBUTION FL. _______________________ PRODUCT Salted butter packaged in 25 kg.(55.115 lb.) cardboard boxes. Recall # F-769-2. CODE 316-8. RECALLING FIRM/MANUFACTURER Graf Creamery Inc., Zachow, WI, by telephone on November 19, 2001. Firm initiated recall is complete. REASON Butter was contaminated with Salmonella. VOLUME OF PRODUCT IN COMMERCE 88-25kg (55.115 lb.) bulk butter in cardboard boxes. DISTRIBUTION IL. _______________________ PRODUCT Raw Mung Bean Sprouts packaged in 5, 10, and 15 lb. plastic bags. Recall # F-770-2. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Hien Van Tran So. Portland, ME, by telephone on February 21, 2002 and letter dated February 22, 2002. Firm initiated recall is complete. REASON Mung Bean Sprouts were associated with an outbreak of Salmonella enteritidis. VOLUME OF PRODUCT IN COMMERCE Approximately 1,000 lbs. DISTRIBUTION MN. _______________________ PRODUCT Whole, halved, and cubed cantaloupes.Recall # F-771-2. CODE Redi-Cut Item Description Case Code Tray Code Use Thru Date 3 Count PH whole DOM 5/7-5/11 No tray code Cantaloupe halved 1 x 15# 5/19-5/23 Use thru 5/19-5/23 Cantaloupe 8x1# 5/12-5/17 Julian 9127-9131 Cantaloupe Chunks 2 x 2.5# 5/16-5/23 Use thru 5/16-5/23 Cant/H-dew 2 x 5# 5/11-5/18 Julian 9126-9131 Cantaloupe/honeydew combo 2 x 5# 5/12-5/19 No tray code Cantaloupe/honeydew combo 2x2.5# 5/17-5/22 Use thru 5/17-5/22 Fruit trio 3 x 2.5# 5/12-5/16 Julian 9127-9131 Retail 4 x 2# mix 5/12-5/17 Julian 9127-9131 Retail Fruit mix 8 x 1 # 5/12-5/17 Julian 9127-9131 PW Retail Combo 8 x 1# 5/12-5/17 Sell by 5/12-5/17 Retail Fruit Combo 8 x 1# 5/12-5/17 Julian 9127-9131 PW Cant/H-dew/W-melon 4x2.5# 5/12-5/17 Sell by 5/12-5/17 3 Melon medley 4x1.32# 5/12-5/17 Julian 9127-9131. RECALLING FIRM/MANUFACTURER Redi-Cut Foods, Inc., Franklin Park, IL, by letter dated May 14, 2002. Firm initiated recall is complete. REASON Cantaloupes were contaminated with Salmonella poona. VOLUME OF PRODUCT IN COMMERCE 5,979 cases. DISTRIBUTION IL, WI, IN, MI, KS, NE, MO, OH and MN. _______________________ PRODUCT Aristoff American Paddlefish Caviar Malossol, refrigerated. Product sold in 1, 4, 7, 8, or 16 ounce glass containers. Recall # F-772-2. CODE 20 pounds. RECALLING FIRM/MANUFACTURER Recalling Firm: Petrossian Distribution, Inc., Dallas, TX, by fax and hand-delivery on 5/17/02. Firm initiated recall is complete. REASON FDA sampling of caviar tested positive for L. monocytogenes. VOLUME OF PRODUCT IN COMMERCE 20 pounds. DISTRIBUTION TX and LA. _______________________ PRODUCT Gustafson brand Chocolate Break Chocolate Flavored Imitation Lowfat Drink packaged in one gallon HDPE plastic containers. Recall # F-774-2. CODE All products with a “sell by” date up to Aug 26 02D. RECALLING FIRM/MANUFACTURER Gustafson's Dairy Green Cove Springs, FL, by fax and telephone on August 5, 2002. FDA initiated recall is ongoing. REASON The product contained undeclared whey powder. VOLUME OF PRODUCT IN COMMERCE 700 gallons, 4 gallons per case. DISTRIBUTION FL. _______________________ PRODUCT The following products sold under the "Vogels Bakery" label: a) Cheese Babka, 16 oz. Recall # F-775-2; b) Crumb Topping Babka, 16 oz. Recall # F-776-2; c) Heavy Italian Bread, 24 oz. Recall # F-777-2; d) Hard Rolls, 8 oz. Recall # F-778-2; e) Rye Bread, 16 oz. and Rye Bread, 24 oz. Recall # F-779-2. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Vogels International Bakery, Utica, NY, by visits on August 13, 2002. FDA initiated recall is complete. REASON The babkas, rolls, and rye bread contained undeclared egg ingredients. The Heavy Italian Bread contained undeclared soybean flour. VOLUME OF PRODUCT IN COMMERCE a) and b) Babkas-48 loaves; c) Heavy Italian Bread-45 loaves; d) hard rolls-360 ea.; e) Rye bread-135 loaves. DISTRIBUTION NY. _______________________ PRODUCT Niki's brand dressings, as follows: a) Greek salad dressing in 16 fl. oz. and 1 gallon containers. Recall # F-780-2; b) Feta Cheese Dressing in 16 fl. oz. containers. Recall # F-781-2; c) Garlic Ranch Dressing in 16 fl. oz. containers. Recall # F-782-2; d) Submarine Dressing in 22 fl. oz. plastic bottles. Recall # F-783-2. CODE All lots not labeled as containing egg. RECALLING FIRM/MANUFACTURER Niki's Food Co., Inc., Detroit, MI, by press release on July 26, 2002. State initiated recall is ongoing. REASON The products contained undeclared egg yolks. VOLUME OF PRODUCT IN COMMERCE 500 cases. DISTRIBUTION Nationwide. _______________________ PRODUCT a) PECAN cookies in 6 oz. plastic containers (8 cookies/container). Recall # F-784-2; b) ALMOND cookies in 6 oz. plastic containers (7 cookies/container). Recall # F-785-2. CODE Best by 9/4. RECALLING FIRM/MANUFACTURER An Xuyen Bakery, Inc., Portland, OR, by visit on August 15, 2002. FDA initiated recall is complete. REASON The products contained undeclared whey solids. VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION OR. _______________________ PRODUCT Mr. C's Deli brand rolls/buns/breads sold in multiple packages: Undeclared whey and FD&C colors No. 5 and No. 6 a) Onion Rolls. Recall # F-786-2; Undeclared whey. b) Dinner Rolls. Recall # F-787-2; c) Sausage Buns. Recall # F-788-2; d) Super Sub Buns. Recall # F-789-2; d) Italian Buns. Recall # F-790-2; f) Hard Crust Italian. Recall # F-791-2; g) Raw Dinner Rolls. Recall # F-792-2; h) Raw Italian Bread. Recall # F-793-2; i) Unsliced Italian Bread. Recall # F-794-2; j) Sub Buns. Recall # F-795-2. k) 12 inch Sub Buns. Recall # F-796-2; l) Jumbo Buns. Recall # F-797-2; m) Italian Bread. Recall # F-798-2; n) American Bread. Recall # F-799-2. CODE Exp. 6/24, 6/25 and 6/26 (Products are coded with expiration date of two days from the date of manufacture). RECALLING FIRM/MANUFACTURER Mr. C's Pizza & Deli, Inc., Roseville, MI, by telephone on June 24, 2002. FDA initiated recall is complete. REASON The products contained undeclared whey. Product a) also contained undeclared FD&C colors No. 5 and No. 6. VOLUME OF PRODUCT IN COMMERCE Approx. 1000 packages. DISTRIBUTION MI. _______________________ PRODUCT a) Smart & Final Brand 3 inch Buttermilk Biscuits, 2 oz., 10 Dozen, Net 15 LB.; frozen, fully baked. Product number 1019. Recall # F-800-2; b) Frosty Acres Brand 3 inch Buttermilk Biscuits, 2 oz., 10 Doz.; frozen, fully baked. Product Number 1019 and Frosty Acres Brand 3 inch Sliced Buttermilk Biscuits, 2 oz., 10 Doz.; frozen, fully baked. Product Number 1024. Recall # F-801-2; c) Frosty Acres Brand 3 inch Country Hy Homestyle Biscuits, 2 oz., 8 Doz.; frozen, fully baked. Product Number 1039. Recall # F-802-2. CODE All lots. RECALLING FIRM/MANUFACTURER Awrey Bakeries Inc., Livonia, MI, by telephone on January 8, 2002. Firm initiated recall is complete. REASON The products contained undeclared eggs. VOLUME OF PRODUCT IN COMMERCE Approx. 9,000 dozen. DISTRIBUTION FL, IL and TX.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________ PRODUCT Fresh Whole Barracuda. Recall # F-773-2. CODE The firm recalled uncoded products that were shipped on July 01, 08, and 11, 2002. RECALLING FIRM/MANUFACTURER Recalling Firm: Stavis Seafood Inc., Boston, MA, by letter on July 24, 2002. State initiated recall is complete. REASON Barracuda may contain ciguatera toxin. VOLUME OF PRODUCT IN COMMERCE 584 pounds. DISTRIBUTION MA, MN and NY. _______________________ PRODUCT Apple Strudel, 24 pcs count, Net Wt. 10 oz., Case Wt 15 lbs. Recall # F-803-2. CODE All Codes. RECALLING FIRM/MANUFACTURER Orange Bakery, Inc., Irvine, CA, by letter on July 12, 2002. Firm initiated recall is complete. REASON The product contained undeclared FD&C Yellow No. 5 and FD&C Yellow No. 6. VOLUME OF PRODUCT IN COMMERCE 660 cases. DISTRIBUTION IL.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________ PRODUCT a) Tend Skin Lotion (acetylsalicylic acid) 9.7%, 4 oz. (118 mL), 8 oz. (236 mL) and 16 oz. (472 mL) bottles. Recall # D-403-2; b) Soft Cell Topical Solution (acetylsalicylic acid) 4 oz bottles. Recall # D-404-2; c) Bump No More Topical Solution (acetylsalicylic acid) 9.7%, 4 oz. (118 mL) and 16 oz. (472 mL) bottles. Recall # D-405-2; d) Hard Top Intrinsic Nail Hardener Liquid (acetylsalicylic acid) 1/2 ounce. Recall # D-406-2; e) PUREFECTION Topical Solid (acetylsalicylic acid) Net Wt 2.1 oz. bottle. Recall # D-407-2. CODE All lot numbers are included in the recall. RECALLING FIRM/MANUFACTURER Recalling Firm: Tend Skin International, Inc., dba The Tend Skin Company, Davie, FL, by telephone January 8, 2002. Firm initiated recall is complete. REASON Failure to comply with Over The Counter monographs (unapproved drug claims). VOLUME OF PRODUCT IN COMMERCE 478,873. DISTRIBUTION Nationwide. _______________________ PRODUCT a) Correctol Stimulant Laxative Tablet (Bisacodyl) Comfort- Coated, 5 mg, box of 10, 30, 60, 75 and 90. Recall # D-409-2; b) Correctol Stimulant Laxative Caplet (Bisacodyl) Comfort- Coated, 5 mg, box of 30. Recall # D-410-2. CODE Description Lot Number Expiration date Correctol Tablets 5 mg (10 count) 0-LFK-81 07/31/02 Correctol Tablets 5 mg (10 count) 0-LFK-100 10/31/02 Correctol Tablets 5 mg (10 count) 0-LFK-103 10/31/02 Correctol Tablets 5 mg (10 count) 0-LFK-202 11/30/02 Correctol Tablets 5 mg (10 count) 0-LFK-204 11/30/02 Correctol Tablets 5 mg (10 count) 1-LFK-3 12/31/02 Correctol Tablets 5 mg (10 count) 1-LFK-33 05/31/03 Correctol Tablets 5 mg (30 count) 0-LFK-104 10/31/02 Correctol Tablets 5 mg (30 count) 1-LFK-9001 07/31/02 Correctol Tablets 5 mg (30 count) 1-LFK-9003 10/31/02 Correctol Tablets 5 mg (30 count) 1-LFK-9004 07/31/02 Correctol Tablets 5 mg (30 count) 1-LFK-9007 11/30/02 Correctol Tablets 5 mg (30 count) 1-LFK-9009 01/31/03 Correctol Tablets 5 mg (30 count) 1-LFK-9010 01/31/03 Correctol Tablets 5 mg (30 count) 1-LFK-9011 05/31/03 Correctol Tablets 5 mg (30 count) 1-LFK-9906 12/31/02 Correctol Tablets 5 mg (60 count) 0-LFK-96 10/31/02 Correctol Tablets 5 mg (60 count) 0-LFK-203 11/30/02 Correctol Tablets 5 mg (60 count) 1-LFK-9602 10/31/02 Correctol Tablets 5 mg (60 count + 15 bonus) 1-LFK-9601 10/31/02 Correctol Tablets 5 mg (60 count + 15 bonus) 1-LFK-9604 01/31/03 Correctol Tablets 5 mg (60 count) 1-LFK-12 12/31/02 Correctol Tablets 5 mg (60 count) 1-LFK-25 05/31/03 Correctol Tablets 5 mg (60 count) 1-LFK-28 05/31/03 Correctol Tablets 5 mg (60 count) 1-LFK-39 06/30/03 Correctol Tablets 5 mg (90 count) 1-LFK-9901 07/31/02 Correctol Tablets 5 mg (90 count) 1-LFK-9903 07/31/02 Correctol Tablets 5 mg (90 count) 1-LFK-9904 12/31/02 Correctol Tablets 5 mg (90 count) 1-LFK-9905 01/31/03 Correctol Tablets 5 mg (90 count) 1-LFK-9906 01/31/03 Correctol Tablets 5 mg (90 count) 1-LFK-9907 01/31/03 Correctol Tablets 5 mg (90 count) 1-LFK-9908 01/31/03 Correctol Tablets 5 mg (90 count) 1-LFK-1 11/30/02 Correctol Tablets 5 mg (90 count) 0-LFK-105 10/31/02 Correctol Caplets 5 mg (30 count) 0-CCT-101 10/31/03 RECALLING FIRM/MANUFACTURER Recalling Firm: Schering-Plough HealthCare Products, Cleveland, TN, by letter dated July 22, 2002. Manufacturer: Schering Laboratories, Kenilworth, NJ. Firm initiated recall is ongoing. REASON Disintegration; test data may not be supportive of expiration date. VOLUME OF PRODUCT IN COMMERCE 5,312,274 packages. DISTRIBUTION Nationwide. _______________________ PRODUCT Arm & Hammer PeroxiCare Baking Soda & Peroxide Tartar Control Toothpaste (Sodium Fluoride 0.24%) 4.3 oz, 6.0 oz and Special Pack tubes. Recall # D-417-2. CODE 4.3 oz tubes --- UPC 33200-18750 Lot Numbers: L2043 L2051 L2057 L2058 L2063 L2064 6.0 oz tubes --- UPC 33200-18770 Lot Numbers: L2022 L2023 L2029 L2030 L2039 L2043 L2044 L2051 L2052 L2058 L2064 L2065 L2066 L2073 L2074 L2112 L2113 L2121 L2135 Special Pack -- UPC 33200-18954 Lot Number: L2120 Mixed Display -- UPC 33200-18044 Eighteen PeroxiCare Tartar Control 6 oz in display of 66 mixed tubes of toothpaste Lot Numbers: L2010 L2079 Mixed Display -- UPC 33200-18045 Six PeroxiCare Tartar Control 6 oz in display of 69 mixed items of toothpaste, gum, and mints Lot Numbers: L2133 Mixed Display -- UPC 33200-18048 Twelve Peroxicare Tartar control 6 oz in display of 69 tubes. (not distributed; 100% still within Company control). RECALLING FIRM/MANUFACTURER Recalling Firm: Church & Dwight Co., Inc., Princeton, NJ, by e-mail and letter on May 24, 2002. Firm initiated recall is ongoing. REASON Labeling; product label does not declare inactive ingredient sodium saccharin. VOLUME OF PRODUCT IN COMMERCE 40,774 cases (978,576 tubes). DISTRIBUTION PA, OH, GA, CA and TX. _______________________ PRODUCT a) Correctol Stimulant Laxative Tablet (Bisacodyl) 5 mg, Comfort- Coated, box of 10, 30, 60, 75 and 90 Tablets. Recall # D-418-2; b) Correctol Stimulant Laxative Caplet (Bisacodyl) 5 mg, Comfort- Coated, box of 30. Recall # D-419-2. CODE Item Code Description Lot Numbers 07299-17 Correctol Tablets 5 mg (90 count) 1LFK9902 07296-18 Correctol Tablets 5 mg (30 count) 1LFK9008 07300-17 Correctol Caplets 5 mg (30 count) 0CCT1, 0CCT2. RECALLING FIRM/MANUFACTURER Recalling Firm: Schering-Plough HealthCare Products Cleveland, TN, by letter dated July 22, 2002. Manufacturer: Schering Laboratories, Kenilworth, NJ. Firm initiated recall is ongoing. REASON Disintegration; failures at the one hour test time (stability). VOLUME OF PRODUCT IN COMMERCE 5,312,274 packages. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I
