MARCH 13, 2002 02-10
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________ PRODUCT a) Dinstuhl’s Peanut Butter Bar, 1.5 oz, Recall # F-305-2; b) Dinstuhl’s Chocolate Pecan Fudge, 16 oz (1 lb), Recall # F-306-2; c) Dinstuhl’s Assorted Chocolates, 8 oz, 16 oz (1 lb), 2 lb, 4 lb, Recall # F-307-2; d) Dinstuhl’s Assorted Nuts, 16oz (1 lb), Recall # F-308-2. CODE All codes beginning with M, S, X, distributed between 9/4/01 and 10/29/01. RECALLING FIRM/MANUFACTURER Dinstuhl's Candies Memphis, TN, by telephone on October 29, 2001. Firm initiated recall is complete. REASON Products contain undeclared milk. VOLUME OF PRODUCT IN COMMERCE Less than 300 boxes. DISTRIBUTION TN. _______________________ PRODUCT Sweet Candy (Dried Carambola Fruit) packed in flexible plastic bags, net wt. 5 oz. (141 grams). Made in China. Recall # F-309-2. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Recalling Firm: Fortuner's Food Co., Inc., Brooklyn, NY, by allergen alert on September 19, 2000 and by letters and visit on October 20, 2000. Manufacturer: Unknown. State initiated recall complete. REASON The product contained undeclared sulfites (1210 ppm) and undeclared color additive sunset yellow FCF (certifiable as FD&C Yellow #6). VOLUME OF PRODUCT IN COMMERCE 7 cases. DISTRIBUTION NY. _______________________ PRODUCT 1) Tuna Salad a) Mrs. Grissom's Salads brand, 10 ¾ ounces b) Houchens brand, 10 ¾ ounces. Recall # F-310-2; 2) Mrs. Grissom's Salads brand Jalapeno Cheese Spread or Dip, 11 ounces. Recall # F-311-2; 3) Cheese Spread a) Mrs. Grissom's Salads brand, 11 ounces b) Houchens brand, 11 ounces. Recall # F-312-2. CODE Codes (Expiration Dates): 1) Tuna Salad a) December 12, 2001, December 29, 2001, or January 5, 2002 b) December 12, 2001, December 26, 2001, or December 28, 2001 2) Mrs. Grissom's Salads brand Jalapeno Cheese Spread or Dip December 29, 2001, or January 26, 2002 3) Cheese Spread a) December 21, 2001, December 28, 2001, or January 5, 2002 b) December 14, 2001, December 21, 2001, January 5, 2002, January 12, 2002, or January 26, 2002. RECALLING FIRM/MANUFACTURER Mrs. Grissom’s Salads, Inc., Nashville, TN, by press release on October 30, 2001. Firm initiated recall is complete. REASON Sandwich spreads contain undeclared egg yolks. VOLUME OF PRODUCT IN COMMERCE 39,255 cartons. DISTRIBUTION TN, AL and KY. _______________________ PRODUCT a) Mrs. Denson’s brand Fruit-Sweetened Chocolate Chip, UPC 69310. Recall # F-313-2; b) Mrs. Denson's brand Fruit-Sweetened Chocolate Chip Macaroon, UPC 69401. Recall # F-314-2; c) Mrs. Denson's brand Wheat-Free/Reduced-Fat Chocolate Chip, UPC 69320. Recall # F-315-2; d) Mrs. Denson's brand Wheat-Free/Reduced-Fat Chocolate Chip Macaroon, UPC 69411. Recall # F-316-2; e) Mrs. Denson's brand Organic Chocolate Chip, UPC 70116. Recall # F-317-2. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Mrs. Denson’s Cookie Company, Inc., Ukiah, CA, by telephone and letters on September 5, 2001. Firm initiated recall is complete. REASON Chocolate chips in Mrs. Denson's cookies contained undeclared milk proteins (>15 ppm). VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION CO, OR, NH, IN, NJ, TX, CA, NY, WA and Canada. _______________________ PRODUCT Bon Campo brand Sun Dried Tomatoes packed in clear plastic trays, net wt. 3 oz. UPC 081517 100193 on front label & no other coding. Recall # F-318-2. CODE All products on the market at the time the recall was initiated. RECALLING FIRM/MANUFACTURER Merex Corporation, Yonkers, NY, by