May 3, 2000 00-18RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT a) 100% Vegan Un-Turkey Salad, packaged in 6.5 ounce clear plastic container with lid; b) 100% Vegan Vegetarian Chicken Salad, Egg-Free Mayonnaise, packaged in 6.5 ounce clear plastic container with lid. Recall #F-294/295-0. CODE a) None; b) 9/21. MANFACTURER Nature Boy Foods, Inc., New York, New York. RECALLED BY Manufacturer, by letter, telephone, and press release on October 18, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, New Jersey. QUANTITY Undetermined. REASON Products contain undeclared egg yolks. ________ PRODUCT Cinnamon-Raisin Bread, 16-ounce loaves. Recall #F-296-0. CODE None. MANFACTURER Atwater Breads, doing business as Bread and Butter, LLC, Linthicum, Maryland. RECALLED BY Manufacturer, by notifying the Food Allergy Network; by placing a notice on its website; and by placing placard at the consignee announcing the recall on March 29, 2000. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 5 loaves were distributed. REASON Undeclared walnuts - Some packages labeled as Cinnamon-Raisin Bread actually contained Walnut Raisin Bread. ________ PRODUCT Reisman's brand Chocolate Classic Croissants in 10-ounce rigid plastic packages. Recall #F-298-0. CODE All packages dated January 14 or before. MANFACTURER Reisman Brothers Bakery, Brooklyn, New York. RECALLED BY Manufacturer, by letter dated December 20, 1999, by visit, and by Allergy Alert issued on December 17, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York and New Jersey. QUANTITY 400 10-ounce packages were distributed. REASON Product contained undeclared egg whites. ________ PRODUCT a) Golden Taste brand White Fish Salad, in 3.5-ounce and 7.5-ounce plastic tub; b) Golden Taste brand Salmon Salad, in 3.5 ounce and 7.5-ounce plastic tub. Recall #F-302/303-0. CODE a) 2/17 and 3/01; b) 2/17. MANFACTURER Golden Taste, Inc., Spring Valley, New York. RECALLED BY Manufacturer, by telephone January 28, 2000, followed by letters on January 30, 2000, and February 10, 2000, and by press releases issued by the New York State Department of Agriculture and Markets on January 28, 2000 and February 11, 2000. Completed recall resulted from sample analysis and follow-up by the NYSDAM. DISTRIBUTION New York and New Jersey. QUANTITY a) 213.5 pounds; b) 20 pounds were distributed. REASON Products were contaminated with Listeria monocytogenes. ________ PRODUCT CWB Herb brand Pueraria Lobata (Chinese herb), in 16-ounce clear plastic bag. Product of China. Recall #F-305-0. CODE None. MANFACTURER CWB Herb, Hong Kong. RECALLED BY Murray International Trading, Inc., Brooklyn, New York, by letter and press release on September 14, 1999, followed by visit. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY 72 packages were distributed. REASON Product contained undeclared sulfites. ________ PRODUCT Sandwich and salad products as follows: Refrigerated Sandwiches And Salads a) F-307-0 Tuna Salad Wedge Sandwich, 4 oz./5 oz. b) F-308-0 Ham Salad Wedge Sandwich, 4 oz./5 oz. c) F-309-0 Chicken Salad Wedge Sandwich, 4 oz./5 oz. d) F-310-0 Egg Salad Wedge Sandwich, 4 oz./5 oz. e) F-311-0 Corned Beef Wedge Sandwich, 4 oz./5 oz. f) F-312-0 Ham & Cheese Wedge Sandwich, 4 oz./5 oz. g) F-313-0 Turkey & Swiss Wedge Sandwich, 4 oz./5 oz. h) F-314-0 Roast Beef & Swiss Wedge Sandwich, 5 oz. i) F-315-0 Ham & Turkey Club Wedge Sandwich, 4 oz./5 oz. j) F-316-0 Salami & Cheese Wedge Sandwich, 4 oz./5 oz. k) F-317-0 Bologna & Cheese Wedge Sandwich, 4 oz./5 oz. l) F-318-0 Chuckwagon Wedge Sandwich, 4 oz./5 oz. m) F-319-0 Deli Ham Wedge Sandwich, 4 oz./5 oz. n) F-320-0 Hamburger, 5.10 oz. o) F-321-0 BBQ Bacon Cheeseburger, 5.60 oz. p) F-322-0 Cheeseburger, 5.85 oz. q) F-323-0 Chili Cheeseburger, 5.85 oz. r) F-324-0 Cheddar & Onion Burger, 6.20 oz. s) F-325-0 Pepper Jack Burger, 5.45 oz. t) F-326-0 Double Burger w/ Cheese, 8.45 oz. u) F-327-0 Breaded Steak Biscuit, 4.75 oz. v) F-328-0 Sausage Cheese Omelet Biscuit, 5.50 oz. w) F-329-0 Sausage Cheese Omelet English Muffin, 