July 31, 2002 02-30
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
_______________________ PRODUCT Mrs. Alison's Tango Cookies; Net Wt. 12 Oz., 12 packages per case; Distributed by: Mrs. Alison's Cookie Co., St. Louis, MO, Made in the U.S.A.; UPC 72413-00638. Recall # F-659-2. CODE Lot S1152B. RECALLING FIRM/MANUFACTURER Recalling Firm: Parmalat Bakery Group North America, Bolingbrook, IL, by telephone on June 14, 2002. Manufacturer: Interbake Foods, Inc., North Sioux City, SD. Firm initiated recall is complete. REASON The product contained undeclared peanuts. VOLUME OF PRODUCT IN COMMERCE 360 cases. DISTRIBUTION MN, MI, TN, TX, OK, SD and NE. _______________________ PRODUCT Glover's Ice Cream products in 3 gallon bulk containers. a) Moose Tracks (peanuts). Recall # F-660-2; b) Snicker Bar (peanuts, egg whites, almonds, wheat). Recall # F-661-2; c) Cookie Dough (eggs, wheat). Recall # F-662-2; d) Heavenly Hash (almonds). Recall # F-663-2; e) Turtle Sundae (pecans). Recall # F-664-2; f) Raspberry Salad Sherbet (pecans). Recall # F-665-2; g) Almond Joy (almonds). Recall # F-666-2; h) Black Walnut (walnuts). Recall # F-667-2; i) Peanut Butter Cup (peanuts). Recall # F-668-2; j) Pecan Praline (pecans). Recall # F-669-2; k) Butter Pecan (pecans). Recall # F-670-2; l) Pecan Krisp Yogurt (pecans). Recall # F-671-2. CODE None. RECALLING FIRM/MANUFACTURER Glover's Ice Cream Company Frankfort, IN, by telephone June 6 and June 7, 2002. FDA initiated recall is complete. REASON The products failed to bear complete ingredient statements- undeclared ingredients are listed above next to the product's name. VOLUME OF PRODUCT IN COMMERCE Approximately 1000 tubs. DISTRIBUTION IN. _______________________ PRODUCT Little Debbie Snacks brand, Salted Peanuts, 1 ounce, packaged in transparent plastic bags. Recall # F-673-2. CODE Sell by: SEP02 0604A4. RECALLING FIRM/MANUFACTURER Recalling Firm: McKee Foods Corporation Collegedale, TN, by e-mail on June 18, 2002. Manufacturer: Tom’s Foods, Inc. Columbus, GA. Firm initiated recall is ongoing. REASON The product contains undeclared cashews. VOLUME OF PRODUCT IN COMMERCE 449 cases. DISTRIBUTION Nationwide. _______________________ PRODUCT Product is packaged in a small cellophane/plastic bag with a label which states in part: "***BADIA Sesame Seed Ajonjoli**Net Wt. 2 oz. (56.7 g)**These almond like seeds are popular in Oriental cuisine. Delicious garnish for hors d'oeuves and salads.** Badia Spices, Inc., Miami, FL **" Recall # F-676-2. CODE "EXP 03-05" appear on some products. RECALLING FIRM/MANUFACTURER Badia Spices, Inc. Miami, FL, by fax on April 1, 2002. State initiated recall is complete. REASON Florida Department of Agriculture and Consumer Services' analysis revealed the presence of Salmonella. VOLUME OF PRODUCT IN COMMERCE 15240/2 oz bags or 1270 cases of 12/2 oz. each. DISTRIBUTION FL, GA, MD, MA AND NY and San Salvador, El Salvador, Barbados, W.I. and Grand Cayman, Cayman Islands. _______________________ PRODUCT a) Down Home brand Strawberry Delight. Recall # F-677-2; b) Cole Slaw. Recall # F-678-2; c) Potato Salad-Mustard. Recall # F-679-2; ready to eat salads, packaged in 5 and 10 lb. plastic tubs, coded with dates 4/25/2002 thru 5/1/2002. CODE Date coded 4/25/2002 thru 5/01/2002. RECALLING FIRM/MANUFACTURER Roy Enterprises, Huntington, WV, by letter starting on May 2, 2002. Firm initiated recall is complete. REASON The salads contain undeclared eggs. VOLUME OF PRODUCT IN COMMERCE Approx 300 lbs. DISTRIBUTION WV, KY and OH. _______________________ PRODUCT Eastwell brand SWEETENED NELON packaged in clear, plastic bags trimmed in green, net wt. 6 oz. (170 g). INGREDIENTS: SWEETENED MELON. PRODUCT OF CHINA. Firm on label - Packed: JIANGMEN FOOD1/E CO. GUANGDONG, CHINA. Recall # F-680-2. CODE "EXPIRATIONO: 18 MONTHS", Barcode # 911749 381883. RECALLING FIRM/MANUFACTURER Recalling Firm: Eastwell Trading Inc., Brooklyn, NY, by letter on January 21, 2002. State initiated recall is complete. REASON The product contained undeclared sulfites. VOLUME OF PRODUCT IN COMMERCE 14 cases (100 - 6 oz. packages per case). DISTRIBUTION NY and MA. _______________________ PRODUCT Earth Grains Onion Buns, 8-count, 19-oz. packages. The responsible firm on the label is The Earthgrains Company, St. Louis, MO. Recall # F-681-2. CODE "BEST IF PURCHASED BY", "GOOD THRU", or "PURCHASE BY" followed by the date, which included product dated June 15 through June 28. RECALLING FIRM/MANUFACTURER Sara Lee Bakery Group, Inc., St. Louis, MO, by visits beginning June 13, 2002. FDA initiated recall is complete. REASON The product contained undeclared eggs. VOLUME OF PRODUCT IN COMMERCE 53,868/8-ct. bags. DISTRIBUTION Nationwide. _______________________ PRODUCT Market Basket Oats & More Brand with Honey, Toasted Mult-Grain Flakes with Honey Oats Clusters, Net Wt. 16 oz (1 Lb). Recall # F-682-2. CODE APR1103J2. RECALLING FIRM/MANUFACTURER Recalling Firm: Demoulas Suprmarkets Inc., Tewksbury, MA, by telephone and e-mail on June 4, 2002. Manufacturer: Roskam Baking Company, Kentwood, MI. Firm initiated recall is complete. REASON Cereal contained undeclared almonds. VOLUME OF PRODUCT IN COMMERCE 396 cases (4,752 cartons). DISTRIBUTION NH and MA. _______________________ PRODUCT Coconut Jelly candies with