January 30, 2002 02-04
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________ PRODUCT Metabolife Diet & Energy bar with special Nutrition Formula, Contians Inulin, Green Tea Extract. Including flavors: 1) Lemony Lemon, Yogurt Coated. Recall #F-144-2; 2) Downright Chocolate, Chocolate Flavor Coated. Recall # F-145-2 3) Perfectly Peanut, Chocolate Flavor Coated. Recall # F-146-2; 4) Outrageous Oatmeal Raisin, Yogurt Coated. Recall # F-147-2. All bars are Net Weight 2 Oz. (56.8 g) CODE Best buy dates 2/16/02 and earlier. RECALLING FIRM/MANUFACTURER Recalling Firm: Metabolife International, San Diego, CA, on May 9, 2001 via press release followed by faxed letters and emails. Manufacturer: MLO Products Fairfield, CA. Firm initiated recall is complete. REASON The products contained excessive amounts of Vitamin A. VOLUME OF PRODUCT IN COMMERCE 4,917,216 bars. DISTRIBUTION Nationwide _______________________ PRODUCT Bauer Butterkase Semi-soft Cheese, in retail and bulk package sizes. The retail sizes are individual weight packages of 7-9 ounces in 5- and 10-pound cases. The bulk size is an individual weight loaf of about 6 pounds, shipped 3 to a case, Recall # F-183-2. CODE Sell-by dates up to 03/19/02 on retail product, and bulk product shipped prior to 6/29/01. RECALLING FIRM/MANUFACTURER Recalling Firm: Swissrose/ConAgra, Foods Moonache, NJ, by telephone on June 26 and 27, 2001 and by letter on June 29, 2001. Manufacturer: J. Bauer KG 83501 Wasserburg, Germany. Firm initiated recall is complete. REASON The product contains undeclared egg white lysozyme. VOLUME OF PRODUCT IN COMMERCE About 3000/10-pound cases of retail product and about 3000/18- pound cases of bulk product. DISTRIBUTION Nationwide. _______________________ PRODUCT 24 lb. cases of frozen Chocolate Chip Cookies with 20 bulk packs of dough per case (this dough is baked into cookies at the store), Recall # F-184-2; Store labeled bags containing 3 dozen chocolate chip cookies, net wt. 28 oz., Recall # F-185-2; Store labeled bags containing 3 dozen cookies, net wt. 28 oz.(assorted cookies), Recall # F-186-2. CODE All products purchased between Aug. 13 and Aug 20, 2001. RECALLING FIRM/MANUFACTURER Recalling Firm: Publix Super Markets Inc. Lakeland, FL, by E- mail on Aug. 21, 2001. Manufacturer: Publix Bakery Plant Lakeland, FL. Firm initiated recall is complete. REASON Chocolate Chip Cookies contained undeclared pecans and almonds. VOLUME OF PRODUCT IN COMMERCE 160/24 lb. cases. DISTRIBUTION FL, GA and SC. _______________________ PRODUCT "La Maree" brand Cold Smoked Fish Products: 1) Smoked Salmon Trimmings, refrigerated, in vacuum packages printed with black lettering on gold foil background and a white stick-on tag, labeled in part: ”xxx La Maree xxx Portier Fine Foods xxx Mamaroneck, NY xxx Smoked Salmon Trimmings xxx Keep refrigerated 38 Degrees xxx Fresh Atlantic Salmon, Salt, Brown sugar xxx”. Packed in the following sizes: ¼ lb., ½ lb., 1 lb., Recall # F-195-2; 2) Smoked Spiritual Salmon, refrigerated, in vacuum packages printed with black lettering on gold foil background and a white stick-on tag, labeled in part: ”xxx La Maree xxx Portier Fine Foods xxx Mamaroneck, NY xxx Smoked Spiritual Salmon xxx Keep Refrigerated 38 Degrees xxx Fresh Atlantic Salmon, Salt, Brown sugar, Tequila/Vodka/Bourbon/Scotch, Hickory/Oak smoked xxx”. Packed in the following sizes: ¼ lb., ½ lb., 1 lb. and bulk-weight sides, Recall # F-196-2; 3) Smoked Pastrami Salmon, refrigerated, in vacuum packages printed with black lettering on gold foil background and a white stick-on tag, labeled in part: ”xxx La Maree xxx Portier Fine Foods xxx Mamaroneck, NY xxx Smoked Pastrami Salmon xxx Keep refrigerated 38 Degrees xxx Fresh Atlantic Salmon, Salt, Brown sugar, Coriender, Pepper & Dextrose, Hardwood smoked xxx”. Packed in the following sizes: ¼ lb., ½ lb., 1 lb. and bulk-weight sides, Recall # F-197-2; 4) Smoked Norwegian Salmon, refrigerated, in vacuum packages printed with black lettering on gold foil background and a white stick-on tag, labeled in part: ”xxx La Maree xxx Portier Fine Foods xxx Mamaroneck, NY xxx Smoked Norwegian Salmon xxx Keep refrigerated 38 Degrees xxx Fresh Atlantic Salmon, Salt, Brown sugar, Hardwood smoked xxx”. Packed in the following sizes: ¼ lb., ½ lb., 1 lb. and bulk-weight sides, Recall # F-198-2; 5) Smoked Scottish Salmon, refrigerated, in vacuum packages printed with black lettering on gold foil background and a white stick-on tag, labeled in part: ”xxx La Maree xx Portier Fine Foods xxx Mamaroneck, NY xxx Smoked Scottish Salmon xxx Keep refrigerated 38 Degrees xxx Fresh Atlantic Salmon, Salt, Brown sugar, Hardwood smoked xxx”. Packed in the following sizes: ¼ lb., ½ lb., 1 lb. and bulk-weight sides, Recall # F-199-2; 6) Smoked Irish Salmon, refrigerated, in vacuum packages printed with black lettering on gold foil background and a white stick-on tag, labeled in part: ”xxx La Maree xxx Portier Fine Foods xxx Mamaroneck, NY xxx Smoked Irish Salmon xxx Keep refrigerated 38 Degrees xxx Fresh Atlantic Salmon, Salt, Brown sugar, Hardwood smoked xxx”. Packed in the following sizes: ¼ lb., ½ lb., 1 lb. and bulk-weight sides, Recall # F-200-2. CODE Initial recalled codes for all 6 products: "packed on Apr 15 sell by Apr 29", "packed on Apr 16 sell by Apr 30", "packed on Apr 17 sell by May 1" Additional codes (5/15/01 extension): "packed on Apr 6 sell by Apr 20" thru "packed on Apr 14 sell by Apr 28" RECALLING FIRM/MANUFACTURER Portier Fine Foods Inc. Mamaroneck, NY, by telephone and press release on May 4, and by letter on May 8 and 15, 2001. FDA initiated recall is complete. REASON The products were contaminated with Listeria monocytogenes. VOLUME OF PRODUCT IN COMMERCE Approximately 780 lbs. DISTRIBUTION CT, NY, PA and Nassau, Bahamas.