_______________________ PRODUCT a) Saphenous Vein, Recall # B-1899-2; b) Tibialis Tendon, Recall # B-1900-2. CODE a) Units 7026668 and 7026694; b) Units 7032451, 7032431, 7032467, and 7032402. RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA, by letters dated July 29, 2002. Firm initiated recall is complete. REASON Human tissues for transplantation was processed from a donor who was found to test positive for hepatitis C virus (HCV) subsequent to distribution. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION MA, TN and WA. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II _______________________ PRODUCT a) Red Blood Cells, Recall # B-1737-2. b) Platelets, Recall # B-1738-2. CODE a) and b) Unit number 3036575. RECALLING FIRM/MANUFACTURER Community Blood Center, Dayton, OH, by letter on June 13, 2002. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION OH. _______________________ PRODUCT Platelets Pheresis, Recall # B-1739-2. CODE Unit number 24FH29397. RECALLING FIRM/MANUFACTURER The American National Red Cross, River Valley Region, Louisville, KY, by telephone on June 11, 2002 and by letter dated June 13, 2002. Firm initiated recall is complete. REASON Platelets Pheresis with an elevated platelet count based on volume of product collected were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION KY. _______________________ PRODUCT Platelets, Recall # B-1741-2. CODE Unit number 1897423. RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY, by letter dated July 12, 2002. Firm initiated recall is complete. REASON Blood product, collected from an ineligible donor due to recent ingestion of aspirin, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION KY. ___________________________ PRODUCT a) Red Blood Cells, Recall # B-1883; b) Platelets, Recall # B-1884-2; c) Fresh Frozen Plasma, Recall # B-1885-2; d) Plasma, Recall # B-1886-2; e) Cryoprecipitated AHF, Recall # B-1887-2. CODE a) units 0323252, 0324242, 0326009, 0326011, 0327049, 0327059, 0327159, 0327877, 0327895, 0328204, 0328207, 0328212, 0329744, 0329763, 0329764, 0329769, 0331226, 0331231, 0331238, 0331239, 0331243, 0331246, 0331249, 0331330, 0332967, 0337109, 0337116, 0338936, 0338944, 0340142, 0340149, 0340219, 0340221, 0340233, 0340240, 0340242, 0340270, 0340273, 0340282, 0340975, 0340977, 0340987, 1289010, 1289067, 1289369, 1289374, 1289416, 1289759, 1289950, 1289996, 1290002, 1290161, 1290196, 1291546, 1291549, 1293201, 1293222, 1293227, 1293228, 1293244, 1293251, 1293258, 1293264, 1293282, 1293309, 1293426, 1293432, 1293439, 1293449, 1293467, 1293469, 1293484, 1293489, 1293493, 1293517, 1293537, 1293542, 1293550, 1293557, 1293572, 1293574, 1293579, 1293583, 1293586, 1293600, 1293604, 1293806, 1293808, 1293820, 1293836, 1293843, 1293858, 1293865, 1293869, 1293871, 1293888, 1293895, 1294049, 1294071, 1294078, 1294081, 1294102, 1294104, 1294114, 1294130, 1294134, 1294146, 1294152, 1294156, 1294165, 1294167, 1294172, 1294180, 1294181, 1294187, 1294198, 1294214, 1294512, 1294568, 1294598, 1294792, 1294803, 1294809, 1294815, 1295045, 1295442, 1295443, 1295540, 1295555, 1295558, 1295562, 1295568, 1295775, 1295778, 1295780, 1295784, 1295785, 1295786, 1295789, 1295790, 1295933, 1295940, 1295947, 1295949, 1295960, 1295963, 1295964, 1295965, 1296001, 1296064, 1296144, 1296149, 1296165, 1296173, 1296176, 1296177, 1296205, 1297926, 1297929, 1297930, 1297934, 1297950, 1297956, 1298170, 1298185, 1298197, 1298205, 1298207, 1298432, 1298437, 1298440, 1298441, 1298448, 1298451, 1298505, 1298511, 1298528, 1298543, 1298548, 1298553, 1298576, 1298580, 1298583, 1298638, 1298643, 1298646, 1298648, 1298658, 1298662, 1298676, 1298681, 1298683, 1298783, 1298786, 1298789, 1298795, 1298818, 1298915, 1298919, 1298920, 1298932, 1298937, 1298938, 1298945, 1298967, 1298971, 1298974, 1298982, 1298997, 1299102, 1299108, 1299110, 1299126, 1299334, 1299351, 1299354, 1299356, 1299362, 1299370, 1299394, 1299397, 1299407, 1299408, 1300007, 1300021, 1300038, 2184770, 2184797, 2185306, 2185308, 2185378, 2185397, 2185402, 2185426, 2185707, 2185709, 2185716, 2185748, 2185756, 2185765, 2185941, 2185948, 2185958, 2185961, 2186307, 2186318, 2186467, 2186817, 2186827, 2186839, 2186867, 2186881, 2186972, 2186980, 2187026, 2187035, 2187045, 2187222, 2187228, 2187236, 2187237, 2187245, 2187330, 2187333, 2187339, 2187350, 2187852, 2187877, 2188557, 2188561, 2188575, 2190417, 2190422, 2190433, 2190442, 2190451, 2190452, 2190457, 2190461, 2190465, 2190489, 2190499, 2190502, 2190509, 2190513, 2190519, 2190520, 2190731, 2190737, 2190740, 2190768, 2190775, 2190913, 2190929, 2190949, 2190961, 2190971, 2190986, 2191033, 2191048, 2191049, 2191098, 2191099, 2191102, 2191105, 2191109, 2191110, 2191449, 2191464, 2191509, 2191566, 2191574, 2191585, 2191592, 2191623, 2191637, 2191658, 2191663, 2191674, 2191693, 2191698, 2191712, 2192736, 2192746, 2192749, 2192761, 2192767, 2192774, 2192776, 2193047, 2193052, 2193371, 2193553, 2193554, 2193556, 2193558, 2193572, 2193589, 2193593, 2194119, 2194123, 2194127, 2194141, 2194385, 2194392, 2194393, 2194411, 2194414, 2194430, 2194453, 2195051, 2195057, 2195062, 2195342, 2195347, 2195435, 2195440, 2195442, 2195472, 2195511, 2195532, 2195536, 2195540, 2195782, 2195789, 2195792, 2195808, 2196042, 2196081, 2196084, 2196111, 2196118, 2196126, 2196128, 2196163, 2196165, 2196167, 2196170, 2196175, 2196179, 2196181, 2196184, 2197417, 2197423, 2197435, 4128413, 4128456, 4128465, 4128475, 4129187, 4129206, 4129243, 4129250, 4129255, 4130416, 4130427, 4130435, 4130440, 4130454, 4130463, 4130470, 4130472, 4130474, 4130485, 4130486, 4130496, 4130507, 4130510, 4130616, 4130624, 4130629, 4130632, 4130637, 4130641, 4130643, 4130646, 4130648, 4130659, 4130797, 4130801, 4130803, 4130810, 4130811, 4130822, 4130826, 4131103, 4131126, 4131128, 4131131, 4131133, 4131169, 4131172, 4131175, 4131184, 4131186, 4131297, 4131300, 4131310, 4131312, 4131428, 4131434, 4131448, 4131449, 4131453, 4131454, 4131475, 4131549, 4131553, 4131554, 4131558, 4131561, 4131562, 4131564, 4132403, 4132410, 4133017, 4133027, 4133037, 4133042, 4133044, 4133046, 4133047, 4133049, 4133051, 4133063, 4133323, 4133329, 4133342, 4133395, 4133399, 4133406, 4133442, 4133656, 4133658, 4133660, 4133666, 4133669, 4133670, 4133757, 4133771, 4133815, 4133830, 4134259, 4134269, 4134396, 4134400, 4134402, 4134405, 4134408, 4134410, 4134411, 4134418, 4134725, 4134733, 4134752, 4134761, 4134781, 4134783, 4134788, 4135516, 4135520, 4135535, 4135536, 4135538, 4135541, 4135553, 4135558, 4135569, 4135584, 4135586, 4135678, 4135703, 4135743, 4135752, 4135812, 4135937, 4135942, 4136224, 4136235, 4136238, 4136239, 4136240, 4136325, 4136679, 4136681, 4136698, 4136701, 4136704, 4136718, 4136828, 4136831, 4136832, 4136834, 4136839, 4136851, 4136857, 4136859, 4136864, 4136866, 4136868, 4136885, 4136890, 4137088, 4137205, 4137210, 4137213, 4137216, 4137219, 4137221, 4137224, 4137229, 4137249, 4137251, 4137252, 4137255, 4137256, 4137490, 4137499, 4138592, 4138629, 4138631, 4138636, 4138669, 4138680, 5076772, 5076787, 5076793, 5076804, 5077169, 5077193, 5079543, 5079548, 5079562, 5079894, 5079895, 5079897, 5080218, 5080220, 5080258, 5080263, 5081069, 5081070, 5081087, 5081089, 5081604, 5081614, 5081630, 5081650, 5081681, 5081687, 5081716, 5081722, 5081729, 5081740, 5081792, 5081811, 5081823, 5081886, 5081887, 5081901, 5081913, 5081916, 5082015, 5082021, 5082030, 5082044, 5082053, 5082055, 5082234, 5082240, 5082243, 5082252, 5082253, 5082257, 5082545, 5082553, 5082555, 5082562, 5082706, 5082713, 5082717, 5082726, 5082728, 5082732, 5082734, 5083194, 5083200, 5083283, and 5083290; b) units 0327877, 0331226, 0338936, 1288996, 1289374, 1289759, 1289800, 1289945, 1290161, 1293217, 1293227, 1293228, 1293244, 1293251, 1293257, 1293426, 1293432, 1293484, 1293493, 1293537, 1293550, 1293579, 1293806, 1293817, 1293836, 1293843, 1293851, 1293869, 1294102, 1294104, 1294114, 1294598, 1294998, 1295011, 1295540, 1295562, 1295786, 1296149, 1296165, 1296173, 1297930, 1298197, 1298511, 1298528, 1298543, 1298548, 1298553, 1298576, 1298583, 1298638, 1298683, 1298818, 1298967, 1298974, 1298997, 1299110, 1299334, 1299337, 1299370, 1299407, 2184770, 2184797, 2185306, 2185397, 2185948, 2185958, 2185961, 2186306, 2186817, 2186907, 2186912, 2187222, 2187237, 2187877, 2188557, 2190433, 2190509, 2190519, 2190520, 2190731, 2190740, 2190929, 2190961, 2190971, 2191075, 2191091, 2191098, 2191099, 2191454, 2191464, 2191574, 2191603, 2191674, 2191712, 2192736, 2193556, 2193558, 2194392, 2195057, 2195062, 2195444, 2195471, 2195472, 2195511, 2195532, 2195782, 2195787, 2195789, 2196040, 2196048, 2196049, 2196184, 2196186, 2197417, 2197423, 4129243, 4129250, 4130427, 4130435, 4130446, 4130472, 4130616, 4130632, 4130659, 4130803, 4130810, 4131184, 4131428, 4131429, 4131438, 4131448, 4131453, 4131454, 4131468, 4134400, 4134790, 4135703, 4135743, 4135752, 4135942, 4136707, 4136856, 4136861, 4136866, 4136868, 4137088, 4137095, 4137213, 4137490, 4138583, 4138592, 4138638, 5079562, 5079893, 5079897, 5081069, 5081630, 5081647, 5081681, 5081729, 5081913, 5082015, 5082030, 5082252, 5082253, 5082290, 5082294, 5083281, 9058590, and 9063189; c) units 0324242, 0326011, 0326014, 0327049, 0327059, 0327159, 0327877, 0327895, 0329744, 0329769, 0331249, 0332971, 1289067, 1290161, 1291533, 1293201, 1293244, 1293251, 1293258, 1293264, 1293432, 1293817, 1293888, 1293895, 1294104, 1294114, 1294506, 1295780, 1295936, 1295940, 1298548, 1298553, 2186817, 2187228, 2187245, 2188557, 2190461, 2190465, 2190509, 2190929, 2190949, 2192761, 2192767, 2195062, 2195102, 2195347, 4130632, 4130637, 4130797, 4130810, 4130811, 4130826, 4131125, 4131126, 4131184, 4131186, 4131312, 4131434, 4131453, 4131454, 4131780, 4131783, 4135678, 4135942, 4136704, 4136710, 4136718, 4136834, 4136851, 4136859, 4136864, 4136868, 5076804, 5079895, 5079897, 5081796, 5081823, 5081838, 5081886, 5081887, 5081901, 5082030, 5082055, 5083200, 5083283, and 5083290; d) units 0324242, 0327059, 0329744, 0331231, 0331249, 0331335, 2186827, 2187236, 4130516, and 5081716; e) units 0324242, 0327059, 0329744, 0331231, 0331236, 0331249, 1290002, 1290196, 2187022, 2190502, 2193554 and 5081716. RECALLING FIRM/MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City, MO, by telephone and/or letter between August 2, 2000, and August 15, 2000. Firm initiated recall complete. REASON Blood products, collected from donors whose health history screening was inadequately performed, were distributed. VOLUME OF PRODUCT IN COMMERCE a) 629 units; b) 170 units; c) 86 units; d) 10 units; e) 12 units. DISTRIBUTION MO, KS, NJ, TX, IN, TN, MD, FL and MA. _______________________ PRODUCT Platelet, Pheresis, Recall # B-1889-2. CODE Unit R66987. RECALLING FIRM/MANUFACTURER HCSC Blood Center, t/a Miller Memorial Blood Center, Bethlehem, PA, by telephone on January 24, 2001. Firm initiated recall is complete. REASON Blood product, which was labeled as leukoreduced, but failed to meet the, criteria for a leukoreduced product, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION PA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1890-2; b) Recovered Plasma, Recall # B-1891-2. CODE a) and b) Unit R57511. RECALLING FIRM/MANUFACTURER HCSC Blood Center, t/a Miller Memorial Blood Center, Bethlehem, PA, by letter dated January 23 or February 23, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who lived in an HIV Group O risk area, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION PA and NJ. