June 21, 2000 00-25RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
PRODUCT Daniel Boulud Smoked Atlantic Salmon, in 4-ounce, 8-ounce, 1-pound, and whole or pre-sliced sides. Recall #F-509-0. CODE Lot 158 EXP 4/16/00 and Lot 160 EXP 4/27/00. MANUFACTURER Browne Trading Company, Portland, Maine. RECALLED BY Manufacturer, by telephone or fax on or before April 12, 2000. Firm- initiated recall complete. DISTRIBUTION Nationwide. QUANTITY Lot 158: 236 pounds distributed; Lot 160: 118.4 pounds distributed. Product is expired, none is expected to remain on market. REASON Product was contaminated with Listeria monocytogenes. ________ PRODUCT 1) Pimento Spread under the following labels and sizes: a) Ruthís Pimento Spread - 7 oz., 12 oz., 24 oz., 5 lb., and 10 lb. b) Bi-Lo Pimento Spread - 7-1/2 oz. and 12-1/2 oz. c) Piggly Wiggly Pimento Spread - 7 oz. and 12 oz. d) Lake Hickory Fresh Air Pimento Spread - 7-1/2 oz. e)IGA Pimento Spread - 12-1/2 oz. 2) Ruthís Old Fashioned Pimento Spread - 16 oz., 5 lb., and 10 lb. 3) Ruthís Lite Pimento Spread - 12 oz., 5 lb., and 10 lb. 4) Ruthís Hot Pimento Spread - 7 oz., 12 oz., and 5 lb. 5) Ruthís Pimento Spread with Pickle - 7 oz. 6) Ruthís Smooth Pimento Cheddar Style Spread - 12 oz. 7) Ruthís Cream Cheese Pineapple-Pecan Spread - 7 oz. and 12-1/2 oz. 8) Bi-Lo Gourmet Style Cheddar Spread - 12-1/2 oz. 9) Ruthís Deviled Egg Spread - 7 oz. and 5 lb. Recall #F-515/523-0. CODE All SELL BY dates between March 17, 2000 and June 7, 2000. MANUFACTURER B & H Foods, Inc., Chester, South Carolina. RECALLED BY B & H Foods, Inc., Charlotte, North Carolina, by telephone and press release on March 17, 2000, followed by visit March 17-22, 2000. Firm- initiated recall complete. DISTRIBUTION North Carolina, South Carolina, Tennessee, Virginia, Alabama. QUANTITY Firm estimates none remains on the market. REASON Products may be contaminated with Listeria monocytogenes. ________ PRODUCT Smoked Salmon: a) Grants Traditional Oak-Smoked Premium Scottish Salmon b) Wegmans' Cured with Honey Scottish Style Smoked Salmon c) Craigellachie Smoked Scottish Salmon d) MacKnight Smoked Salmon. Recall #F-548/551-0. CODES a) All codes; b) All codes; c) Batch 144; d) Batch 144. MANUFACTURER Grants Smoked Foods, Ltd., Maryport, United Kingdom. RECALLED BY MacKnight Smoked Foods, Inc., New Britain, Pennsylvania, by letter faxed on March 16, 2000, and by fax on April 6, 2000. The New York State Department of Agriculture issued a press release on March 13, 2000. The recall announcement appeared on a seafood newsletter "SEAFAX FIRST NEWS" dated March 15, 2000. The Department of Agriculture issued press release on April 5, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York and Pennsylvania. QUANTITY Firm estimates none remain on the market. REASON The New York State Department of Agriculture and Markets (NYSDAM) found three of the products contaminated with Listeria monocytogenes. The MacKnight Smoked Salmon was made from the same batch (144) as the Craigellachie brand salmon, which was found to be positive for Listeria monocytogenes.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT La Mexicana brand Green Corn Tortilla products: a) Green Corn Tortillas, 3 dozen per package, 18 packages per case; b) Tri-Colored 4" Corn Tortillas, 3 dozen per package, 24 packages per case; c) Tri-Colored Chip, 3 dozen per package, 24 packages per case. Recall #F-511/513-0. CODE All with date code 5/12/00 or prior. MANUFACTURER La Mexicana, Inc., Seattle, Washington. RECALLED BY Manufacturer, by visit beginning on May 19, 2000, followed by fax. Firm- initiated field correction (relabeling) complete. DISTRIBUTION Washington state and Oregon. QUANTITY Firm estimates none remain on the market. REASON Products contained