4.50 oz. x) F-330-0 Bacon & Cheese English Muffin, 3.75 oz. y) F-331-0 Tuna Salad Croissant, 5.00 oz. z) F-332-0 Chicken Salad Croissant, 5.00 oz. aa) F-333-0 Egg Salad Croissant, 5.00 oz. bb) F-334-0 Ham & Cheese Croissant, 5.00 oz. cc) F-335-0 Roast Beef & Swiss Croissant, 5.00 oz. dd) F-336-0 Ham & Turkey Club Croissant, 5.00 oz. ee) F-337-0 Chicken & Swiss Croissant, 6.00 oz. ff) F-338-0 Sausage & Cheese Omelet Croissant, 5.50 oz. gg) F-339-0 Canadian Bacon Omelet Croissant, 5.25 oz. hh) F-340-0 Ham & Cheese Bun Sandwich, 5.00 oz. ii) F-341-0 Roast Beef & Cheddar Bun Sandwich, 5.00 oz. jj) F-342-0 Ham & Turkey Club Bun Sandwich, 5.00 oz. kk) F-343-0 Chuckwagon Bun Sandwich, 5.00 oz. ll) F-344-0 Meatloaf w/ Ketchup Bun Sandwich, 6.00 oz. mm) F-345-0 Deli Roasted Chicken Bun Sandwich, 5.25 oz. nn) F-346-0 Smoked Turkey Parmesan Bun Sandwich, 5.25 oz. oo) F-347-0 Chicken Fried Steak Bun Sandwich, 7.00 oz. pp) F-348-0 Double Pork Chop Bun Sandwich, 7.84 oz. qq) F-349-0 Hickory BBQ Chicken Bun Sandwich, 6.10 oz. rr) F-350-0 Sloppy Joe Bun Sandwich, 6.00 oz. ss) F-351-0 Pork Rib w/ BBQ Bun Sandwich, 5.75 oz. tt) F-352-0 Chicken & Mushroom Bun Sandwich, 6.50 oz. uu) F-353-0 Fish & Cheese Bun Sandwich, 6.00 oz. vv) F-354-0 BBQ Beef Bun Sandwich, 5.50 oz. ww) F-355-0 Frisco Chicken Bun Sandwich, 6.50 oz. xx) F-356-0 Roast Beef w/ Horseradish Bun Sandwich, 5.50 oz. yy) F-357-0 Salisbury w/ A-1 Bun Sandwich, 7.50 oz. zz) F-358-0 Buffalo Chicken Bun Sandwich, 6.00 oz. aaa) F-359-0 Cajun Chicken Bun Sandwich, 6.00 oz. bbb) F-360-0 Grilled Ham & Cheese Sandwich, 6.50 oz. ccc) F-361-0 Grilled BBQ Club Sandwich, 6.75 oz. ddd) F-362-0 Grilled Turkey & Raspberry Sandwich, 5.50 oz. eee) F-363-0 Grilled Western Omelet Sandwich, 6.50 oz. fff) F-364-0 Grilled Cheese Sandwich, 6.00 oz. ggg) F-365-0 Jumbo Hot Dog, 6.25 oz. hhh) F-366-0 Twin Chili & Cheese Dog, 7.70 oz. iii) F-367-0 Polish Sausage, 5.45 oz. jjj) F-368-0 Jalapeno Cheese Dog, 6.95 oz. kkk) F-369-0 Monster Sub Sandwich, 7.75 oz. lll) F-370-0 Philly & Swiss Sub Sandwich, 6.75 oz. mmm) F-371-0 CheeseSteak w/ Onions Sub Sandwich, 6.75 oz. nnn) F-372-0 Deluxe Sub Sandwich, 6.05 oz. ooo) F-373-0 Pepperoni Melt Bun Sandwich, 5.50 oz. ppp) F-374-0 Submarine Sandwich, 6.00 oz. qqq) F-375-0 Ham & Turkey Club Bun Sandwich, 6.00 oz. rrr) F-376-0 Ham & Swiss Sub Sandwich, 6.60 oz. sss) F-377-0 Peppered Turkey & Swiss Sub Sandwich, 6.00 oz. ttt) F-378-0 Roasted Chicken & Swiss Sub Sandwich, 6.50 oz. uuu) F-379-0 Macaroni Salad, 6.00 oz. vvv) F-380-0 Garden Salad, 6.50 oz. www) F-381-0 Veggies w/ Dip, 8.00 oz. xxx) F-382-0 Chef Salad, 7.00 oz. yyy) F-383-0 Taco Salad, 7.00 oz. zzz) F-384-0 Grilled Reuben, 6 oz. aaaa) F-385-0 Grilled Cheese Deluxe Sandwich, 5.7 oz. Products a) - yyy) were distributed refrigerated under the following labels: - Grand Deli, Grand Foods, Inc., Minneapolis, MN 55414 - Snacks Plus, Gwinner, ND / Bismarck, ND 58504 - Sweets and Eats on Sixth, 505 South Sixth Street, Wahpeton, ND 58075 - T-S Vending, Sioux Falls, SD 57104 - Apple Automatic, St. Louis Park, MN - Aramark, St. Paul, MN - UDS, University Dining Services, Roseville, MN 55113 - Breaktime Beverage, Incorporated, Minneapolis, MN 55416 - C & C Vending’s Sweets and Eats, Aberdeen, SD 56740 - D & R Vending, 2207 7th Street, Rochester, MN 55901 - Davidson’s Vending Systems, Burnsville / Red Wing, MN - HUB Vending Inc., Osseo, MN 55369 - jji (Jimmy Jingle) Deli Classics, Minneapolis, MN 55407 - Sodexho Marriott Services, Mpls, MN - Midwest Vending, Mpls, MN 55337 - NorVend, Inc., Duluth / Grand Rapids (MN) - Vendrite, Inc., Hastings, MN - Vendstar, St. Paul, MN 55107 - Versa Vend Vending, Inc. St. Cloud, MN (This firm has the Versa Vend and the Smart Menu brands) - Viking Food Service, Edina, MN 55439 - Colonel Lea Sandwiches PX Vending, Albert Lea, MN 56007 - Omega Trading, Minneapolis, MN 55421 - Royal Vending, Inc., New Hope, MN 55427 - Ryer Food Service, Minneapolis, MN 55413 - Theisen Vending Company, 3800 Nicollet Avenue South, Minneapolis, Minnesota 55409 - Quality Service North, Inc., Forest Lake, MN 55025 -Sunrise Vending, Minneapolis, MN 55423 Products zzz) - aaaa) were distributed under the following label: Supermom’s, St. Paul Park, MN 55071 Products a), b), c), d), e), f), g), h), i), j), k), l), m), kkk), lll), mmm), nnn), ooo), ppp), qqq), rrr), sss), ttt) were distributed under the following label: Signature Dining, Richfield, MN 55423 Frozen Sandwiches The following frozen sandwiches were distributed under the Grand Foods brand, and labeled as prepared by Grand Foods, Minneapolis, MN: A) F-386-0 Ham & Cheese Sandwich, 4 oz. B) F-387-0 Turkey & Swiss Sandwich, 4 oz. C) F-388-0 Ham & Turkey Club Sandwich, 4 oz. D) F-389-0 Cheeseburger, 4.75 oz. E) F-390-0 Ham Omelet English Muffin, 4.5 oz. F) F-391-0 Sausage English Muffin with Egg and Cheese, 4.5 oz. G) F-392-0 Ham & Cheese Croissant, 5 oz. H) F-393-0 Turkey & Swiss Croissant, 5 oz. I) F-394-0 Roast Beef & Swiss Croissant, 5 oz. J) F-395-0 Ham & Turkey Club Croissant, 5 oz. K) F-396-0 Sausage, Egg & Cheese Croissant, 5.5 oz. L) F-397-0 Breakfast Croissant - Canadian Bacon, 5 oz. M) F-398-0 Chuckwagon, 5 oz. N) F-399-0 Cheesesteak Hoagie, 4.5 oz. and 7.05 oz. O) F-400-0 Turkey & Swiss Sub Sandwich, 6.5 oz. P) F-401-0 Chicken Sandwich, 5 oz. Q) F-402-0 Rib Hoagie, 4.5 oz. R) F-403-0 Grilled Panini - Salami & Pepper Cheese Sandwich, 5 oz. S) F-404-0 Fish Sandwich with Tarter Sauce, 6.5 oz. T) F-405-0 Pork Tenderloin Sandwich, 4.5 oz. U) F-406-0 Grilled Ham & Cheese, 6.2 oz. V) F-407-0 Grilled Reuben, 6 oz. W) F-408-0 Italian Sub, 7 oz. X) F-409-0 Ham & Turkey Club Sub Sandwich, 6.5 oz. Y) F-410-0 Roast Beef & American Sandwich, 6 oz. Z) F-411-0 Frisco Chicken Sandwich, 6.5 oz. AA) F-412-0 Salisbury with A-1 Sandwich, 5.75 oz. BB) F-413-0 Twin Chili Dog, 7.5 oz. CC) F-414-0 Pork Roast and Swiss Sandwich, 5 oz. DD) F-415-0 Pepperoni Melt Sub, 6.5 oz. EE) F-416-0 English Muffin Sandwich - Canadian Bacon, Egg & Cheese, 4.5 oz. FF) F-417-0 Pork Tenderloin Sandwich, 6 oz. CODE All refrigerated sandwich products and salads on the market at the time of recall initiation and all frozen sandwich products coded 042 through 076. MANFACTURER Grand Foods, Inc., Minneapolis, Minnesota. RECALLED BY Manufacturer, by telephone and letter on March 16, 2000, and by letter and telephone on March 21, 2000. Ongoing recall resulted from sample analysis and follow-up by the Minnesota Department of Agriculture. DISTRIBUTION Minnesota, Wisconsin, Michigan, Florida. QUANTITY Approximately 137,244 fresh sandwiches and approximately 100,000 refrigerated and frozen sandwiches were distributed. REASON Products may be contaminated with Listeria monocytogenes. ________ PRODUCT Sabra Salads brand Lox Spread, in 6-ounce and 5-pound tubs. Recall #F-418-0. CODE 32300. MANFACTURER Blue & White Food Products Corporation, Astoria, New York. RECALLED BY Manufacturer, by press release on March 13, 2000, and by letter on or about March 14, 2000. Firm-initiated recall ongoing. DISTRIBUTION New York. QUANTITY 1,229 6-ounce units and 5 5-pound units were distributed were distributed. REASON Product was contaminated with Listeria monocytogens and the 5-pound tub size of this product also contained undeclared FD&C Yellow No. 5.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
_________ PRODUCT SEAMAZZ brand Raw Shrimp, pink shrimp in 1-pound plastic bag. Recall #F- 297-0. CODE None. All product received in the 7/12/99 shipment from Pakpanang. MANFACTURER Pakpanang Cold Storage Company Limited, Bangkok, Thailand. RECALLED BY The Mazzetta Company, Highland Park, Illinois, by letter January 10, 2000. Ongoing recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, Pennsylvania, Ohio, Oregon, Florida, Illinois. QUANTITY Undetermined. REASON Product contains undeclared sulfites. ________ PRODUCT Aji Zukushi Y300 brand Mixed Wheat Cracker, packaged in 7.76-ounce flexible plastic bag. Product of Japan. Recall #F-299-0. CODE None. MANFACTURER Itoh Trading Company, Ltd., Mizunami City, Japan. RECALLED BY Hadson Toko