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1892-2; b) Platelets, Recall # B-1893-2; c) Fresh Frozen Plasma, Recall # B-1894-2. CODE a); b) and c) Unit 22FR70315. RECALLING FIRM/MANUFACTURER American Red Cross, Penn-Jersey Region, Philadelphia, PA, by letter dated September 24, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who provided post donation information regarding having tested positive for hepatitis A, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION PA and NJ. _______________________ PRODUCT a) Red Blood Cells, Leukoreduced, Recall # B-1904-2; b) Red Blood Cells, Leukoreduced, Irradiated, Recall # B-1905-2; c) Platelets, Recall # B-1906-2; d) Fresh Frozen Plasma, Recall # B-1907-2; e) Cryoprecipitate, Pooled, Recall # B-1908-2; f) Recovered Plasma, Recall # B-1909-2. CODE a) Units 1796324, 1751564; b) Unit 1765739; c) Unit 1751564; d) Unit 1751564; e) Unit 4014230; f) Units 1765739, 1796324. RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX, by telephone and fax on July 9 or 10, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who provided post donation information of having liver disease, were distributed. VOLUME OF PRODUCT IN COMMERCE 8 units. DISTRIBUTION TX and FL. _______________________ PRODUCT Platelet, Pheresis, Recall # B-1919-2. CODE Unit R89121. RECALLING FIRM/MANUFACTURER HCSC Blood Center, t/a Miller Memorial Blood Center, Bethlehem, PA, by telephone on December 11, 2001 and by letter dated December 26, 2001. Firm initiated recall is complete. REASON Blood product, which had an unacceptable red cell count, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION PA. _______________________ PRODUCT Platelets, Leukocytes Reduced, Recall # B-1920-2. CODE Unit 16LG38876. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by telephone on April 23, 2002 and by letter dated May 1, 2002. Firm initiated recall is complete. REASON Blood product, corresponding to a unit of Red Blood Cells that was implicated in a transfusion reaction and found to be contaminated with Staphylococcus epidermitis, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OH. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1921-2; b) Fresh Frozen Plasma, Recall # B-1922-2. CODE a) and b) Unit 10728-4529. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on May 13, 2002. Manufacturer: United Blood Services, Scottsdale, AZ. Firm initiated recall is complete. REASON Blood products, collected from a donor whose temperature was not accurately determined, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION AZ. _______________________ PRODUCT Source Plasma, Recall # B-1925-2. CODE Units G92771-076, G87177-076. RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA, by fax on November 26, 2001. Manufacturer: Alpha Therapeutic Corporation, Fayetteville, NC. Firm initiated recall complete. REASON Source Plasma, collected from a donor who had a tattoo applied within the past 12 months, was distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION Switzerland. _______________________ PRODUCT Platelets, Pheresis, Recall # B-1927-2. CODE Unit R83158. RECALLING FIRM/MANUFACTURER HCSC Blood Center, t/a Miller Memorial Blood Center, Bethlehem, PA, by letter dated November 14, 2001. Firm initiated recall is complete. REASON Blood product, manufactured with an increased red cell count, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION PA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1936-2. CODE Unit number M13910. RECALLING FIRM/MANUFACTURER Northern Illinois Blood Bank, Inc., Rockford, IL, by telephone on June 18, 2002 and by letter on June 24, 2002. Firm initiated recall is complete. REASON Blood product, that tested positive for Cytomegalovirus (CMV), but was labeled negative for CMV, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WI. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1941-2; b) Platelets, Recall # B-1942-2; c) Cryoprecipitated AHF, Recall # B-1943-2; d) Recovered Plasma, Recall # B-1944-2. CODE a); b); c) and d) Unit number 30GE20865. RECALLING FIRM/MANUFACTURER The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by telephone on September 20, 2000 and by letters on September 22 and November 1, 2000. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor due to a history of jaundice, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION PA, MA, NY and Switzerland. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced. Recall # B-1945-2. b) Platelets, Recall # B-1946-2. c) Cryoprecipitated AHF, Recall # B-1947-2; d) Recovered Plasma, Recall # B-1948-2. CODE a); b); c) and d) Unit number 30LV04215. RECALLING FIRM/MANUFACTURER The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by telephone and letter on November 16, 2000. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor due to a history of jaundice, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION PA, NY and Switzerland. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1949-2. b) Platelets, Recall # B-1950-2; c) Platelets Pheresis, Recall # B-1951-2. CODE a) and b) Unit number 30GJ40729; c) Unit numbers 30GP19527, 30GP18692, 30GP18471, and 30GP17810 (all units distributed as two split units). RECALLING FIRM/MANUFACTURER The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by letter on September 5, 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 10 units. DISTRIBUTION PA. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-1952-2; b) Red Blood Cells, Frozen, Recall # B-1953-2; c) Platelets, Recall # B-1954-2. CODE a) Unit number 30GN31405; b) and c) Unit number 30GN28512. RECALLING FIRM/MANUFACTURER The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by telephone on October 20, 2000 and by letter on October 23, 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 3 units. DISTRIBUTION PA and CT. _______________________ PRODUCT Source Plasma, Recall # B-1955-2. CODE Unit numbers BRKVYK, BRKXNW, BRLCKQ, BRLJNL, BRLKKN, BRMLPV, BRMMQZ, BRMPCN, BRMQCN, BRMRFM, BRMSQQ, BRMTGJ, BRMXCJ, and BRQHSJ. RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis Bio-Services, Inc., Knoxville, TN, by fax on July 1, 2002. Manufacturer: Aventis Bio-Services, Inc., Akron, OH. Firm initiated recall is complete. REASON Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to body piercing in the previous 12 months, were distributed. VOLUME OF PRODUCT IN COMMERCE 14 units. DISTRIBUTION IL and Germany. _______________________ PRODUCT Counterfeit PROCRIT? (Epoetin Alfa) labeled as 40,000 IU/mL, NDC # - 59676-340-01; 13,472 distributed. Recall # B-1956-2. CODE Lot numbers: P002641 - Exp. Date 9/03 P002384 - Exp. Date 3/03. RECALLING FIRM/MANUFACTURER Recalling Firm: Bindley Trading Company, Grapevine, TX, by letters dated June 3 and 11, 2002. Manufacturer: Unknown. Firm initiated recall is complete. REASON Counterfeit drug products, with a concentration of active ingredient less than labeled, were distributed. VOLUME OF PRODUCT IN COMMERCE 13,472. DISTRIBUTION Nationwide. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1957-2. CODE Units 04FS45055, 04FS45061. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, New England Region, Dedham, MA, by telephone on May 30, 2002 and by letter dated June 10, 2002. Firm initiated recall is complete. REASON Blood products, that lacked assurance of sterility, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION NY. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1958-2. CODE Units 042G30721, 042R59346, 042C09764, 042FE62665, 042FE67461, 042FE67472, 042FE67462, 042FE67474, 042FE67465, 042FE67475, 042E37707, 042FJ04857, 042FJ04853, 042FJ04849, 042FJ04859, 042Y27010, 042FR93720, 042M03902, 042X37454, 042T99665, 042FE67466, 042FE67476, 042FE67467, 042FE67477, 042FE67471, 042FQ98669, 042FJ04852, 042FJ04860, 042FJ04858, 042FJ04856, 042FY33670. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH, by letters dated June 19 and 24 and July 9 and 10, 2002. Firm initiated recall is complete. REASON Blood products, that were not leukoreduced within a 24-hour time frame, or lacked assurance of sterility, were distributed. VOLUME OF PRODUCT IN COMMERCE 31 units. DISTRIBUTION OH. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1960-2. CODE Unit 03S08471. RECALLING FIRM/MANUFACTURER American Red Cross, Southern Region, Atlanta, GA, by letter dated May 8, 2002. Firm initiated recall is 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 GA. _______________________ PRODUCT Platelets, Recall # B-1961-2. CODE Unit 03GZ26738. RECALLING FIRM/MANUFACTURER American Red Cross, Southern Region, Atlanta, GA, by letter dated October 10, 2001. Firm initiated recall is 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 GA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1962-2. CODE Unit 03LC19596. RECALLING FIRM/MANUFACTURER American Red Cross, Southern Region, Atlanta, GA, by telephone on June 10, 2002 and by letter dated June 14, 2002. Firm initiated recall is complete. REASON Blood product, collected from a donor who had not completed a nvCJD increased risk question, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION GA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1963-2; b) Platelets, Recall # B-1964-2; c) Fresh Frozen Plasma, Recall # B-1965-2; d) Cryoprecipitate AHF, Recall # B-1966-2; e) Recovered Plasma, Recall # B-1967-2. CODE a) Units 30LV02834, 30LV02008, 30GY12011; b) and c) Unit 30GY12011; d) Unit 30LV02008; e) Units 30LV02834, 30LV02008. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northwestern Pennsylvania Region, Ashley, PA by letter dated August 11, 2000. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of having a confirmed positive test for Hepatitis B, were distributed. VOLUME OF PRODUCT IN COMMERCE 8 units. DISTRIBUTION PA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1985-2. CODE Unit number 18225-2729. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter on April 12, 2002. Manufacturer: Blood Systems, Inc., Cheyenne, WY. Firm initiated recall is ongoing. 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 WY. _______________________ PRODUCT a) Cryoprecipitated AHF, Recall # B-1986-2; b) Plasma, Recall # B-1987-2. CODE a) and b) Unit number 30GE27973. RECALLING FIRM/MANUFACTURER The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by letter on March 19, 2002. Firm initiated recall is complete. REASON Blood products, corresponding to a unit of Red Blood Cells that was possibly contaminated with coagulase negative Staphylococcus sp. bacteria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MA and NY. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1994-2; b) Red Blood Cells Leukocytes Removed, Recall # B-1995-2; c) Fresh Frozen Plasma, Recall # B-1996-2; d) Plasma, Recall # B-1997-2; e) Cryoprecipitated AHF, Recall # B-1998-2; f) Recovered Plasma, Recall # B-1999-2. CODE a) Unit 30LE01772; b) Units 30LV05371, 30LE02174, 30LE01885, and 30LE01434; c) Unit 30LE01772; d) Unit 30LV0537; e) Units 30LV05371 and 30LE02174; f) Units 30LE02174 and 30LE01434. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northeastern Pennsylvania Region, Ashley, PA, by letters dated January 15 and February 14, 2001. Firm initiated recall is complete. REASON Blood products, which were collected from a donor with a history of jaundice, were distributed. VOLUME OF PRODUCT IN COMMERCE 11 units. DISTRIBUTION PA, NY and Switzerland. _______________________ PRODUCT Source Plasma, Recall # B-2009-2. CODE Unit 71FPBJCM. RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Greenville, SC, by letter dated March 3, 2002. Firm initiated recall is complete. REASON Blood product, which was not tested for syphilis, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Switzerland. _______________________ PRODUCT a) Red Blood Cells, Recall # B-2015-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-2016-2; c) Platelets, Recall # B-2017-2; d) Platelets, Leukocytes Reduced. Recall # B-2018-2. CODE a) and c) Unit number 42FS67962; b) and d) Unit number 42X43881. RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH, by letter dated December 4, 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, Leukocytes Reduced, Recall # B-2020-2; b) Fresh Frozen Plasma, Recall # B-2021-2. CODE a) and b) Unit number 04N07571. RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA, by telephone on June 12, 2002 and by letter on June 14, 2002. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor due to recent inoculation with the rabies vaccine, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-2022-2; b) Platelets, Recall # B-2023-2; c) Fresh Frozen Plasma, Recall # B-2024-2. CODE a); b) and c) Unit number 22KP36835. RECALLING FIRM/MANUFACTURER The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by letter on August 8, 2000. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor due to medication with the drug Methotrexate, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION NJ and PA. _______________________ PRODUCT a) Platelets, Leukocytes Reduced, Recall # 2026-2; b) Fresh Frozen Plasma, Recall # B-2027-2; c) Red Blood Cells for further manufacture into non-injectable products, Recall # B-2028-2. CODE a); b) and c) Unit number 22KC30238. RECALLING FIRM/MANUFACTURER 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. REASON The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by letter on January 11, 2002. Firm initiated recall is complete. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION PA, NJ and NE. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-2029-2; b) Fresh Frozen Plasma, Recall # B-2030-2; c) Recovered Plasma, Recall # B-2031-2. CODE a) Unit numbers 22KM68562 and 22GY97494; b) Unit number 22GY97494; c) Unit number 22KM68562. RECALLING FIRM/MANUFACTURER The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by letters on August 16 and 21 and September 14, 2001. 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 4 units. DISTRIBUTION PA, NJ and NY. _______________________ PRODUCT a) Red Blood Cells, Recall # B-2033-2; b) Fresh Frozen Plasma, Recall # B-2034-2. CODE a) and b) Unit number 36262-0977. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on April 1 and June 3, 2002. Manufacturer: Blood Systems, Inc., Ventura, CA. Firm initiated recall is complete. REASON Blood products, collected from an unsuitable donor due to a history of residing in the United Kingdom for more than 6 months, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Platelets, Recall # B-1740-2. CODE Unit number 24KL55649. RECALLING FIRM/MANUFACTURER The American National Red Cross, River Valley Region, Louisville, KY, by telephone on June 14, 2002 and by letter dated June 17, 2002. Firm initiated recall is complete. REASON Blood product, manufactured from a unit of Whole Blood that had a discrepant collection time, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION IN. _______________________ PRODUCT Recovered Plasma. Recall # B-1888-2. CODE Recovered Plasma, units 0323252, 0327086, 0327875, 0328204, 0328207, 0329763, 0331226, 0331239, 0331243, 0331330, 0331332, 0338936, 0338938, 0338946, 0338947, 0340975, 0340979, 1289369, 1289416, 1289800, 1289945, 1291529, 1291546, 1291549, 1293227, 1293426, 1293467, 1293484, 1293489, 1293493, 1293509, 1293523, 1293806, 1293813, 1293836, 1293843, 1293851, 1293858, 1293865, 1293869, 1293871, 1293898, 1294049, 1294130, 1294134, 1294152, 1294165, 1294167, 1294172, 1294180, 1294187, 1294512, 1294518, 1294568, 1294592, 1294792, 1295045, 1295059, 1295442, 1295443, 1295540, 1295555, 1295562, 1295568, 1295775, 1295778, 1295949, 1295963, 1296064, 1296144, 1296149, 1296173, 1296176, 1296177, 1296205, 1296237, 1298177, 1298437, 1298440, 1298441, 1298448, 1298451, 1298505, 1298511, 1298528, 1298580, 1298583, 1298638, 1298648, 1298783, 1298786, 1298789, 1298795, 1298818, 1298915, 1298919, 1298920, 1298928, 1298932, 1298937, 1298938, 1298945, 1298967, 1298971, 1298974, 1298997, 1299102, 1299126, 1299397, 1300006, 1300007, 1300009, 1300023, 1300037, 1300038, 2184770, 2185306, 2185308, 2185309, 2185395, 2185707, 2185709, 2185756, 2185765, 2185804, 2185941, 2185958, 2185961, 2186294, 2186306, 2186307, 2186318, 2186467, 2186839, 2186881, 2186907, 2186912, 2186931, 2186998, 2187222, 2187333, 2187339, 2187350, 2188575, 2190422, 2190452, 2190520, 2190727, 2190731, 2190737, 2190768, 2190891, 2190949, 2190986, 2191033, 2191075, 2191091, 2191098, 2191099, 2191102, 2191105, 2191449, 2191454, 2191464, 2191566, 2191574, 2191592, 2191603, 2191658, 2191663, 2191674, 2191693, 2191712, 2191739, 2192732, 2192736, 2192746, 2192774, 2192781, 2193371, 2193553, 2193571, 2193572, 2193585, 2193593, 2194123, 2194127, 2194385, 2194392, 2194430, 2194433, 2194453, 2195051, 2195057, 2195435, 2195782, 2195787, 2195789, 2195792, 2195808, 2195818, 2195828, 2196037, 2196039, 2196040, 2196042, 2196048, 2196049, 2196052, 2196163, 2196165, 2196170, 2196175, 2196179, 2196181, 2196184, 2196186, 2197417, 2197422, 2197423, 4128451, 4128456, 4128465, 4128517, 4129187, 4129206, 4129250, 4129255, 4130416, 4130418, 4130435, 4130440, 4130470, 4130474, 4130485, 4130616, 4130621, 4130624, 4130629, 4130641, 4130643, 4130648, 4130659, 4131128, 4131133, 4131294, 4131297, 4131310, 4131562, 4131564, 4132047, 4132403, 4133017, 4133044, 4133046, 4133047, 4133051, 4133058, 4133323, 4133329, 4133342, 4133399, 4133400, 4133442, 4133658, 4133660, 4133670, 4133766, 4134259, 4134394, 4134396, 4134400, 4134402, 4134405, 4134410, 4134414, 4134418, 4134725, 4134761, 4134763, 4135516, 4135520, 4135535, 4135536, 4135538, 4135541, 4135544, 4135553, 4135558, 4135569, 4135570, 4135574, 4135580, 4135584, 4135586, 4135664, 4136224, 4136235, 4136238, 4136239, 4136240, 4136313, 4136679, 4136681, 4136828, 4136831, 4136832, 4136839, 4136857, 4137088, 4137095, 4137205, 4137219, 4137221, 4137249, 4137252, 4137256, 4137499, 4137501, 4138592, 4138629, 4138636, 4138638, 4138667, 4138669, 4138673, 4138680, 4138686, 4138688, 5076787, 5076793, 5077193, 5079548, 5079562, 5080218, 5080220, 5080258, 5080263, 5081069, 5081070, 5081604, 5081606, 5081614, 5081624, 5081626, 5081630, 5081647, 5081650, 5081671, 5081687, 5081715, 5081722, 5082015, 5082021, 5082044, 5082252, 5082253, 5082257, 5082287, 5082294, 5082560, 5082584, 5082706, 5082713, 5082717, 5082722, 5082726, 5082728, 5082732, 5082734, and 5083281. RECALLING FIRM/MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City, MO. by fax or telephone, followed by letter between August 4, 2000, and August 14, 2000. Firm Initiated recall complete. REASON Blood products, collected from donors whose health history screening was inadequately performed, were distributed. VOLUME OF PRODUCT IN COMMERCE 371 units. DISTRIBUTION CA, CO, VT, GA, MI, MO, Canda and Switzerland. _______________________ PRODUCT Fresh Frozen Plasma, Recall # B-1898-2. CODE Unit 41LV18672 RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Alabama Region, Birmingham, AL, by telephone on August 28, 2000 and by letter dated September 7, 2000. Firm initiated recall is complete. REASON Blood product, which was incorrectly labeled as Fresh Frozen Plasma, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION AL. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-1959-2. CODE Units 042E37707, 042FJ04852, 042FJ04857 042FJ04860, 042FJ04853, 042FJ04858, 042FJ04849, 042FJ04856, 042FJ04859, 042FY33670. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH, by letters dated June 19 and 24 and July 9 and 10, 2002. Firm initiated recall is complete. REASON Blood products, that were not leukoreduced within a 24-hour time frame, or lacked assurance of sterility, were distributed. VOLUME OF PRODUCT IN COMMERCE 10 units. DISTRIBUTION OH. _______________________ PRODUCT a) Platelets, Recall # B-1968-2; b) Fresh Frozen Plasma, Recall # B-1969-2. CODE a) and b) Unit 30GJ28040. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northeastern Pennsylvania Region, Ashley, PA, by letter dated April 20, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor with a history of Idiopathic Thrombocytopenic Purpura, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION PA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1970-2. CODE Units 30GX44034, 30GX44049, 30LL00170, 30GX44010, 30GT08307, 30GT08304 RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northeastern Pennsylvania Region, Ashley, PA, by letter dated December 8, 2000. Firm initiated recall is complete. REASON Blood products, which were stored at an unacceptable temperature, were distributed. VOLUME OF PRODUCT IN COMMERCE 6 units. DISTRIBUTION PA. _______________________ PRODUCT a) Cryoprecipitated AHF, Recall # B-1971-2; b) Platelets, Recall # B-1972-2. CODE a) and b) Unit 30GS19981. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northeastern Pennsylvania Region, Ashley, PA, by letter dated August 31, 2001. Firm initiated recall is complete. REASON Blood products, manufactured from a unit of Whole Blood with an extended collection time, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION MA and SC. _______________________ PRODUCT a) Red Blood Cells, Recall # B-1973-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-1974-2; c) Red Blood Cells, Washed, Recall # B-1975-2; d) Red Blood Cells, Irradiated, Recall # B-1976-2; e) Red Blood Cells, Leukocytes Reduced Irradiated, Recall # B-1977-2; f) Red Blood Cells, Frozen, Recall # B-1978-2; g) Platelets, Recall # B-1979-2; h) Platelets, Irradiated, Recall # B-1980-2; i) Cryoprecipitated AHF, Recall # B-1981-2; j) Fresh Frozen Plasma, Recall # B-1982-2; k) Plasma, Recall # B-1983-2; l) Recovered Plasma, Recall # B-1984-2. CODE a) Unit numbers 1776850, 1777219, 1777221, 1777224, 1777228, 1777229, 1777233, 1777236, 1777242, 1777247, 1777249, 1777259, 1777264, 1777324, 1777330, 1777341, 1777347, 1777348, 1777350, 1777352, 1777363, 1777364, 1777508, 1777515, 1777517, 1777518, 1777520, 1777524, 1777528, 1777530, 1777531, 1777533, 1777534, 1777540, 1777830, 1777831, 1777832, 1777834, 1777835, 1777837, 1777838, 1777839, 1777840, 1777841, 1777846, 1777847, 1778007, 1778009, 1778012, 1778013, 1778015, 1778018, 1778020, 1778021, 1778023, 1778309, 1778310, 1778372, 1778374, 1778376, 1778377, 1778378, 1778379, 1778380, 1778382, 1778384, 1778387, 1778390, 1778398, 1778575, 1779126, 1779127, 1779331, 1779341, 2221788, 2221798, 2221802, 2221815, 2221826, 2221827, 2221842, 2221848, 2221849, 2221856, 2221864, 2221867, 2221930, 2221932, 2221934, 2221937, 2221938, 2221939, 2221940, 2221941, 2221943, 2221963, 2221967, 2221969, 2221972, 2221974, 2448676, 2448682, 2448687, 2448694, 2448705, 2448734, 2448739, 2448744, 2448769, 2448777, 2448779, 2448790, 2448813, 2448820, 2449091, 2449095, 2449380, 2449418, 2449425, 2449426, 2449436, 2449439, 2449482, 2449493, 2449501, 2449505, 2449512, 2449519, 2449537, 2449665, 2449670, 2449687, 2449689, 2449692, 2449699, 2449700, 2449719, 2449741, 2449755, 2449763, 2449768, 2449779, 2449784, 2449791, 2449793, 