undeclared FD&C Yellow No. 5. ________ PRODUCT Lemonade packaged in waxed cardboard quart and pint cartons. Recall #F-514-0. CODE Quart EXP dates - May 17, 2000 and July 3, 2000; Pint EXP dates - June 20, 2000 and July 3, 2000. MANUFACTURER Barber Pure Milk Company, doing business Barber Dairies, Inc., Birmingham, Alabama. RECALLED BY Manufacturer, by fax and telephone on May 5, 2000. Firm-initiated recall complete. DISTRIBUTION Alabama. QUANTITY 7,286 quarts and 9,690 pints were distributed; firm estimates none remains on the market. REASON Product contained undeclared FD&C Yellow No. 5. ________ PRODUCT Various Flavored Syrups for Espresso Drinks and Italian Ices, in 12.7- fluid ounce and 25.4-fluid ounce bottles: a) Chocolate Mint; b) Creme De Cacao; c) Kahula Almond Fudge; d) Sugar Free Chocolate; e) Sugar Free Macadamia Nut; f) Eggnog; g) Peach; h) Pineapple; i) Huckleberry; j) Banana; k) Creme De Menthe; l) Lime; m) Kiwi; n) Creamy Orange; o) Passion Fruit. Recall #F-524/538-0. CODE None. MANUFACTURER East Gate Foods, Inc., Monroe, Washington. RECALLED BY Lowery's Specialty Foods Company, Inc., doing business as Pasanos' Syrups, Snohomish, Washington, by letter on May 3, 2000, followed by telephone beginning the week of May 22, 2000. Firm-initiated recall complete. DISTRIBUTION Washington state, Oregon, Idaho, Montana, Michigan, Colorado. QUANTITY Approximately 2,500 bottles per week were distributed. REASON a-e) These syrups contained undeclared FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Red No. 40, FD&C Blue No. 1 f-g) These syrups contained undeclared FD&C Yellow No. 5, FD&C Yellow No. 6, and FD&C Red No. 40 h) This syrup contained undeclared FD&C Yellow No. 5, FD&C Yellow No. 6 i) This syrup contained undeclared FD&C Yellow No. 5, FD&C Blue No. 1, and FD&C Red No. 40 j) This syrup contained undeclared FD&C Yellow No. 5 and FD&C Red No. 40 k-l) These syrups contained undeclared FD&C Yellow No. 5 and FD&C Blue No. 1 m) This syrup contained undeclared FD&C Yellow No. 5 n-o) These syrups contained undeclared FD&C Yellow No. 6.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT Jerseymaid Old Fashioned Real Vanilla Ice Cream packaged in paperboard round half-gallon cartons. Recall #F-510-0. CODE 011001 1Plt 06-2394. MANUFACTURER Safeway, Inc., Los Angeles Ice Cream Plant, Los Angeles, California. RECALLED BY Safeway Inc. (Vons Companies, a wholly owned subsidiary of Safeway, Inc.), Pleasanton, California, by intra-company E-mail on May 3, 2000. Firm-initiated recall complete. DISTRIBUTION California and Nevada. QUANTITY 2,000 cases (12,000 units) were distributed. REASON Product is unfit for food due to contamination with ammonia. ________ PRODUCT Various Flavored Syrups for Espresso Drinks and Italian Ices, in 12-7 fluid ounce and 25.4-fluid ounce bottles: a) Bing Cherry; b) Blackberry; c) Boysenberry; d) Raspberry; e) Sugar Free Raspberry; f) Spicy Cinnamon; g) Strawberry; h) Watermelon; i) Sugar Free Strawberry. Recall #F-539/547-0. CODE None. MANUFACTURER East Gate Foods, Inc., Monroe, Washington. RECALLED BY Lowery's Specialty Foods Company, Inc., doing business as Pasanos' Syrups Snohomish, Washington, by letter on May 3, 2000, followed by telephone beginning the week of May 22, 2000. Firm-initiated recall complete. DISTRIBUTION Washington state, Oregon, Idaho, Montana, Colorado, Michigan. QUANTITY Approximately 2,500 bottles per week were distributed. REASON a-f) These syrups contain undeclared FD&C Blue No.1 and FD&C Red No. 40 g-i) These syrups contain undeclared FD&C Red No. 40.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