press release and letters on December 6, 2000. State initiated recall is complete. REASON The product contained undeclared sulfites (6900 ppm). VOLUME OF PRODUCT IN COMMERCE Unknown. DISTRIBUTION NY and NJ. _______________________ PRODUCT Liquid Whole Egg (refrigerated) packaged in 30 pound plastic buckets or 2000 pound returnable plastic totes. Recall # F-319-2. CODE Lot #262-1 and one tote of lot 261-1 (80 pounds of lot 262-1 were co-mingled with one tote and sent out with the Lot 262-1 shipment). RECALLING FIRM/MANUFACTURER Cutler Egg Products, Abbeville, AL, by telephone on September 24, 2001. Firm initiated recall is complete. REASON Liquid Whole Egg product is contaminated with Salmonella. VOLUME OF PRODUCT IN COMMERCE 31,680 pounds. DISTRIBUTION GA and KY.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________ PRODUCT STR brand Dried Plum, packed in flexible plastic packages, net wt. 14 oz. (400 g), gross weight 16 oz. Product of China. Firm on label - Strong International Corp. Recall # F-303-2. CODE Product has barcode # 6 43806 88607 4 and no other coding. RECALLING FIRM/MANUFACTURER Recalling Firm: Strong America Limited, Brooklyn, NY, by letter on Oct. 10, 2000. Manufacturer: Xiamen Da Chang Hua Imp. & exp. Co., Ltd., Xiamen, Fujian. State initiated recall is complete. REASON The product contained undeclared sodium benzoate, a preservative, & saccharin which is not permitted for use in this type of food. VOLUME OF PRODUCT IN COMMERCE 48 cases. DISTRIBUTION NY and FL. _______________________ PRODUCT Grissom's Blueberry Muffins, net wt. 9 oz. (3 muffins per 9-oz. package), 10/9-oz. packages per case. The responsible firm on the label shows the product is distributed by Moran Foods, Inc., Earth City, MO. Recall # F- 304-2. CODE All product on the market at the time the recall was initiated (product was not coded). RECALLING FIRM/MANUFACTURER Recalling Firm: Save-A-Lot Ltd., Earth City, MO, by E-mail and fax on October 31, 2001. Manufacturer: Coastal Foods, Inc., Houston, TX. FDA initiated recall is complete. REASON Total carbohydrates on nutrition facts panel is incorrect. VOLUME OF PRODUCT IN COMMERCE 112,600/10/9-oz. package cases. DISTRIBUTION Nationwide. _______________________ PRODUCT Big K Koolers, Kiwi Strawberry, in 12 oz cans, 24 cans per pack. UPC #11110-49707. Recall # F-321-2. CODE CODE: Sell By 01-28-02A2. RECALLING FIRM/MANUFACTURER Recalling Firm: The Kroger Co. Cincinnati, OH, by electronic recall message on July 31, 2001. Manufacturer: America's Beverage Company, Irving, TX. Firm initiated recall is complete. REASON Product has an off-flavor and may cause a burning sensation of mouth/throat. VOLUME OF PRODUCT IN COMMERCE 4,431 cases. DISTRIBUTION Nationwide. _______________________ PRODUCT United Dairy Farmer's Premium Homemade brand Vanilla Ice Cream, packed in one-pint paper cup-shaped containers. Recall # F-322-2. CODE Code Numbers: A 04/23/02 and AR 04/23/02. The code is printed on the bottom of the pint containers. RECALLING FIRM/MANUFACTURER United Dairy Farmers, Inc., Norwood, OH, by telephone and letters on June 6, 2001. Firm initiated recall is complete. REASON Product is contaminated with chemicals from a cleaning solvent. VOLUME OF PRODUCT IN COMMERCE 2,900 pint containers. DISTRIBUTION OH, MI, KY, IN, and PA. _______________________ PRODUCT Bareman Dairy brand Crystal Clear Drinking Water packaged in one gallon containers. Recall # F-323-2. CODE Sell by date starts with DEC8JD. RECALLING FIRM/MANUFACTURER Bareman Dairy, Inc., Holland, MI, by press release and telephone on August 17, 2001. State initiated recall is complete. REASON May contain equipment sanitizer. VOLUME OF PRODUCT IN COMMERCE 19,700 gallons. DISTRIBUTION IL, IN and MI.RECALLS AND FIELD CORRECTIOS: FOODS -- CLASS III