Konjac/Konnyaku, packaged under the following brands: a) Don-Empire, Don Empire Enterprises Co., Ltd., 6F-1, No. 41, Sec. 1 Chang-Shan Rd., Changhua City, Taiwan R.O.C. b) No brand name - only Chinese characters with butterflies on the label, Chian Yeu Food Co., Ltd., No. 934 Yuan Tsau Rd., Yuan Lin Chang-Hua, Taiwan, R.O.C. c) My Love and COco (where one "c" is inside a larger "C" and one "o" is inside a larger "O' at the tail of the large "C"), Pack for Grand Western Foods Co. Ltd., No. 451, 28 Rd., Taichung Industrial Park, Taichung City, Taiwan, R.O.C. The product is packaged in individual serving sized plastic cups with foil lids, with the product meant to be squeezed out of the cup directly into the mouth. The 16.5-17 gram individual serving cups are packaged in 300 gram plastic bags/30 bags per case, 510 gram plastic panda bear-shaped jars/12 jars per case, and 1200 gram round plastic jars/6 jars per case. The following labels and flavors are known to have been imported and distributed by Golden Country Oriental Foods, Chicago, IL: a) COco Longan Jelly in 227 g bag, Grand Western Foods, UPC #712390-251998 and 1150 g plastic jars. Recall # F-684-2; b) COco Taro Jelly in 227 g bag, Grand Western Foods, UPC #712390-251875. Recall # F-685-2; c) COco Peach Jelly in 227 g bag, Grand Western Foods. Recall # F-686-2; d) My Love Durians Konnyaku Coconut Jelly in 227 g bag, Grand Western Foods, UPC #712390-253855, Recall # F-687-2; e) Don Empire Taro Flavor Konnyaku Coconut Jelly in 300 g bags, UPC #718064-000121. Recall # F-688-2; f) Don Empire Lychee Flavor Konnyaku Coconut Jelly in 300 g bags, UPC #15685-12225, and 510 g panda bear-shaped jars, UPC #718064-000190, Recall # F-689-2; g) Don Empire Mango Flavor Mini Fruit Jelly in 300 g bags, 1200 g jars, UPC #718064-000077, and 510 g panda bear- shaped jars, UPC #718064-000190, Recall # F-690-2; h) 2 Don Empire Orange Flavor Mini Fruit Jelly in 1200 g jars, UPC #718064-000077, and 510 g panda bear-shaped jars, Recall # F-691-2; i) Don Empire Pineapple Flavor Mini Fruit Jelly in 1200 g jars, UPC #718064-000077, and 510 g panda bear-shaped jars, Recall # F-692-2; j) Don Empire Assorted Flavor Mini Fruit Jelly in 510 g panda bear-shaped jars, UPC #718064-000190, Recall # F-693-2; k) Don Empire Peach Flavor Mini Fruit Jelly in 1200 g jars and 510 g panda bear-shaped jars, Recall # F-694-2; l) Don Empire Longan Flavor Mini Fruit Jelly in 300 g bags, Recall # F-695-2; m) Don Empire Apple Flavor Mini Fruit Jelly in 1200 g jars and 510 g panda bear-shaped jars, Recall # F-696-2; n) Don Empire Soursop Flavor Mini Fruit Jelly in 1200 g jars, Recall # F-697-2; o) Don Empire Grape Flavor Mini Fruit Jelly in 510 g panda bear-shaped jars, Recall # F-698-2; p) Don Empire Strawberry Flavor Mini Fruit Jelly in 510 g panda bear-shaped jars, Recall # F-699-2; q) No brand name - only Chinese characters with butterflies on the label, Assorted Flavor Fruit Coconut Jelly, Chian Yeu Food, in 1150 g jars, UPC #714230-064317, Recall # F-700-2. CODE All lots of all flavors. RECALLING FIRM/MANUFACTURER Recalling Firm: Golden Country Oriental Food, L.L.C., Chicago, IL, by letter dated February 6,2002. Manufacturer: Grand Western Foods Corp., Taichung City. Firm initiated recall is complete. REASON This candy is in violation of section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it is unfit for food due to the characteristics that result in a serious choking hazard. VOLUME OF PRODUCT IN COMMERCE 9,158 cases. DISTRIBUTION IL, IA, IN, KY, OH, WI, FL, MI, MO, SD and KS.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_______________________ PRODUCT Glover's Ice Cream products in 3 gallon bulk containers. Cookies N Cream (wheat). Recall # F-672-2. CODE None. RECALLING FIRM/MANUFACTURER Glover's Ice Cream Company Frankfort, IN, by telephone June 6 and June 7, 2002. FDA initiated recall is complete. REASON The products failed to bear complete ingredient statements- undeclared ingredients are listed below next to the product's name. VOLUME OF PRODUCT IN COMMERCE Approximately 1000 tubs. DISTRIBUTION IN. _______________________ PRODUCT Queso Mexicano Semisoft Cheese for Quesadillas And Enchiladas, net weight 5 pounds. Recall # F-674-2. CODE Lot 178 11902. RECALLING FIRM/MANUFACTURER Recalling Firm: Specialty Cheese Co. Inc., Lowell, WI, by letters dated October 30, 2001. Manufacturer: Specialty Cheese Co. Inc., Reeseville, WI. Firm initiated recall is complete. REASON The recalled lot contained more than 110,000 E. coli organisms per gram and a sample of one of the lots contained 2000 Enterotoxigenic E. Coli per gram. VOLUME OF PRODUCT IN COMMERCE 1798 pounds. DISTRIBUTION GA, IL and WI.