March 14, 2001 01-10RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT: Marshall’s Best Smoked Whitefish Salad, sold in 8 oz and 5 lb containers. Recall #F-267-1. CODE: Use by 01/05/01 batch #11777. MANUFACTURER: Premier Smoked Fish, Inc., dba Hommarus/Marshall Smoked Fish, Inc., Bensalem, PA. RECALLED BY: Manufacturer, by telephone and press release on 12/15/00. Completed recall resulted from follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION: New York. QUANTITY: 20 totes of the 5lb tubs (600 lbs) and 30 cases of the 8 oz (2880 oz). REASON: The product was contaminated with Listeria monocytogenes. ________ PRODUCT: a) Silver Creek Fresh Prep Mini Veggie Trays. Recall #F-279-1; b) Super Nacho Trays. Recall #F-280-1. CODE: a & b) Best used by dates September 14 and prior. MANUFACTURER: Silver Creek Fresh Prep, Rupert, ID., and Quality Produce, Garden City, ID. RECALLED BY: Silver Creek Fresh, Inc., Garden City, ID., by faxed letter and press release on 9/8/00. Firm-initiated recall complete. DISTRIBUTION: Utah, Idaho, Nevada, Wyoming and Montana. QUANTITY: a) 342 cases; b) 137 cases. REASON: a) The product contains undeclared egg yolks. b) The product contains undeclared eggs, egg yolks, FD&C Yellow No. 5, and No. 6, FD&C Red No. 40 and FD&C Blue No. 1.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT: a) Cherry Danish, 3.0 oz. Recall #F-281-1; b) Cherry & Cheese Danish, 3.0 oz. Recall #F-282-1; c) Cheese Danish, 3.0 oz. Recall #F-283-1; d) Apple Danish, 3.0 oz. Recall #F-284-1; e) Pineapple Danish, 3.0 oz. Recall #F-285-1; f) Pineapple Cheese Danish, 3.0 oz. Recall #F-286-1; g) Bavarian Cream Croissant, 3.0 oz. Recall #F-287-1. CODE: No codes. MANUFACTURER: Daisy’s Bakery, Passaic, NJ. RECALLED BY: Manufacturer, by letter dated 11/30/2000. Firm-initiated recall complete. DISTRIBUTION: New York and New Jersey. QUANTITY: 1865 dozen (including products listed under F-288/289-1). REASON: The products contains undeclared certified colors as follows: a) FD&C Red No. 40 and FD&C Yellow No. 5 b) FD&C Red No. 40 and FD&C Yellow No. 5 c) FD&C Yellow No. 5 d) FD&C Yellow No. 5 e) FD&C Yellow No. 5 f) FD&C Yellow No. 5 g) FD&C Yellow No. 5 and FD&C Yellow No. 6 ________ PRODUCT: Cutler’s Pasteurized Frozen Egg Product, Cutler’s Angel Whip. Recall #F-290-1. CODE: 030-1 MANUFACTURER: Cutler Egg Products, Abbeville, AL. RECALLED BY: Manufacturer, by telephone on February 7, 2001. Firm-initiated recall complete. DISTRIBUTION: Ohio and Florida. QUANTITY: 94 – 30 pound containers. REASON: The product was contaminated with salmonella. ________ PRODUCT: Lanio Cola Roja Nicaraguan Soda in 2 liter plastic bottles. Recall #F- 291-1. CODE: All product with the expiration date of 10/21/01 or earlier (last misbranded lot was manufactured 10/21/00). MANUFACTURER: Southeast-Atlantic Corporation, Miami, FL. RECALLED BY: Sunshine Bottling Company, Miami, FL, by telephone on 11/22/00. Firm- initiated recall complete. DISTRIBUTION: Monroe, Miami-Dade and Broward Counties in Southeast Florida. QUANTITY: 5113 cases. REASON: The product contains undeclared FD&C Yellow No. 5 and FD&C Red No. 40. ________ PRODUCT: a) Nivea for Men-Double Action Face Wash 5 Fl. OZ 150mL tube. Recall #F- 292-1; b) Men's Grooming Kit containing Nivea for Men-Double Action Face Wash 0.5 Fl. OZ. 15 mL tube. Recall #F-293-1. CODE: All lots. MANUFACTURER: Beiersdorf, inc., Juvena, Germany. RECALLED BY: Beiersdorf, Inc., Norwalk, CT, by e-mail on 2/08/01 and by letter on 2/14/01. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: a) 5 fl. Oz = 2,142 cases; b) 0.5 fl. Oz in kits = 33,000 cases. REASON: The face wash contains the unapproved color additive acid red 14 (formerly certifiable as Ext. D&C Red No. 10).RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT: a) Lintzer Tart, 4.0 oz. Recall #F-288-1; b) Guava Pound Cake, 5 oz. Recall #F-289-1. CODE: No codes. MANUFACTURER: Daisy’s Bakery, Passaic, NJ. RECALLED BY: Manufacturer, by letter dated 11/30/2000. Firm-initiated recall complete. DISTRIBUTION: New York and New Jersey. QUANTITY: 1865 dozen (including products listed under F-281/287-1 under class II above). REASON: The products contains undeclared certified colors as follows: a) FD&C Red No. 40, FD&C Blue No. 1, and FD&C Blue No. 2 b) FD&C Red No. 40 and FD&C Blue No. 1.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT: Pharmacy’s Prescription, Fast-Acting Antacid Anti-gas, Original Flavor, 12 fl oz. Recall #D-139-1. CODE: Lot Number C-1188, Antacid Anti-Gas, Pharmacy’s Prescription Brand, NDC 49580-0106-2. MANUFACTURER: Aaron Industries, Inc., Lynwood, CA. RECALLED BY: Manufacturer, by telephone and letter. Firm-initiated recall ongoing. DISTRIBUTION: KY,CA, TN, NY. QUANTITY: 10,498 units. REASON: Microbial contamination-(Bacillus licheniformis).