________ PRODUCT Herbal Dietary Supplements: a) Zhen Qi, Herbal Extract Capsules, 500 mg capsules, in 60-unit bottles; b) Diabetes Angel Pearl Hypoglycemic Capsules, 0.5 grams per capsule, in 60-unit bottles; c) Diabetes Angel Hypoglycemic Capsules, 0.5 grams per capsule, in 60- unit bottles. Recall #D-406/408-0. CODE All lot codes. MANUFACTURER Tongyi Tang Pharmaceuticals Company, Harbin, China. RECALLED BY Sino American Health Products, Inc., Torrance, California., by letter and press release on February 18, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY Undetermined. REASON Misbranded - All three products contain the undeclared prescription ingredient glyburide.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT Goldline brand Acetaminophen Suppositories, USP, OTC indicated for the temporary relief of fever, ache, pains, and headaches, for rectal administration: a) 120 mg, Pediatric, units of 12, NDC #0182-1662-11; b) 650 mg, units of 12, NDC #0182-1095-11. Recall #D-404/405-0. CODE Lot #AL 606 EXP 9/20/02. MANUFACTURER Clay-Park Labs, Inc. (CPL), Bronx, New York. RECALLED BY Manufacturer, by letter dated November 30, 1999. Firm-initiated recall ongoing. DISTRIBUTION Kentucky. QUANTITY 49,392 suppositories were distributed. REASON Misbranding - Some 650 mg (correctly labeled) suppositories were packaged into cartons labeled as 120 mg.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT Vasotec Tablets (Enalapril Maleate), 5 mg, in 1,000 and 10,000 tablet bottles, Rx indicated for the treatment of hypertension, it is also indicated for the treatment of symptomatic congestive heart failure usually in combination with diuretics and digitalis. NDC Numbers: 0006- 712-87 and 0006-712-82. Recall #D-396-0. CODE Lot Numbers: K0634 EXP 12/01 and K0635 EXP 12/01. MANUFACTURER Merck Manufacturing Division, Division of Merck & Company, Inc., Caguas, Puerto Rico. RECALLED BY Manufacturer, by letter on March 12, 2000. Firm-initiated recall ongoing. DISTRIBUTION Florida, Nevada, New Mexico, Texas, Arizona, South Dakota, Illinois. QUANTITY 149 units were distributed. REASON Dissolution (low) failure. ________ PRODUCT Nasacort AQ (Triamcinolone Acetonide) Nasal Spray, Rx indicated for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 6 years of age and older. The NDA number is 20-468. The NDC numbers are 0075-1506-16, 58087-323-16, and 0075-1506-06: a) Nasacort AQ , Nasal Spray (Triamcinolone acetonide-16.5 grams), 120 metered actuations; b) Nasacort AQ , Nasal Spray (Triamcinolone acetonide-6.5 grams), 30 metered actuations, Recall #D-409/410-0. CODE a) All lots with expiration dates March 2000(03/2000) through November 2001 (11/2001); b) All lots with expiration dates March 2000(03/2000) through January 2002 (01/2002). MANUFACTURER Rhone Poulenc Rorer Puerto Rico, Inc., Manati, Puerto Rico. RECALLED BY Aventis Pharmaceuticals Products, Inc., Collegeville, Pennsylvania, by letter dated March 31, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 11,870,820 units were distributed; firm estimated that 350,000 units remained on market at time of recall initiation. REASON Stability: (Super-potency) potential for patients to receive a higher dose than labeled of triamcinolone acetonide.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukoreduced; c) Recovered Plasma. Recall #B-770/772-0. CODE Unit Numbers: a) 04FJ91904; b)04FJ77467; c) 04FJ91904 and 04FJ77467. MANUFACTURER American Red Cross, Dedham, Massachusetts. RECALLED BY Manufacturer, by letter dated November 19, 1999. Firm-initiated recall complete. DISTRIBUTION Massachusetts, New Hampshire, California. QUANTITY a) 1 unit; b) 1 unit; c) 2 units were distributed. REASON Blood products were collected from a donor with a history of having tested positive for Hepatitis C. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-773/774-0. CODE Unit #04FJ64487. MANUFACTURER American Red Cross, Dedham, Massachusetts. RECALLED BY Manufacturer, by letter dated December 16, 1999. Firm-initiated recall complete. DISTRIBUTION Massachusetts and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of having tested positive for hepatitis. ________ PRODUCT a) Red Blood Cells, Leukoreduced; b) Platelets. Recall #B-775/776-0. CODE Unit #04GF00278. MANUFACTURER American Red Cross, Dedham, Massachusetts. RECALLED BY Manufacturer, by letters dated December 17, 1999, and February 7, 2000. Firm-initiated recall complete. DISTRIBUTION New York and Maine. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c) Recovered Plasma. Recall #B-801/803-0. CODE Unit #8859637. MANUFACTURER The Blood Center, New Orleans, Louisiana. RECALLED BY Manufacturer, by telephone on November 4, 1998, and by fax on December 10, 1998. Firm-initiated recall complete. DISTRIBUTION Louisiana, New Jersey, Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who was previously deferred at another blood center. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-804/806-0. CODE Unit #8844250. MANUFACTURER The Blood Center, New Orleans, Louisiana. RECALLED BY Manufacturer, by telephone on September 9, 1998. Firm-initiated recall complete. DISTRIBUTION Louisiana. QUANTITY 1 unit of each component was distributed. REASON Blood products were distributed after receiving post donation information concerning possible high risk behavior. ________ PRODUCT Platelets, Pooled. Recall #B-807-0. CODE Unit #3099375. MANUFACTURER The Blood Center, New Orleans, Louisiana. RECALLED BY Manufacturer, by letter dated September 30, 1999. Firm-initiated recall complete. DISTRIBUTION Louisiana. QUANTITY 1 unit was distributed. REASON Pooled product contained two expired units. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-808/809-0. CODE Unit #8917666. MANUFACTURER The Blood Center, New Orleans, Louisiana. RECALLED BY Manufacturer, by telephone on August 4, 1999. Firm-initiated recall complete. DISTRIBUTION Louisiana. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor whose medical history screening was inadequately performed. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Platelets for further manufacture; d) Fresh Frozen Plasma; e) Source Leukocytes; f) Recovered Plasma. Recall #B-811/816-0. CODE Unit Numbers: a) 25N95303, 25E92180, 25E98391, 25V41984, and 01GL29817; b) 25E92180, 25E98391, and 25V41984; c) 25N95303 d) 25E92180, 25E98391, and 25V41984; e) 01GJ11136; f) 25N95303 and 01GL29817. MANUFACTURER American Red Cross Blood Services, Syracuse, New York. RECALLED BY Manufacturer, by letter dated August 30, 1999, by E-mail on August 23, 1999. Firm-initiated recall complete. DISTRIBUTION New York, California, New Jersey, Switzerland. QUANTITY a) 5 units; b) 3 units; c) 1 unit; d) 3 units; e) 1 unit; f) 2 units were distributed. REASON Blood products were incorrectly tested for the Hepatitis B Surface Antigen (HBsAg), or which tested negative for HBsAg, but were collected from a donor whose previous donation was incorrectly tested for HBsAg. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Source Leukocytes. Recall #B-817/820-0. CODE Unit #11FM28492. MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri. RECALLED BY Manufacturer, by letter dated June 1, 1999. Firm-initiated recall complete. DISTRIBUTION Missouri and New Jersey. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported a history of Addison's Disease and exposure to hepatitis A.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT Red Blood Cells. Recall #B-777-0. CODE Unit #7149828. MANUFACTURER U.S. Department of the Air Force, 74th Medical Group, Wright Patterson AFB, Ohio. RECALLED BY Manufacturer, by letters dated November 17 and 18, 1998. Firm-initiated recall complete. DISTRIBUTION New Jersey and Maryland. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had an elevated body temperature. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-778/779-0. CODE Unit #4190151. MANUFACTURER Blood Bank of Alaska, Inc., Anchorage, Alaska. RECALLED BY Manufacturer, by letters dated March 20, or 21, 2000. Firm-initiated recall complete. DISTRIBUTION California and New Jersey. QUANITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who received a tissue transplant (surgery) within a year of donation. ________ PRODUCT Platelets Pheresis, Leukocytes Reduced, Irradiated. Recall #B-792-0. CODE Unit #3767970. MANUFACTURER The Blood Center, New Orleans, Louisiana. RECALLED BY Manufacturer, by telephone on October 6, 1999, and by letters dated October 15 and 26, 1999. Firm-initiated recall complete. DISTRIBUTION Louisiana. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who took the drug Propecia. ________ PRODUCT Red Blood Cells, Irradiated. Recall #B-793-0. CODE Unit #8922205. MANUFACTURER The Blood Center, New Orleans, Louisiana. RECALLED BY Manufacturer, by telephone on October 10, 1999. Firm-initiated recall complete. DISTRIBUTION Louisiana. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-794/795-0. CODE Unit Numbers: a) 8825558; b) 8825558 and 8825563. MANUFACTURER The Blood Center, New Orleans, Louisiana. RECALLED BY Manufacturer, by telephone on May 15, 1998. Firm-initiated recall complete. DISTRIBUTION Louisiana. QUANTITY a) 1 unit; b) 2 units were distributed. REASON Blood products were labeled with extended expiration dates. ________ PRODUCT Red Blood Cells, Leukocytes Removed. Recall #B-796-0. CODE Unit #8829824. MANUFACTURER The Blood Center, New Orleans, Louisiana. RECALLED BY Manufacturer, by telephone on September 24, 1998. Firm-initiated recall complete. DISTRIBUTION Louisiana. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. ________ PRODUCT Platelets, Pheresis. Recall #B-799-0. CODE Unit #K10311. MANUFACTURER The Blood Center, New Orleans, Louisiana. RECALLED BY Manufacturer, by telephone and letter on April 27, 1998. Firm-initiated recall complete. DISTRIBUTION Louisiana. QUANTITY 1 unit was distributed. REASON Blood product was received at an unacceptable temperature, was redistributed. ________ PRODUCT Red Blood Cells, Autologus. Recall #B-800-0. CODE Unit #8851725 and 8823926. MANUFACTURER The Blood Center, New Orleans, Louisiana. RECALLED BY Manufacturer, by telephone on December 30, 1998. Firm-initiated recall complete. DISTRIBUTION Louisiana. QUANTITY 2 units were distributed. REASON Blood products were labeled with extended expiration dates. _______ PRODUCT Recovered Plasma. Recall #B-810-0. CODE Unit #8917666. MANUFACTURER The Blood Center, New Orleans, Louisiana. RECALLED BY Manufacturer, by fax on August 9, 1999. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose medical history screening was inadequately performed.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT Peripherally Inserted Central Venous Catheter Trays containing Clinipad Cliniguard Protective Dressing Prep. Recall #Z-811-0. CODE Catalog number C-PICS-301. Lot F804662 Catalog number C-PICS-301-CHOP-103097. Lot F790253. Catalog number C-PICS-301J. Lots F833591, 952989, 955791, 950762, 952988, 959369, 950763, F824639, F794489, F796661, F801539, F806269, F811737, F817595, F809235, F822207, F826239, F834114, F839371, F838672, F840052 and F838672X. Catalog number C-PICS-301J-SACRED-HEART-062591-PKG. Lots F771187 and F791507. Catalog number C-PICS-301J-UTAH-070992. Lots 947003, 947002, 951258, 951257, 956120, 956121 and 956892. Catalog number C-PICS-401. Lots 956894 and 960721. Catalog number C-PICS-401-CHOP-103097. Lots F794621, F793680, F801365, F02215 and F806310. Catalog number C-PICS-401J. Lots 