_______________________ PRODUCT Barq's Root Beer (No Caffeine) beverage in 12 oz. cans packaged in 6 packs and 12 packs, and 20 oz. PET bottles, and Barq's Caffeine-Free Root Beer syrup, 5 gallon BIB (Bag-In-Box) containers for Fountain Beverage dispensing equipment. Recall # F-320-2. CODE 12 oz. cans in 6 packs and 12 packs FEB1802SWA FEB1802SWB FEB1802TOC MAR1102TOC; 20 oz. PET AUG2001SWD; 5 gallon BIB (Bag-In-Box) C108051401 C106052001. RECALLING FIRM/MANUFACTURER Recalling Firm: Cocoa-Cola North America, Atlanta, GA, by telephone and letter of June 18, 2001. Manufacturer: Coca-Cola Fountain, Ontario, CA; Swire Coca-Cola, Salt Lake City, UT. Firm initiated recall is ongoing. REASON Product is labeled as not containing caffeine when it actually does. VOLUME OF PRODUCT IN COMMERCE 31,920 12 oz. cans; 1,543 20 oz. PET bottles; 120/5 gal. BIB containers. DISTRIBUTION AK, AZ, CA, CO, ID, NE, NV, OR, UT, WA and WY.**********CORRECTIONS********** RECALL NUMBERS D-200-2 GEMZAR and D-201-2 SODIUM CHLORIDE INJECTION, ON THE MARCH 6, 2002 ENFORCEMENT REPORT SHOULD BE CLASS III NOT CLASS II RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________ PRODUCT Trandate Tablets (labetalol hydrochloride), 300 mg, packaged in 100 unit bottles and 100 unit dose packages (10x10 tablets). Indicated in the management of hypertension. Recall # D-204-2. CODE a) Lot OZP1108 (300 mg X 100s); b) Lot 9ZM2082A (300 mg X 100 UD). RECALLING FIRM/MANUFACTURER Recalling Firm: Prometheus, San Diego, CA, by letter sent February 19, 2002. Manufacturer: Glaxo Welcome, Zebulon, NC. Firm initiated recall is ongoing. REASON Dissolution Failure (at stability testing). VOLUME OF PRODUCT IN COMMERCE a) 5224 mfd., 5179 dist., 45 retained; b) 4244 mfd., 4111 dist., 133 retained. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT Platelets, Recall # B-0889-2. CODE Unit 9294776. RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA, by telephone on August 15, 2001. Firm initiated recall is complete. REASON Blood product, which was incorrectly tested and found negative for the antibody to the human T-lymphotropic virus types I & II (anti-HTLV-I/II) on initial testing but tested repeatedly reactive for anti-HTLV-I/II upon subsequent retesting, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MS. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0890-2; b) Red Blood Cells, Leukocytes Reduced, Recall # B-0891-2; c) Recovered Plasma, Recall # B-0892-2. CODE a) Unit number 8935070; b) Unit number 8984762; c) Unit numbers 8935070 and 8984762. RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA, by telephone and letter on May 8, 2000. Firm initiated recall is complete. REASON Blood products, that tested negative for antibodies to human immunodeficiency virus (anti-HIV), but were collected from a donor that previously tested repeatedly reactive for anti-HIV, were distributed. VOLUME OF PRODUCT IN COMMERCE 4 units. DISTRIBUTION LA and Switzerland. _______________________ PRODUCT Red Blood Cells, Recall # B-0893-2. CODE Unit number 8969834. RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA, by telephone June 22, 2000. Firm initiated recall is complete. REASON Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION LA. _______________________ PRODUCT Red Blood Cells, Recall # B-0897-2. CODE Unit number 9271171. RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA, by telephone May 9, 2001. Firm initiated recall is complete. REASON Blood product, that tested repeatedly reactive for the antibodies to human T lymphotropic virus, types I and II (anti-HTLV-I/II), was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MS. _______________________ PRODUCT a) Platelets, Recall # 0898-2; b) Fresh Frozen Plasma, Recall # B-0899-2. CODE a) and b) Unit number 9293817. RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA, by telephone September 17, 2001. 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 LA. _______________________ PRODUCT a) Red Blood Cells, Leukocytes Reduced, Recall # B-0900-2; b) Platelets, Recall # B-0901-2. CODE a) Unit numbers 01KT58194, 01KT56643, and 01KY17555; b) Unit numbers 01KT58194 and 01KT56643. RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, New York-Penn Region, West Henrietta, NY, by letter on June 14, 2001. Manufacturer: American Red Cross Blood Services, Binghamton, NY. 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 5 units. DISTRIBUTION NY and PA. _______________________ PRODUCT Ragweed Mix - Giant/Short, Allergenic Extract, 50 milliliter bottle, 10,000 PNU/ml., Recall # B-0903-2. CODE Lot number E1021046. RECALLING FIRM/MANUFACTURER Allergy Laboratories of Ohio, Inc., Columbus, OH, by letter dated December 12, 2001. Firm initiated recall is complete. REASON Allergenic extract, labeled with an incorrectly high antigen E concentration, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 lot. DISTRIBUTION PA. _______________________ PRODUCT Platelets, Recall # B-0913-2. CODE Unit number 03F05224. RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross,Southern Region, Atlanta, GA, by telephone on December 30, 1997, and by letter dated January 5, 1998. Manufacturer: American Red Cross Blood Services, Miami, FL. Firm initiated recall is complete. REASON Blood product, that tested reactive for the causative agent of Chagas’ disease, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION FL. _______________________ PRODUCT a) Red Blood Cells, Recall # B-0917-2; b) Fresh Frozen Plasma, Recall # B-0918-2. CODE a) Unit 06GR52567; b) Units 06GR52567 and 06GR63455. RECALLING FIRM/MANUFACTURER American National Red Cross, Southern California Region, Los Angeles, CA, by telephone on May 15 and by letter dated May 24, 2001. REASON Blood products, which were collected from a donor who had a history of jaundice, were distributed. VOLUME OF PRODUCT IN COMMERCE 3 units. DISTRIBUTION CA.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Red Blood Cells, Recall # B-0894-2. CODE Unit numbers 8730906 and 8730907. RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA, by telephone July 17, 1997. Firm initiated recall is complete. REASON Blood products, labeled with the incorrect expiration date, were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION LA. _______________________ PRODUCT Red Blood Cells, Irradiated, Recall # B-0895-2. CODE Unit number 9227748. RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA, by telephone December 1, 2000. Firm initiated recall is complete. REASON Blood product, labeled with the incorrect expiration date, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION LA. _______________________ PRODUCT Whole Blood, Recall # B-0896-2. CODE Unit number 