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________ PRODUCT 1) Condensed Milk With Sugar and Coffee, packaged in metal cans, net weight 14 oz. Made in Latvia, Recall # F-175-2; 2) Condensed Milk With Sugar and Cocoa, packaged in metal cans, net weight 14 oz. Made in Latvia, Recall # F-176-2; 3) Sweetened Condensed Milk, packaged in metal cans, net weight 14 oz. Product of Latvia, Recall # F-177-2. Firm listed on labeling: Imported by Hudson Industries International, Ltd. Queens, N.Y. USA CODE 1) can code 300901 L77 9001; 2) can code 300901 L77 9001; 3) can codes 9006 L52 191100 and 9005 L28 20 11 00. RECALLING FIRM/MANUFACTURER Recalling Firm: Hudson Industries International, Ltd. Bayside, NY, by telephone on Oct. 10, 2000 and letter on Oct. 20, 2000. Manufacturer: Stock Company Rezekne Dairies and Canneries Rezneke, Latvia. FDA initiated recall is complete. REASON Products packed in metal cans with lead soldered seams. VOLUME OF PRODUCT IN COMMERCE 1000 cases. DISTRIBUTION Nationwide and Canada. _______________________ PRODUCT Jamaican Blend Lemix Cocktail Mix, packaged in 1-gallon jugs, 4 one-gallon jugs/case, Recall # F-179-2. CODE Uncoded. All products distributed from 7/9/2001 through 8/27/2001 are subject to this recall. RECALLING FIRM/MANUFACTURER Lemix, Inc. East Canton, OH, by telephone on Oct. 17, 2001 and letter on Oct. 19, 2000. FDA initiated recall is ongoing. REASON Product contains undeclared FD&C Yellow No. 5. VOLUME OF PRODUCT IN COMMERCE 72 cases (288 gallons). DISTRIBUTION OH. _______________________ PRODUCT E. Wedel brand Pierniczki Alpejskie Nadzienie Truskawkowe, Chocolate Covered Gingerbread Hearts W/Strawberry Filling, Product of Poland, Barcode # 76841 01671, net weight 7.93 oz (225 g). Recall # F-181-2. CODE None. RECALLING FIRM/MANUFACTURER Recalling Firm: Adamba Imports International Inc., Brooklyn, NY, by letter dated April 23, 2001. Manufacturer: E. Wedel S.A., Warsaw, Poland. State initiated recall is complete. REASON The product contained Ponceau 4R (E124, Acid Red 18), an unapproved color. VOLUME OF PRODUCT IN COMMERCE 700 cases (12 packages per case). DISTRIBUTION NY, NJ, CA , FL, WA, TX, CT, MA and IL. _______________________ PRODUCT Welch's White Grape Fruit Juice Cocktail from Concentrate, 64 oz. carton, refrigerated. Recall # F-182-2. CODE Pull Date Codes: May 24, Jun 07, May 23, Jun 5, May 12, May 19, May 26, Jun 02. Located at the seal of the gable-topped container. RECALLING FIRM/MANUFACTURER Recalling Firm: Welch's, Billerica, MA, by E-mail or fax on April 12, 2001. Firm initiated recall is complete. REASON Label fails to declare sulfites and the correct percentage of juice VOLUME OF PRODUCT IN COMMERCE 15,757 cases. DISTRIBUTION Nationwide. _______________________ PRODUCT Gang Wei Long brand Rapid Dissolve Green Bean Paste, Barcode # 6 920760 000024, packaged in flexible plastic foil pouch, net wt. 180 grams (6 oz.), 40 - 180 gram pouches per case, Recall # F-194-2. CODE None. RECALLING FIRM/MANUFACTURER Recalling Firm: Strong America Limited, Brooklyn, NY, by recall notice on Oct. 2, 2000. Manufacturer: Haikou Bada Imp. & Exp. Co., Haiku, China. State initiated recall is complete. REASON The product contained undeclared tartrazine (certifiable as FD&C Yellow #5) and brilliant blue FCF (certifiable as FD&C Blue #1). VOLUME OF PRODUCT IN COMMERCE 30 cases DISTRIBUTION NY, TN, MA, FL and IL. _______________________ PRODUCT Lemon-Lime Punch Base, 4/1 Gal, Recall # F-202-2; Lime Punch Base, 4/1 Gal, Recall # F-203-2; Mango Tropical Punch Base, 4/ 1 Gal, Recall # F-204-2; Pineapple Punch Base, 4 / 1 Gal, Recall # F-205-2; Lemon Slush Base, Gallons, Recall # F-206-2; Lemon-Lime Slush Base, 4/ 1 Gal, Recall # F-207-2; Lime Slush Base, Gallon and 4 /1 Gal, Recall # F-208-2; #30 Lemon Lime Syrup, 4 /1 Gal, Recall # F-209-2; RTU Lime Syr., 4/1 Gal, Recall # F-210-2; Lemon Sno-Cone Syrup, 4/ 1 Gal, Recall # F-211-2; Mango Sno-Cone Syrup, 4/ 1 Gal, Recall # F-212-2; Blue-Lemon Sno-Cone Syrup, 4/ 1 Gal, Recall # F-213-2; Banana Sno-Cone Syrup, 12/ 1 quart, Recall # F-214-2; Creme de Menthe Syrup, 4/ 1 gal, Recall # F-215-2; Lime Fountain Flavor Base, Gallon, Recall # F-216-2; Imitation Lemon Flavor, 4/1 Gal and 12/ 1 quart, Recall # F-217-2; Imitation Pineapple Extract, 4/ 1 Gal, 12/ 1 pint, and 12 /1 quart, Recall # F-218-2; Imitation Peppermint Extract, 12/1 pint and 12/ 1 quart, Recall # F-219-2; Pina Colada Disp Pak, 6/ Half Gallon, Recall # F-220-2. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Felbro Food Products, Inc. Los Angeles, CA, by letter, telephone and visit on Nov. 6, 2001. Firm initiated recall is complete. REASON Drink bases and flavors contained undeclared FD&C Yellow 5. VOLUME OF PRODUCT IN COMMERCE Undetermined. DISTRIBUTION AZ, CA, HI, KS, NV, UT. _______________________ PRODUCT Shellstock oysters, Recall # F-221-2; Shucked oysters, Recall # F-222-2. All oysters were packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters harvested from Florida areas 1642 and 1662 Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER Hick's Seafood East Point, FL. The State of Florida Dept. of Agriculture issued a Recall Notice by mail on 10/5/01. State Initiated recall complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE 212 bags, 92 pints and 14 gallons of shellstock and shucked. DISTRIBUTION FL. And GA _______________________ PRODUCT Shellstock oysters. Recall # F-223-2; Shucked oysters. Recall # F-224-2. All oysters were packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER Allen Brothers Seafood Eastpoint, FL. The State of Florida Dept. of Agriculture issued a Recall Notice by mail on 10/5/01. State Initiated recall complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE Unknown DISTRIBUTION FL and SC _______________________ PRODUCT Shellstock oysters. Recall # F-225-2; Shucked oysters. Recall # F-226-2. All oysters packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER Leavins Seafood Inc. Apalachicola, FL. The State of Florida Dept. of Agriculture issued a Recall Notice by mail on 10/5/01. State initiate recall complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE 324/30 lb. boxes, 6/20 lb boxes, 99/60 lb. boxes and 40/45 lb. boxes DISTRIBUTION FL, GA, SC and NC. _______________________ PRODUCT Shellstock oysters. Recall # F-227-2; Shucked oysters. Recall # F-228-2. All oysters packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER The Shrimp House, Eastpoint, FL. The State of Florida Dept. of Agriculture issued a Recall Notice by mail on 10/5/01. State initiated recall complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE 152 bags and 10 gallons DISTRIBUTION FL, GA and AL. _______________________ PRODUCT Shellstock oysters. Recall # F-229-2; Shucked oysters. Recall # F-230-2. All oysters packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER Stiner's Oyster House, Carrabelle, FL. The State of Florida Dept. of Agriculture issued a Recall Notice by mail on 10/5/01. State initiated recall complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE 8/60 lb. bags DISTRIBUTION FL. _______________________ PRODUCT Shellstock oysters. Recall # F-231-2; Shucked oysters. Recall # F-232-2. All oysters packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER Allen's Seafood, Apalachicola, FL. The State of Florida Dept. of Agriculture issued a Recall Notice by mail on 10/5/01. State initiated recall complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE Unknown DISTRIBUTION FL. _______________________ PRODUCT Shellstock oysters. Recall # F-233-2; Shucked oysters. Recall # F-234-2. All oysters packaged in bulk with no labeling other than the harvest tags which indicate harvest date and harvest area. CODE All oysters harvested from Florida Areas 1642 and 1662, Apalachicola Bay, with harvest dates of 9/15/2001 through 9/30/2001 were subject to recall. RECALLING FIRM/MANUFACTURER Mineral Springs Seafood, Crawfordville, FL. The State of Florida Dept. of Agriculture issued a Recall Notice by mail on 10/5/01. State initiated recall complete. REASON These oysters were harvested from the same area as oysters associated with a foodborne illness outbreak. VOLUME OF PRODUCT IN COMMERCE 4 bags DISTRIBUTION FL.RECALLS AND FIELD CORRECTIOS: FOODS -- CLASS III
_______________________ PRODUCT Golden Buttermilk Biscuits, Recall # F-165-2; a) UPC 94562-06290 - frozen baked; mini, 140 units, net weight 8 lbs. 12 oz. b) UPC 94562-06291 - frozen baked; medium, 96 units, net weight 13 lbs. 8 oz. c) UPC 94562-06295 - frozen baked easy split, 96 units, net weight 13 lbs. 8 oz. d) UPC 94562-06296 - frozen baked easy split, 90/case, net weight 16 lbs. Homestyle Biscuits, Recall # F-166-2; a) UPC 18000-85516 - frozen, net wt. 25 oz. b) UPC 18000-85524 - 3-25 oz. reclosable bags, net wt. 4 lbs. 11 oz. c) UPC 94562-06300 - net wt. 1 lb. 9 oz. Frozen Southern Style Biscuits - UPC 94562-06285, 120-2 oz., net wt. 15 lbs., Recall # F-167-2; Southern Style Cheese Biscuit Dough - UPC 94562-06256, 240- 2oz., net wt. 30 lbs., Recall # F-168-2; Cheese and Herb Biscuits, 18 biscuits, net wt. 21.6 oz. under Schwan's label, Recall # F-169-2; Frozen Buttermilk Biscuits UPC 94562-06283, 120-2oz., net wt. 15 lbs., Recall # F-170-2; Burger King Frozen Biscuit Dough, UPC 18000-37660 168 pieces, 33.2 lbs., Recall # F-171-2; Wal-Mart Baked, Uniced Marble Half Sheet Cakes (dough), UPC 21582-05354, 6 units - 55 oz., Recall # F-172-1; Southern Style Biscuit Dough, Recall # F-173-1; a) UPC 18000-37657 KFC, 264 count/2 oz. units, 33 lbs. b) UPC 94562-06246 Lee's, 216/2.2 oz., net wt. 29.7 lbs. c) UPC 94562-06249 Easy split, 168-3.17 oz., net wt. 32.2 lbs. d) UPC 94562-06250 120/2.2 oz., net wt. 16.5 lbs. e) UPC 94562-06252 216/2.2 oz., net wt. 29.7 lbs. f) UPC 94562-06253 Shoney's, 216/2.2. oz., net wt. 29.7 lbs. g) UPC 94562-06273 Dunkin Donuts, easy split, 168-3.17 oz., net wt. 33.2 lbs. h) UPC 94562-06275 Wal-Mart i) UPC 94562-06312 Schwan's, 18 biscuits, net wt. 39 oz., CODE Retail products: Pillsbury Homestyle (or Home Baked Classics) Frozen Buttermilk Biscuits UPC 18000-85516 Lot #: F1 1062 11 Pillsbury Homestyle Frozen Biscuits - Southern Style (3 pack) UPC 18000-85515 Lot #: F1 1062 08 F1 1062 18 F1 1062 19 F1 1062 20 F1 1062 22 F1 1062 