949398, 955792, 949401, 956606, 956607, 956608, 949400, 960481, 948053, 955793, 955795, 932069X, 955794, 949399, 960482, F789187, F796784, F797974, F801540, F806623, F806270, F810223, F816240, F819630, F822721, F824841, F826240, F833302, F791829, F810408 and F828140. Catalog number C-PICS-401J-JGH-121698. Lots F794145, F809021 and F811276. Catalog number C-PICS-401J-SACRED-HEART-062591-PKG. Lots F784415, F801146, F800823, F818856 and F833973. Catalog number C-PICS-401J-UTAH-070992. Lots 951914, 945532, 949403, 951915, 932792X, 956896, 957631, 956895, 956123, 956122 and 945530 Catalog number C-PICS-401J-X. Lot F811185. Catalog number C-PICS-501. Lots F794146, F810409, and F828141. Catalog number C-PICS-501-ANDREWS-021191. Lots F804082 and F830783. Catalog number C-PICS-501E-MCCREADY-041994. Lot F797212. Catalog number C-PICS-501J. Lots F791623, F827945, 959620, 957447, 945802, 959618, 950481, 959621, 950482, F789188, F790483, F794490, F796662, F796785, F799725, F801541, F802192, F806271, F810986, F817596, F819631, F820587, F821289, F826998, F822208, F834115, F839372, F840053, 957446, F810410, F828142, and 945801. Catalog number C-PICS-501J-ST-MARK-060391. Lot F792267. Catalog number C-PICS-501J-UTAH-070992. Lots F833885, F833992, F832109, F800450, F803795, F81222, F801538, F834317, and F805245. Catalog number C-PICSY-301J-RP-011195. Lots 947305 and954515 Catalog number C-PICSY-401J. Lots 952430, 952431, 955796, 956899, 954222, 954223, 955797, 963886, 958901, and 956901. Catalog number PICS-301-MPIS. Lots 956622, 954243, 954241, 958626, 958628, 958627, 943780, 951932, 951933, 956621, 954242, 957849, 956623, 954244X, 957850, 951930X, 943781, 957851, 960528, 957848, 960529, 958625, 954244 and 932824 Catalog number PICS-301-MPIS-A. Lots 952696, 95049,7 950498, 958629, 940831X, 942163, 942164, 958630, 960216, 960215, 958631 and 936028. Catalog number PICS-301-MPIS-CMC-072899. Lot F794588. Catalog number PICS-301-MPIS-NT. Lots F811680, F807565, F823367, F834675, F823631, F788865, and F815245. Catalog number PICS-301-MPIS-WOC. Lots 953050, 953051, 954930, 959895, 954931, 947316, 944002, 947314, 945820 and 959897 Catalog number PICS-301-MPIS-WOC-NT. Lots F796253, F808401, F793351, F797779, F803200, F808243, F814403, F804945 and F831196 Catalog number PICS-401-MPIS. Lots 951935, 949429, 953673, 953682, 957860, 959652, 951938, 953674, 953676, 956955, 957857, 959654, 959658, 961686, 951944, 956962, 957853, 959655, 959659, 942533X, 953679, 956961, 953680, 951936, 951937, 951947, 953678, 953677, 956960, 956959, 957854, 956958, 959656, 951939, 951940, 953676X, 956956, 959657, 956954, 956957, 951943, 957855, 957856, 951944X, 957852, 951942, 951941, 951945, 953681, 957859, 957858, 953671, 961692, 961689, 953672, 951946, 953675, F796338, 959653, 961690, F790506, F793794, F797481, F794509, F798001, F799742, F801563, F806294, F816278, F809247, F819660, F820610, F822748, F824879, F831102, F840130, F809671 and F828982. Catalog number PICS-401-MPIS-A. Lots F818826, F832821 and F786275 Catalog number PICS-401-MPIS-A-NT. Lot F784799. Catalog number PICS-401-MPIS-NT. Lots 953369, 955847, 965127, 960219, 958632, 960217, 958633, 960218, 963916, 962112, 966520, 962111, 953368, 963917, 956427, 953367, 948897, 965128, 955846, 955845, 956428, 966521, F819556 and 948896. Catalog number PICS-401-MPIS-WOC. Lots F803427, F821904, F841997, 958105, 952170, 953684, 961442, 948125X, 959388, 952169, 948125, 953683, 963918, 961441, 958106, 952169X, 959387, F790507, F822529, F824880 and F828983. Catalog number PICS-401-MPIS-WOC-NT. Lots 953052, 962113, 958108, 957467, 958107, 957468, 956151, 950097, 950096, 962114, 956152, 953053, 959898, 959899 and 957469. Catalog number PICS-501-ANDREWS-021191. Lot F817156. Catalog number PICS-501-MNP-ABMH-071895. Lots