9259896. RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA, by telephone June 14, 2001. Firm initiated recall is complete. REASON Blood product, collected in an expired collection bag, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION MS. _______________________ PRODUCT Corneas, Recall # B-0902-2. CODE Numbers 183-OD, 129-OD, 120-OD, 132-OS, 135-OS, 116-OD, 131-OD, 173-OD, 183-OS, 116-OS, 167-OD, 114-OS, 115-OS, 128-OD, 132-OD, 167-OS, 110-OD, 110-OS, 178-OD, 178-OD (Sclera), 123-OD, C-01-113-OD, C-01-113-OS, C-01-121-OD, C-01-128-OS, C-01-114-OD, C-01- 178-OS, C-01-121-OS, C-01-122-OS, C-01-123-OS, 120-OS, C-01-169-OD, C-01-184-OD, and C-01-184-OS RECALLING FIRM/MANUFACTURER Lions Eye and Tissue Bank, Inc., Lions of District 22-C Eye Bank, Seabrook, MD, by letters on October 9 November 5, 2001, and January 8, 2002. REASON Corneas that tested negative for human immunodeficiency virus (HIV) and hepatitis B surface antigen (HBsAg), but were tested using kits that had not been approved for use with cadaveric blood samples, were distributed. VOLUME OF PRODUCT IN COMMERCE 34 corneas. DISTRIBUTION MD, DC, NY, CA, NJ and Jordan.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
_______________________ PRODUCT Premier Adenoclone Type 40/41, an EIA diagnostic test kit. Recall # Z- 0556-2. CODE Lot Number: 696006.015. Expiration Date: 04 Feb 02. RECALLING FIRM/MANUFACTURER Meridian Bioscience, Inc., Cincinnati, OH, by letters on Dec. 10, 2001. Firm initiated recall is ongoing. REASON The kits may product false positive test results due to cross-reactivity. VOLUME OF PRODUCT IN COMMERCE 695 kits. DISTRIBUTION Nationwide and Canada, Italy, Japan, Great Britain and Belgium. _______________________ PRODUCT Vacuette 3.5 ml Coagulation Tube (blue top tubes), Item # 454327. Recall # Z-0557-2. CODE Lot No. A040109 and A040110. RECALLING FIRM/MANUFACTURER Recalling Firm: Greiner bio-one North America, Inc., Monroe, NC, by letter on October 9, 2001. Manufacturer: Greiner bio-one, Austria. Firm initiated recall is ongoing. REASON Partially filed tubes which can cause erroneous results. VOLUME OF PRODUCT IN COMMERCE 347 boxes. DISTRIBUTION Nationwide. _______________________ PRODUCT Torisoft Daily Wear Soft Contact Lens. Recall # Z-0558-2. CODE 1290275, 1297633, 1291090, 1295628, 1295636, 1296202, 1298017, 1298014. RECALLING FIRM/MANUFACTURER Ciba Vision Corp., Duluth, GA, by letter on Nov. 30, 2001. Firm initiated recall is ongoing. REASON Experimental design tool was used to manufacture product. VOLUME OF PRODUCT IN COMMERCE 18 lenses. DISTRIBUTION AZ, LA, MI, MN, NJ, NY, OH, UT and VA. _______________________ PRODUCT Symmetry Bypass System Aortic Connector, Model Number ACN-5055. Recall # Z-0559-2. CODE Lot Number: 65930. RECALLING FIRM/MANUFACTURER St. Jude Medical ATG, Inc., St. Jude Medical, Inc., Maple Grove, MN, by visit on December 18, 2001. Firm initiated recall is ongoing. REASON The wrong sized vein transfer sheath was included in the product packages. VOLUME OF PRODUCT IN COMMERCE 45 devices. DISTRIBUTION Nationwide. _______________________ PRODUCT Parallax brand EZflow Cement Delivery System. Recall # Z-0560-2. CODE All Lot numbers including: 111300 021401 030901 050101 050701 060201 080301 100201 100201. RECALLING FIRM/MANUFACTURER Parallax Medical, Inc., Scotts Valley, CA, by fax and telephone on January 10, 2002 and by letters on January 11, 2002. Firm initiated recall is ongoing. REASON The cannula may break when subjected to high torsional load. VOLUME OF