Trading, Inc., Brooklyn, New York, by letter on September 27, 1999. Completed field correction (relabeling) resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, New Jersey, Virginia, Georgia, Florida, Missouri, Ohio, Montana, Illinois. QUANTITY 50 cases (16 bags per case). REASON Product contained the uncertified color additive sunset yellow FCF (certifiable as FD&C Yellow No. 6). ________ PRODUCT Margus Breaded Popcorn Buffalo Shrimp Oven Ready, in 8-ounce containers. Recall #F-301-0. CODE All product shipped before 2/1/00. MANFACTURER Kitchens of the Oceans, Deerfield Beach, Florida. RECALLED BY Manufacturer, by letter on March 22, 2000. Firm-initiated recall ongoing. DISTRIBUTION Florida, Pennsylvania, Washington state, Vermont, New Jersey, New York, Georgia, Oklahoma, Missouri, California, Ohio, Virginia, Massachusetts, Illinois, Maryland, Virgin Islands. QUANTITY 3,110 cases were distributed. REASON Product contains undeclared FD&C Yellow No. 5.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT Minute Maid Hi-C Orange Drink in 200ml drink boxes (pasteurized aseptic pack). Recall #F-293-0. CODE AUG 1600 DZ 08:40 AAA and AUG 1700 DZ 08:40 AAA. MANFACTURER Cutrale Citrus Juices USA, Auburndale, Florida. RECALLED BY The Minute Maid Company, Houston, Texas, by letter dated February 2, 2000. Firm-initiated recall complete. DISTRIBUTION Florida, Georgia, South Carolina, North Carolina, and Pennsylvania. QUANTITY 15,400 cases (10 boxes per case) were distributed. REASON The product has an off-flavor. ________ PRODUCT Bee’s Queen brand Pure Chinese Honey, packaged in 10-ounce glass jars. Recall #F-300-0. CODE None. MANFACTURER Shanghai Native Produce L/E Corporation, Shanghai, China. RECALLED BY Tai Wing Hong Importer, Inc., Brooklyn, New York, by letter on August 13, 1999. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, Florida, Pennsylvania, Tennessee, Virginia, Illinois, and the District of Columbia. QUANTITY 450 cases (48 jars per case) were distributed. REASON The product, falsely labeled as "Pure Honey", is adulterated as it was found to contain sugars of cane or corn origin. ________ PRODUCT Kosher Gourmet brand Diet Jello, packaged in 4-ounce plastic containers. Recall #F-304-0. CODE All product on the market at the time of recall initiation. MANFACTURER Tuv Taam Corporation, Brooklyn, New York. RECALLED BY Manufacturer, by telephone on December 16, 1999. Completed recall resulted from inspection and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York and New Jersey. QUANTITY 32 cases (24 containers per case) were distributed. REASON The product contained aspartame but did not bear the warning statement "PHENYLKETONURICS: CONTAINS PHENYLALANINE" as required by 21CFR 172.804. In addition, the product contains undeclared FD&C Red No. 40.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma; c) Recovered Plasma. Recall #B-577/579-0. CODE Unit Numbers: a) X68636, X41073; b) X68636; c) X41073. MANFACTURER Aurora Area Blood Bank, Heartland Blood Centers, Aurora, Illinois. RECALLED BY Manufacturer, by letter dated January 21 or 24, 2000. Firm-initiated recall complete. DISTRIBUTION Illinois and Switzerland. QUANTITY a) 2 units; b) 1 unit; c) 1 unit. REASON Blood products were collected from a donor with a history of having tested positive for hepatitis. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-580/581-0. CODE Unit #X61997. MANFACTURER Aurora Area Blood Bank, Heartland Blood Centers, Aurora, Illinois. RECALLED BY Manufacturer, by letters dated January 6, 2000 or December 12, 1999. Firm-initiated recall complete. DISTRIBUTION Illinois and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from an unsuitable donor. ________ PRODUCT Platelets. Recall #B-582-0. CODE Unit #H74748. MANFACTURER Northern Illinois Blood Bank, Rockford, Illinois. RECALLED BY Manufacturer, by letter dated January 11, 2000. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with an elevated ALT. ________ PRODUCT Platelets Pheresis, Leukocytes Reduced. Recall #B-584-0. CODE Unit #H73322. MANFACTURER Northern Illinois Blood Bank, Rockford, Illinois. RECALLED BY Manufacturer, by letter dated December 27, 1999. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product had a high white cell count. ________ PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Cryoprecipitated AHF. Recall #B-585/586-0. CODE Unit #40LQ02616. MANFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by telephone on February 22, 2000. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor taking the drug Famciclovir. ________ PRODUCT Red Blood Cells, Leukoreduced. Recall #B-591-0. CODE Unit #29KL15823. MANFACTURER American Red Cross Blood Services, Norfolk, Virginia. RECALLED BY Manufacturer, by telephone on January 31, 2000, and by letter dated February 4, 2000. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-593/594-0. CODE Unit #FL05785. MANFACTURER Central Illinois Community Blood Bank, Springfield, Illinois. RECALLED BY Manufacturer, by fax on January 26, 2000, and March 15, 2000. Firm- initiated recall complete. DISTRIBUTION Illinois and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products tested negative for the antibody to the human T- lymphotropic virus type I and II (anti-HTLV-I/II, but was collected from a donor who previously tested reactive for anti-HTLV I/II. ________ PRODUCT a) Red Blood Cells; b) Platelets for Manufacturing; c) Recovered Plasma. Recall #B-595/597-0. CODE Unit #16LE49887. MANFACTURER American Red Cross Blood Services, Columbus, Ohio. RECALLED BY Manufacturer, by letter dated February 4, 2000. Firm-initiated recall complete. DISTRIBUTION Ohio, Tennessee, New York. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from an unsuitable donor. ________ PRODUCT Red Blood Cells. Recall #B-598-0. CODE Unit Numbers: 01E38090, 01GW27073, 01KH28896, 01Q32069, 01Y24848. MANFACTURER American Red Cross Blood Services, Rochester, New York. RECALLED BY Manufacturer, by letter dated May 14, 1999. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 5 units were distributed. REASON Blood products were exposed to unacceptable shipping and storage temperatures. ________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-599/600-0. CODE Unit #0411797. MANFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, Ohio. RECALLED BY Manufacturer, by letter dated November 29, 1999. Firm-initiated recall complete. DISTRIBUTION Ohio and Florida. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor taking the drug Proscar. ________ PRODUCT Source Plasma. Recall #B-602-0. CODE Unit Numbers: 4QT932A, 4QU097A, 4QU308A. MANFACTURER Centeon Bio Services, Inc., (now known as Aventis Bio-Services, Inc., Wichita, Kansas. RECALLED BY Manufacturer, by fax dated April 29, 1999, and by a corrected fax dated May 5, 1999. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 3 units were distributed. REASON Blood products were collected from a donor who had been incarcerated.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocyte Reduced; c) Fresh Frozen Plasma. Recall #B-505/507-0. CODE Unit Numbers: a) 0387900, 0408296, 0409867, 0413468, 0421815, 0421826, 0421827, 0421831 b) 0408986; c) 0408296, 0408986,0409867. MANFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, Ohio. RECALLED BY Manufacturer, by letter dated May 19, 1999. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY a) 8 units; b) 1 unit; c) 3 units were distributed. REASON Blood products corresponded to a unit of pooled Platelets which was positive for Propionbacterium species. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-572/573-0. CODE Unit #16351-3220. MANFACTURER Blood Systems, Inc., Meridian, Mississippi. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on January 14, 2000, and by letter dated January 31, 2000. Firm-initiated recall complete. DISTRIBUTION Alabama and Mississippi. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor taking the antibiotic Cipro. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-574/576-0. CODE Unit #0665258. MANFACTURER Memorial Blood Centers of Minnesota, Minneapolis, Minnesota. RECALLED BY Manufacturer, by letter dated July 2, 1999. Firm-initiated recall complete. DISTRIBUTION Minnesota and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products tested reactive for syphilis. ________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall #B-583-0. CODE Unit Numbers: H72891 and H72783. MANFACTURER Northern Illinois Blood Bank, Rockford, Illinois. RECALLED BY Manufacturer, by letter dated December 17, 1999. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 2 units were distributed. REASON Red Blood Cells were leukoreduced by filtration greater than five days past the time of collection. GOOD MORNING,RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT Pro Med Kits assembles first aid kits on key chains each containing a CLINIPAD Alcohol Prep, Antiseptic. Recall #Z-575-0. CODE No kit codes, all kits contain Clinipad Alcohol Prep, Antiseptic, coded "920311". MANFACTURER Promed Kits, Davis, California. RECALLED BY Manufacturer, by letter on March 20, 2000, followed by telephone. Firm requested customers to remove all kits from shelves and hold until replacement kits could be sent. Firm-initiated recall ongoing. COMPONENT MANFACTURER Clilnipad Corporation, Charlotte, North Carolina. DISTRIBUTION California. QUANTITY 2,500 kits. REASON Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility. ________ PRODUCT PEG kits, T-J Tube kits, Epidural Trays, Spinal Procedure, Universal Block trays, Paracentesis Trays containing recalled Clinipad products: Models 0150-14, 0150-20, 0150-24, 0160-14, 0160-20, 0160-24, 0260-16, 0260-18, 0260-22, 182125, 182131, 182184, 182224, 182229, 182230, 18236, 18259, 18283, 18289, 18668, 18178, 18184, 18202, 60432, 60433. Recall #Z-577-0. CODE 0150-14 0150-20 0150-24 0160-14 0160-20 0160-24 0260-16 0260-18 0260-22 182125 182131 182184 182224 182229 182230 18236 18259 18283 18289 18668 18178 18184 18202 60432 60433 MANFACTURER Ballard Medical Products, Draper, Utah. RECALLED BY Manufacturer, by letter on April 7, 2000, instructing customers to remove and destroy the Clinipad components or to return the kit to Ballard. Firm-initiated recall ongoing. COMPONET MANFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION Nationwide and Puerto Rico. QUANTITY 41,231 kits/trays. REASON Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility. ________ PRODUCT Procedure kits containing recalled Clinipad products: a) LEEP Redikit - Product Number: 6060 b) Hysteroscopy Kit -Product Number: 6160 c) Cervical Block Kit- Product Number: 6161. Recall #Z-578-0. CODE All lots. MANFACTURER CooperSurgical, Inc., Shelton, Connecticut. RECALLED BY Manufacturer, by letter the week of April 14, 2000, and providing stickers to be placed on kits advising users not to use the alcohol prep pads. Firm-initiated recall ongoing. COMPONENT MANFACTURER Clinipad Corporation, Rocky Hill, Connecticut. DISTRIBUTION Nationwide. QUANTITY 32,145 kits. REASON Kits contain Clinipad products labeled as sterile for which Clinipad is unable to assure the sterility. _______ PRODUCT T.E.D. Sequential Compression Sleeves: a) Model No. 5329 SCD Blue Sleeves, Knee Length; b) Model No. 5330 SCD Blue Sleeves, Thigh Length Medium; c) Model No. 5345 SCD Blue Sleeves, Thigh Length Small; d) Model No. 5480 SCD Blue Sleeves, Thigh Length Large. Recall #Z-579/582-0. CODE All lot numbers beginning with B01, B02, B03, B04, B05, B07, B09, and B10. MANUFACTURER The Kendall Co. LP, Seneca, South Carolina. RECALLED BY The Kendall Co. LP, Mansfield, Massachusetts, by letter dated February 24, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 6,292 cases were distributed. REASON The compression sleeves may have occluded airway tubes. ________ PRODUCT Dual Stage Venous Return Cannula with Bullet Tip, intended for use as a single tube venous drainage from the right atrium and vena cava during extracorporeal circulation for open-heart surgery: a) Model No. DWF-3651S; b) Model No. DWF-3240S; c) Model No. DWF-3446S; d) Model