_________ PRODUCTS: a. Colgate Total Super Size 7.8 oz Toothpaste; b. Colgate Total Family size 6.0 oz Toothpaste; c. Colgate Great Regulator Flavor size 6.0 oz Toothpaste. Recall #D-140 - 141-1. CODES: a. SKU 74004, Exp. Date 03NOV02 b. SKU 74003, Exp. Date 03NOV02 c. SKU 72600, Exp. Date 03NOV02 MANUFACTURER: Colgate Palmolive, Jeffersonville, IN. RECALLED BY: Colgate Palmolive, Piscataway, NJ, by FedEx letters and telephone on January 12, 2001. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: a) Colgate Total Super size 7.8 oz -- 2813 cases b) Colgate Total Family size 6.0 oz -- 2700 cases c) Colgate Great Regular Flavor 6.0 oz -- 1862 cases REASON: Microbial contamination-(Bacillus licheniformis).RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_________ PRODUCTS: a) Red Blood Cells. Recall #B-525-1; b) Recovered Plasma. Recall #B-526-1. CODES: a) and b) Unit 27R53339. MANUFACTURER: The American National Red Cross, Greater Alleghenies Region, Johnstown, PA. RECALLED BY: Manufacturer, by letter dated June 2, 2000. Firm-initiated recall complete. DISTRIBUTION: West Virginia, California. QUANTITY: Two units. REASON: Blood products, that tested negative for antibodies to human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor that previously tested repeatedly reactive for anti-HIV-1, were distributed. ________ PRODUCT: Cryoprecipitate. Recall #B-778-1. CODE: Unit 3615888 MANUFACTURER: Gulf Coast Regional Blood Center, Houston, TX. RECALLED BY: Manufacturer, by fax on 5/28/99. Firm-initiated recall complete. DISTRIBUTION: New Jersey. QUANTITY: One unit. REASON: Blood product, corresponding to a unit of Red Blood Cells that was implicated in a transfusion reaction and found to be contaminated with Staphylococcus aureus, was distributed. ________ PRODUCT: Platelets Pheresis. Recall #B-779-1. CODE: Unit 890 2057. MANUFACTURER: Arizona Blood Institute, Inc. Tucson, AZ. RECALLED BY: Blood Systems, Inc., Scottsdale, AZ, by telephone on. Firm-initiated recall complete. DISTRIBUTION: Arizona. QUANTITY: One unit. REASON: Blood product, collected from a donor whose body temperature was not documented, was distributed. ________ PRODUCT: Red Blood Cells. Recall #B-783-1. CODES: Units 38H27899, 38Y08342. MANUFACTURER: American Red Cross Blood Services, Fort Wayne, IN. RECALLED BY: Manufacturer, by telephone on July 27, 1999. Firm-initiated complete. DISTRIBUTION: Indiana QUANTITY: Two Units. REASON: Blood products, collected from donors whose hematocrit was not determined, were distributed. ________ PRODUCT: Platelet Concentrates. Recall #B-784-1. CODE: Units 36256-0832, 36258-5125 MANUFACTURER: United Blood Services, Ventura, CA. RECALLED BY: Blood Systems, Inc. Scottsdale, AZ., by telephone on May 01, 2000 and by letter dated May 30, 2000. Firm-initiated recall complete. DISTRIBUTION: California. QUANTITY: Two units. REASON: Platelets, prepared from donors who were not questioned as to their recent aspirin ingestion, were distributed. ________ PRODUCT: Platelets, Pheresis. Recall # B-785-1. CODE: Unit K14579 MANUFACTURER: Mississippi Valley Regional Blood Center, Davenport, IA. RECALLED BY: Manufacturer, by letter dated April 13, 2000. Firm-initiated recall complete. DISTRIBUTION: New York. QUANTITY: One unit. REASON: Platelet, collected from a donor whose recent aspirin ingestion had not been documented, was distributed. ________ PRODUCT: Platelets, Pheresis. Recall # B-786-1. CODE: Unit G06836 MANUFACTURER: Northern Illinois Blood Bank, Rockford, IL. RECALLED BY: Manufacturer, by letter dated October 11, 2000. Firm-initiated recall complete. DISTRIBUTION: Illinois. QUANTITY: One unit. REASON: Platelets, Pheresis product, labeled as Leukocyte Reduced, which did not have a white blood cell count determination, was distributed. ________ PRODUCT: Platelets, Pheresis. Recall #B-787-1. CODE: Units E60497, E63035 MANUFACTURER: Sacramento Medical Foundation Blood Center, Sacramento, CA. RECALLED BY: Manufacturer, by telephone on March 23, 1999. Firm-initiated recall complete. DISTRIBUTION: California and New York. QUANTITY: Two units. REASON: Platelets, Pheresis products, labeled as Leukocyte Reduced, which did not have white blood cell count determinations, were distributed. ________ PRODUCT: Red Blood Cells. Recall #B-807-1. CODE: Unit 18FT23405. MANUFACTURER: The American National Red Cross, Great Lakes Region, Lansing, MI RECALLED BY: Manufacturer, by letter dated February 15, 2000. Firm-initiated recall complete. DISTRIBUTION: Michigan. QUANTITY: One unit. REASON: Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed. _________ PRODUCTS: a) Red Blood Cells, Leukocytes Removed. Recall #B-808-1; b) Platelets. Recall #B-809-1. CODES: a) unit numbers 18FV17496 and 18FR38237; b) unit number 18FR38237. MANUFACTURER: The American National Red Cross, Great Lakes Region, Lansing, MI. RECALLED BY: Manufacturer, by letter dated March 15, 2000. Firm-initiated recall complete. DISTRIBUTION: Michigan. QUANTITY: Three units. REASON: Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed. ________ PRODUCT: Red Blood Cells, Leukocytes Removed. Recall #B-810-1. CODE: Unit number 40FW22158 MANUFACTURER: The American National Red Cross, Heart of America Region, Peoria, IL RECALLED BY: Manufacturer, by letter dated December 6, 2000. Firm-initiated recall complete. DISTRIBUTION: Georgia. QUANTITY: One unit. REASON: Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. ________ PRODUCT: Red Blood Cells, Leukocytes Removed. Recall #B-811-1. CODE: Unit number 40GH35582. MANUFACTURER: The American National Red Cross, Heart of America Region Peoria, IL. RECALLED BY: Manufacturer, by letter dated January 2, 2001. Firm-initiated recall complete. DISTRIBUTION: Georgia. QUANTITY: One unit. REASON: Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed. _________ PRODUCTS: a) Red Blood Cells, Leukocytes Removed. Recall #B-812-1; b) Platelets. Recall #B-813-1. CODE: a) unit number 13GC81267; b) unit number 13GC81267. MANUFACTURER: The American National Red Cross, Southeastern Michigan Region, Detroit, MI. RECALLED BY: Manufacturer, by letter dated October 16, 2000. Firm-initiated recall complete. DISTRIBUTION: Michigan. QUANTITY: Two units. REASON: Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed. ________ PRODUCT: Recovered Plasma. Recall #B-819-1. CODE: Unit number 54KK38280. MANUFACTURER: The American National Red Cross, Puerto Rico Region, San Juan, PR. RECALLED BY: Manufacturer, by letter on August 24, 2000. Firm-initiated recall complete. DISTRIBUTION: California. QUANTITY: One unit. REASON: Blood product, possibly untested for viral markers, was distributed.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT: Red Blood Cells, Leukoreduced. Recall #B-551-1. CODE: Unit 35V41922 MANUFACTURER: American Red Cross, Appalachian Region Blood Services, Roanoke, VA RECALLED BY: Manufacturer, by letters dated October 13 and October 24, 2000. Firm- initiated recall complete. DISTRIBUTION: West Virginia. QUANTITY: One unit. REASON: Blood product, collected from a donor with a history of Idiopathic Thrombocytopenic Purpura, was distributed. ________ PRODUCT: Platelets. Recall #B-564-1. CODE: Unit 02FG37195. MANUFACTURER: American Red Cross Blood Services, Central Plains Region, Wichita, KS. RECALLED BY: Manufacturer, by telephone on October 21, 1997 and by letter dated October 30, 1997. Firm initiated recall complete. DISTRIBUTION: Kansas. QUANTITY: One unit. REASON: Blood product, collected from a donor who developed a hematoma during the collection process, was distributed. ________ PRODUCT: Red Blood Cells. Recall #B-567-1. CODE: Units 009LL27273, 009LL27274, 009LL27275, 009LL27276, 009LL27277. MANUFACTURER: American Red Cross Blood Services, Midwest Region, Omaha, NE. RECALLED BY: Manufacturer, by telephone on December 13, 1996. Firm initiated recall complete. DISTRIBUTION: Iowa and Nebraska QUANTITY: Five units. REASON: Blood products, for which temperature after shipment was not recorded upon receipt, were distributed. ________ PRODUCT: Platelets. Recall B-575-1. CODE: Unit 29KJ07094. MANUFACTURER: The American Red Cross Blood Services, Mid-Atlantic Region, Norfolk, VA. RECALLED BY: Manufacturer, by letter dated July 26, 2000. Firm-initiated recall complete. DISTRIBUTION: Connecticut. QUANTITY: One unit. REASON: Blood Product, prepared from a unit of Whole Blood with an extended collection time, was distributed. ________ PRODUCT: Cryoprecipitate AHF. Recall #B-576-1. CODE: Unit 29FW37328. MANUFACTURER: The American Red Cross Blood Services, Mid-Atlantic Region, Norfolk, VA. RECALLED BY: Manufacturer, by letter dated July 26, 2000. Firm-initiated recall complete. DISTRIBUTION: Virginia. QUANTITY: One unit. REASON: Blood Product, prepared from a unit of Whole Blood with an extended collection time, was distributed. ________ PRODUCT: Red Blood Cells. Recall #B-578-1. CODE: Unit 0422027. MANUFACTURER: Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, Ohio. RECALLED BY: Manufacturer, by letter dated September 1, 2000. Firm-initiated recall complete. DISTRIBUTION: Ohio. QUANTITY: One unit. REASON: Blood Product, that was not quarantined after receiving information concerning a post donation illness, was distributed. ________ PRODUCT: Source Plasma. Recall #B-581-1. CODE: Unit 93291415. MANUFACTURER: Sera-Tec Biologicals, Norfolk, VA. RECALLED BY: Sera-Tec Biologicals, Harrisburg, PA, by letter dated January 27, 1998. Firm-initiated recall complete. DISTRIBUTION: North Carolina. QUANTITY: One unit. REASON: Blood product, which had an acceptable ALT, but was collected from a donor who previously had an elevated ALT on two separate occasions, was distributed. ________ PRODUCT: Platelets Pheresis. Recall B-756-1. CODE: (3 units), unit numbers 5OP27156 (split unit) and 5OP27155. MANUFACTURER: The American National Red Cross, Great Lakes Region, Lansing, MI. RECALLED BY: Manufacturer, by letter dated December 14, 2000. Firm-initiated recall complete. DISTRIBUTION: Michigan. QUANTITY: 3 units. REASON: Blood products, shipped at an elevated temperature, were distributed. ________ PRODUCT: Red Blood Cells, Leukocytes Removed. Recall #B-814-1. CODES: (5 units), unit numbers 18FF05941, 18FF05943, 18FF05944, 18FF05945, and 18FF05946 MANUFACTURER: The American National Red Cross , Great Lakes Region, Lansing, MI. RECALLED BY: Manufacturer, by letter on April 21, 2000. Firm-initiated