PRODUCT IN COMMERCE 1084 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Coulter GEN S (tm) Hematology Analyzers. Recall # Z-0561-0563-2. CODE Part Numbers: 6605381, 6605360, 6605470. RECALLING FIRM/MANUFACTURER Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on November 12, 2001. Manufacturer: Beckman Coulter Inc., Miami, FL. Firm initiated recall is ongoing. REASON Erroneous low results as an artifact of dilution of blood sample at aspiration. VOLUME OF PRODUCT IN COMMERCE 2000. DISTRIBUTION Nationwide and Canada. _______________________ PRODUCT Simplastin HTF, Recall # Z-0564-2. CODE Lot 161600. RECALLING FIRM/MANUFACTURER bioMerieux, Inc., Durham, NC, by letter on December 19, 2001. Firm initiated recall is ongoing. REASON Increased frequency of inconsistent & possibly incorrect clot times. VOLUME OF PRODUCT IN COMMERCE 612 kits. DISTRIBUTION CO, GA, IL, NY, NC and Canada, China and the United Kingdom. _______________________ PRODUCT Portex Inner Cannula for the Blue Line Tracheal Tube. Recall # Z-0565-2. CODE Portex Inner Cannula for the Blue Line Tracheal Tube: a) Inner Cannula Size 7.0mm Catalog Number: 566070 Lot Number: 108760 b) Inner Cannula Size: 8mm Catalog Numbers: 109055, 110735, 111493, 111578 c) Inner Cannula Size: 9.0mm Catalog Number: 566090 Lot Numbers: 110736, 111579. RECALLING FIRM/MANUFACTURER Portex, Inc., Keene, NH, by letter on January 22, 2002. Firm initiated recall is ongoing. REASON Sterility of the device may be compromised due to loss of package seal integrity. VOLUME OF PRODUCT IN COMMERCE 3536. DISTRIBUTION Nationwide and Canada. _______________________ PRODUCT Nellcor Puritan Bennett LP Power Motor Board Kits, Model L-1687 for LP Series (LP6 and LP10) Ventilators. Recall # Z-0568-2. CODE Lots YW25640 and YW26024. RECALLING FIRM/MANUFACTURER Nellcor Puritan Bennett, Inc., Minneapolis, MN, by telephone beginning January 11, 2002. Firm initiated recall is complete. REASON Power Motor Board failure could lead to ventilator failure. VOLUME OF PRODUCT IN COMMERCE 10 kits. DISTRIBUTION NJ, SC, TN, Singapore and Japan. _______________________ PRODUCT a) LeMaitre Vascular VascuTape Glow'n Tell Tape, Sterile Product. Recall # Z-0569-2; b) LeMaitre Vascular VascuTape Stent Guide. Recall # Z-0570-2. CODE a) Product Nos.: 1100-20 (20 strips), 1100-50 (50 Strips) and 1100- 00 (100 strips). Lot No. SGL 1042; b) Product Nos.: 1102-20 (20 strips), 1102-50 (50 strips) and 1102- 00 (100 strips). Lot Number: LSG 1028. RECALLING FIRM/MANUFACTURER LEmaitre Vascular, Inc., Burlington, MA, by letter on December 7, 2001. Firm initiated recall is ongoing. REASON Sterility of the device may be compromised due to a loss of seal integrity. VOLUME OF PRODUCT IN COMMERCE a) Glow'n Tape= 4,610 boxes; b) Stent Guide=2,840 boxes. DISTRIBUTION Nationwide. _______________________ PRODUCT PSA Reagent Pack For in vitro diagnostic use only, 100 test units per pack. Distributed by: Ortho-Clinical Diagnostics, Amersham, UK. Recall # Z-0571-2. CODE Lot 190, Exp. 2/22/02. RECALLING FIRM/MANUFACTURER Recalling Firm: Ortho-Clinical Diagnostics, Inc., Rochester, NY, by letters dated January 10, 2002. Manufactured by: Centocor Diagnostics of PA, Inc. Firm initiated recall is ongoing. REASON Product labeled for use outside U.S. shipped to domestic customers. VOLUME OF PRODUCT IN COMMERCE 473 reagent packs. DISTRIBUTION Nationwide and Internationally.END OF ENFORCEMENT REPORT FOR MARCH 13, 2002 ####
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