2449813, 2449814, 2449816, 2449819, 2449821, 2449822, 2449824, 2450159, 2450165, 2450166, 2450167, 2450173, 2450174, 2450179, 2450187, 2450191, 2450194, 2450196, 2450200, 2450201, 2450205, 2450503, 2450505, 2450655, 2450705, 2450711, 2450724, 2451052, 2451056, 2451059, 2451064, 2451072, 2451081, 2451092, 2451096, 2451099, 2451105, 2451107, 2451275, 2451280, 2451290, 2451297, 2451304, 2451308, 2451309, 2451320, 2451329, 2451335, 2451337, 2451338, 2451384, 2451388, 2451389, 2451394, 2451397, 2451398, 2451400, 2451402, 2451404, 2451408, 2451409, 2451416, 2451425, 2451481, 2451483, 2451489, 2451492, 2451493, 2451502, 2451513, 2451636, 2451639, 2451640, 2451667, 2451670, 2451676, 2451681, 2451684, 2451688, 2451695, 2451698, 2451703, 2451705, 2451710, 2451717, 2451759, 2451774, 2451785, 2451789, 2451801, 2451803, 2451808, 2451811, 2451827, 2451847, 2451856, 2451883, 2451884, 2451886, 2451893, 2451903, 2452896, 2452900, 2452903, 2452910, 2453077, 2453081, 2453085, 2453097, 2453101, 2453107, 2453115, 2453116, 2453968, 2453969, 2453974, 2453976, 2453980, 2453983, 2453984, 2453988, 2453990, 2453998, 2454571, 2454573, 2454575, 2454578, 2454580, 2454581, 2454583, 2454584, 2454586, 2454588, 2454591, 2454594, 2454599, 2454601, 2454608, 2454611, 2454614, 2454620, 2454624, 2454646, 2454691, 2454694, 2454710, 2454711, 2454714, 2454717, 2454722, 2454726, 2454734, 2454742, 2454744, 2454745, 2454750, 2454754, 2455601, 2455605, 2455607, 2455610, 2455613, 2455614, 2455616, 2455619, 2455620, 2455621, 2455623, 2455632, 2455633, 2455643, 2455648, 2455732, 2455745, 2455746, 2455794, 2455807, 2455831, 2455834, 2455835, 2455837, 2455841, 2455843, 2455845, 2455858, 2455863, 2455867, 2455872, 2455874, 2455878, 2455880, 2709550, 2709552, 2709562, 2709564, 2709568, 2709571, 2709577, 2709580, 2709582, 2709589, 3901343, 3901347, 3901348, 3901350, 3901360, 3901362, 3901363, 3901364, 3901579, 3901601, 4329185, 4329188, 4329189, 4329190, 4329195, 4329197, 4329201, 4329210, 4329230, 4329235, 4329237, 4330244, 4330246, 4330248, 4330249, 4330251, 4330256, 4330258, 4330260, 4330264, 4330267, 4330268, 4330883, 4330899, 4330967, 4330968, 4330970, 4330971, 4330972, 4330974, 4330976, 4331062, 4331212, 4331221, 4331227, 4331909, 4331912, 4331915, 4331919, 4331921, 4331923, 4332316, 4332326, 4332693, 4332694, 4332696, 4332699, 4332701, 4332703, 4332709, 4332711, 4332712, 4332714, 4332715, 4332719, 4333117, 4333119, 4333123, 4333125, 4333129, 4333134, 4428480, 4428481, 4428482, 4428484, 4428487, 4428489, 4428498, 4428502, 4428508, 4428512, 4428515, 4428540, 4428542, 4428551, 4428552, 4428553, 4428576, 4428577, 4428581, 4428582, 4428587, 4428590, 4428592, 4428598, 4428858, 4428861, 4428862, 4428868, 4428872, 4428875, 4428878, 4429307, 4429308, 4429311, 4429314, 4429317, 4429318, 4429319, 4429324, 4429328, 4429330, 4429338, 4429596, 4429602, 4429608, 4429622, 4429633, 4429634, 4429645, 4429888, 4429889, 4429892, 4429901, 4429907, 4429911, 4429913, 4429919, 4429924, 4429926, 4429927, 4429929, 4430711, 4430714, 4430718, 4430727, 4430729, 4431105, 4431119, 4431122, 4431127, 4431133, 4431139, 5825042, 5825047, 5825049, 5825484, 5826032, 5826103, 5826107, 5826128, 5826149, 5826319, 5826324, 5826371, 5826395, 5826396, 5826405, 5826409, 5826544, 5826555, 5826564, 5826565, 5826567, 5826573, 5826574, 5826610, 5826629, 5827690, 5827692, 5827759, 5827767, 5827785, 5827794, 5827811, 5827822, 5827837, 5827844, 5827854, 5827862, 5828106, 5828108, 5828617, 5828619, 5828622, 5828648, 5828650, 5917209, 5917212, 5917219, 5917220, 5917223, 5917224, 5917227, 5918042, 5918054, 5918084, 5918087, 5918154, 5918155, 5918158, 5918160, 5918770, 5918773, 5918775, 5918776, 5918778, 5918784, 5918788, 5918789, 5918790, 5918793, 5918794, 5919218, 5919220, 5919224, 5919225, 5919226, 5919230, 5919233, 5919236, 5919237, 5919240, 5919243, 5919245, 5919247, 5919249, 5919320, 5919324, 5919761, 5919763, 5919764, 5919765, 5919774, 5919780, 5919784, 5919786, 5919788, 5919789, 5919792, 5919917, 5919919, 5919923, 5919924, 5919926, 5919927, 5919929, 5919930, 5919931, 5919933, 5919934, 5919935, 5919938, 5919939, 5920041, 5920144, 5920145, 5920146, 5920148, 5920149, 5920150, 5920153, 5920156, 5920163, 5920164, 5920165, 5920166, 5920168, 5920533, 5920536, 5920537, 5920539, 5920548, 5920552, 5920558, 5920656, 5920664, 6134925, 6134932, 6134933, 6134942, 6134943, 6134946, 6134948, 6134958, 6134966, 6134967, 6134969, 6134971, 6134973, 6134976, 6134978, 6134981, 6134987, 6134989, 6134995, 6134997, 6135006, 6135008, 6135073, 6135075, 6135085, 6135086, 6135094, 6135104, 6135109, 6135113, 6135117, 6135121, 6135125, 6135130, 6135146, 6135154, 6135160, 6135164, 6135165, 6135563, 6135569, 6135572, 6135575, 6135579, 6135584, 6135597, 6135601, 6135608, 6135617, 6135624, 6135626, 6135631, 6135635, 6135641, 6135648, 6135656, 6135658, 6135667, 6135676, 6135684, 6135685, 6135691, 6135693, 6136220, 6136224, 6136225, 6136232, 6136233, 6136242, 6136245, 6136246, 6136252, 6136253, 6136267, 6136275, 6136283, 6137206, 6137297, 6137301, 6137402, 6137480, 6137490, 6137493, 6137499, 6137542, 6137550, 6137574, 6137595, 6137597, 6137623, 6137625, 6137627, 6137634, 6137636, 6137641, 6138290, 6138297, 6138321, 6138323, 6138327, 6138795, 6138819, 6138827, 6138838, 6138876, 6138897, 6138902, 6139256, 6139268, 6139274, 6139277, 6139278, 6139287, 6139334, 6139341, 6139352, 6139353, 6139359, 6139360, 6139395, 6139500, 6139513, 6139519, 6139520, 6139521, 6139526, 6139531, 6139532, 6139624, 6139626, 6139628, 6139637, 6139649, 6139657, 6139660, 6139666, 6140039, 6140043. 6140046, 6140050, 6140054, 6140060, 6140071, 6140074, 6140076, 6140077, 6140082, 6140084, 6140089, 6140134, 6140649, 6140653, 6140658, 6140662, 6140678, 6140684, 6140686, 6140698, 6140704, 6140711, 6140712, 6140724, 6140725, 6140766, 6140771, 6140803, 6141484, 6141489, 6141493, 6141495, 6141504, 6141508, 6141513, 6141515, 6141518, 6141519, 6234753, 6234754, 6234756, 6234758, 6234761, 6234764, 6234766, 6234768, 6234770, 6234775, 6234777, 6234778, 6234779, 6234781, 6234814, 6234819, 6235403, 6235652, 6235660, 6235664, 6235716, 6235739, 6235740, 6235752, 6235756, 6235757, 6236437, 6236439, 6236441, 6236444, 6236446, 6236451, 6236457, 6236462, 6236464, 6236465, 6236962, 6319788, 6319790, 6319796, 6319799, 6319805, 6319807, 6319811, 6319812, 6319818, 6319819, 6319823, 6319824, 6319826, 6319827, 6319836, 6319843, 6319844, 6319848, 6319855, 6319857, 6319861, 6319863, 6320882, 6320884, 6320887, 6320889, 6320893, 6320901, 6320903, 6321101, 6321112, 6321115, 6321121, 6321124, 6321126, 6321130, 6321135, 6321138, 6321142, 6321143, 6321145, 6321152, 6321158, 6322652, 6322654, 6322658, 6322659, 6322661, 6322665, 6322667, 6322673, 6618551, 6618561, 6618570, 6618574, 6618587, 6618592, 6618594, 6618599, 6618608, 6618610, 6618611, 6618617, 6618619, 6618620, 6618622, 6619817, 6619819, 6619826, 6619828, 6619829, 6619830, 6619832, 6620125, 6620126, 6620128, 6620135, 6620136, 6620139, 6620141, 6620150, 6620155, 6620159, 6620160, 6620170, 6620207, 6620212, 6620218, 6620220, 6620225, 6620230, 6620254, 6620256, 6620259, 6620262, 6620265, 6620266, 6620269, 6620272, 6620275, 6620278, 6620282, 6620289, 6620292, 6620293, 6620302, 6620304, 6620307, 6620308, 6620311, 6620313, 6620316, 6620320, 6620321, 7546313, 7547786, 7547787, 7547800, 7547803, 7547808, 7547814, 7547819, 7547935, 7547937, 7547939, 7547941, 7547944, 7547950, 7547961, 7547964, 7863942, 7863946, 7863947, 7863949, 7863951, 7863952, 7863953, 7863956, 7863957, 7863958, 7863959, 7863961, 7864179, 7864181, 7864184, 7864193, 7864195, 7864198, 7864202, 7864204, 7864205, 7864712, 7864719, 7864726, 7864727, 7864728, 7864730, 7864731, 7864733, 7864734, 7864735, 7865135, 7934465, 7934468, 7934478, 7934479, 7934483, 7934484, 7934486, 7934488, 7934489, 7934507, 7934513, 7934517, 7934523, 7934525, 7934534, 7934537, 7934555, 7934569, 7934580, 7934584, 7934621, 7934631, 7934636, 7934648, 7934649, 7934655, 7934664, 7934731, 7934732, 7934735, 7934736, 7934738, 7934740, 7934741, 7934744, 7934752, 7934757, 7935533, 7935536, 7935539, 7935542, 7935545, 7935548, 7935550, 7935554, 7935555, 7935559, 7935561, 7935565, 7935569, 7935573, 7935577, 7935580, 7936531, 7936553, 7936554, 7936557, 7936563, 7936566, 7936575, 7936577, 7936579, 7936583, 7936590, 7936599, 7936601, 7936920, 7936922, 7936926, 7936929, 7936943, 7936944, 7936949, 7936952, 7936955, 7936961, 7936967, 7936973, 7936975, 7936977, 7936980, 7936981, 7936984, 7936985, 7936987, 7936989, 7936990, 7936999, 7937002, 7937005, 7937006, 7937010, 7937011, 7937014, 7937016, 7937021, 7937022, 7937052, 7937060, 7937066, 7937071, 7937079, 7937083, 7937094, 7937097, 7937108, 7937110, 7937112, 7937125, 7937127, 7937137, 7937144, 7937149, 7937158, 7937170, 7937189, 7937700, 7937702, 7937706, 7937718, 7937733, 7937736, 7937760, 7937960, 7937967, 7937970, 7937972, 7937974, 7937975, 7937976, 7937978, 7937989, 7937995, 7937996, 7937998, 7938000, 7938003, 7938006, 7938155, 7938158, 7938167, 7938181, 7938183, 7938185, 7938187, 7938193, 7938197, 7938201, 7938206, 7938211, 7938217, 7938228, 7938232, 7938236, 7938279, 7938295, 7938299, 7938306, 7938311, 7938317, 7938320, 7938321, 7938331, 7938336, 7938341, 7938344, 7938399, 7938400, 7938403, 7938404, 7938406, 7938407, 7938408, 7938411, 7938412, 7938413, 7938415, 7938416, 7938417, 7938419, 7938420, 7938421, 7938422, 7938639, 7938642, 7938644, 7938659, 7938660, 7938677, 7938728, 7938762, 7938763, 7938766, 7938779, 7938791, 7938800, 8182827, 8182833, 8182837, 8182838, 8182839, 8182841, 8182844, 8182846, 8182849, 8182850, 8182851, 8182852, 8182853, 9047285, 9047287, 9047290, 9047291, 9047292, 9047296, 9047298, 9047302, 9047304, 9047306, 9047308, 9047311, 9047315, 9047317, 9047319, 9047321, 9817515, 9817540, 9817541, 9817543, 9817545, 9817546, 9817608, 9817611, 9817616, 9817618, 9817622, 9817624, 9817625, 9817633, 9817635, 9817649, 9817652, 9817712, 9817727, 9817728, 9817735, 9817745, 9817747, 9817755, 9817756, 9817771, 9817773, 9817774, 9817780, 9817784, 9817785, 9817787, 9817792, 9817796, 9817798, 9817800, 9817803, 9817806, 9817807, 9817819, 9817821, 9817822, 9817826, 9817831, 9817833, 9817836, 9817837, 9817840, 9817971, 9817972, 9817973, 9817975, 9817977, 9817982, 9817983, 9817987, 9817988, 9817991, 9817993, 9817994, 9817995, 9817997, 9818238, 9818246, 9818251, 9818255, 9818256, 9818263, 9818272, 9818958, 9818960, 9818962, 9818963, 9819053, 9819062, 9819063, 9819087, 9819305, 9819307, 9819309, 9819311, 9819312, 9819313, 9819315, 9819317, 9819318, 9819319, 9819320, 9819972, 9819974, 9819975, 9819977, 9819979, 9819982, 9819984, 9819986, 9819989, 9819991, 9819993, 9819998, 9819999, 9820000, 9820699, 9820702, 9820714, 9820720, 9820729, 9820731, 9820734, 9820736, 9820743, 9820744, 9820746, 9821641, 9821644, 9821655, 9821656, 9821666, 9821668, 9821670, 9822220, 9822224, 9822762, 9822765, 9822770, 9822771, 9822777, 9822781, 9822784, 9822785, 9822791, 9822793, 9822795, 9822807, 9822839, 9822843, 9822846, 9822852, 9822853, 9822859, 9822860, 9822896, 9822901, 9822902, 9822905, 9822918, 9822929, 9822934, 9822939, 9822943, 9822953, 9822960, 9822964, 9822971, 9822978, 9822988, 9822989, 9822993, 9822999, 9823006, 9823007, 9823008, 9823012, 9823015, 9823017, 9823019, 9823031, 9823046, 9823057, 9823059, 9823060, 9823075, 9823078, 9823140, 9823141, 9823147, 1777337, 1777842, 1778389, 1779342, 1779350, 2221924, 2448699, 2448711, 2448732, 2448746, 2448793, 2448801, 2449401, 2449415, 2449710, 2449716, 2449773, 2449810, 2449817, 2449823, 2451076, 2451291, 2451511, 2451756, 2452905, 2453100, 2453996, 2454638, 2454698, 2455882, 2709592, 3901358, 3901580, 4329231, 4333135, 4428491, 4428497, 4428505, 4428541, 4428571, 4428864, 4429610, 4429904, 5826413, 5826561, 5827781, 5827876, 5828660, 5917216, 5920141, 6135092, 6136248, 6136288, 6137503, 6137570, 6138330, 6139529, 6139535, 6140063, 6140067, 6140676, 6140779, 6140823, 6235661, 6319794, 6319834, 6319850, 6618614, 6620138, 6620153, 6620296, 7547955, 7863950, 7864721, 