23 F1 1062 25 Food service products: Production codes of June 6 to June 25, 2001. RECALLING FIRM/MANUFACTURER Recalling Firm: Pillsbury Company, St. Paul, MN, by letters dated June 29 and July 2, 2001. Manufacturer: Pillsbury Bakeries and Food Service, Joplin, MO. Firm initiated recall is complete. REASON The product was contaminated with poly fibers from broken filtering screen in frozen biscuit dough. VOLUME OF PRODUCT IN COMMERCE 784,585 cases. DISTRIBUTION Nationwide. _______________________ PRODUCT Salad Mate Salad Dressing, packaged in 32-fl. oz. plastic bottles. The responsible firm on the label shows the product is distributed by Aldi Inc., Batavia, IL, Recall # F-174-2. CODE All product with code 092701CBA. RECALLING FIRM/MANUFACTURER Mrs. Clark's Foods L.C., Ankeny, IA, by telephone on March 22, 2001. Firm initiated recall is complete. REASON The product was contaminated with yeast. VOLUME OF PRODUCT IN COMMERCE 3,472/12-btl. cases. DISTRIBUTION IL, IA, MO, and WI. _______________________ PRODUCT Woodstock Farms Pineapple Rings, Unsulphored. Net Wt. 16 oz (454 gm). INGREDIENTS:PINEAPPLE AND SUGAR*** PRODUCT OF THAILAND***". Recall # F-178-2. CODE Lot codes: "Best if used by 3/16/02." RECALLING FIRM/MANUFACTURER Recalling Firm: United Natural Foods, Inc., Stow Mills Chesterfield, NH, by telephone on 8/15/01 followed by letter 8/16/01. Manufacturer: Hersey Import (Repacker) Rahway, NJ Firm initiated recall ongoing. REASON The product contained undeclared sulfites. VOLUME OF PRODUCT IN COMMERCE 208 cases containing 1,664 (16 oz.) retail units. DISTRIBUTION Eastern USA _______________________ PRODUCT Dried Shrimp, Unlimited Brand in 8oz. retail packages. Repacked by Wholesale Unlimited, Inc., Honolulu, HI, Recall # F-180-2. CODE Product is not coded. RECALLING FIRM/MANUFACTURER Recalling Firm: Wholesale Unlimited, Inc., Honolulu, HI, by telephone on May 21, 2001. Manufacturer: Roy J. Picou, Inc., Chauvin, LA. FDA initiated recall is complete. REASON The product contains undeclared sulfites. VOLUME OF PRODUCT IN COMMERCE 50 lbs. DISTRIBUTION HI.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
_______________________ PRODUCT GenTeal Lubricant Eye Drops, 0.3% Hydroxypropyl methylcellulose 0.845 FL.OZ. (25mL) bottles, Recall # D-084-2. CODE Lot No. 96455. RECALLING FIRM/MANUFACTURER Novartis Ophthalmics, Inc. Duluth, GA, by letter dated Sept. 25, 2001. Firm initiated recall is ongoing. REASON Non-Sterile-contamination with penicillum sp. VOLUME OF PRODUCT IN COMMERCE 22,272 units. DISTRIBUTION Nationwide. _______________________ PRODUCT A) Humalog Injection Kits, insulin lispro injection (rDNA origin), 3 ml disposable insulin delivery device, Recall # D-085-2; B) Humacart 3/7 Kits, Humalog Pen, 3.0 mL disposable insulin delivery device (70% human insulin isophane suspension 30% human insulin injection (rDNA origin)) 100 units per mL., Recall # D-086-2; C) Humacart R Kits, Humalog Pen (pre-filled) disposable insulin delivery device, Recall # D-087-2. CODE A) Humalog kits lot FF1E79J; B) Humacart 3/7 kits; lots FF1J79J and FF1J79N.Exp. 05/2003; C) Humacart R kits; lots FF1J71K and FFOV67A. Exp. 5/2003 and 9/2003. RECALLING FIRM/MANUFACTURER Eli Lilly and Co., Indianapolis, IN, by press release on Dec. 3 and 20, 2001. Firm initiated recall is ongoing. REASON Subpotency (Last dose may deliver less insulin than expected due to breakage of pen internal parts). VOLUME OF PRODUCT IN COMMERCE Approx. 115,000 pens. DISTRIBUTION Japan. _______________________ PRODUCT Anectine (succinylcholine chloride) Injection, 200 mg/10mL (20mg/mL),10 mL Multiple Dose vial, Rx only, Recall # D-088-2; Retrovir (zidovudine) IV Infusion, sterile, 10 mL/mL, 20 mL single use vial, Tray of 10 vials, Rx only, Recall # D-089-2. CODE Anectine Injection - Lot Number 0L2080; Retrovir IV Infusion - Lot Number 9K2300. RECALLING FIRM/MANUFACTURER Recalling Firm: GlaxoSmithKline Zebulon, NC, by letter on Nov. 5, 2001. Manufacturer: DSM Catalytica Pharmaceuticals, Greenville, NC. Firm initiated recall is ongoing. REASON Lack of assurance of sterility (glassware may exhibit cracks). VOLUME OF PRODUCT IN COMMERCE Anectine - 8,162 units and Retrovir - 1,062 units. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT Source Plasma. Recall # B-0474-2. CODE Units: G-48394-056, G-48025-056, G-38638-056, G-37978-056, G-35883-056, G-35780-056, G-34200-056, G-33772-056, G-29890-056, G-29440- 056, G-26378-056, G-25993-056, G-93361-056, G-93132-056, G-49156-056, G- 48765-056, G-13125-056, G-12399-056, G-12130-056, G-11479-056, G-11263- 056, G-10600-056, G-10357-056, G-84454-056, G-18297-056, G-18082-056, G- 14859-056, G-14623-056, G-08786-056. RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA, by fax on July 13, 2000. Manufacturer: Alpha Therapeutic Corporation, Fontana, CA. Firm initiated recall is complete. REASON Blood products, which tested negative for Hepatitis B Surface Antigen (HBsAg), but were collected from a donor who previously tested reactive for HBsAg, were distributed. VOLUME OF PRODUCT IN COMMERCE 29 units. DISTRIBUTION CA, VA, Spain, Germany and Italy. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0543-2; b) Red Blood Cells, Leukocytes Removed, Recall # B-0544-2. CODE a) Unit 21KK35266; b) Unit 21GW30233. RECALLING FIRM/MANUFACTURER American Red Cross, Portland, OR, by letters dated Dec. 20, 2000 and Jan. 29, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0545-2; b) Platelets, pooled, Recall # B-0546-2. CODE a) Unit E136841; b) Unit E136841; pool number EP01429. RECALLING FIRM/MANUFACTURER Puget Sound Blood Center and Program, Seattle, WA, by letter dated April 11, 2001. REASON Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION WA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0547-2; b) Platelets, pooled, Recall # B-0548-2. CODE a) Unit N115528; b) Unit N115528; pool number AP16227. RECALLING FIRM/MANUFACTURER Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter dated April 20, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION WA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0549-2; b) Platelets, Recall # B-0550-2. CODE a) Units 8508783, 1135702; b) Unit 1135702. RECALLING FIRM/MANUFACTURER Community Blood Center (CBC), Dayton, OH, by letter dated Nov. 9, 2001. Firm initiated recall is complete. REASON Blood products, not tested for CMV antibodies and labeled CMV negative, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION OH and IN. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0551-2; b) Platelets, Recall # B-0552-2; c) Fresh Frozen Plasma, Recall B-0553-2. CODE a), b) and c) Unit 2218610. RECALLING FIRM/MANUFACTURER LifeSource Blood Services, Glenview, IL, by telephone on May 15, 2001. Firm initiated recall is complete. REASON Blood products, collected from a donor who took the drug Proscar, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION IL. _______________________ PRODUCT Red Blood Cells, Recall # B-0554-2. CODE Unit 21FM63277. RECALLING FIRM/MANUFACTURER American Red Cross, Portland, OR, by letter dated May 3, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who reported having lived in area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION WA. _______________________ PRODUCT Platelet, Recall # B-0555-2. CODE Unit 1824390. RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Lexington, KY, by letter dated Sept. 6, 2001. Firm initiated recall is complete. REASON Platelets, which were prepared from a unit collected from a donor who had taken aspirin within three days of donation, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION KY. _______________________ PRODUCT Recovered Plasma, Recall # B-0556-2. CODE Units Y60440, Y60441. RECALLING FIRM/MANUFACTURER Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA, by fax on July 31, 2000. Firm initiated recall is complete. REASON Blood products, not tested for viral markers, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA _______________________ PRODUCT a) Red Blood Cells, Recall # B-0592-2; b) Platelets, Recall # B-0593-2; c) Recovered Plasma B-0594-2. CODE a), b) and c) Unit G33027; RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Grand Rapids, MI, by letter May 15, 2001. Firm initiated recall is complete. REASON Blood products, collected from an ineligible donor due to risk of infection with Group O type human immunodeficiency virus (HIV), were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION MI and Switzerland. _______________________ PRODUCT Red Blood Cells, Recall # B-0597-2. CODE Unit number 22416-8110. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on Dec. 21, 2000. Manufacturer: Blood Systems, Inc., Las Vegas, NV. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NV. _______________________ PRODUCT a) Platelets Pheresis; b) Leukocytes Reduced. Recall # B-0598-2. CODE a) Unit 22418-6595-01; b) Unit 22418-6595-02. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ , by telephone on Dec. 22, 2000 and by letter on Jan. 24, 2001. Manufacturer: Blood Systems, Inc. Las Vegas, NV. Firm initiated recall is complete. REASON Platelets with an elevated platelet count were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION NV. _______________________ PRODUCT Source Plasma, Recall # B-0599-2. CODE Unit numbers 0140756148, 0040623808, 0040823805, 0120211580, 0590141808, 0110681976, and 8010090164. RECALLING FIRM/MANUFACTURER Nabi, Miami, FL, by letter on March 20, 2000. Firm initiated recall is complete. REASON Blood products, that tested initially reactive for either hepatitis B surface antigen (HBsAg), the antibody to hepatitis C virus (anti-HCV), or the antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV- 1/2), and were not correctly retested in duplicate, were distributed. VOLUME OF PRODUCT IN COMMERCE 7 units. DISTRIBUTION NC, NY, TN, CA and Germany. _______________________ PRODUCT Red Blood Cells, Recall # B-0651-2. CODE Unit 21KL32346. RECALLING FIRM/MANUFACTURER American Red Cross, Portland, OR, by letter dated June 13, 2001. Firm initiated recall is complete. REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OR. ___________________ PRODUCT Red Blood Cells, Recall # B-0716-2. CODE Unit 42N15248. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Cleveland, OH, by telephone on Oct. 18, 2001. Firm initiated recall is complete. REASON Blood product, not quarantined after receiving information concerning post donation illness, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OH. _______________________ PRODUCT Platelets, Recall # B-0717-2. CODE Unit 1845706. RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Lexington, KY, by letter dated Nov. 27, 2001. Firm initiated recall is complete. REASON Platelets, prepared from a donor that had ingested aspirin within 36 hours, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION KY. _______________________ PRODUCT Platelets, Recall # B-0720-2. CODE Unit 1835970. RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Lexington, KY, by letter dated Nov. 27, 2001. Firm initiated recall is complete. REASON Platelets, prepared from a donor that had ingested aspirin within 36 hours, were distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION KY.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0581-2. CODE Unit 42Q71434. RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Cleveland, OH, by telephone on Oct. 9 and by letter dated Oct. 16, 2001. Firm initiated recall is complete. REASON Blood product, that failed red cell recovery ratio, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION OH. _______________________ PRODUCT Platelets Pheresis, Recall # B-0582-2. CODE Unit P05047. RECALLING FIRM/MANUFACTURER Northern California Community Blood Bank, Eureka, CA, by letter dated March 30, 1998. Firm initiated recall is complete. REASON Blood product, collected from an ineligible donor who recently had surgery for an arm wound, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0583-2; b) Platelets, Recall # B-0584-2; c) Cryoprecipitated AHF, Pooled, Recall # B-0585-2. CODE a), b) and c) Unit 0525732. RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, Cincinnati, OH, by letter dated Nov. 20, 2000. Firm initiated recall is complete. REASON Blood products, collected from ineligible donor due to a history of Herpes Simplex, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION OH. _______________________ PRODUCT Fresh Frozen Plasma, Recall # B-0577-2. CODE Unit numbers 3927197, 3927203, 3927207, 3927169, 3927170, 3927172, 3927176, 3927099, 3927101, 3927108, 3927111, 3927118, 3927119, 3927120, 3948748, 3968478, 3976993, 3976994, 3948757, 3948758, 3948762, 3948766, 3948771, 3948773, 3948775, 3948779, 3948780, 3968487, 3976996, 3948784, 3948785, 3948788, 3948795, 3948797, 4017448, 3927137, 3927138, 3927140, 3927143, 3927145, 3927146, 3927147, 3927150, 3927151, 3937167, 3937169, 3937173, 3964855, 3815795, 3815796, 3815797, 3815800, 3815806, 3723396, 4022611, 4022612, 3941973, 3941959, 3965109, 3965110, 3965115, 3965119, 3965124, 3965126, 3965130, 3982222, 3982224, 3982228, 3981957, 3982234, 3965141, 3981972, 3927057, 3964854, 3964856, 3815807, 3815823, 3723395, 3723399, 3723401, 3723402, 3723441, 3723444, 3723445, 3723450, 3723452, 4022597, 4022613, 4022634, 3965107, 3965116, 3965117, 3965122, 3965135, 3982213, 3982215, 3982218, 3982225, 3982233, 3981951, 3981952, 3981956, 3981958, 3981959, 3981961, 3981962, 3981964, 3981966, 3981967, 3981968, 3981969, 3981971, 3981973, 3981974, 3981975, 3982235, 3927182, 3815810, 3941975, 3965108, 3965112, 3965118, 3965128, 3982211, 3981953, 3927082, 3927059, 3979209, 3964864, 3965111, 3965113, 3927124, 3927130, 3927131, 3927132, 3964851, 3964863, 3815828, 3815829, 3815843, 3815845, 3815854, 3941977, 3941956, 3941960, 3941990, 3941984, 3941983, 3941981, 3965123, 3965129, 3965132, 3965133, 3965134, 3965137, 3965140, 3965142, 3965143, 3965144, 3965145, 3965150, 3982212, 3982216, 3982220, 3982223, 3982230, 3982231, 3982232, 3981954, 3981955, 3981963, 3981965, 3981970, 3981977, 3979250, 3979212, 3979224, 3927194, 3927078, 3979245, 3965114, 3965125, 3965127, and 3965139 RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX, by letters on April 26, May 9 and 15, 2001. Firm initiated recall is complete. REASON Blood products, collected with expired needles, were distributed. VOLUME OF PRODUCT IN COMMERCE 184 units. DISTRIBUTION TX. _______________________ PRODUCT Red Blood Cells, Leukocytes Reduced, Recall # B-0618-2. CODE Unit numbers 22420-3101 and 22420-6698. RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on Jan. 31, 2001. Manufacturer: Blood Systems, Inc., Las Vegas, NV. Firm initiated recall is complete. REASON Blood products that were out of controlled storage for more than 30 minutes were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION NV. _______________________ PRODUCT Hemocare Blood Bank Data Management System Software, Recall # B-0626-2. CODE Versions 5.1, 5.2, 5.2a, and 5.2b. RECALLING FIRM/MANUFACTURER Mediware Information Systems, Inc., Melville, NY by fax and letter on May 29, 2001. Firm initiated recall is complete. REASON Computer software that could allow the assignment of an extended expiration date to blood products was distributed. VOLUME OF PRODUCT IN COMMERCE 4 versions. DISTRIBUTION Nationwide and Canada.