recall complete. DISTRIBUTION: Michigan and California. QUANTITY: 5 units. REASON: Blood products, labeled with the incorrect expiration date, were distributed. ________ PRODUCT: Red Blood Cells, Leukocytes Removed. Recall #B-815-1. CODE: Unit number 6530710. MANUFACTURER: Central Indiana Regional Blood Center, Inc., Indianapolis, IN. RECALLED BY: Manufacturer, by telephone on December 22, 2000. Firm-initiated recall complete. DISTRIBUTION: Indiana. QUANTITY: One unit. REASON: Blood product, labeled with the incorrect expiration date, was distributed. ________ PRODUCT: Red Blood Cells, Leukocytes Removed. Recall #B-816-1. CODE: Unit number H82908 MANUFACTURER: Regional Health Resource Center, Community Blood Services of Illinois Urbana, IL. RECALLED BY: Manufacturer, by telephone on November 22, 2000. Firm-initiated recall complete. DISTRIBUTION: Illinois. QUANTITY: One unit. REASON: Blood product, labeled with the incorrect expiration date, was distributed. _________ PRODUCTS: a) Platelets. Recall #B-817-1. b) Platelets, Pheresis. Recall #B-818-1. CODES: a)(459 units), unit numbers 38H42921, 38H42928, 38H42934, 38H42938, 38H42941, 38H42954, 38H42957, 38H42959, 38H42963, 38H42974, 38H42942, 38H42930, 38H42931, 38H42943, 38H42945, 38H42946, 38H42951, 38H42958, 38H42961, 38H42967, 38H42972, 38H42973, 38H42978, 38H42979, 38H42982, 38H42984, 38H42922, 38H42932, 38H42944, 38H42948, 38H42955, 38H42975, 38H42985, 38H42991, 38H42927, 38H42949, 38H42952, 38H42956, 38H42965, 38H42971, 38H42983, 38H42989, 38FC58461, 38FC58465, 38FC58481, 38FC58485, 38FE57177, 38FE57214, 38FE57187, 38FE57213, 38FE57215, 38FE57233, 38FE57234, 38FE57235, 38FE57237, 38FE57245, 38FC58436, 38FC58439, 38K99154, 38K99163, 38K99167, 38K99168, 38K99169, 38K99172, 38K99173, 38K99175, 38K99179, 38K99189, 38FC58486, 38H42976, 38K99204, 38FC58470, 38FC58471, 38FC58473, 38FC58509, 38FC58511, 38FC58516, 38FC58557, 38H42996, 38H43004, 38H43031, 38H43039, 38H43047, 38FC58522, 38H43012, 38K99402, 38K99409, 38K99427, 38K99433, 38FE57179, 38FE57217, 38FC58318, 38FE57194, 38FE57248, 38FE57253, 38FE57256, 38FC58333, 38FC58337, 38FC58344, 38FE57178, 38FE57182, 38FE57196, 38FE57223, 38FE57224, 38FC58349, 38FE57236, 38FE57263, 38H42739, 38H42750, 38H42751, 38H42753, 38H42781, 38K99095, 38K99072, 38K99075, 38K99076, 38K99078, 38K99091, 38K99092, 38K99103, 38K99119, 38K99126, 38K99128, 38K99142, 38K99155, 38K99158, 38K99161, 38K99162, 38K99164, 38K99165, 38K99177, 38K99188, 38K99068, 38K99073, 38K99134, 38K99135, 38K99136, 38K99145, 38K99148, 38K99152, 38FC58426, 38FC58431, 38FC58444, 38FC58447, 38FC58450, 38K99066, 38K99070, 38K99079, 38K99111, 38K99115, 38K99124, 38K99174, 38K99178, 38K99180, 38K99181, 38K99182, 38K99082, 38K99108, 38K99109, 38K99114, 38K99133, 38K99139, 38K99153, 38K99089, 38K99096, 38K99105, 38K99123, 38K99141, 38K99144, 38K99146, 38K99149, 38K99137, 38FC58416, 38K99094, 38K99097, 38K99121, 38FC58491, 38K99156, 38K99193, 38K99195, 38K99196, 38K99197, 38K99203, 38K99209, 38FC58533, 38FC58538, 38FC58539, 38FC58542, 38H43030, 38H43077, 38K99392, 38K99396, 38FC58328, 38FE57204, 38FC58343, 38FE57185, 38FE57188, 38FE57192, 38FE57195, 38FE57202, 38FE57226, 38FE57227, 38H43015, 38H43049, 38H43070, 38H43071, 38K99381, 38K99385, 38H43041, 38H43045, 38FC58441, 38FC58420, 38FC58552, 38FE57181, 38FE57184, 38FE57193, 38FE57197, 38FE57207, 38FE57228, 38FC58362, 38H42765, 38FC58459, 38FC58468, 38FC58476, 38FC58478, 38FC58493, 38FC58517, 38FC58466, 38FC58467, 38H42993, 38H43032, 38K99401, 38H43009, 38H43013, 38K99388, 38H42995, 38H43001, 38K99415, 38K99420, 38K99421, 38K99426, 38K99434, 38K99438, 38FC58513, 38FC58523, 38FC58524, 38FC58527, 38H42923, 38H42929, 38H42926, 38H42935, 38FE57179, 38FC58320, 38FE57199, 38FE57206, 38FE57211, 38FE57238, 38FE57239, 38FE57244, 38FE57270, 38H42733, 38H42736, 38H42738, 38H42747, 38H42757, 38H42758, 38H42759, 38H42803, 38FE57183, 38FE57189, 38FE57201, 38FE57203, 38FE57208, 38FE57212, 38FE57219, 38H42789, 38FE57247, 38FE57260, 38H42740, 38H42764, 38FC58319, 38FC58322, 38FE57221, 38K99125, 38K99143, 38FC58389, 38FC58406, 38FC58417, 38FC58438, 38FC58442, 38K99085, 38K99087, 38K99101, 38K99113, 38K99127, 38FC58419, 38FC58428, 38FC58437, 38K99116, 38K99129, 38K99138, 38K99151, 38K99166, 38K99184, 38K99191, 38H42921, 38H42928, 38H42934, 38H42938, 38H42941, 38H42954, 38H42957, 38H42959, 38H42963, 38H42974, 38H42966, 38H43080, 38K99437, 38H43024, 38H43060, 38H42937, 38H42939, 38H42962, 38H42969, 38H42970, 38H43058, 38K99419, 38K99431, 38H42999, 38H43003, 38H43043, 38H43044, 38H43067, 38H43069, 38K99410, 38K99413, 38H43007, 38H43008, 38H43011, 38H43014, 38H43016, 38H43021, 38H43022, 38H43028, 38FE57261, 38FE57266, 38H42744, 38H42782, 38H42806, 38H42813, 38H42745, 38H42746, 38H42754, 38H42756, 38H42799, 38H42802, 38H42804, 38H42805, 38H42807, 38H42809, 38FC58410, 38FC58335, 38FC58346, 38FC58386, 38FC58388, 38FC58403, 38FC58366, 38FC58369, 38FC58378, 38FC58379, 38FC58382, 38FC58396, 38FC58398, 38FC58411, 38FC58412, 38FE57249, 38FC58427, 38K99199, 38K99200, 38K99205, 38K99207, 38K99208, 38K99217, 38K99220, 38H42984, 38H42992, 