7934504, 7934548, 7936528, 7936934, 7936942, 7936965, 7937009, 7937154, 7937755, 7938282, 7938649, 7938755, 9817725, 9817824, 9818948, 9819994, 9822922, 9823011, and 9823070; b) Unit numbers 2221832, 2221837, 2448689, 2449746, 2449749, 2449756, 2449812, 2450504, 2451084, 2454631, 2709558, 2709572, 2709586, 2709587, 4329191, 4431115, 5826104, 5917214, 5917218, 6135025, 6139514, 6620264, 6620286, 6620298, 7934613, 7934625, 7935582, 7936529, 7937183, 7937988, 7937992, 7938005, 8182836, 9822211, 9822213, 9822218, 9822222, and 9823002; c) Unit number 4428572; d) Unit numbers 9047322, 1778571, 2454633, 4429334, 5919239, 6139534, 7937121, 7938219, 9823022, and 9823038; e) Unit number 7937177; f) Unit number 6139636; g) Unit numbers 1777219, 1777221, 1777228, 1777233, 1777236, 1777242, 1777249, 1777259, 1777324, 1777330, 1777341, 1777347, 1777348, 1777350, 1777352, 1777363, 1777364, 1777517, 1777520, 1777524, 1777528, 1777533, 1777534, 1777830, 1777831, 1777832, 1777834, 1777835, 1777838, 1777839, 1777840, 1777841, 1777846, 1777847, 1778015, 1778309, 1778310, 1778571, 1779127, 1779128, 1779341, 2221788, 2221798, 2221802, 2221815, 2221826, 2221827, 2221832, 2221842, 2221848, 2221849, 2221856, 2221864, 2221867, 2221930, 2221932, 2221934, 2221937, 2221938, 2221939, 2221940, 2221941, 2221943, 2221969, 2221972, 2221974, 2448656, 2448676, 2448682, 2448687, 2448689, 2448694, 2448705, 2448734, 2448739, 2448744, 2448769, 2448777, 2448779, 2448790, 2448820, 2449091, 2449095, 2449380, 2449418, 2449425, 2449436, 2449439, 2449482, 2449493, 2449501, 2449505, 2449512, 2449519, 2449537, 2449687, 2449689, 2449692, 2449699, 2449700, 2449719, 2449746, 2449749, 2449755, 2449756, 2449763, 2449784, 2449791, 2449793, 2449812, 2449813, 2449814, 2449816, 2449819, 2449821, 2449822, 2449824, 2450166, 2450174, 2450191, 2450194, 2450196, 2450200, 2450205, 2450504, 2450505, 2450655, 2450705, 2450711, 2450724, 2451052, 2451056, 2451059, 2451064, 2451072, 2451084, 2451096, 2451105, 2451107, 2451275, 2451280, 2451290, 2451297, 2451304, 2451309, 2451320, 2451329, 2451337, 2451338, 2451388, 2451389, 2451394, 2451397, 2451398, 2451400, 2451402, 2451404, 2451416, 2451423, 2451425, 2451489, 2451493, 2451636, 2451640, 2451676, 2451681, 2451688, 2451703, 2451759, 2451774, 2451785, 2451801, 2451803, 2451808, 2451811, 2451827, 2451847, 2451856, 2451886, 2451893, 2452900, 2452910, 2453081, 2453107, 2453969, 2453974, 2453976, 2453980, 2453983, 2453990, 2453998, 2454571, 2454573, 2454575, 2454580, 2454581, 2454584, 2454586, 2454591, 2454594, 2454599, 2454601, 2454608, 2454611, 2454614, 2454620, 2454624, 2454631, 2454633, 2454646, 2454710, 2454711, 2454714, 2454717, 2454722, 2454726, 2454742, 2454744, 2454745, 2454754, 2455601, 2455605, 2455607, 2455610, 2455613, 2455616, 2455619, 2455620, 2455621, 2455643, 2455732, 2455745, 2455794, 2455807, 2455831, 2455834, 2455843, 2455872, 2456120, 2709550, 2709552, 2709558, 2709562, 2709564, 2709568, 2709571, 2709572, 2709577, 2709580, 2709582, 2709586, 2709587, 2709589, 3901343, 3901347, 3901348, 3901350, 3901353, 3901360, 3901362, 3901363, 3901364, 3901579, 3901601, 4329189, 4329190, 4329191, 4329193, 4329195, 4329197, 4329201, 4329210, 4329230, 4329237, 4330244, 4330246, 4330249, 4330251, 4330256, 4330258, 4330264, 4330267, 4330268, 4330883, 4330899, 4330967, 4330968, 4330971, 4330972, 4330974, 4330976, 4331062, 4331221, 4331909, 4331919, 4331923, 4332693, 4332694, 4332699, 4332701, 4332703, 4332709, 4332711, 4332712, 4332714, 4332715, 4332719, 4333117, 4333119, 4333123, 4333125, 4428489, 4428512, 4428524, 4428542, 4428552, 4428553, 4428572, 4428576, 4428577, 4428581, 4428582, 4428587, 4428590, 4428598, 4428858, 4428861, 4428862, 4428868, 4428872, 4428875, 4428878, 4429307, 4429314, 4429319, 4429323, 4429324, 4429328, 4429330, 4429334, 4429608, 4429622, 4429634, 4429892, 4429901, 4429907, 4429911, 4429913, 4429919, 4429926, 4429927, 4429929, 4430711, 4430718, 4430729, 4431115, 4431122, 4431127, 4431133, 4431139, 5825042, 5825047, 5825049, 5826032, 5826103, 5826104, 5826107, 5826128, 5826149, 5826319, 5826371, 5826395, 5826396, 5826573, 5826610, 5827690, 5827692, 5827759, 5827785, 5827794, 5827811, 5827822, 5827844, 5827854, 5827862, 5828619, 5828622, 5828648, 5828650, 5917209, 5917212, 5917213, 5917214, 5917218, 5917220, 5917223, 5917224, 5917227, 5918043, 5918087, 5918155, 5918158, 5918160, 5918773, 5918775, 5919218, 5919220, 5919224, 5919225, 5919226, 5919236, 5919239, 5919240, 5919241, 5919243, 5919247, 5919249, 5919320, 5919324, 5919763, 5919764, 5919765, 5919784, 5919786, 5919788, 5919789, 5919792, 5919917, 5919919, 5919923, 5919924, 5919926, 5919927, 5919929, 5919930, 5919931, 5919933, 5919934, 5919935, 5919938, 5920041, 5920144, 5920145, 5920146, 5920148, 5920149, 5920150, 5920153, 5920156, 5920163, 5920164, 5920165, 5920166, 5920168, 5920536, 5920539, 5920548, 5920552, 5920646, 5920656, 5920661, 5920664, 5920665, 6134925, 6134932, 6134933, 6134942, 6134946, 6134948, 6134958, 6134966, 6134967, 6134969, 6134971, 6134973, 6134976, 6134978, 6134981, 6134989, 6134995, 6135025, 6135073, 6135075, 6135085, 6135086, 6135094, 6135104, 6135109, 6135113, 6135117, 6135121, 6135125, 6135130, 6135142, 6135146, 6135154, 6135164, 6135165, 6135563, 6135572, 6135575, 6135579, 6135597, 6135624, 6135626, 6135631, 6135635, 6135658, 6135684, 6135685, 6135691, 6136220, 6136224, 6136225, 6136232, 6136242, 6136245, 6136246, 6136283, 6137297, 6137456, 6137480, 6137499, 6137542, 6137550, 6137595, 6137597, 6137627, 6137634, 6137636, 6137641, 6138297, 6138321, 6138323, 6138327, 6138795, 6138827, 6138873, 6138876, 6138897, 6139256, 6139274, 6139341, 6139352, 6139353, 6139359, 6139360, 6139500, 6139514, 6139519, 6139520, 6139521, 6139526, 6139531, 6139532, 6139534, 6139624, 6139626, 6139628, 6139636, 6139637, 6139649, 6139657, 6139660, 6139666, 6140043, 6140046, 6140050, 6140054, 6140060, 6140071, 6140074, 6140076, 6140077, 6140084, 6140134, 6140658, 6140662, 6140678, 6140684, 6140698, 6140704, 6140724, 6140725, 6140771, 6140803, 6141484, 6141489, 6141493, 6141495, 6141508, 6141513, 6141515, 6141518, 6141519, 6234756, 6234764, 6234766, 6234779, 6234819, 6235403, 6235660, 6235740, 6236439, 6236441, 6236444, 6236451, 6236462, 6236464, 6236465, 6319788, 6319790, 6319796, 6319807, 6319812, 6319818, 6319819, 6319826, 6319827, 6319844, 6320882, 6320884, 6320889, 6320893, 6320903, 6321101, 6321112, 6321115, 6321121, 6321124, 6321126, 6321135, 6321138, 6321142, 6321152, 6321158, 6322652, 6322654, 6322658, 6322659, 6322661, 6322665, 6322667, 6322668, 6618551, 6618561, 6618570, 6618574, 6618587, 6618594, 6618611, 6618617, 6618619, 6618620, 6618622, 6619817, 6619819, 6619826, 6619828, 6619829, 6620254, 6620256, 6620266, 6620275, 6620278, 6620286, 6620289, 6620293, 6620308, 6620311, 6620320, 6620321, 7546313, 7547786, 7547805, 7547814, 7547937, 7547939, 7547944, 7547964, 7863942, 7863946, 7863947, 7863949, 7863951, 7863952, 7863953, 7863956, 7863957, 7863958, 7863959, 7864179, 7864195, 7864198, 7864202, 7864204, 7864712, 7864719, 7864727, 7864728, 7864730, 7864731, 7864734, 7934468, 7934478, 7934484, 7934486, 7934507, 7934513, 7934517, 7934523, 7934534, 7934537, 7934555, 7934569, 7934580, 7934584, 7934621, 7934631, 7934649, 7934655, 7934664, 7934731, 7934732, 7934735, 7934736, 7934738, 7934740, 7934741, 7934744, 7934752, 7934757, 7935533, 7935536, 7935539, 7935542, 7935545, 7935550, 7935554, 7935561, 7935565, 7935573, 7935577, 7935582, 7936529, 7936531, 7936554, 7936566, 7936575, 7936579, 7936920, 7936922, 7936926, 7936943, 7936944, 7936949, 7936952, 7936955, 7936967, 7936975, 7936977, 7936980, 7936981, 7936984, 7936985, 7936987, 7936989, 7936999, 7937002, 7937006, 7937011, 7937014, 7937052, 7937060, 7937066, 7937071, 7937094, 7937097, 7937108, 7937110, 7937112, 7937121, 7937127, 7937137, 7937144, 7937149, 7937158, 7937183, 7937189, 7937700, 7937702, 7937706, 7937718, 7937733, 7937736, 7937760, 7938158, 7938183, 7938185, 7938187, 7938197, 7938201, 7938206, 7938211, 7938217, 7938219, 7938232, 7938279, 7938295, 7938299, 7938317, 7938320, 7938321, 7938331, 7938336, 7938341, 7938344, 7938416, 7938419, 7938420, 7938421, 7938422, 7938639, 7938644, 7938659, 7938660, 7938677, 7938728, 7938762, 7938763, 7938791, 7938800, 8182827, 8182833, 8182837, 8182838, 8182839, 8182841, 8182844, 8182846, 8182851, 9047285, 9047287, 9047290, 9047291, 9047292, 9047296, 9047298, 9047302, 9047304, 9047306, 9047308, 9047311, 9047315, 9817540, 9817543, 9817545, 9817546, 9817611, 9817616, 9817618, 9817622, 9817727, 9817735, 9817747, 9817755, 9817771, 9817773, 9817774, 9817780, 9817784, 9817785, 9817796, 9817798, 9817800, 9817806, 9817819, 9817821, 9817822, 9817831, 9817836, 9817971, 9817972, 9817973, 9817977, 9817980, 9817982, 9817983, 9817987, 9817988, 9817991, 9817993, 9817995, 9817997, 9818238, 9818246, 9818251, 9818255, 9818256, 9818272, 9818958, 9818962, 9818963, 9819053, 9819087, 9819305, 9819307, 9819309, 9819311, 9819312, 9819313, 9819315, 9819317, 9819318, 9819319, 9819320, 9819972, 9819975, 9819977, 9819979, 9819982, 9819986, 9819989, 9819991, 9819993, 9819999, 9820000, 9820714, 9820729, 9820731, 9820736, 9820743, 9820744, 9820746, 9822211, 9822213, 9822222, 9822224, 9822762, 9822765, 9822771, 9822784, 9822793, 9822795, 9822807, 9822839, 9822843, 9822846, 9822852, 9822860, 9822896, 9822901, 9822918, 9822929, 9822934, 9822939, 9822943, 9822989, 9822993, 9823141, 9823147, 2451081, 2455746, 4329235, 4428484, 5826324, and 7934489 h) Unit numbers 2221963, 2221967, 6138290, 9822902, 9822905, 9820734, and 9822988; i) Unit numbers 9821641, 9821644, 9821655, 9821656, 9821666, and 9821668; j) Unit numbers 1777219, 1777221, 1777224, 1777228, 1777233, 1777236, 1777247, 1777249, 1777259, 1777264, 1777324, 1777330, 1777341, 1777347, 1777348, 1777350, 1777363, 1777364, 1777508, 1777515, 1777517, 1777518, 1777520, 1777524, 1777528, 1777531, 1777533, 1777534, 1777540, 1777830, 1777831, 1777832, 1777834, 1777835, 1777837, 1777840, 1777846, 1777847, 1778007, 1778009, 1778013, 1778015, 1778018, 1778020, 1778021, 1778023, 1778309, 1778571, 1778575, 1779126, 1779128, 1779331, 1779341, 2221788, 2221798, 2221802, 2221826, 2221827, 2221837, 2221842, 2221849, 2221864, 2221867, 2221930, 2221932, 2221934, 2221937, 2221938, 2221939, 2221940, 2221943, 2221963, 2221967, 2221969, 2221972, 2221974, 2448656, 2448676, 2448682, 2448687, 2448689, 2448694, 2448705, 2448769, 2448777, 2448779, 2448790, 2448820, 2449091, 2449095, 2449380, 2449418, 2449425, 2449426, 2449436, 2449482, 2449493, 2449505, 2449512, 2449519, 2449537, 2449665, 2449670, 2449687, 2449689, 2449699, 2449700, 2449749, 2449755, 2449756, 2449763, 2449768, 2449779, 2449784, 2449791, 2449793, 2449813, 2449814, 2449819, 2449821, 2449822, 2450173, 2450174, 2450191, 2450194, 2450196, 2450200, 2450205, 2450505, 2450655, 2450705, 2450711, 2451056, 2451064, 2451072, 2451081, 2451084, 2451092, 2451096, 2451099, 2451275, 2451280, 2451290, 2451297, 2451304, 2451309, 2451329, 2451337, 2451338, 2451389, 2451394, 2451397, 2451398, 2451400, 2451402, 2451404, 2451416, 2451423, 2451425, 2451492, 2451502, 2451636, 2451639, 2451640, 2451667, 2451670, 2451676, 2451681, 2451684, 2451688, 2451695, 2451698, 2451710, 2451717, 2451759, 2451774, 2451785, 2451789, 2451801, 2451803, 2451808, 2451827, 2451847, 2451856, 2451883, 2451886, 2451893, 2451903, 2452900, 2452903, 2452910, 2453077, 2453081, 2453097, 2453115, 2453116, 2453984, 2453990, 2453998, 2454571, 2454573, 2454575, 2454581, 2454584, 2454591, 2454594, 2454599, 2454601, 2454608, 2454611, 2454614, 2454631, 2454633, 2454646, 2454691, 2454710, 2454711, 2454717, 2454722, 2454726, 2454745, 2455601, 2455607, 2455610, 2455613, 2455616, 2455619, 2455620, 2455621, 2455632, 2455633, 2455643, 2455648, 2455732, 2455745, 2455746, 2455835, 2455837, 2455841, 2455843, 2455845, 2455858, 2455867, 2455872, 2455874, 2456120, 2709550, 2709552, 2709558, 2709564, 2709582, 2709586, 2709587, 2709589, 3901347, 3901350, 3901353, 3901363, 3901364, 3901579, 