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
_______________________ PRODUCT La VacaRica Queso Quesadilla Semisoft Cheese for Melting, net weight 5 pounds and Kenafa Queso Quesadilla Semisoft Cheese, net weight 5 pounds. Recall # F-675-2. CODE Lot 178 11792. RECALLING FIRM/MANUFACTURER Recalling Firm: Specialty Cheese Co. Inc., Lowell, WI, by letters dated October 30, 2001. Manufacturer: Specialty Cheese Co. Inc., Reeseville, WI. Firm initiated recall is complete. REASON The recalled lot contained more than 110,000 E. coli organisms per gram and a sample of one of the lots contained 2000 Enterotoxigenic E. Coli per gram. VOLUME OF PRODUCT IN COMMERCE 1798 pounds. DISTRIBUTION GA, IL and WI. _______________________ PRODUCT Pantry Pride brand white bread in plastic bag, label stating in part "PANTRY PRIDE WHITE ENRICHED EAD NET WT 1 LB 6.5 OZ ** INTERSTATE BRANDS COMPANIES ** GENERAL OFFICE, KANSAS CITY, MO 64111 ** SELL BY DATE ON PACKAGE***". Recall # F-683-2. CODE SELL BY DATE"s of 062202 through 062602 and 062902 through 070302. RECALLING FIRM/MANUFACTURER Interstate Brands Companies Lakewood, WA, by telephone on July 21, 2002. Firm initiated recall is complete. REASON The nutrition facts panel declared 35 g carbohydrates per serving when in fact the product only contained 14 g carbohydrates per serving. VOLUME OF PRODUCT IN COMMERCE 4,772 loaves. DISTRIBUTION WA.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
_______________________ PRODUCT Acyclovir Tablets, USP, 400 mg, Rx Only,100-count bottles, Manufactured by: IVAX Pharmaceuticals, Miami, FL 33137, NDC 0172-4267-60. Recall # D-353-2. CODE Lot No. 106091A Exp. date Mar 04. RECALLING FIRM/MANUFACTURER Recalling Firm: Ivax Pharmaceuticals, Inc., Miami, FL, by letters on May 21, 2002. Manufacturer: Ivax Pharmaceuticals Caribe, Inc., Cidra, Puerto Rico. Firm initiated recall is ongoing. REASON Tablet crumbling. VOLUME OF PRODUCT IN COMMERCE 11, 483 bottles. DISTRIBUTION Nationwide. _______________________ PRODUCT a) Luvox (Fluvoxamine Maleate) Tablets (scored), 25 mg, 100 count bottles and unit dose packages of 100, Rx Only. Recall # D-354-2; b) Luvox (Fluvoxamine Maleate) Tablets (scored), 50 mg, 100 count bottles and unit dose packages of 100, Rx Only. Recall # D-355-2; c) Luvox (Fluvoxamine Maleate) Tablets (scored), 100 mg, 100 count bottles and unit dose packages of 100, Rx Only. Recall # D-356-2. CODE a)LUVOX 25mg - Lots 90645, 90646, 91001, 91338, 91375, 91721, 92032, 92038; b) LUVOX 50mg - Lots 90576, 90610, 90611, 90612, 90613, 90614, 90615, 90644, 90731, 90733, 90734, 90735, 90736, 90737, 90841, 90842, 90843, 90844, 90845, 90846, 90996, 90997, 90998, 90999, 91000, 91229, 91230, 91232, 91233, 91234, 91235, 91236, 91237, 91320, 91321, 91322, 91323, 91376, 91377, 91378, 91379, 91380, 91543, 91544, 91617, 91618, 91619, 91620, 91621, 91646, 91653, 92094, 92165; c) LUVOX 100mg - Lots 90410, 90411, 90414, 90415, 90454, 90455, 90456, 90457, 90555, 90556, 90557, 90558, 90559, 90560, 90561, 90562, 90563, 90564, 90699, 90700, 90701, 90702, 90703, 90704, 90705, 90713, 90714, 90715, 90716, 90717, 90718, 90719, 90720, 90721, 90722, 90831, 90832, 90833, 90834, 90835, 90836, 90837, 90838, 90849, 90850, 90851, 90852, 90853, 90854, 90855, 90856, 90857, 90858, 90865, 90866, 90867, 90868, 90869, 90870, 90931, 90932, 90933, 90934, 90935, 90936, 91003, 91004, 91005, 91006, 91007, 91008, 91009, 91010, 91011, 91112, 91113, 91114, 91115, 91116, 91117, 91118, 91119, 91120, 91238, 91240, 91241, 91242, 91243, 91244, 91245, 91246, 91247, 91289, 91290, 91291, 91292, 91294, 91295, 91296, 91297, 91315, 91316, 91317, 91324, 91325, 91326, 91327, 91328, 91329, 91330, 91331, 91364, 91365, 91366, 91367, 91368, 91369, 91370, 91371, 91372, 91373, 91374, 91384, 91385, 91386, 91387, 91388, 91389, 91390, 91391, 91392, 91393, 91394, 91395, 91396, 91397, 91398, 91399, 91535, 91536, 91537, 91538, 91539, 91540, 91541, 91542, 91610, 91611, 91645, 91647, 91648, 91649, 91650, 91651, 91652, 91658, 92091, 92092, 92093, 92113, 92114, 92115, 92116, 92117, 92118, 92119, 92120, 92121, 92163. RECALLING FIRM/MANUFACTURER Recalling Firm: Solvay Pharmaceuticals, Inc., Marietta, GA, by letter on May 29, 2002. Manufacturer: Solvay Pharmaceuticals, Inc., Baudette, MN.Firm initiated recall is ongoing. REASON Inaccuracies in data submitted to the New Drug Application by Solvay (stability). VOLUME OF PRODUCT IN COMMERCE 1,503,114 units. DISTRIBUTION Nationwide.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_______________________ PRODUCT Source Plasma, Recall # B-1657-2. CODE Unit 0100410961 RECALLING FIRM/MANUFACTURER Nabi, Chattanooga, TN, by fax on December 7, 2000. Firm initiated recall is complete. REASON Blood product, collected in a manner that compromises the sterility of the unit, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION NC. _______________________ PRODUCT Source Plasma, Recall # B-1658-2. CODE Unit 35256991. RECALLING FIRM/MANUFACTURER Nabi, Johnson City, TN, by telephone on May 13, 2000 and by letter dated July 17, 2000. Firm initiated recall is complete. REASON Blood product, collected in a manner that compromises the sterility of the unit, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT Source Plasma, Recall # B-1659-2. CODE Unit 35354109. RECALLING FIRM/MANUFACTURER Nabi, Johnson City, TN, by fax on July 5, 2000. Firm initiated recall is complete. REASON Blood product, collected from a donor who had not completed the CJD/nvCJD increased risk questions, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION CA. _______________________ PRODUCT a) Platelets Pheresis, Leukocytes Reduced, Recall # B-1696-2; b) Platelets Pheresis, Leukocytes Reduced Irradiated, Recall # B-1697-2. CODE a) Unit numbers