F786365, F822816, and F822816X. Catalog number PICS-501-MPIS. Lots F799511, F799557, F804730, 953083, 953063X, 956432, 956435, 956430, 950830, 955197, 955201, 950826, 950819, 959394, 959395, 959401, 953067, 953062, 953059, 955186, 955177, 956446, 959406, 950832, 953071, 953077, 955172, 956441, 957879, 959391, 957886, 959402, 956447X, 955194, 956437, 961449, 959412, 956436, 956440, 956438, 956442, 956448, 957864, 959396, 959408, 953058, 961460, 953075, 953055, 953068, 953073, 959399, 956445, 963065, 963068, 950818, 956429, 961453, 948931X, 948926X, 950806, 953081, 959409, 950822, 950825, 950831, 953082, 957869, 957870, 959407, 959398, 950833, 959393, 959400, 961462, 961465, 953061, 955202, 955195, 961464, 961459, 953079, 956433, 955184, 955176, 961446, 961444, 961445, 959404, 956447, 955178, 955188, 950824, 955171, 953078, 953063, 956452, 956449, 963083, 963072, 957876, 955196, 957874, 957886, 953084, 953072, 956451, 950817, 953056, 953060, 961452, 961451, 957862, 959397, 961455, 961461, 961463, 953085, 963086, 956450, 955179, 956431, 956444, 957863, 957884, 957880, 957882, 953066, 963084, 950821, 953073X, 963070, 955175, 963078, 955182, 950804, 957875, 955172X, F790508, F794510, F799743, F807506, F809248, F819687, F831103, F836367, F840131, 961454, 961456, 953080, F794069, F809672, F808803, F828984, 950811, 950808, 959410, 957861X, 961448, 957877, 956431X, 955190, 957867, 963067, 950816X, 956453, 953080X and 953081X. Catalog number PICS-501-MPIS-A. Lots 957198, 938781, 950836, 957199, 955849, 955848, 959167, 950835 and 950814. Catalog number PICS-501-MPIS-MSH-091098. Lot F0802114. Catalog number PICS-501-MPIS-NT. Lots 950851, 953089, 953093, 953097, 958645, 953094, 953099, 956966, 956963, 956974, 96972, 959672, 959662, 961103, 962121, 961110, 95494B, 958637, 961106, 953098, 954933, 954934, 954935, 959663, 961111, 954946, 956968, 959670, 961105, 961108X, 961102, 958641, 958644, 959668, 959666, 958634, 956970, 958638, 958640, 962115, 959671, 954942, 961108, 959669, 954947, 956973, 953086, 953088, 950838, 950839, 950846, 950848, 950849, 956969, 956975, 956976, 954939, 956965, 956967, 962123, 962118, 962122, 962125, 954938, 961104, 950852, 959661, 961100, 954944, 958635, 961107, 963642, 954940, 961101, 958639, 953087, 959665, 9533096, 954945, 962117, 962120, 963638, 953091, 961109, 958642, 953095, 953100, 954937, F789125, 953090, 950845, 956977, 953092, 954936, 958643, 956964, 959667, 956971, F796337, 950847, 954943, 948603, F819555, 954950, 961112, 954941, 954932, 958636, 953099X, 954949, 959670X, 959664, 959661X, 962116 and 950844. Catalog number PICS-501-NT-MCLELLAN. Lot F793031. Catalog number PICS-501-MPIS-NT-PGHC-122396. Lots F832007 and F827711. Catalog number PICS-501-MPIS-ON. Lot F801842. Catalog number PICS-501-MPIS-WOC. Lots 959674, 951641, 951642, 951644, 954248, 954245, 954246, 958111, 959673, 958112, 948623, 951645, 959676, 954247, 951639, 951643, 958110, 959675, 948617, 954249, 951640, 948622, 929837X, 933160X, 958109, F790509, F788527, F815515, F822749, F834890, F796429, F809673 and F828985. Catalog number PICS-501-MPIS-WOC-NT. Lots 957887, 956625, 952439, 952441, 954951, 957889, 952442, 952440, 948625, 960221, 955852, 955851, 960220, 955853, 956626, 957888, 956624, 960220X, F796693, F820611, F840132 and 960222.Catalog number PICS-ST-VINCENT-040593. Lots F828118 and F829634. Catalog number PICS-401-MPIS. Lots 946700, 950499, 957890, 957891, 959900, 963332 and 959901. Catalog number PICSY-501-MPIS. Lots 950502, 951948, 954955, 951949, 954250, 956978, 956979, 954251, 954956, 950501 and 958646. These products are packaged with Clinipad CLINIGUARD, Protective, Dressing, Prep, 1, Prep, Pad-Clinipad, Reorder Code 8133S-B, HK8133S. Lot number 914358 [Contains: Isopropyl, Alcohol, 