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________ PRODUCT Dimension Clinical Chemical Analyzer XL/RxL/ARx with software revision 5.2, Recall # Z-0433-02. CODE Revision 5.2 The following serial numbers are involved in the recall: 971807, 973002, 970457, 973278, 970598, 970454, 970049, 971979, 973242, 970864, 973218, 970219, 973498, 970152, 950208, 971645, 970300, 950207, 972376, 970919, 970066, 970521, 971949, 972903, 971202, 973145, 972464, 973143, 971229, 971939, 973140, 973100, 973083, 971966, 970480, 950209, 970037, 972495, 972628, 971098, 971660, 972850, 971102, 971052, 972117, 972173, 970705, 972590, 971625, 971526, 973150, 970599, 972904, 973014, 970880, 970327, 971414, 970561, 971200, 971953, 972373, 971813, 972137, 971845, 973074, 972040, 971830, 970481, 972222, 970173, 971023, 972664, 970836, 990281, 971226, 970471, 970860, 970588, 973080, 973190, 973192, 972273, 973195, 970639, 973193, 973191, 950446, 970033, 972363, 970550, 970249, 972425, 970164, 970649, 973406, 971640, 971650, 971679, 972471, 972474, 972596, 970382, 972176, 972270, 971260, 950165, 971721, 972884, 972451, 950341, 971701, 970518, 972232, 970824, 971241, 972301, 970464, 970035, 971388, 973285, 972743, 973128, 971310, 970847, 990267, 990270, 973257, 971277, 972581, 971794, 973208, 971838, 950380, 972338, 970572, 971094, 973153, 971131, 972368, 970697, 972441, 972962, 973206, 970087, 972079, 973213, 970978, 973365, 973325, 950108, 950421, 973028, 972393, 973339, 990257, 950286, 971653, 972911, 972269, 972663, 970359, 970692, 970337, 972920, 970343, 970889, 970041, 970622, 970969, 971422, 971641, 970808, 970890, 972378, 971655, 971293, 970324, 970560, 971442, 970222, 972790, 971057, 971271, 970261, 970242, 970048, 970214, 971121, 970477, 950170, 970056, 972572, 970289, 970702, 971711, 972494, 970032, 970654, 971025, 970754, 973509, 970821, 990184, 972369, 972321, 971384, 971461, 971027, 971937, 972559, 970128, 971194, 971570, 971602, 950176, 971833, 970220, 972266, 970282, 970874, 973290, 970929, 970358, 971133, 973228, 971666, 971592, 970790, 970111, 971196, 971129, 973088, 971901, 972438, 973428, 973036, 971413, 971572, 971500, 990139, 990186, 971841, 972459, 971429, 990221, 973072, 973268, 972364, 973320, 971993, 972260, 971930, 972528, and 971829. RECALLING FIRM/MANUFACTURER Recalling Firm: Dade Behring, Inc. Newark, DE, by telephone on Nov. 11 and by letter on Nov. 19, 2001. Manufacturer: Dade Behring, Inc. Brookfield, CT. Firm initiated recall is complete. REASON Instructions to software revision are missing a step. VOLUME OF PRODUCT IN COMMERCE 256 sets. DISTRIBUTION Nationwide. _______________________ PRODUCT Ballard Cytology Brush Disposable Cat. No. 60311, 1.8mm x 120 cm catheter, 2.0 mm bristle diameter, Recall # Z-0490-02; Cat. No. 60312, 1.8mm x 120 cm catheter, 3.0 mm bristle diameter, Recall # Z-0491-02; Cat. No. 60313, 1.8mm x 160 cm catheter, 2.0 mm bristle diameter, Recall # Z-0492-02; Cat. No. 60314, 1.8mm x 160 cm catheter, 3.0 mm bristle diameter, Recall # Z-0493-02. CODE Catalog Numbers 60311, 60312, 60313, 60314. RECALLING FIRM/MANUFACTURER Recalling Firm: Ballard Medical Products, Draper, UT, by letter on Dec. 5, 2000. Manufacturer: Ballard Medical Products, Pocatello, ID. Firm initiated recall is ongoing. REASON Radiopaque distal tip may detach from the cytology brush. VOLUME OF PRODUCT IN COMMERCE 33,802 units. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT ITI Dental Implant System Handpiece Adapters, Recall # Z-0494-02/Z-0495- 02. CODE a) Catalog No. 046.470, Extra Short. Lot No, 1200; b) Catalog No. 046.471, Short. Lot No. 1200. RECALLING FIRM/MANUFACTURER Recalling Firm: Straumann USA. Waltham, MA, by letter dated Dec. 7, 2001. Manufacturer: Institut Strauman AG Waldenburg, Switzerland. Firm initiated recall is ongoing. REASON Dental Handpiece Adapter fails specification and may remain lodged in the unit. VOLUME OF PRODUCT IN COMMERCE 83 units. a) 78 units; b) 5 units. DISTRIBUTION Nationwide. _______________________ PRODUCT ADAC brand Forte Gamma Camera System An Scintillation Gamma Camera, Tomography, Computed Emission, Recall # Z- 0496-02. CODE Model numbers: 2155-3000, 3001, 3002, 3004, 3004, 3006. RECALLING FIRM/MANUFACTURER ADAC Laboratories Milpitas, CA, by visit on Nov. 1, 2000. Firm initiated recall is complete. REASON Collimator drawer could drop to the floor causing injury to the user/patient. VOLUME OF PRODUCT IN COMMERCE 125 units. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Therapeutic Plasma Exchange Set, Recall # Z-0497-02. CODE LMT 193. RECALLING FIRM/MANUFACTURER Recalling Firm: Fresenius HemoCare, Inc., Redmond, WA, by telephone on Dec. 14, 2001. Manufacturer: Fresenius HemoCare GmbH, The Netherlands. Firm initiated recall is ongoing. REASON Return line of tubing set smaller than normal. VOLUME OF PRODUCT IN COMMERCE 1905 sets. DISTRIBUTION Nationwide. _______________________ PRODUCT Lubricated latex condoms, model number 9030, Recall # Z-0498-02. CODE Lot number 0661123. RECALLING FIRM/MANUFACTURER Alatech Healthcare, LLC Slocomb, AL, by certified mail on Dec. 11, 2001. Firm initiated recall is ongoing. REASON Failed FDA leak testing. VOLUME OF PRODUCT IN COMMERCE 109 cases of 1000. DISTRIBUTION Nationwide and Canada. _______________________ PRODUCT Apligraf(Graftskin), Recall # Z-0499-02. CODE Lot #GS0111.06.02.1A Exp. Date: December 7, 2002. RECALLING FIRM/MANUFACTURER Organogenesis Inc. Canton, MA, by telephone beginning on Dec. 7 and by fax on Dec. 10, 2001. Firm initiated recall is ongoing. REASON Product is contaminated with staphlococcus cohnii. VOLUME OF PRODUCT IN COMMERCE 107 units. DISTRIBUTION Nationwide. _______________________ PRODUCT ADAC brand Forte Gamma Camera System An Scintillation Gamma Camera, Tomography, Computed Emission, Recall # Z- 0500-02. CODE Model #s: 2155-3000, 3001, 3002, 3004, 3004, 3006 Catalog #s: N-FT-3/8B, N-FT-5/8B, N-FT-MCDB. RECALLING FIRM/MANUFACTURER Adac Laboratories Milpitas, CA, by visit in March 2000. Firm initiated recall is complete. REASON A sensor may not activate if proper contact is not