GS08939, GS08942, GS08947, GS08949, GS08955, GS08965, GS08966, GS08974, GS08976, GS08982, GS08984, GS09003, GS09013, GS09020, GS09029, GS09039, GS09073, GS09088, GS09101, GS09124, GS09885, GS09887, GS09889, GS09897, GS09904, GS09920, GS09925, GS09929, GS09939, GS09956, GS09967, GS09974, GS09979, GS09981, GS09987, GS09992, GS10005, GS10023, GS10028, GS10231, GS11132, GS11134, GS11139, GS11142, GS11144, GS11152, GS11155, GS11156, GS11158, GS11175, GS11186, GS11194, GS11198, GS11207, GS11208, GS11216, GS11218, GS11227, GS11230, GS11236, GS11242, GS11254, GS11261, GS12296, GS12300, GS12308, GS12324, GS12334, GS12340, GS12346, GS12348, GS12352, GS12357, GS12358, GS12361, GS12362, GS12363, GS12364, GS12374, GS12377, GS12379, GS12381, GS12384, GS12385, GS12386, GS12389, GS12391, GS12394, GS12395, GS12396, GS12397, GS12404, GS12405, GS12406, GS12407, GS12411, GS12417, GS12424, GS12427, GS12429, GS12433, GS12434, GS12436, GS12441, GS12460, GS12470, GS12473, GS12474, GS12476, GS12478, GS12491, GS12495, GS12498, GS12500, GS12501, GS12502, GS12503, GS12507, GS12508, GS12514, GS12523, GS12526, GS12530, GS12537, GS12541, GS12542, GS12544, GS12546, GS12549, GS12550, GS12551, GS12554, GS12558, GS12560, GS12562, GS12563, GS12565, GS12568, GS12569, GS12570, GS12572, GS12574, GS12575, GS12576, GS12581, GS12583, GS12584, GS12588, GS12589, GS12597, GS12598, GS12611, GS12627, GS12629, GS12645, GS12653, GS12655, GS12660, GS12666, GS12667, GS12669, GS12672, GS12677, GS12684, GS12687, GS12691, GS12694, GS12695, GS12696, GS12708, GS12711, GS12719, GS12722, GS12723, GS12732, GS12734, GS12735, GS12737, GS12744, GS12745, GS12747, GS12752, GS12755, GS12759, GS12762, GS12769, GS12772, GS12773, GS12778, GS12787, GS12788, GS12789, GS12792, GS12795, GS12800, GS12817, GS12839, GS12840, GS12841, GS12844, GS12855, GS12858, GS12864, GS12872, GS12873, GS12883, GS12884, GS12890, GS12892, GS12895, GS12896, GS12899, GS12904, GS12916, GS12917, GS12918, GS12919, GS12921, GS12926, GS12927, GS12929, GS12947, GS12948, GS12955, GS12957, GS12970, GS12971, GS12972, GS12974, GS12977, GS12988, GS12989, GS09909, GS12332, GS12370, GS09014, GS09030, GS09045, GS09054, GS09092, GS09105, GS09948, GS09959, GS09961, GS09977, GS09988, GS10010, GS10229, GS11135, GS11143, GS11148, GS11159, GS11161, GS11164, GS11169, GS11171, GS11172, GS11195, GS11196, GS11209, GS11212, GS11213, GS11219, GS11229, GS11247, GS11248, GS11251, GS11256, GS12298, GS12303, GS12306, GS12307, GS12322, GS12329, GS12367, GS12399, GS12410, GS12431, GS12450, GS12452, GS12457, GS12459, GS12462, GS12464, GS12469, GS12471, GS12472, GS12475, GS12477, GS12482, GS12499, GS12505, GS12519, GS12532, GS12547, GS12556, GS12557, GS12567, GS12571, GS12580, GS12582, GS12595, GS12621, GS12626, GS12636, GS12641, GS12681, GS12693, GS12704, GS12706, GS12707, GS12709, GS12715, GS12721, GS12724, GS12736, GS12749, GS12750, GS12756, GS12763, GS12777, GS12780, GS12785, GS12793, GS12798, GS12807, GS12810, GS12816, GS12818, GS12822, GS12823, GS12830, GS12834, GS12845, GS12848, GS12849, GS12852, GS12859, GS12863, GS12874, GS12882, GS12888, GS12897, GS12909, GS12915, GS12932, GS12934, GS12936, GS12939, GS12940, GS12942, GS12945, GS12946, and GS12984; and the following unit numbers were distributed as two split units: GS08954, GS08975, GS08986, GS08989, GS09012, GS09035, GS09037, GS09040, GS09046, GS09050, GS09055, GS09059, GS09061, GS09067, GS09068, GS09087, GS09095, GS09096, GS09110, GS09115, GS09118, GS09888, GS09891, GS09900, GS09910, GS09912, GS09919, GS09931, GS09943, GS09946, GS09950, GS09957, GS09973, GS09976, GS09984, GS10007, GS10009, GS10029, GS11131, GS11133, GS11136, GS11137, GS11140, GS11141, GS11145, GS11147, GS11149, GS11153, GS11163, GS11165, GS11166, GS11167, GS11168, GS11173, GS11174, GS11176, GS11178, GS11180, GS11182, GS11183, GS11184, GS11187, GS11189, GS11190, GS11191, GS11192, GS11198, GS11199, GS11200, GS11201, GS11202, GS11206, GS11211, GS11214, GS11215, GS11217, GS11221, GS11222, GS11224, GS11225, GS11226, GS11228, GS11231, GS11232, GS11233, GS11234, GS11237, GS11238, GS11239, GS11241, GS11243, GS11244, GS11245, GS11246, GS11249, GS11253, GS11255, GS11257, GS11258, GS11259, GS11260, GS11262, GS12295, GS12297, GS12299, GS12302, GS12304, GS12305, GS12310, GS12312, GS12313, GS12315, GS12316, GS12317, GS12319, GS12320, GS12321, GS12323, GS12325, GS12326, GS12327, GS12330, GS12331, GS12333, GS12335, GS12336, GS12337, GS12338, GS12339, GS12341, GS12342, GS12343, GS12344, GS12347, GS12351, GS12353, GS12360, GS12365, GS12366, GS12368, GS12369, GS12371, GS12372, GS12375, GS12376, GS12380, GS12382, GS12387, GS12388, GS12390, GS12392, GS12393, GS12398, GS12401, GS12402, GS12403, GS12408, GS12409, GS12412, GS12413, GS12414, GS12415, GS12416, GS12418, GS12419, GS12420, GS12421, GS12422, GS12423, GS12425, GS12426, GS12430, GS12435, GS12437, GS12438, GS12440, GS12442, GS12443, GS12445, GS12447, GS12449, GS12451, GS12453, GS12454, GS12455, GS12456, GS12458, GS12461, GS12463, GS12465, GS12468, GS12480, GS12481, GS12483, GS12484, GS12485, GS12487, GS12488, GS12490, GS12492, GS12493, GS12494, GS12496, GS12497, GS12504, GS12506, GS12509, GS12510, GS12511, GS12512, GS12513, GS12516, GS12517, GS12521, GS12522, GS12524, GS12527, GS12528, GS12529, GS12531, GS12533, GS12535, GS12536, GS12538, GS12539, GS12540, GS12543, GS12545, GS12553, GS12555, GS12559, GS12561, GS12564, GS12566, GS12573, GS12577, GS12578, GS12585, GS12590, GS12594, GS12596, GS12600, GS12601, GS12602, GS12603, GS12605, GS12606, GS12