3901601, 4329193, 4329195, 4329197, 4329201, 4329210, 4329230, 4329235, 4329237, 4330244, 4330249, 4330251, 4330256, 4330258, 4330260, 4330264, 4330883, 4330899, 4330971, 4330972, 4330974, 4330976, 4331062, 4331212, 4331221, 4331227, 4331909, 4331912, 4331915, 4331919, 4331921, 4331923, 4332693, 4332694, 4332699, 4332701, 4332703, 4332709, 4332711, 4332712, 4332714, 4332715, 4332719, 4333123, 4333129, 4428480, 4428482, 4428484, 4428487, 4428489, 4428502, 4428524, 4428540, 4428542, 4428552, 4428553, 4428572, 4428576, 4428577, 4428587, 4428590, 4428598, 4428858, 4428862, 4428868, 4428872, 4428875, 4428878, 4429307, 4429308, 4429311, 4429314, 4429318, 4429319, 4429323, 4429324, 4429328, 4429336, 4429338, 4429596, 4429602, 4429608, 4429622, 4429633, 4429634, 4429645, 4429919, 4429924, 4429927, 4429929, 4430711, 4430718, 4431115, 4431119, 4431122, 4431127, 4431133, 4431139, 5825042, 5826032, 5826103, 5826104, 5826107, 5826319, 5826324, 5826395, 5826396, 5826405, 5826409, 5826544, 5827690, 5827692, 5827759, 5827785, 5827794, 5827811, 5827822, 5827837, 5827844, 5827854, 5827862, 5828648, 5917209, 5917212, 5917213, 5917214, 5917218, 5917219, 5917223, 5918054, 5918155, 5918158, 5918160, 5919218, 5919225, 5919226, 5919230, 5919236, 5919237, 5919239, 5919241, 5919245, 5919247, 5919249, 5919784, 5919786, 5919788, 5919789, 5919792, 5919917, 5919923, 5919924, 5919931, 5919934, 5919935, 5919938, 5919939, 5920144, 5920145, 5920146, 5920149, 5920536, 5920539, 5920552, 6134925, 6134932, 6134933, 6134942, 6134943, 6134948, 6134958, 6134966, 6134967, 6134969, 6134971, 6134973, 6134976, 6134978, 6134981, 6134989, 6134995, 6135073, 6135085, 6135104, 6135125, 6135130, 6135146, 6135164, 6135165, 6135563, 6135569, 6135572, 6135575, 6135579, 6135597, 6135601, 6135617, 6135624, 6135626, 6135631, 6135635, 6135641, 6135648, 6135667, 6135676, 6135684, 6135685, 6135691, 6136220, 6136225, 6136232, 6136233, 6136242, 6136246, 6136253, 6136267, 6136275, 6137297, 6137301, 6137402, 6137456, 6137480, 6137490, 6137499, 6137542, 6137550, 6137595, 6137623, 6137627, 6137634, 6137641, 6138290, 6138297, 6138321, 6138323, 6138327, 6138796, 6138819, 6138827, 6138897, 6139256, 6139274, 6139277, 6139278, 6139287, 6139334, 6139341, 6139352, 6139353, 6139500, 6139514, 6139519, 6139520, 6139521, 6139526, 6139531, 6139532, 6140039, 6140043, 6140046, 6140050, 6140054, 6140060, 6140074, 6140076, 6140077, 6140082, 6140084, 6140089, 6140649, 6140658, 6140662, 6140684, 6140698, 6140704, 6140711, 6140724, 6140725, 6140771, 6140803, 6141484, 6141489, 6141493, 6141495, 6141508, 6141515, 6141518, 6141519, 6234754, 6234756, 6234768, 6234773, 6234775, 6234777, 6234778, 6234779, 6234781, 6234819, 6235403, 6235652, 6235716, 6235756, 6235757, 6236439, 6236451, 6236462, 6236464, 6320903, 6321101, 6321112, 6321115, 6321121, 6321124, 6321126, 6321138, 6321142, 6321152, 6322654, 6322661, 6322668, 6618570, 6618574, 6618587, 6618592, 6618593, 6618594, 6618611, 6618617, 6618619, 6618620, 6618622, 6619817, 6619826, 6619829, 6619832, 6620254, 6620259, 6620262, 6620265, 6620266, 6620272, 6620275, 6620278, 6620282, 6620286, 6620289, 6620293, 6620302, 6620307, 6620311, 6620313, 6620316, 6620320, 6620321, 7546313, 7547786, 7547787, 7547935, 7547937, 7547939, 7547941, 7547943, 7547944, 7547950, 7547964, 7863942, 7863943, 7863945, 7863946, 7863947, 7863953, 7863956, 7864179, 7864184, 7864193, 7864195, 7864198, 7864202, 7864204, 7864727, 7864728, 7864730, 7864731, 7864733, 7864734, 7934465, 7934468, 7934478, 7934479, 7934507, 7934513, 7934517, 7934523, 7934537, 7934555, 7934569, 7934580, 7934613, 7934621, 7934631, 7934648, 7934649, 7934655, 7934664, 7934731, 7934732, 7934735, 7934736, 7934738, 7934740, 7934741, 7934744, 7934752, 7934757, 7936961, 7936970, 7936973, 7936975, 7936980, 7936981, 7936984, 7936985, 7936987, 7936989, 7936990, 7936999, 7937002, 7937005, 7937006, 7937010, 7937011, 7937014, 7937016, 7937021, 7937022, 7937052, 7937060, 7937066, 7937071, 7937083, 7937094, 7937097, 7937121, 7937127, 7937144, 7937158, 7937170, 7937177, 7937189, 7937706, 7937733, 7937736, 7937760, 7938181, 7938183, 7938185, 7938193, 7938197, 7938211, 7938217, 7938219, 7938228, 7938279, 7938295, 7938299, 7938317, 7938320, 7938331, 7938336, 7938341, 7938344, 7938416, 7938417, 7938419, 7938420, 7938421, 7938422, 7938642, 7938644, 7938659, 7938660 ,7938677, 7938728, 7938762, 7938763, 7938766, 7938779, 7938791, 8182841, 8182851, 9047285, 9047287, 9047290, 9047292, 9047298, 9047302, 9047304, 9047308, 9047311, 9047319, 9047321, 9817515, 9817541, 9817543, 9817546, 9817616, 9817618, 9817624, 9817625, 9817633, 9817649, 9817652, 9817727, 9817735, 9817745, 9817747, 9817771, 9817784, 9817785, 9817787, 9817792, 9817796, 9817798, 9817800, 9817803, 9817806, 9817807, 9817819, 9817821, 9817822, 9817831, 9817833, 9817836, 9817837, 9817971, 9817972, 9817973, 9817975, 9817977, 9817980, 9817982, 9817983, 9817987, 9817988, 9817991, 9817993, 9817995, 9817997, 9818238, 9818251, 9818263, 9818272, 9818958, 9818960, 9818962, 9818963, 9819053, 9819062, 9819063, 9819087, 9819305, 9819307, 9819309, 9819311, 9819312, 9819313, 9819315, 9819317, 9819318, 9819319, 9819320, 9819972, 9819974, 9819975, 9819977, 9819979, 9819982, 9819984, 9819986, 9819991, 9819993, 9819998, 9820000, 9820702, 9820714, 9820736, 9820743, 9820744, 9822211, 9822213, 9822218, 9822222, 9822224, 9822762, 9822765, 9822770, 9822771, 9822777, 9822784, 9822785, 9822793, 9822807, 9822839, 9822843, 9822852, 9822859, 9822902, 9822905, 9822929, 9822934, 9822939, 9822943, 9822988, 9822989, 9822993, 9823140, and 9823147 k) Unit number 9821656 l) Unit numbers 1777530, 1778376, 1778387, 2448664, 2450179, 2450503, 2451308, 2451335, 2451384, 2451705, 2451884, 2453969, 2453974, 2453976, 2453980, 2453983, 2453988, 2454734, 2455623, 4330970, 4332316, 4332696, 4429889, 4430714, 5825484, 5826034, 5826555, 6134997, 6135008, 6135160, 6137206, 6137574, 6137625, 6138902, 6139395, 6139513, 6140653, 6140766, 6236457, 6319861, 6320901, 6321145, 6620125, 6620126, 6620128, 6620135, 6620136, 6620139, 6620141, 6620150, 6620155, 6620159, 6620160, 6620170, 6620230, 6620269, 6620280, 6620292, 6620298, 7547961, 7864181, 7864205, 7864735, 7934636, 7936577, 7936590, 7936599, 7937079, 7938155, 7938306, 7938311, 9817622, 9817994, 9820699, 9820720, 9821641, 9821644, 9821655, 9821666, 9821668, 9821670, 1776850, 1777229, 1777242, 1777352, 1777838, 1777839, 1777841, 1777844, 1778012, 1778310, 1778372, 1778374, 1778377, 1778378, 1778379, 1778380, 1778382, 1778384, 1778390, 1778398, 1778558, 1779127, 2221815, 2221832, 2221848, 2221856, 2221941, 2448734, 2448739, 2448744, 2449439, 2449501, 2449692, 2449719, 2449741, 2449746, 2449806, 2449812, 2449816, 2449824, 2450165, 2450166, 2450201, 2450504, 2450724, 2451052, 2451059, 2451105, 2451107, 2451320, 2451388, 2451408, 2451409, 2451483, 2451489, 2451493, 2451513, 2451703, 2451811, 2452896, 2453085, 2453101, 2453107, 2453968, 2454578, 2454580, 2454583, 2454620, 2454624, 2454714, 2455605, 2455614, 2455794, 2455880, 2709562, 2709568, 2709571, 2709572, 2709574, 2709577, 2709580, 3901343, 3901348, 3901360, 3901362, 4329185, 4329188, 4329189, 4329190, 4329191, 4330246, 4330248, 4330267, 4330268, 4330967, 4330968, 4332326, 4333117, 4333119, 4428498, 4428512, 4428581, 4428582, 4428861, 4428883, 4429317, 4429330, 4429334, 4429888, 4429892, 4429901, 4429907, 4429911, 4429913, 4429926, 4430727, 4430729, 4431105, 5825047, 5825049, 5826128, 5826149, 5826371, 5826567, 5826573, 5826574, 5826610, 5826629, 5827767, 5828106, 5828108, 5917220, 5917224, 5917227, 5918042, 5918043, 5918084, 5918087, 5918770, 5918773, 5918775, 5918776, 5918778, 5918784, 5918788, 5918789, 5918790, 5918793, 5918794, 5919220, 5919224, 5919240, 5919243, 5919320, 5919324, 5919761, 5919763, 5919764, 5919765, 5919774, 5919780, 5919919, 5919926, 5919927, 5919929, 5919930, 5919933, 5920041, 5920533, 5920548, 5920558, 6134946, 6134987, 6135006, 6135025, 6135075, 6135086, 6135092, 6135094, 6135109, 6135113, 6135117, 6135121, 6135138, 6135142, 6135154, 6135584, 6135607, 6135656, 6135658, 6135662, 6135693, 6136224, 6136245, 6136252, 6137493, 6137597, 6137636, 6138795, 6138838, 6138873, 6138876, 6139359, 6139360, 6139534, 6139624, 6139626, 6139628, 6139636, 6139637, 6139649, 6139657, 6139660, 6139666, 6140071, 6140134, 6140678, 6140686, 6140712, 6141513, 6234753, 6234758, 6234761, 6234764, 6234766, 6234770, 6234814, 6235660, 6235664, 6235739, 6235740, 6235752, 6236437, 6236441, 6236444, 6236465, 6319788, 6319790, 6319796, 6319799, 6319805, 6319807, 6319811, 6319812, 6319818, 6319819, 6319823, 6319824, 6319826, 6319827, 6319843, 6319844, 6319848, 6319855, 6319857, 6319863, 6320882, 6320884, 6320887, 6320889, 6320893, 6321106, 6321130, 6321135, 6321141, 6321158, 6322673, 6618551, 6618561, 6618564, 6618599, 6618610, 6618789, 6619819, 6619828, 6619830, 6620207, 6620212, 6620218, 6620220, 6620225, 6620256, 6620264, 6620304, 6620308, 7547800, 7547803, 7547805, 7547808, 7547814, 7547819, 7863949, 7863951, 7863952, 7863957, 7863958, 7863959, 7863961, 7864712, 7864719, 7934483, 7934484, 7934486, 7934488, 7934489, 7934534, 7934584, 7934625, 7935533, 7935536, 7935539, 7935542, 7935545, 7935554, 7935573, 7935577, 7935580, 7935582, 7936529, 7936531, 7936553, 7936554, 7936557, 7936563, 7936566, 7936575, 7936579, 7936583, 7936601, 7936920, 7936922, 7936926, 7936929, 7936943, 7936944, 7936949, 7936952, 7936955, 7936967, 7936977, 7937024, 7937108, 7937110, 7937112, 7937149, 7937183, 7937700, 7937702, 7937718, 7937960, 7937967, 7937970, 7937972, 7937974, 7937975, 7937976, 7937978, 7937988, 7937989, 7937992, 7937995, 7937996, 7937998, 7938000, 7938003, 7938005, 7938006, 7938158, 7938167, 7938187, 7938201, 7938206, 7938227, 7938232, 7938321, 7938399, 7938400, 7938403, 7938404, 7938406, 7938407, 7938408, 7938411, 7938412, 7938413, 7938415, 7938639, 8182827, 8182833, 9047291, 9047296, 9047306, 9047315, 9047317, 9047322, 9817540, 9817545, 9817608, 9817611, 9817635, 9817712, 9817728, 9817755, 9817756, 9817773, 9817774, 9817780, 9817826, 9817829, 9817840, 9818246, 9818247, 9818255, 9818256, 9819989, 9819999, 9820729, 9820731, 9820734, 9820746, 9821651, 9822220, 9822795, 9822918, 9822953, 9822960, 9822964, 9822971, 9822978, 9823002, 9823006, 9823007, 9823008, 9823012, 9823015, 9823017, 9823019, 9823022, 9823031, 9823038, 9823046, 9823057, 9823059, 9823060, 1777337, 1777842, 1778389, 2221924, 2448699, 2448711, 2448732, 2448746, 2448793, 2448801, 2448813, 2449401, 2449415, 2449710, 2449716, 2449773, 2449810, 2449817, 2449823, 2451291, 2451511, 2451756, 2453996, 2454588, 2454638, 2454694, 2454698, 2709554, 2709592, 3901358, 3901580, 4329231, 4333135, 4428481, 4428491, 4428497, 4428505, 4428508, 4428515, 4428541, 4428551, 4428571, 4428592, 4429610, 4429904, 5826413, 5826561, 5827781, 5827876, 5917216, 5918154, 5920141, 6135608, 6136248, 6136288, 6137503, 6137570, 6138330, 6139268, 6139529, 6139535, 6140063, 6140067, 6140676, 6140779, 6140823, 6141504, 6235661, 6236962, 6319794, 6319834, 6319850, 6618608, 6618614, 6620296, 7547955, 7863950, 7864721, 7934504, 7934548, 7936528, 7936934, 7936942, 7936965, 7937009, 7937125, 7937154, 7937755, 7938282, 7938649, 7938755, 9817725, 9817824, 9818948, 9819994, 9822922, 9823011, 9823070. RECALLING FIRM/MANUFACTURER LifeSource Blood Services, Glenview, IL, by telephone on June 21 and 24, 2002 and by fax and letters on July 1 and 2, 2002. Firm initiated recall is complete. REASON Blood products, that were collected by an employee who was observed on at least one occasion to collect blood in a manner that may compromise the sterility of the product, were distributed. VOLUME OF PRODUCT IN COMMERCE a) 1492 units; b) 38 units; c) 1 unit; d) 10 units; e) 1 unit; f) 1 unit; g) 967 units; h) 7 units; i) 6 units; j) 877 units; k) 1 unit; l) 623 units. DISTRIBUTION IL, WI, FL, Switzerland and Scotland. _______________________ PRODUCT Platelets, Recall # B-1988-2. CODE Unit numbers 30GJ48226, 30GM11183, 30GW35751, 30GW35763, 30GW35764, 30LE02779, 30GF32183, 30GK04002, 30GN48575, 30GN48582, 30GN48592, 30GS29232, 30GT10073, 30LV06407, 30LV06408, and 30LV06412. RECALLING FIRM/MANUFACTURER The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by telephone on September 26, 2001 and by letter on October 1, 2001. Firm initiated recall is complete. REASON Blood products, exposed to unacceptable temperatures, were distributed. VOLUME OF PRODUCT IN COMMERCE 16 units. DISTRIBUTION PA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-2019-2. CODE Unit number 04FR62564. RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA, by telephone on May 30, 2002 and by letter on June 26, 2002. Firm initiated recall is complete. REASON Blood product, that was not leukoreduced within the appropriate time period from collection, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MA. _______________________ PRODUCT Platelets, Recall # B-2025-2. CODE Unit number 22KK43735. RECALLING FIRM/MANUFACTURER The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on October 2, 2001 and by letter on October 15, 2001. Firm initiated recall is complete. REASON Blood product, whose collection time exceeded the maximum time in the firm’s standard operating procedures, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION PA. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-2032-2. CODE Unit number 36264-3533. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on March 19, 2002. Manufacturer: Blood Systems, Inc., Ventura, CA. Firm initiated recall is complete. REASON Blood product, that did not have the complete amount of additive solution included, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
_______________________ PRODUCT LCx Neisseria gonorrhoeae Assay, Amplification & Detection Kit, 96 tests. Recall # Z-1214-2. CODE All lots list 8A48-81: lots 84073M400, 84075M400, 84142M300, 84146M300, 85099M300, 85487M20085488M200, 85489M200 list 8A48-82: lots 86800M300, 87007M400, 87103M400, 87225M100, 87240M100, 87243M100, 87376M200, 87377M200, 87378M200, 87818M100, 87899M200, 87905M200, 88097M300, 88105M300, 88106M300, 88107M300, 88110M300, 88111M300, 88439M200, 88439M201, 88556M300, 88850M300, 89177M300, 89187M100. RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Abbott Park, IL, by letters dated July 18, 2002. Firm initiated recall is ongoing. REASON May not meet sensitivity specifications. VOLUME OF PRODUCT IN COMMERCE 15,084. DISTRIBUTION Nationwide and Internationally.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
****CORRECTIONS****
The following recall from September 18, 2002 Enforcement Report is NOT a recall. The product was subject to a market withdrawal; there was no health risk, nor was there a violation of FDA laws or regulations: Radionics Recording Electrode Kits: a) Recording Electrode Kit for PMD-D (REK-PMD). Recall #Z-1322-2; b) Recording Electrode Kit for AccuDrive (REK-FMD). Recall # Z-1323-2. The ER of September 18, 2002, Recall # Z-1288-2, HP Deskjet 970Cxi Printer, listed an incorrect Recall #. The correct recall # is: Z-1286- 2. _______________________ PRODUCT Diagnost 88 with a monitor support arm 9804-404-10X03, 9804-404-40X03 [where X is any number 0-9]. Recall # Z-1327-2. CODE Diagnost 88 with a monitor support arm 9804-404-10X03, 9804-404-40X03 [where X is any number 0-9] RECALLING FIRM/MANUFACTURER Philips Medical Systems North America, Inc., Shelton, CT, by field change order between August 4, 2001 and April 2002. Firm initiated recall is complete. REASON Monitor may fall due to failure of support arm. VOLUME OF PRODUCT IN COMMERCE 6. DISTRIBUTION MS, NJ and NY. _______________________ PRODUCT Trade name: EmpowerCT Injector System, Model/Catalog #: 9800. Legally Marketed Name: PercuPump II with EDA CT Injector Recall # Z-1328-2. CODE Injectors Affected by the "Service Advisory" with software version 1.02a or earlier have serial numbers P61012 – P61076. The system can be configured with various accessories which include the following catalog numbers: 9830, 9820, 9825, 9870, 9850, 9851, 9852, 9853, 9855, 9856, 9857, 9858, 9860, 9871, 9875, 9876, 9877, 9885S M & L, 9886S M & L, 9887, 9888, 9895, 9896, 6720, 7881. RECALLING FIRM/MANUFACTURER E-Z-EM, Inc., Westbury, NY, by service advisory bulletin dated April 2, 2002. Firm initiated recall is ongoing. REASON Software anomaly can cause excess contrast agent to be injected during test injection. VOLUME OF PRODUCT IN COMMERCE 61 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Opera & Tempo Patient Lifts, Non-AC Powered: a) model KPB3500-21US - Opera Combi. Recall # Z-1329-2; b) model KPB3002-21US - Opera Combi with Scale. Recall # Z-1330-2; c) model KPB3100-22US - Opera PPP (Power Patient Positioning). Recall # Z-1331-2; d) model KPB3160-22US - Opera PPP with Scale. Recall # Z-1332-2; e) model KPB5100-23US - Tempo PPP (Power Patient Positioning). Recall # Z-1333-2; f) model KPB5150-23US - Tempo PPP with Scale. Recall # Z-1334-2; g) model KPB5000-23US - Tempo with 4 Point Hanger Bar. Recall # Z-1335-2; h) model KPB5050-23US - Tempo with 4 Point Hanger and Scale. Recall # Z-1336-2. CODE Opera Patient Lifts with serial numbers prior to GB2002896045002; Tempo Patient Lifts with serial numbers prior to GB1902895367001. RECALLING FIRM/MANUFACTURER Recalling Firm: Arjo, Inc., Roselle, IL, by letter on August 9, 2002. Manufacturer: Arjo Ltd., Gloucester, United Kingdom. Firm initiated recall is ongoing. REASON Hanger bar and jib may detach from the patient lift. VOLUME OF PRODUCT IN COMMERCE 660 lifts. DISTRIBUTION Nationwide. _______________________ PRODUCT Becton Dickinson's EpiCenter Data Management System software. Recall # Z-1338-2. CODE EpiCenter Software, version 3.20B, Catalog #441007. RECALLING FIRM/MANUFACTURER Becton Dickinson Microbiology Systems, Sparks, MD, by letter on August 1, 2002. Firm initiated recall is ongoing. REASON IVD software defect may cause incorrect patient results to be reported. VOLUME OF PRODUCT IN COMMERCE 336 units. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT SurgAssist Circular Stapler DLU, Digital Loading Unit. The device is a single use sterile device. The device has 24 implantable titanium staples with it. The device is individually packaged and sold/shipped 6 devices per box. Recall # Z-1340-2/Z-1341-2. CODE SurgAssist CS29, Circular Stapler DLU, 29mm - lots: DS000103; DS000105; DS000108 and DS000110. SurgAssist CS33, Circular Stapler DLU, 33mm - lots: DS000009; DS000014; DS000020; DS000022; DS000025; DS000029; DS000031; DS000034; DS00003 5; DS000060; DS000066; DS000067; DS000074; DS000079; DS000080; DS000098; DS000101 and DS000109. RECALLING FIRM/MANUFACTURER Power Medical Interventions, Inc., New Hope, PA, by letters on May 3, 2002. Firm initiated recall is complete. REASON Does not complete firing cycle. VOLUME OF PRODUCT IN COMMERCE 1080 units. DISTRIBUTION Nationwide and Germany, Italy and Ireland. _______________________ PRODUCT Tosoh brand AIA-PACK Progesterone Calibrator Set. Recall # Z-1342-2. CODE Catalog # 020381, Lot # C332226, Expiration Date 3/2003. RECALLING FIRM/MANUFACTURER Recalling Firm: Tosoh Medics, Inc., South, San Francisco, CA, by telephone on August 8, 2002. Firm initiated recall is ongoing. REASON This product does not meet the stated claim for shelf life stability. VOLUME OF PRODUCT IN COMMERCE 35. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT The Power Cord from the printer that may be sent as an accessory to the Architect i2000 System or Abbott Commander. Recall # Z-1343-2. CODE Not specified. RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX, by telephone on or about January 31, 2002. Firm initiated recall is complete. REASON Power Cord recalled from Supplier. VOLUME OF PRODUCT IN COMMERCE 337. DISTRIBUTION Nationwide and Singapore, Hong Kong and Korea. _______________________ PRODUCT Exactech brand AcuDriver Carbide punch, long, Model Name Carbide punch, sterile, Catalog Number 400-40-25. Recall # Z-1344-2. CODE Serial Numbers 0105608-0105621. RECALLING FIRM/MANUFACTURER Exactech, Inc., Gainesville, FL, by letter on July 1, 2002. Firm initiated recall is ongoing. REASON Sterility barrier may be compromised in some packaging. VOLUME OF PRODUCT IN COMMERCE 8. DISTRIBUTION FL, LA, MN, ME, NY, NV AND WA.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________ PRODUCT Huber Plus Safety Infusion Set, product code MM 2034. The proprietary name is Huber Plus Safety Infusion Set and the common name is Huber Needle and Administration Set. Recall # Z-1337-2. CODE Lot number 2D018MK. RECALLING FIRM/MANUFACTURER Now Medical Distribution Inc., West Chester, PA, by letter dated May 23, 2002. Firm initiated recall is complete. REASON Device labeled with incorrect gauge size. VOLUME OF PRODUCT IN COMMERCE 4575 units. DISTRIBUTION CA, KS, MN, NY, OH, PA and WA. _______________________ PRODUCT Premier HSV, an EIA diagnostic test kit, packaged under the Meridian Premier brand label. Recall # Z-1339-2. CODE --- Premier HSV kits --- Lot Numbers and Exp. Dates: #550010.079, Exp. 02 Aug 02 #550010.080, Exp. 02 Aug 02 #550010.082, Exp. 26 Jul 02 The catalog number is #550010. --- OPD Substrate Tablets (kit component) --- Lot Number: 9677.043 RECALLING FIRM/MANUFACTURER Meridian Bioscience, Inc., Cincinnati, OH, by letter dated May 23, 2002. Firm initiated recall is ongoing. REASON The OPD Substrate Tablets have deteriorated due to moisture, and may result in inaccurate test results. VOLUME OF PRODUCT IN COMMERCE 594 kits (lot .07930; lot .080 2; lot .082 2). DISTRIBUTION Nationwide. _______________________ PRODUCT Focus Night and Day extended wear contact lens. Recall # Z-1345-2. CODE Lot 2517083. RECALLING FIRM/MANUFACTURER Recalling Firm: Ciba Vision Corp., Duluth, GA, by letter dated July 19, 2002. Firm initiated recall is ongoing. REASON A 2-Week Focus lens found inside carton of Focus Night and Day lens. VOLUME OF PRODUCT IN COMMERCE 933/six-pack cartons. DISTRIBUTION Nationwide and Internationally.RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II
_______________________ PRODUCT Product is flavor enhancer intended for use in pet food, labeled in part: "8280 FLAVOR GENERATOR #1" packaged in 1,000 and 2,000 pound bags. Recall # V-163-2. CODE All lots shipped prior to 04/09/02. RECALLING FIRM/MANUFACTURER Roche Vitamins, Inc., Fort Worth, TX, by telephone on April 5, 2002. FDA initiated recall is complete. REASON Product contains beef protein but is not labeled with the warning statement regarding prohibited for use as feed for ruminants. VOLUME OF PRODUCT IN COMMERCE 680,200 lbs. DISTRIBUTION KS, CA, KY and IN.RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS III
_______________________ PRODUCT Fort Dodge Hyalovet, Hyaluronate Sodium, Veterinary Injection for Intra- Articular Administration, 20 mg. hyaluronate sodium per 2-ml. vial, for use in horses only for the intra-articular treatment of carpal or fetlock joint dysfunction due to acute or chronic noninfectious synovitis associated with equine osteoarthritis, RX, NADA # 140-806, product of Italy. The label shows the product is Distributed by Fort Dodge Animal Health, Fort Dodge, IA. Recall # V-161-2. CODE Lot 014000, Exp. Feb-02 Lot 014100, Exp. Mar-02 Lot 014200, Exp. Sep-02 Lot 014300, Exp. Sep-02 Lot 014400, Exp. Dec-02 Lot 014500, Exp. Feb-03 Lot 014600, Exp. Apr-03 Lot 014700, Exp. Jun-03 Lot 014800, Exp. Sep-03 Lot 014900, Exp. Oct-03 Lot 015000, Exp. Dec-03 Lot 015100, Exp. Feb-04 Lot 015200, Exp. Feb-04 Lot 015300, Exp. Mar-04. RECALLING FIRM/MANUFACTURER Recalling Firm: Fort Dodge Animal Health, Fort Dodge, IA, by letter on December 14, 2001. Manufacturer: Fidia S.p.A., Padua, Italy. Firm initiated recall is complete. REASON Failed pH specifications. VOLUME OF PRODUCT IN COMMERCE 82,613/2-ml. Vials. DISTRIBUTION Nationwide.END OF ENFORCEMENT REPORT FOR SEPTEMBER 25, 2002 ####
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2002-SEP-26.