38H42994, 38H42997, 38H42998, 38H43018, 38H43025, 38H43026, 38H43042, 38H43051, 38H43054, 38H43053, 38H43055, 38H43061, 38H43063, 38H43064, 38H43066, 38FC58526, 38FC58531, 38H43005, 38H43006, 38H43010, 38H43029, 38H43034, 38H43038, 38H43072, 38H43073, 38H43076, 38K99382, 38K99384, 38K99389, 38K99391, 38K99399, 38FC58546, 38FC58547, 38FC58548, 38FC58551, 38FC58351, 38FC58357, 38FC58358, 38FC58359, 38FC58361, 38FC58372, 38H42735, 38H42737, 38FC58384, 38FC58387, 38FC58392, 38FC58393, 38FC58405, 38FC58407, 38H42774, 38H42775, 38H42776, 38H42787, 38FC58373, 38H42762, 38H42771, 38H42779, 38H42791, 38H42815, 38H42784, 38FC58363, 38H43763, 38H42766, 38H42772, 38H42783, 38H42792, 38H42801, 38H42811, 38H42814, 38FC58543, 38FC58482, 38FC58483, and 38FC58488. b)(252 units), unit numbers 38FC58464, 38FV00051, 38FV00053, 38FV00057, 38FV00058, 38FV00059, 38FV00060, 38FV00061, 38FV00063, 38FV00065, 38P59707 (split unit), 38P59708 (split unit), 38P59709 (split unit), 38P59710, 38P59711 (split unit), 38P59712, 38P59713 (split unit), 38P59714 (split unit), 38P59716, 38P59717 (split unit), 38P59718 (split unit), 38P59719 (split unit), 38P59720 (split unit), 38P59721 (split unit), 38P59723, 38P59724, 38P59726, 38P59727 (split unit), 38P59728, 38P59729, 38P59730, 38P59731 (split unit), 38P59732 (split unit), 38P59733 (split unit), 38P59734, 38P59735 (split unit), 38P59736 (split unit), 38P59737 (split unit), 38P59738, 38P59739 (split unit), 38P59740 (split unit), 38P59741, 38P59742 (split unit), 38P59743 (split unit), 38P59744 (split unit), 38P59745 (split unit), 38P59746 (split unit), 38P59747 (split unit), 38P59748 (split unit), 38P59749, 38P59751 (split unit), 38P59752 (split unit), 38P59753, 38P59754 (split unit), 38P59755, 38P59756, 38P59757, 38P59758 (split unit), 38P59759, 38P59761, 38P59762, 38P59763 (split unit), 38P59764 (split unit), 38P59765 (split unit), 38P59766, 38P59767, 38P59769 (split unit x3), 38P59770, 38P59771, 38P59772, 38P59773 (split unit), 38P59774 (split unit), 38P59775, 38P59778 (split unit), 38P59779, 38P59781(split unit), 38P59783, 38P59784, 38P59785, 38P59786 (split unit), 38P59787 (split unit), 38P59788, 38P59790, 38P59791, 38P59792 (split unit x3), 38P59793, 38P59794 (split unit), 38P59795, 38P59796 (split unit), 38P59797 (split unit), 38P59798 (split unit), 38P59799, 38P59800 (split unit), 38P59801 (split unit), 38P59802 (split unit), 38P59803 (split unit), 38P59804 (split unit), 38P59805, 38P59807, 38P59808 (split unit), 38P59809 (split unit), 38P59810, 38P59811 (split unit), 38P59814 (split unit), 38P59815, 38P59816, 38P59818 (split unit), 38P59819 (split unit), 38P59820, 38P59821 (split unit), 38P59822 (split unit), 38P59823 (split unit), 38P59825 (split unit), 38P59826, 38P59827, 38P59828, 38P59829 (split unit), 38P59830 (split unit), 38P59831 (split unit), 38P59832 (split unit), 38P59833, 38P59834 (split unit), 38P59835 (split unit), 38P59836, 38P59837 (split unit), 38P59838, 38P59840, 38P59842(split unit), 38P59843, 38P59844 (split unit), 38P59846, 38P59847, 38P59848, 38P59849 (split unit), 38P59850, 38P59851 (split unit), 38P59852 (split unit), 38P59853 (split unit), 38P59854, 38P59855, 38P59856, 38P59857, 38P59858 (split unit), 38P59859, 38P59861 (split unit), 38P59862 (split unit), 38P59863 (split unit), 38P59864, 38P59865 (split unit), 38P59866 (split unit), 38P59867 (split unit), 38P59868, 38P59869, 38P59870 (split unit), 38P59871 (split unit), 38P59872 (split unit), 38P59873, 38P59874 (split unit), 38P59876 (split unit), 38P59877 (split unit), 38P59878, and 38P59879 MANUFACTURER: The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN. RECALLED BY: Manufacturer, by telephone on March 16, 2000, and by letters dated April 26, 2000, and May 31, 2000. Firm-initiated recall complete. DISTRIBUTION: Indiana and Ohio. QUANTITY: 71i1 units. REASON: Blood products, stored at unacceptable temperatures, were distributed.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT: Obturator for Mitral Valves Model No. 1162, sizes 25mm-35mm. Recall #Z-277-1. CODE: All. MANUFACTURER: Edwards Lifesciences LLC, Irvine, CA. RECALLED BY: Manufacturer, by letter on December 8, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 1,520 of the bioprostheses plus obturators. REASON: Sizers do not match the heart valves and the directions for use are inadequate. ________ PRODUCT: Ash Split Cathether Repair Kit. Recall #Z-0281-1. CODE: Part Number ASPCRPK. All product is being recalled some units were shipped without lot numbers. Lots M017810 and M020880 are involved in the recall. MANUFACTURER: Medical Components, Inc., Harleysville, PA. RECALLED BY: Manufacturer, by letter on 6/28/00. Firm-initiated recall complete. DISTRIBUTION: Nationwide and Hemodialyse, Brussel, Beligum. QUANTITY: 354 kits. REASON: No 510k clearance & potentially not sterile. ________ PRODUCT: Hemo-Flow Long Term High Flow Access Catheters. Recall #Z-0282-1 to Z- 0289-1. CODE: All lot numbers are being recalled for all catheter sizes. Size Catalog/Model numbers: 14.5F x 24 cm HFS24 (set) and HFT24 (tray) 14.5F x 28 cm HFS28 