608, GS12609, GS12613, GS12616, GS12617, GS12619, GS12620, GS12623, GS12624, GS12630, GS12634, GS12638, GS12639, GS12640, GS12642, GS12643, GS12644, GS12646, GS12647, GS12648, GS12649, GS12650, GS12652, GS12654, GS12657, GS12658, GS12659, GS12661, GS12663, GS12664, GS12665, GS12668, GS12676, GS12678, GS12685, GS12686, GS12688, GS12690, GS12697, GS12702, GS12705, GS12710, GS12712, GS12713, GS12714, GS12716, GS12725, GS12728, GS12729, GS12731, GS12733, GS12738, GS12739, GS12743, GS12751, GS12753, GS12757, GS12758, GS12761, GS12764, GS12765, GS12766, GS12768, GS12770, GS12775, GS12779, GS12781, GS12782, GS12783, GS12786, GS12790, GS12791, GS12794, GS12796, GS12797, GS12799, GS12801, GS12802, GS12804, GS12805, GS12806, GS12809, GS12812, GS12813, GS12820, GS12825, GS12831, GS12835, GS12836, GS12837, GS12838, GS12842, GS12843, GS12846, GS12853, GS12856, GS12866, GS12870, GS12876, GS12879, GS12880, GS12881, GS12885, GS12886, GS12893, GS12900, GS12901, GS12902, GS12903, GS12905, GS12907, GS12908, GS12910, GS12924, GS12928, GS12930, GS12931, GS12941, GS12943, GS12944, GS12949, GS12951, GS12952, GS12953, GS12954, GS12956, GS12959, GS12961, GS12963, GS12964, GS12966, GS12967, GS12968, GS12973, GS12975, GS12976, GS12979, GS12980, GS12985, GS12991, and GS12992 b) Unit numbers GS09000, GS09074, GS09125, GS09926, GS11150, GS11252, GS12356, GS12534, GS12625, GS12633, GS12635, GS12673, GS12700, GS12717, GS12808, GS12829, GS12847, GS12851, GS12865, GS12913, GS12983, GS09014, GS09054, GS09078, GS09948, GS09961, GS09977, GS11143, GS11159, GS11161, GS11171, GS11172, GS11209, GS11212, GS11247, GS11248, GS11251, GS12298, GS12307, GS12322, GS12329, GS12399, GS12410, GS12431, GS12464, GS12466, GS12471, GS12472, GS12475, GS12489, GS12505, GS12519, GS12532, GS12547, GS12556, GS12557, GS12567, GS12571, GS12621, GS12626, GS12636, GS12641, GS12681, GS12693, GS12707, GS12721, GS12724, GS12736, GS12749, GS12750, GS12756, GS12763, GS12777, GS12780, GS12785, GS12793, GS12798, GS12818, GS12819, GS12834, GS12848, GS12849, GS12852, GS12857, GS12863, GS12869, GS12874, GS12882, GS12888, GS12897, GS12911, GS12915, GS12932, GS12934, GS12939, GS12942, GS12945, and GS12984; and the following unit numbers were distributed as two split units: GS09947, GS12978, GS12981, GS12923, GS12854, GS12754, GS12689, GS12692, GS12651, GS12675, GS12679, GS12610, GS12618, GS11204, GS11205, GS11162, GS11160, GS11151, and GS09964 RECALLING FIRM/MANUFACTURER Blood Bank of San Bernadino and Riverside Counties, San Bernadino, CA, by letter on February 5, 2002. Firm initiated recall is complete. REASON Platelets with a decreased platelet count were distributed. VOLUME OF PRODUCT IN COMMERCE a) 1,130 units. b) 136 units. DISTRIBUTION CA. _______________________ PRODUCT Source Plasma, Recall # B-1736-2. CODE Unit number XB65504. RECALLING FIRM/MANUFACTURER Recalling Firm: Community Bio-Resources, Inc., Hoover, AL, by fax on January 20, 1998. Manufacturer: Community Bio-Resources, Inc., St. Cloud, MN. Firm initiated recall is complete. REASON Blood product, that was not quarantined after testing elevated for the alanine aminotransferase (ALT) assay, was distributed. VOLUME OF PRODUCT IN COMMERCE 1 unit. DISTRIBUTION Austria.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
_______________________ PRODUCT Source Plasma, Recall # B-1735-2. CODE Unit numbers 57185583 and 61191778. RECALLING FIRM/MANUFACTURER SeraCare, Inc., Topeka, KS, by fax on July 27, 2001. Firm initiated recall is complete. REASON Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), were collected from a donor that subsequently tested repeatedly reactive to anti-HCV, were not properly quarantined, and were distributed. VOLUME OF PRODUCT IN COMMERCE 2 units. DISTRIBUTION CA.RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
_______________________ PRODUCT CryoValve Allograft - Heart valve. Recall # Z-1123-2. CODE Serial No. 6773739, Model No. PV00. RECALLING FIRM/MANUFACTURER Cryolife, Inc. Kennesaw, GA, by visit on April 5, 2002. Firm initiated recall is complete. REASON Aortic valve donor was associated with alleged case of Endocarditis. VOLUME OF PRODUCT IN COMMERCE One valve. DISTRIBUTION CA. _______________________ PRODUCT LTV Series Ventilators. Recall # Z-1136-2. CODE LTV 1000, LTV 950 and LTV 800 Series Ventilator Serial numbers affected are: A03816-A03840 C03168-C03197 D01006-D01010, D01013, D01015, D01021, D01022. RECALLING FIRM/MANUFACTURER Pulmonetic Systems, Inc., Colton, CA, by letters on November 30, 2001. Firm initiated recall is complete. REASON EMI shield short circuits units, potential for fire. VOLUME OF PRODUCT IN COMMERCE 64. DISTRIBUTION PA, OH, FL, NC, GA, PA, WA, CA and to Canada, Japan, and Taiwan. _______________________ PRODUCT Ct Tri Pak Sterile disposable syringe kits. Recall # Z-1145-2. CODE Catalog number CTP-200-FLS. Lot numbers 29764, 29765, and 29766. RECALLING FIRM/MANUFACTURER Medrad, Inc., Indianola, PA, by letters dated May 7, 2002. Firm initiated recall is ongoing. REASON May exceed endotoxin specification limits VOLUME OF PRODUCT IN COMMERCE 41650 kits DISTRIBUTION Nationwide and Sultanate of Oman, Korea, Taiwan and BR. _______________________ PRODUCT Intera 1.0T and 1.5T MR Systems Magnetic Resonance Systems are indicated for use as diagnostic devices that