79%, Butyl, Mono, Ester, Dimetyl, Phthalate]. MANUFACTURER Cook Inc., Bloomington, Indiana (tray); Venetec International, Inc., San Diego, California (stalock anchoring device) RECALLED BY Cook, Inc., Bloomington, Indiana, by letter mailed and faxed on March 23, 2000. Firm-initiated recall ongoing. COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION Nationwide and international. QUANTITY 21,520 Cook kits were distributed. REASON Kits/trays contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ________ PRODUCT Osteonics Scorpio Posteriorly Stabilized Total Knee: a) Catalog Number: 71-5105L; b) Catalog Number: 71-5105R c) Catalog Number: 71-5107L; d) Catalog Number: 71-5107R e) Catalog Number: 71-5109L; f) Catalog Number: 71-5109R g) Catalog Number: 71-5111L; h) Catalog Number: 71-5111R i) Catalog Number: 71-5113L. Recall #Z-744/752-0. CODE a) Case Codes: K00A257, K00A87, K00A88, K99W347, K99W348, K99W349, K99W459, K99W460 b) Case Codes: K00A258, K00A89, K00A90, K99W461 c) Case Codes: K00A91, K00A92, K00A93, K99W462, K99W463, K99W464,K99W89 d) Case Codes: K00A262, K00A94, K00A95, K00A96, K00A97, K99S246, K99W465, K99W467, K99W468, K99W469, K99W607 e) Case Codes: K00A100, K00A500, K00A98, K00A99, K99W472, K99W471, K99W783 f) Case Codes: K00A101, K00A102, K00A103, K00A265, K99W188, K99W474, K99W475, K99W477, K99W610 g) Case Codes: K00A429, K99W193, K99W749, K99W750, K99W751 h) Case Codes: K99W196, K99W197, K99W753, K99W754 i) Case Code: K99W198. MANUFACTURER Howmedica Osteonics Corporation, Allendale, New Jersey. RECALLED BY Manufacturer, by letter dated March 3, 2000. Firm-initiated recall ongoing. DISTRIBUTION> Nationwide and international. QUANTITY 10 units were distributed. REASON Product labeling has additional line stating "All Polyethylene" below the product name. ________ PRODUCT Amplified Mycobacterium Tuberculosis, in-vitro diagnostic test kit: a) Part No. 301001, Lot Nos. 909399, 911170, 911172, Exp. Date 08/02/00; Recall Number Z-805/808-0. INTERNATIONAL KITS: b) Part No. 301001E, Lot Nos. 909400, 909410, 912246, Exp. Date 08/02/00; c) Part No. 301001F, Lot Nos. 909352, 912294, Exp. Date 08/02/00; d) Part No. 301002J, Lot Nos. 909135 Exp. Date 02/23/00, 909254 Exp. Date 03/18/00, 910352 Exp. Date 04/11/00; Part No. 301011J, Lot Nos. 909136 Exp. Date 02/23/00, 909255 Exp. Date 03/18/00, 910353 Exp. Date 04/11/00; CODE Domestic: a) Lot Nos. 909399, 911170, 911172, Exp. Date 08/02/00; INTERNATIONAL KITS: b) Lot Nos. 909400, 909410, 912246, Exp. Date 08/02/00; c) Lot Nos. 909352, 912294, Exp. Date 08/02/00; d) Lot Nos. 909135 Exp. Date 02/23/00, 909254 Exp. Date 03/18/00, 910352 Exp. Date 04/11/00 (Part #301002J); Lot Nos. 909136 Exp. Date 02/23/00, 909255 Exp. Date 03/18/00, 910353 Exp. Date 04/11/00 (Part No. 301011J). MANUFACTURER Gen-Probe, Inc., San Diego, California. RECALLED BY Manufacturer, by telephone on February 2, 2000, and by letter on February 7, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Puerto Rico, Switzerland, Canada. QUANTITY 1,414 kits were distributed. REASON The above reagent experienced a reduced shelf life after being reconstituted. The reduced shelf life may result in inadequate amplification of some specimens during a test run. Inadequate amplification may produce false negative results. ________ PRODUCT DeVilbiss Portable Ultrasonic Nebulizer DC Power Cord. Recall #Z-809-0. CODE Catalog #5500D-616. MANUFACTURER Sunrise Medical HHG, Inc., Somerset, Pennsylvania. RECALLED BY Manufacturer, by telephone followed by letter faxed on April 7, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY 370 units. REASON The wrong DC power cord was supplied with the nebulizer. END OF ENFORCEMENT REPORT FOR JUNE 21, 2000.####
Office of Public Affairs
Hypertext uploaded by tg 2000-JUNE-20.