and HFT28 14.5F x 32 cm HFS32 and HFT32 14.5F x 36 cm HFS36 and HFT36 14.5F x 55 cm HFS55 and HFT55 MANUFACTURER: Medical Components, Inc., Harleysville, PA. RECALLED BY: Manufacturer, by letter on 4/20/00. Firm-initiated recall complete. DISTRIBUTION: LA and CT. QUANTITY: 961 kits. REASON: Marketed without 510k clearance. ________ PRODUCT: Puritan-Bennett 740 and Puritan-Bennett 760 Ventilator. Recall #Z-0290-1 to Z-0291-1. CODE: Ventilators containing safety valve assemblies that have lot numbers 9850, 9901, 9905, 0004, 0007, 0013, and 0017. MANUFACTURER: Nellcor Puritan Bennett Ireland, LTD., Galway, Ireland. RECALLED BY: Mallinckrodt, Inc., St. Louis, MO, by letters dated 7/24/00. Firm- initiated recall ongoing. DISTRIBUTION: Nationwide, Canada and Mexico. QUANTITY: 615. REASON: Remote probability for the ventilator to remain in Safety Valve Open condition. ________ PRODUCT: AngioJet Rheolytic Thrombectomy System Pump Set. Recall #Z-0293-1. CODE: Lot number range of 18612 to 19146. MANUFACTURER: Possis Medical, Inc., Minneapolis, MN. RECALLED BY: Manufacturer, by letter dated August 30, 2000. Firm-initiated recall complete. DISTRIBUTION: Nationwide, worldwide. QUANTITY: 3292 pumps. REASON: Holes in outer sterile packages. ________ PRODUCT: Nuclear Medicine Scanner, DS Series. Recall #Z-0294-1. CODE: All Serial Numbers for Models: DST-XL, DST-Xli, and DSXi. MANUFACTURER: SMV International, Cedex, France. RECALLED BY: SMV America, Twinsburg, OH, by letter on 9/6/2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide and worldwide. QUANTITY: 191 units – domestic. REASON: Improper latching mechanism may allow collimator to disengage during camera use. ________ PRODUCT: Zevex Inc., EnteralEZ Enteral Feeding Pump. Recall #Z-0295-1. CODE: Model EZ4500, 671 individually serialized units. MANUFACTURER: ZEVEX, Inc., Salt Lake City, UT. RECALLED BY: Manufacturer, on 8/30/2000 by letter. Firm-initiated recall ongoing. DISTRIBUTION: FL, IL, MA, MN, OH, NC, PA, RI, TX. QUANTITY: 769 pumps. REASON: Enteral feeding pump delivers feeding solution at rates lower than specified. ________ PRODUCT: Smith & Nephew RotorC Drill. Recall #Z-0297-1. CODE: Lot Numbers: 419348, 419349, and 419350. MANUFACTURER: Smith & Nephew, Inc., Mansfield, MA. RECALLED BY: Smith & Nephew, Inc., Andover, MA., by letter dated 9/12/2000. Firm- initiated recall ongoing. DISTRIBUTION: Canada, Australia, Spain, South Africa, Italy, UK, Netherlands, Germany and Switzerland. QUANTITY: 244. REASON: Potential for drill to puncture sterile package. ________ PRODUCT: Home Health Monitoring System. Recall #Z-0298-1. CODE: All monitors distributed prior to 07/18/200 are affected. MANUFACTURER: AvidCare Corporation, Milwaukee, WI. RECALLED BY: Manufacturer, by electronic message on 7/20/2000. Firm-initiated recall ongoing. DISTRIBUTION: New York. QUANTITY: 18 units in commercial distribution and about 274 at IRB/NSR ide sites. REASON: Lack of 510(k) clearance for new device features. ________ PRODUCT: CliniCath IR Peripherally Inserted Central Catheter, 5 French, Reorder Number 21-2575. Recall #Z-0299-1. CODE: Lot numbers 65784, 70656 and 71318. MANUFACTURER: Medical Specialties, Inc., Tarpon Springs, FL. RECALLED BY: Sims Deltec, Inc., St. Paul, MN., by letter dated 10/4/00. Firm- initiated recall complete. DISTRIBUTION: Alabama, Georgia, Michigan, Texas and Wisconsin. QUANTITY: 66 catheter kits. REASON: Product packages contain the wrong size introducer. ________ PRODUCT: a) Bartels CMV EIA kit, catalog #B1029-91. Recall #Z-0300-1. b) CMV IEA Antibody & Conjugate Kit, catalog #B1029-91A. Recall #Z-0301- 1. CODE: a) CMV IEA Kit: LOT NO. EXPIRATION DATE 0D198 01Mar01 0D289 01Mar01 0D292 01Mar01 0E160 01Mar01 0E276 16Mar01 0F171 16Mar01 0G190 16Mar01 0G160 16Mar01 b) CMV IEA Antibody & Conjugate: Lot 0D386, expiration 01Mar01. MANUFACTURER: Intracel Corporation, Issaquah, WA. RECALLED BY: Manufacturer, by letter dated 10/9/00. Firm-initiated recall complete. DISTRIBUTION: Nationwide, Canada and Australia. QUANTITY: 312 units. REASON: Diminishing fluorescence. ________ PRODUCT: Olympic Warm-Scale - infant scale equipped with a heater that provides warmth for an infant while being weighed. Recall #Z-0302-1. CODE: Model Numbers 23 and 28, Catalog Numbers 56323 and 56328. MANUFACTURER: Olympic Medical Corp., Seattle, WA. RECALLED BY: Manufacturer by fax dated 10/11/00. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide, including 1 USPHS Indian Health Service hospital and 1 Air Force hospital. QUANTITY: 160. REASON: Potential for tray and warming platform to overheat. ________ PRODUCT: Supplemental Reference Manuals: a) IsoMed Constant-Flow Infusion System, Clinical Reference Guide for Pain Therapy. B) IsoMed Constant-Flow Infusion System, Catheter Access Port Procedure, Quick Reference Tool for Intrathecal Drug Delivery. c) IsoMed Constant-Flow Infusion System, Clinical Reference Guide for Hepatic Arterial Infusion Therapy. d) IsoMed Constant-Flow Infusion System, Catheter Access Port Procedure, Quick Reference Tool for Hepatic Arterial Infusion for Chemotherapy. Recall #Z-0304-1 to Z-0307-1. CODE: Product catalog #: 182369-101/UC199901594 EN NP3821 182507-101/UC200003706 EN NP4163 182371-101/UC199901596 EN NP3823 182509-101/UC200003707 EN NP4164 MANUFACTURER: MEDTRONIC, INC., Neurological Division, Minneapolis, MN. RECALLED BY: Manufacturer, by letter dated 10/18/2000. Firm-initiated recall complete. DISTRIBUTION: Nationwide and in Australia. QUANTITY: 91 copies of the manuals. REASON: Manuals contain incorrect table for calculating time for drug to traverse catheter. ________ PRODUCT: StatView Receiver used with the StatView System. Recall #Z-0308-1. CODE: StatView receiver part #s 300-0302-01 through 300-0302-30, and 300-0305- 01 through 300-0305-30, firmware versions 3.00.11 and 3.01.00 respectively. MANUFACTURER: Data Critical Corp., Bothell, WA. RECALLED BY: Manufacturer, by letter dated 9/15/00. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 1299 units. REASON: Random and/or missed pages for patient monitoring. ________ PRODUCT: Utah Medical Products a) Umbilicup and b) Umbilicup II Umbilical Cord Blood Sampling System. Recall #Z-0309-1 to Z-0310-1. CODE: a) Umbilicup Umbilical Cord Blood Sampling System, Cat #UMB- 100, All Lot Numbers, including: 182373-1, 190789-1, 191124- 1, 100150-1, 100577-1, 100578-1, 100580-1, 100581-1, 101015- 1, 101446-1. b) Umbilicup II Umbilical Cord Blood Sampling System. Catalog #UMB-200, All Lot Numbers, including: 182374-1. MANUFACTURER: Utah Medical Products, Inc., Midvale, UT. RECALLED BY: Manufacturer, by telephone, beginning 11/6/2000. Firm-initiated recall complete. DISTRIBUTION: Nationwide and Canada, Syria, Mexico, Japan and Italy. QUANTITY: 5,296 units. REASON: Sterility of the units can not be guaranteed. ________ PRODUCT: FREEHAND Electrode Positioning Kits (EPK), Model 1111-1. Recall #Z-0311- 1. CODE: Serial Numbers: 402, 409, 414, 415, 416, & 426. MANUFACTURER: Neurocontrol Corp. Valleyview, Ohio. RECALLED BY: Manufacturer, by certified letter on 11/30/2000. Firm-initiated recall complete. DISTRIBUTION: OH, NY, and PA. QUANTITY: 28 kits. REASON: Device does not comply with the performance standard for electrode lead wires and patient cables, 21 CFR 898. ________ PRODUCT: FluidSense FS-01 Infusion Pump. Recall #Z-0312-1. CODE: S/N's: 100303 through 100836 (not inclusive) MANUFACTURER: Fluidsense Corp., Newburyport, MA. RECALLED BY: Manufacturer, hand delivered a Field Correction Notice on November 18, 2000. Firm-initiated recall complete. DISTRIBUTION: Lehigh Acres, FL and Fort Myers, FL. QUANTITY: 163. REASON: If two microprocesors simultaneously reboot, an alarm would not sound. ________ PRODUCT: IUI Tomcat Catheters Kit. Recall #Z-0362-1. CODE: Lots: 791004, 791202, and 700302. MANUFACTURER: Bioteque America, Inc., Langhorne, PA. RECALLED BY: Manufacturer, by letters on 12/4/00. FDA-initiated recall complete. DISTRIBUTION: TX, PA, IL, CA, AR, GA, NV, and UT. QUANTITY: 2093 units. REASON: No 510k clearance and lack of sterility assurance. ________ PRODUCT: WC400 Word/Bartholin Catheters. Recall #Z-0363-1. CODE: Lots: 381121 and 79102. MANUFACTURER: Bioteque America, Inc., Langhorne, PA. RECALLED BY: Manufacturer, by letters on 12/5/00. FDA initiated recall complete. DISTRIBUTION: MN. QUANTITY: 1408 units. REASON: No 510k clearance and lack of sterility assurance. ________ PRODUCT: The STERIS Quick Connect Kit Booklets, for STERIS Quick Connect Kits #C1402, #C1403, and C1622 that are used to process Pentax 30/40/30K series gastroscopes in the STERIS SYSTEM I. Recall #Z-0364-1 to Z-0366-1. CODE: All Steris System I Quick Connect Kit Processing Instructions for Pentax 30/40/30k series GI Gastroscopes; Quick Connect Kits #C1402, C1403, and #C1622. MANUFACTURER: Steris Corp., Mentor, OH. RECALLED BY: Manufacturer, by letter on 12/20/2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide and Canada, Germany, Italy, and Mexico. QUANTITY: 1,255 booklets (1 per kit). REASON: Inadequate instructions may result in ineffective sterilization of water jet port. ________ PRODUCT: AngioJet® Rheolytic™ Thrombectomy System Pump Set. Recall #Z-0367-1. CODE: All lots. MANUFACTURER: Possis Medical, Inc., Minneapolis, MN. RECALLED BY: Manufacturer, by an "Urgent Product Packaging Recall letter dated December 18, 2000. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide and Australia, Canada, England, Germany, Greece, Italy, Taiwan, and Turkey. QUANTITY: Estimated 2200 pumps in distribution. REASON: Holes in sterile packaging. ________ PRODUCT: Flexilab Laboratory Information System (not for use in blood banks). Recall #Z-0369-1. CODE: Flexilab version 5.23 with RBR module. MANUFACTURER: Sunquest Information Systems, Inc., Tucson, AZ. RECALLED BY: Manufacturer, by fax on January 15, 2001. Firm-initiated recall ongoing. DISTRIBUTION: WI, WA, MI, VA, NM, OH, AZ, and Denmark. QUANTITY: 15 laboratories. REASON: Software anomaly allows misprint of patient information. _______ PRODUCT: Duracon Unicompartmental Knee System: Z-371-1 - Right Medial/Left Lateral Small Tibial Component Catalog No. 