display the internal structure and/or function of the head, body or extremeties. The coils are used to obtain optimal imaging. Recall # Z-1147-2/Z-1148-2. CODE Software version R7.1.2 and higher RECALLING FIRM/MANUFACTURER Recalling Firm: Philips Medical Systems North America, Inc., Bothell, WA, by letter dated October 26, 2001. Manufacturer: Philips Medical Systems Nederland B.V. Netherlands. Firm initiated recall is complete. REASON Higher than expected current in the insulation of the coil cable. VOLUME OF PRODUCT IN COMMERCE 3. DISTRIBUTION FL and WA. _______________________ PRODUCT STAAR Surgical UV Absorbing Posterior Chamber Intraocular Lens, Model - AQ5010V. Recall # Z-1151-2. CODE Serial Numbers 3033515 3040022 3040026 3523618 3523692 3033498 3033542 3040615 3040616 3033529 3523628 3178667 3033540 3431112 3431109 3040666 3050410 3178655 3431093 3037418 3040623 3432070 3034695 3432088 3174470 3044717 3413510 3431119 3040647 3044721 3151535 3151546 3174464 3040621 3408081 3033508 3151441 3151513 3040646 3040655 3033570 3033571 3037477 3040031 3151439 3040037 3040046 3040067 3037476 3432064 3033555 3033556 3413514 3178643 3178644 3050437 3040614 3037434 3033520 3040638 3431111 3523208 3040051 3040033 3040049 3432083 3151437 3431095 3431116 3040054 3431108 3037485 3033573 3432075 3033561 3037456 3037457 3033568 3033569 3050440 3151536 3037435 3037442 3033538 3151438 3432069 3523186 3040613 3033521 3523187 3523188 3523701 3040060 3037464 3037465 3174458 3431106 3523207 3523197 3037492 3432067 3034699 3151443 3033541 3033550 3040610 3040624 3040637 3174453 3523604 3523210 3033511 3432066 3040038 3432598 3523679 3033576 3033577 3151528 3178647 3523195 3040612 3033500 3033501 3040035 3408082 3523695 3033516 3431094 3432618 3523696 3034704 3040620 3033533 3033539 3523213 3432089 3432065 3432597 3523621 3040651 3040660 3033527 3431113 3040639 3040640 3432609 3432610 3408087 3432074 3037470 3040619 3040635 3040063 3432603 3040052. RECALLING FIRM/MANUFACTURER Staar Surgical Co. Monrovia, CA, by letter on May 15, 2002. Firm initiated recall is ongoing. REASON Mislabeled as to diopter. VOLUME OF PRODUCT IN COMMERCE 156. DISTRIBUTION Nationwide and Puerto Rico and the Dominican Republic. _______________________ PRODUCT Ela/Angeion Lyra Model 2020, 2021, and 2022 Implantable Cardioverter Defibrillators. Recall # Z-1152-2/Z-1154-2. CODE All of the defibrillators are involved, and all of these units have been implanted. The devices are no longer in distribution. The last implant occurred on August 18, 2000. RECALLING FIRM/MANUFACTURER Recalling Firm: Angeion Corporation, St. Paul, MN, by letter dated June 27, 2002. Manufacturer: Ela-Angeion, Plymouth, MN, by letter dated June 27, 2002. Firm initiated recall is ongoing. REASON The devices could stop providing therapy due to premature battery depletion. VOLUME OF PRODUCT IN COMMERCE 494. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Dyonics Direct View and Video Arthroscopes 4.0 mm as follows: a) Part Number: 3622R, Video Arthroscope, 4mm x 30 degree, Repair. Recall # Z-1155-2; b) Part Number: 3622S, Video Arthroscope, 4mm x 30 degree, Service. Recall # Z-1156-2; c) Part Number: 3626R, Arthroscope, 4mm x 30 degree, Repair. Recall # Z-1157-2. d) Part Number: 3626S, Arthroscope, 4mm x 30 degree, Service. Replacement. Recall # Z-1158-2. e) Part Number: 4125S, Arthroscope, 4mm x 30 degree, Service Replacement. Recall # Z-1159-2. CODE a) Serial Number: HD208005 b) Serial Numbers: HD207995 HD208006 HD208009 HD208740 HD207981 c) Serial Number: HD208802 d) Serial Numbers: HD207980 HD207984 HD207997 HD208008 HD208721 HD208731 HD208790 HD208760 HD208761 HD208762 HD208771 HD208780 HD208772 HD208779 HD208788 HD208789 HD209557 HD209559 HD209576 HD209589 HD209603 HD207988 HD208751 e) Serial Numbers: HD207986 HD208749 HD209577 RECALLING FIRM/MANUFACTURER Smith & Nephew, Inc. Andover, MA, by letter dated April 29, 2002. Firm initiated recall is ongoing. REASON Arthroscopes may be missing weld and contamination may penetrate resulting in inadequate sterilization. VOLUME OF PRODUCT IN COMMERCE 33. DISTRIBUTION Nationwide and Australia, Mexico and the United Kingdom. _______________________ PRODUCT Stryker brand TPS U2 drill for use with the Stryker Total Performance System. Recall # Z-1160-2. CODE Model 5100-100-000 drills built or repaired, and model 5100-100-900 drills with motor repairs made, from 3/7/02 to 3/26/02. RECALLING FIRM/MANUFACTURER Stryker Corporation, Stryker Instruments Division, Kalamazoo, MI, by letter dated April 29, 2002. Firm initiated recall is complete. REASON Possible shock hazard. VOLUME OF PRODUCT IN COMMERCE 84 drills. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Surgeons Vest. Recall # Z-1161-2. CODE Lot Numbers 1020250, 1020320, 1020370, 1020380, 1020530. RECALLING FIRM/MANUFACTURER Precept Medical Products, Inc. Arden, NC, by letter dated April 3, 2002. Firm initiated recall is ongoing. REASON Incomplete seal on packaging. VOLUME OF PRODUCT IN COMMERCE 187 cases/30 per case or 5,610 units. DISTRIBUTION Nationwide. _______________________ PRODUCT SONOLINE Antares, Diagnostic Ultrasound System. The SONOLINE Antares is a high-resolution, digital, broadband diagnostic ultrasound imaging system. It supports the following diagnostic applications: abdominal, OB/GYN, small parts, musculoskeletal, vascular, and urology. Recall # Z-1162-2. CODE Units with software version 1.0 or 1.1. RECALLING FIRM/MANUFACTURER Semens Medical Systems, Inc., Issaquah, WA, by letter dated January 2002. Firm initiated recall is ongoing. REASON Software anomalies that affect measurement and calculation data. VOLUME OF PRODUCT IN COMMERCE 260 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Kimberly-Clark Multifunction Electrodes, R2 Pads, Self-adhesive Pre-gelled low impedance electrodes. Manufactured by Ballard Medical Products. Recall # Z-1163-2. CODE Catalog No. 3200-1715. Lot Numbers: 144766, 145094, 146041, 146042, 146636, 147350, 147352, 149095, 149096, 149885, 149886, 149887, 150667, 150668, 150669, 151605, 151987, 151988, 152848, 153541, 153592, 153671, 153878, 155327, 155928, 155929, 156742, 156743, 157681, 157682, 158661, 159261, 160052, 160053, 160061, 160062, 161079, 161080 RECALLING FIRM/MANUFACTURER Ballard Medical Products, Draper, UT, by letter on March 25, 2002. Firm initiated recall is ongoing. REASON Unit label incorrectly identifies the pads as radiolucent. VOLUME OF PRODUCT IN COMMERCE 88,518 units. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT ISPAN, Sulfur Hexafluoride (SF6) and Perfluoropane (C3F8) Liquified Gas under Pressure, for intraocular use. Cylinder series LD2, LD1, and LD. Recall # Z--1164-2/Z-1165-2. CODE Device Catalog Number 8065-7971-01 Alcon Customer Lot Information: Transfill Lot # Quantity Released Size 021519 41 LD2 021605 42 LD2 021606 42 LD1 021812 42 LD2 022002 42 LD2 022119 7 LD2 022310 42 LD1 022403 34 LD1 023401 30 LD 023518 42 LD2 023519 42 LD2 023520 42 LD2 023521 41 LD2 024403 40 LD2 024404 23 LD 024505 42 LD2 024515 42 LD2 024917 38 LD2 024918 42 LD2 025006 28 LD2 025020 42 LD2 025103 41 LD2 025114 40 LD2 025126 35 LD1 025210 32 LD 025220 12 LD1 025620 25 LD2 025843 28 LD1 026221 33 LD 026222 34 LD 026318 6 LD 029809 33 LD 031323 9 LD 034605 42 LD1 034619 14 LD1 034708 27 LD 108005 42 LD2 108038 42 LD2 108101 27 LD2 108102 41 LD2 108223 7 LD 110806 24 LD 110917 27 LD1 112225 35 LD2 112401 30 LD1 114321 42 LD2 114322 23 LD2 116525 26 LD2 116311 34 LD 117934 34 LD1 120708 42 LD2 120709 42 LD2 120815 22 LD2 120818 31 LD1 121318 32 LD 124002 39 LD2 126423 19 LD2 126424 42 LD2 126425 42 LD2 126426 28 LD1 129010 42 LD2 129028 40 LD2 129108 28 LD2 129502 33 LD1 Escalon Customer Lot Information: Transfill Lot # Quantity Released Size 021504 41 LD1 021616 42 LD1 021738 41 LD1 022433 16 LD1 025802 42 LD1 025807 42 LD1 025924 42 LD1 025902 42 LD1 025903 42 LD1 025904 42 LD1 026201 42 LD1 026202 41 LD1 034103 42 LD1 034104 30 LD1 101019 17 LD1 101020 15 LD1 101127 28 LD1 101133 14 LD1 108504 22 LD1 108711 28 LD1 112914 33 LD1 115001 42 LD1 121319 41 LD1. RECALLING FIRM/MANUFACTURER Scott Medical Products, Plumsteadville, PA, by letters on April 3, 2001. FDA initiated recall is ongoing. REASON Post-operative warning against use of nitrous oxide gas before intraocular gas has dissipated from the eye. VOLUME OF PRODUCT IN COMMERCE 2900 cylinders/ 2nd notification: 4205 cylinders. DISTRIBUTION Nationwide. _______________________ PRODUCT Baxter Ipump Pain Management System infusion pump, product codes 2L3107 and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL. Recall # Z-1166-2. CODE Product codes 2L3107 and 2L3107R, all serial numbers. RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated April 10, 2002. Manufacturer: Baxter Healthcare Pte. Ltd., Singapore, SG. Firm initiated recall is ongoing. REASON Software anomaly allows access to change prescription or program bolus without security. VOLUME OF PRODUCT IN COMMERCE 9,927 pumps. DISTRIBUTION Nationwide. _______________________ PRODUCT Boston Scientific/Medi-Tech Dual Lumen Vaxcel PICC (Peripherally Inserted Central Catheter) as follows: Catalog Number Product Description a) 45-413 VAXCEL 5F DUAL LUMEN PICC. Recall # Z-1167-2; b) 45-426 VAXCEL 6F DUAL LUMEN PICC. Recall # Z-1168-2. c) 45-445 PICC VAXCEL 5F DL/CLAMPABLE/60CM WIRE/OB. Recall Z-1169-2; d) 45-446 PICC VAXCEL 6F DL/CLAMPABLE/60CM WIRE/OB. Recall # Z-1170-2. CODE Lot Numbers a) 628022A 626091AR 604101AR b) 611032B 618032B c) 628022B 611032C d) 611032C RECALLING FIRM/MANUFACTURER Recalling Firm: Boston Scientific Corp./Medi-Tech, Watertown, MA, by letters on April 22, 2002. Manufacturer: Medsource Technologies LLC, Navajoa, Sonora. Firm initiated recall is ongoing. REASON Catheter Extension tube detached from hub upon being flexed. VOLUME OF PRODUCT IN COMMERCE 5,214. DISTRIBUTION Nationwide. _______________________ PRODUCT Vaxcel Single Lumen Peripherally Inserted Central Catheter (PICC) as follows: Catalogue Number Description a) 45-430 4F SL/Clamp/130 cm PICC. Recall # Z-1173-2; b) 45-432 5F SL/Clamp/130 cm PICC. Recall # Z-1174-2. CODE Lot Number a) 605121A 608111B b) 628081A. RECALLING FIRM/MANUFACTURER Recalling Firm: Boston Scientific Corp.Medi-Tech, Natick, MA, by letters on March 25, 2002. Manufacturer: Medsource Technologies LLC, Navajoa, Sonora. Firm initiated recall is ongoing. REASON Guidewire is incorrectly coiled in protective hoop with luer fitting at wrong end. VOLUME OF PRODUCT IN COMMERCE 1112 units. DISTRIBUTION Nationwide and Canada. _______________________ PRODUCT a) Model IM2 Licox Bolt