made. VOLUME OF PRODUCT IN COMMERCE 125 units. DISTRIBUTION Nationwide and internationally. _______________________ PRODUCT Polarus Broach. Instrument belongs to the Polarus Humeral Rod System product line which is a system of rods and screws for the fixation of humeral fractures and their accompanying instrumention. The broach is reusable and provided non-sterile, Recall # Z-0501-02. CODE Lot # W03397. RECALLING FIRM/MANUFACTURER Acumed, Inc., Beaverton, OR, by fax or E-mail on Nov. 9, 2001. Firm initiated recall is ongoing. REASON The word "lateral" was etched on the medial side of the broach. VOLUME OF PRODUCT IN COMMERCE 27. DISTRIBUTION United Kingdom, Finland, Spain and The Netherlands. _______________________ PRODUCT AxSYM Troponin-I Calibrators, list 3C29-01;6 bottles of calibrators A-F; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064, Recall # Z-0502-02. CODE Calibrator lots 78883M300, Exp. 9/21/01; 78884M300 and 78884M301, exp. 11/1/01; 81410M100 and 81410M101, exp. 11/22/01. RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc. Abbott Park, IL, by letter dated Nov. 12, 2001. Firm initiated recall is ongoing. REASON Incorrect High Control readout due to stability failures of the calibrators. VOLUME OF PRODUCT IN COMMERCE 5,414 kits. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT MediVators brand Rapicide High-Level Disinfectant and Sterilant. Active ingredient: Glutaldehyde, Recall # Z-0505-02. CODE Lots L101111, l101112, L101511. RECALLING FIRM/MANUFACTURER Ecolab Inc. Huntington, IN, by letter to the distributor in November, 2001. Firm initiated recall is ongoing. REASON Leaking bottles. VOLUME OF PRODUCT IN COMMERCE Approx. 3,000 cases. DISTRIBUTION MN. _______________________ PRODUCT Symmetry Aortic Connector System, Model Numbers CAN-4550, Recall # Z- 0508-02. CODE Lots 53739, 54085, 54296, 54330, 54616. RECALLING FIRM/MANUFACTURER ST. Jude Medical ATG, Inc., Maple Grove, MN, by visit on Oct. 6, 2001. Firm initiated recall is complete. REASON The tubeset was not securely held within the handle of the delivery system on some units. VOLUME OF PRODUCT IN COMMERCE 228 units. DISTRIBUTION Nationwide and France, Netherlands, Finland, and Australia.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________ PRODUCT Immulite Cat Specific IgE; radioallergosorbent immunological test system. 100 test kit, Id# LKE11 115, Recall # Z-0437-02. CODE Immulite Cat Specific IgE, LKE11 115 RECALLING FIRM/MANUFACTURER Diagnostic Products Corp. Los Angeles, CA, by telephone and fax on Oct. 31, 2001. Firm initiated recall is ongoing. REASON Packaging equipment failure, missing bead component. VOLUME OF PRODUCT IN COMMERCE 40 kits. DISTRIBUTION Internationally. _______________________ PRODUCT AxSYM REA Ethanol Reagent. Distributed under the following brand: AxSYM Abbott Laboratories USA North, Recall # Z-0503-02. CODE List No. 03B32-20. Lot No. Exp. Date 71356Q100 7/10/2001 72265Q100 7/22/2001 73456Q100 9/2/2001 73721Q100 10/9/2001 75536Q100 10/26/2001 76487Q100 11/14/2001. RECALLING FIRM/MANUFACTURER Abbott Health Products, Inc. Barceloneta, Puerto Rico, by letters on 11/8/01. Firm initiated recall is ongoing. REASON Failure/inability to obtain a valid calibration curve VOLUME OF PRODUCT IN COMMERCE 12,776 units. DISTRIBUTION Internationally. _______________________ PRODUCT Roche Glucl Cobas Integra Glucose HK Liquid, catalog # 2055651, Recall # Z-0504-02. CODE Lot 624277-01. RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated Nov. 13, 2001. Manufacturer: Roche Diagnostics, Mannheim, Germany. Firm initiated recall is complete. REASON Reduced linearity/does not meet linearity range in directions for use. VOLUME OF PRODUCT IN COMMERCE 1620 cassettes. DISTRIBUTION Nationwide and Puerto Rico. _______________________ PRODUCT LocaLisa IntraCardiac Navigation System, Model Numbers 9670000, 9670025, Recall # Z-0506-02. CODE BBJ0106OO1, BBJ0107OO2, BBJ0107OO3, BBJ0107OO4, BBJ0107OO6, BBK0106OO1, BBK0107OO2. RECALLING FIRM/MANUFACTURER Medtronic, Inc. Minneapolis, MN, by letter on Sept. 6, 2001. Firm initiated recall is complete. REASON A read only CD drive was installed in the system in place of a read-write CD drive. VOLUME OF PRODUCT IN COMMERCE 7 units. DISTRIBUTION FL, IA and internationally. _______________________ PRODUCT MedGraphics Pulmonary Function Gas, Reference Gas, 21% O2, Bal N2, Recall # Z-0507-02. CODE Lot number 116617 exp. June 2004 catalog number 536053-009. RECALLING FIRM/MANUFACTURER Scott Medical Products, Plumsteadville, PA, by telephone and letter dated Sept. 28, 2001. Firm initiated recall is ongoing. REASON Concentration of oxygen is less than value stated on label. VOLUME OF PRODUCT IN COMMERCE 23 cylinders. DISTRIBUTION Nationwide. _______________________ PRODUCT Pepsin 1:3000 NF XII Powder, packaged 500g in plastic bottles, 27mg in 2ml plastic vials, and 6,000g bulk bags inside plastic pails, Recall # Z- 0509-02. CODE Lot Numbers: 3051B27, 3071B31, 3291B45, 3461B32. RECALLING FIRM/MANUFACTURER Amresco, Inc. Solon, OH, by fax on May 15, 2001. Firm initiated recall is complete. REASON The product is contaminated with Salmonella bacteria. VOLUME OF PRODUCT IN COMMERCE 12,046g (26.5 LBS). DISTRIBUTION MA, IL, NJ and Canada and China.END OF ENFORCEMENT REPORT FOR JANUARY 30, 2002 ####
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