6634-9-108, 8 mm Catalog No. 6634-9-110, 10 mm Catalog No. 6634-9-112, 12 mm Catalog No. 6634-9-114, 14 mm Catalog No. 6634-9-116, 16 mm Z-372-1 - Left Medial/Right Lateral Small Tibial Component Catalog No. 6634-9-008, 8 mm Catalog No. 6634-9-010, 10 mm Catalog No. 6634-9-012, 12 mm Catalog No. 6634-9-014, 14 mm Catalog No. 6634-9-016, 16 mm Z-373-1 - Right Medial/Left Lateral Medium Tibial Component Catalog No. 6634-9-308, 8 mm Catalog No. 6634-9-310, 10 mm Catalog No. 6634-9-312, 12 mm Catalog No. 6634-9-314, 14 mm Catalog No. 6634-9-316, 16 mm Z-374-1 - Left Medial/Right Lateral Medium Tibial Component Catalog No. 6634-9-208, 8 mm Catalog No. 6634-9-210, 10 mm Catalog No. 6634-9-212, 12 mm Catalog No. 6634-9-214, 14 mm Catalog No. 6634-9-216, 16 mm Z-375-1 - Right Medial/Left Lateral Medium/Large Tibial Component Catalog No. 6634-9-508, 8 mm Catalog No. 6634-9-510, 10 mm Catalog No. 6634-9-512, 12 mm Catalog No. 6634-9-514, 14 mm Catalog No. 6634-9-516, 16 mm Z-376-1 - Left Medial/Right Lateral Medium/Large Tibial Component Catalog No. 6634-9-408, 8 mm Catalog No. 6634-9-410, 10 mm Catalog No. 6634-9-412, 12 mm Catalog No. 6634-9-414, 14 mm Catalog No. 6634-9-416, 16 mm Z-377-1 - Right Medial/Left Lateral Large Tibial Component Catalog No. 6634-9-708, 8 mm Catalog No. 6634-9-710, 10 mm Catalog No. 6634-9-712, 12 mm Catalog No. 6634-9-714, 14 mm Catalog No. 6634-9-716, 16 mm Z-378-1 - Left Medial/Right Lateral Large Tibial Component Catalog No. 6634-9-608, 8 mm Catalog No. 6634-9-610, 10 mm Catalog No. 6634-9-612, 12 mm Catalog No. 6634-9-614, 14 mm Catalog No. 6634-9-616, 16 mm Z-379-1 - Right Medial/Left Lateral Extra Large Tibial Component Catalog No. 6634-9-908, 8 mm Catalog No. 6634-9-910, 10 mm Catalog No. 6634-9-912, 12 mm Catalog No. 6634-9-914, 14 mm Catalog No. 6634-9-916, 16 mm Z-380-1 - Left Medial/Right Lateral Extra Large Tibial Component Catalog No. 6634-9-808, 8 mm Catalog No. 6634-9-810, 10 mm Catalog No. 6634-9-812, 12 mm Catalog No. 6634-9-814, 14 mm Catalog No. 6634-9-816, 16 mm CODE: All. MANUFACTURER: Howmedica Osteonics Corporation, Rutherford, NJ RECALLED BY: Manufacturer, by letter, on July 28, 2000. Firm-initiated Recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 247. REASON: Polyethylene components may be oxidizing. ________ PRODUCT: Surgical Procedure Packs. Recall #Z-382-1. CODE: Sterile Lot No. 2101578610. MANUFACTURER: Sterile Recoveries, Inc., Clearwater, FL. RECALLED BY: Manufacturer, by letter on June 7, 2000. Firm-initiated recall complete. DISTRIBUTION: Florida. QUANTITY: 45. REASON: The sterilization process did not meet one temperature parameter.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT: Fischer Needle Guide: a) Catalog No. GF1200 (12 Gauge Needle Guide). Recall #Z-278-1; b) Catalog No. GF1416 (14/16 Gauge Needle Guide).Recall #Z-279-1 CODE: a) Lot No. 22FK3363; b) Lot No. 22FK3362. MANUFACTURER: C. R. Bardm Inc., Covington, GA. RECALLED BY: Manufacturer, by letter on September 8, 2000. Firm-initiated recall complete. DISTRIBUTION: CA, GA, MD, MI, NV, OH, TN. QUANTITY: 875 units. REASON: Contains 12 gauge needle guide but labeled as containing 14/16 gauge needles. ________ PRODUCT: Medtronic PT Cartridge, Prothrombin Time Cartridge. Recall #Z-0292-1. CODE: Model 402-05, Lots 0005000402, 0005000446, 0006000188, 0006000245, 0006000381, 0007000206. MANUFACTURER: Medtronic, Inc., Parker, CO. RECALLED BY: Manufacturer, by telephone on 8/22/2000. Firm-initiated recall complete. DISTRIBUTION: Nationwide, Cyprus, Germany and Hungary. QUANTITY: 342 boxes of 20. REASON: Inactive thromboplastin causes invalid clotting times. ________ PRODUCT: SEDRite Plus Hematology Erythrocyte Sedimentation Rate Control. Recall #Z-0368-1. CODE: Lot SR011-1. MANUFACTURER: R & D Systems, Inc., Minneapolis, MN. RECALLED BY: Manufacturer, by letter dated January 11, 2001. Firm-initiated recall ongoing. DISTRIBUTION: Nationwide. QUANTITY: 168 Kits. REASON: Microbiological contamination in the control caused the red blood cells to lyse. ________ PRODUCT: Lifecore SuperCAT Self-Tap Implant, NP Mnt 3.3x10 mm (SD), Titanium, Catalog number TC3310. Recall #Z-0370-1. CODE: Lot 75001287. MANUFACTURER: Lifecore Biomedical, Inc., Chaska, MN. RECALLED BY: Manufacturer, by telephone on 1/11/01 and follow-up letters on 1/26 and 1/29/2001. Firm-initiated recall complete. DISTRIBUTION: Nevada, New York and Chile and Italy. QUANTITY: 12 implants. REASON: Dental implant mislabeled as to length. ________ PRODUCT: Integrated Endosurgery EndoALPHA Software Version 3.01. Recall #Z-381-1. CODE: Catalog #UCES (Control Unit for Endosurgery), software version 3.01. MANUFACTURER: Olympus America, Inc., Melville, NY. RECALLED BY: Manufacturer, by letter and facsimile on October 1, 1999. Firm- initiated recall complete. DISTRIBUTION: CA, VA, AL, and NV. QUANTITY: 31. REASON: The device software version 3.01 prevented the control unit from retaining the user-programmer coagulation setting.END OF ENFORCEMENT REPORT FOR MARCH 14, 2001. ####
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