System, Double Lumen. Recall # Z-1175-2; b) Model IM3 Licox Bolt System, Triple Lumen. Recall # Z-1176-2; c) Model IM2.S Complete Licox Probe Kit, Double Lumen. Recall # Z-1177-2; d) Model IM3.S Complete Licox Probe Kit, Triple Lumen. Recall # Z-1178-2; e) Model Im3.ST Complete Licox Probe Kit with Temperature Probe, Triple Lumen. Recall # Z-1179-2. CODE a) Lots 050301A, 290301A, 120501, 151200, 160101A; b) Lots 261101, 271101, 151200, 050301A, 290301B, 31101, 181001, 040101A,140401, 150601, 120501, 51001, 260101A,290301A, 160601; c) Lots 02449, 02649, 02751, 02883, 02539, 02680, 02780, 02889, 02604, 02731, 02813, 02920; d) Lots 02441, 02748; e) Lots 02416, 02478, 02550, 02666, 02722, 02765, 02778, 02829, 02847, 02890, 02419, 02508, 02561, 02696, 02747, 02766, 02789, 02838, 02856, 02900, 02432, 02522, 02620, 051001,02755, 02773, 02796, 02842, 02879, 02904. RECALLING FIRM/MANUFACTURER Integra Neuro Care LLC, San Diego, CA, by letter on April 30, 2002. Firm initiated recall is ongoing. REASON Catheter/ bolt incompatibilty may result in erroneous intracranial pressure measurements. VOLUME OF PRODUCT IN COMMERCE 388 bolts. DISTRIBUTION Nationwide. _______________________ PRODUCT Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting. Model 110-4L. Recall # Z-1180-2. CODE All lots. RECALLING FIRM/MANUFACTURER Integra Neurocare LLC, San Diego, CA, by letter on April 26, 2002. Firm initiated recall is ongoing. REASON Catheter collapse may result in erroneously high pressure readings. VOLUME OF PRODUCT IN COMMERCE 44 estimated in distribution. DISTRIBUTION Nationwide. _______________________ PRODUCT GE Signa .5T, 1.0T, and 1.5T MR/I Extremity coils. Recall # Z-1181-2. CODE All serial numbers are affected. RECALLING FIRM/MANUFACTURER General Electric Medical Systems, Waukesha, WI, by issuing field modification instructions on March 8, 2002. Firm initiated recall is ongoing. REASON Extremity coil pads could catch on fire and burn patient. VOLUME OF PRODUCT IN COMMERCE 2573 devices. DISTRIBUTION Nationwide and Internationally. _______________________ PRODUCT Ti cann Troch Fixation Nail (Trochanteric Fixation Nail). The responsible firm on the label is Synthes USA, Monument, CO. Recall # Z-1182-2/Z-1183-2. CODE 456.315S, lot 4381555 expiration date March 19, 2011 456.318S, lot 4381514 expiration date March 19, 2011. RECALLING FIRM/MANUFACTURER Recalling Firm: Synthes (USA), Paoli, PA, by letters on May 16, 2002. Manufacturer: Synthes (USA), Monument, CO. Firm initiated recall is complete. REASON Manufactured outside design specification. VOLUME OF PRODUCT IN COMMERCE 16 units. DISTRIBUTION AZ, CO, FL, MO, MS, OR, PA and TX.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
_______________________ PRODUCT Choice A.B. (aberation blocking) Daily wear soft (hydrophilic) contact lens. The product is packaged in trial and multipacks. Recall # Z-1146-2. CODE Lot No. 0620, 1016, 1009, 0912, 0924, 0925, 0926, 1025, 1004, 0926, 1015, 0829, 0912, 1023, 0912, 0921, 0717, 0916, 10620, 11025, 10823, 10730. RECALLING FIRM/MANUFACTURER Recalling Firm: Ciba Vision Corp., Duluth, GA, by letter on May 24, 2002. Manufacturer: Specialty Ultravision, St. Hubert, Quebec, Canada. Firm initiated recall is ongoing. REASON The polymer was undercured, lens may appear cloudy. VOLUME OF PRODUCT IN COMMERCE 781 units. DISTRIBUTION Nationwide. _______________________ PRODUCT a)Cardiac/ Peritoneal Catheter, Standard Barium Impregnated, 90cm Catalog No. 43103. Recall # Z-1149-2; b) Peritoneal Catheter, Open end with wall slits, Standard, Barium impregnated, 90 cm, Catalog No. 43522. Recall # Z-1150-2. CODE a)Catalog Number 43103, Product lots Y1953 and Y1954; b)Catalog Number 43522, Product lots Y1955 and Y1956. The first catalog number product and lots are contained in the second catalog number product and lots packaging and labeling. RECALLING FIRM/MANUFACTURER Medtronic Neurosurgery, Goleta, CA, by letter on May 14, 2002. Firm initiated recall is ongoing. REASON Product Mix-up/ Substitution/ Mislabeling. VOLUME OF PRODUCT IN COMMERCE 219. DISTRIBUTION Nationwide and Canada, Australia and Korea. _______________________ PRODUCT Bone Stack Calcium Sulfate. Recall # Z-1171-2. CODE Catalog No. 6184-5-050; 6184-5-100; 6184-5-200; 6184-3-200; 6184-3-400. Lot Code: 95181; 95799A; 95799; 95905A; 95803; 958051; 95805; 958061; 95806. RECALLING FIRM/MANUFACTURER Recalling Firm: Howmedica Osteonics Corp., Allendale, NJ, by letter on January 10, 2001. Manufacturer: Stryker Howmedica Osteonics Limerick, Ireland. Firm initiated recall is ongoing. REASON Volume of pellets is less than listed on the labeling. VOLUME OF PRODUCT IN COMMERCE 193 units. DISTRIBUTION Nationwide. _______________________ PRODUCT Hemashield Gold Woven Double Velour 4-Branch Vascular Graft in 28 and 30mm sizes. Catalog Number 175928 and 175930. Recall # Z-1172-2. CODE For the 28mm size: Lot 4019302RW For the 30mm size: Lot 3743489RW. RECALLING FIRM/MANUFACTURER Boston Scientific Corp./Medi-Tech Wayne, NJ, by letters on March 25, 2002. Firm initiated recall is ongoing. REASON 28 and 30mm sizes were mislabeled. VOLUME OF PRODUCT IN COMMERCE 17 -- 28mm size; 17 -- 30mm size. DISTRIBUTION Nationwide.END OF ENFORCEMENT REPORT FOR JULY 31, 2002 ####
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