No. DWF-3651S; e) Model No. UDW3651; f) Model No. UDW3240; g) Model No. UDW3446. Recall #Z-583/589-0. MANFACTURER Chase Medical, Inc., Athens, Texas. RECALLED BY Chase Medical, Inc., Richardson, Texas, by letter dated February 29, 2000. Firm-initiated recall ongoing. DISTRIBUTION Pennsylvania, Texas, Nebraska, Wisconsin, Virginia, Louisiana, Massachusetts, Washington state, Virginia, New Jersey, Connecticut, and international. QUANTITY 1,787 units were distributed. REASON The cannula may separate between the tip and body during use. ________ PRODUCT 24French Aortic Arch Cannula, indicated for use for perfusion of the ascending aorta during surgical procedures requiring cardiopulmonary bypass: a) Model No. ANC-S824S b) Model No. ANC-P824S; c) Model No. ANC-L824S; d) Model No. ANC-S824S-NF; e) Model No. ANC-P824S-NF f) Model No. ANC-L824-NF; g) Model No. AWC-S824S h) Model No. UACs824S; i) Model No. UACP824S j) Model No. UACL824S; k) Model No. FACL824 l) Model No. UWCS824. Recall #Z-590/601-0. CODE All lots manufactured from 4/1/98 to 11/30/99. MANFACTURER Chase Medical, Inc., Athens, Texas. RECALLED BY Chase Medical, Inc., Richardson, Texas, by mail from February 29, 2000 to March 1, 2000, followed by fax on or about April 14, 2000. Firm- initiated recall ongoing. DISTRIBUTION Texas, California, Florida, Minnesota, Alabama, Massachusetts, Mississippi, Georgia, Virginia, New Jersey, Connecticut, and international. QUANTITY 3,860 units were distributed. REASON The cannula may leak under certain flow and device manipulation conditions. ________ PRODUCT Bayer SETpoint Unconjugated Estriol Reagent (uE3) for Bayer Immuno 1 System, an assay to measure unconjugated estriol in human serum. Recall #Z-609-0. CODE Kit Lot #T37369 EXP 3/31/01. MANFACTURER Bayer Corporation, Business Group Diagnostics, Middletown Manufacturing Plant, Middletown, Virginia. RECALLED BY Bayer Corporatiaon, Elkhart, Indiana, by fax on February 25, 2000. Firm- initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 330 units were distributed. REASON The device is associated with a failure to calibrate the assay on the system RSS limits, erratic quality control results, and a calibration interval of less than seven days. ________ PRODUCT ARCHITECT i System with Software Version 1.0 Processing Module, List No. 08C89-00-1, designed to perform automated immunoassay tests bassed on the use of Chemiluminescent Microparticle Immunoassay CMIA) detection technology. Recall #Z-611-0. CODE All units. MANFACTURER Abbott Laboratories, Diagnostics Division, Irving, Texas. RECALLED BY Manufacturer, by telephone on February 25, 2000, and by letters dated February 24, 1999. Firm-initiated recall complete. DISTRIBUTION California, Florida, Illinois, Massachusetts, Michigan, Missouri, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, Texas, Utah, Virginia, international. QUANTITY 22 units were distributed. REASON Software errors can potentially result in printed Patient Report to incorrectly associate tests results with patients Ids under certain conditions. ________ PRODUCT Roche/Hitachi 917 Disk System Chemistry Analyzer, Catalog #917000. Recall #Z-612-0. CODE All units/software versions. MANFACTURER/SOFTWARE SITE/SOFTWARE SITE: Hitachi Instruments Division, Ibari-ken, 312 Japan. RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana, by letter dated March 17, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY 500 units were distributed. REASON There is a potential for mismatch of sample identification information and results on all versions of software. ________ PRODUCT Roche Hitachi 914 Chemistry Analyzer, used for diagnostic testing for routine and specialty chemistry analytes. Recall #Z-613-0. CODE Catalog number 914000. All units with software version 3.0. MANFACTURER/SOFTWARE SITE Roche Diagnostic Corporation, Indianapolis, Indiana. RECALLED BY Manufacturer, by letter dated March 17, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Indiana, Kansas, Michigan, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico and Texas. QUANTITY 56 units were distributed REASON There is a potential for mismatch of sample identification information and results on this version of software. ________ PRODUCT LCS Total Knee System - PS Tibial Insert: a) Small Size, Catalog Nos. 1781-20-100, 1781-20-125, 1781-20-150, 1781- 20-175, 1781-20-200; b) Small + Size, Catalog Nos. 1781-21-100, 1781-21-125, 1781-21-150, 1781-21-175, 1781-21-200; c) Standard Size, Catalog Nos. 1781-22-100, 1781-22-125, 1781-22-150, 1781-22-175, 1781-22-200; d) Standard + Size, Catalog Nos. 1781-23-100, 1781-23-125, 1781-23-150, 1781-23-175, 1781-23-200; e) Large Size, Catalog Nos. 1781-24-100, 1781-24-125, 1781-24-150, 1781- 24-175, 1781-24-200; f) Large + Size, Catalog Nos. 1781-25-100, 1781-25-125, 1781-25-150, 1781-25-175, 1781-25-200. Recall #Z-616/621-0. CODE All lot numbers. MANFACTURER Depuy Orthopaedics, Inc., Warsaw, Indiana. RECALLED BY Manufacturer, by letter dated December 20, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 236 units are subject to recall. REASON The devices can cause the escape of fluid from blood vessels into the tissues or a cavity and cause knee pain. ________ PRODUCT Sarns MP-6 Integrated Cardioiplegia Sets, used for delivery of temperature controlled cardioplegia solutions to the heart during cardiopulmonary bypass surgery: a) MP-6 Integrated Cardioplegia Set, Catalog No. 4972, Lot No. 98-0702- 1659-7 (1:1 Ratio, No Recirculation); b) MP-6 Integrated Cardioplegia Set, Catalog No. 4973, Lot No. 98-0702- 1660-5 2:1 Ratio, No Recirculation); c) MP-6 Integrated Cardioplegia Set, Catalog No. 4974, Lot No. 98-0702- 1661-3 (4:1 Ratio, No Recirculation); d) MP-6 Integrated Cardioplegia Set, Catalog No. 4975, Lot No. 98-0702- 1662-1 4:1 Ratio, With Bridge, No Recirculation); e) MP-6 Integrated Cardioplegia Set, Catalog No. 4976, Lot No. 98-0702- 1663-9 (8:1 Ratio, No Recirculation); f) MP-6 Integrated Cardioplegia Set, Catalog No. 4977, Lot No. 98-0702- 1664-7 (4:1 Ratio, No Recirculation). Recall #Z-622/627-0. CODE See above. These units were manufactured during the time period of 10/27/99 through 3/13/00 and each device has an expiration of 3 years. MANFACTURER Terumo Cardiovascular Systems Corporation, Ann Arbor, Michigan. RECALLED BY Manufacturer, by letters on March 31, and April 3, 2000, and by telephone. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Germany. QUANTITY 708 units were distributed. REASON Holes in the mylar side of the passdown line pouch are inadequate which results in compromising the sterility of the device.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT a) Ankle Contracture Boot and Boot Sole Accessory, Model Numbers: 4300, 4301, 4302, 4305, 4306, and R4307; b) Boot Sole Accessory #4300/05WK. Devices intended to stabilize the ankle after trauma or injury. Recall #Z-532/533-0. CODE None. MANFACTURER DeRoyal Industries, Powell, Tennessee. RECALLED BY Manufacturer, by letters dated September 23, 1999 and February 14, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 22,538 units were distributed. REASON The device fails to bear a caution label that it is not intended for weight bearing purposes, and as a result, the bolt on the bottom of the boot holding the boot sole in place, cracks and breaks, causing the sole to dislodge. __________ PRODUCT Model 250 NeuroCybernetic Prostheses (NCP) Programming Software Versions a) 4/1; b) 4.4, implanted autonomic nerve stimulator for he treatment of epilepsy. CODE Lot numbers a) 23952C; b) 26023C, 27137C, 27735C. Recall #Z-570/571-0. MANFACTURER Cyberonics, Inc., Inc., Houston, Texas. RECALLED BY Manufacturer, by telephone and letter on August October 6, 1999. Firm- initiated field correction complete. DISTRIBUTION a) Canada; b) Belgium and Europe. QUANTITY a) 1 unit of lot number 23952C; b) 10 units of lot number, 26023C, 10 units of lot 27137C and 50 units of lot 27735C were distributed. REASON The label insert sheets were printed with the incorrect lot number. ________ PRODUCT IMMUNOCARD H. Pylori, for the detection of IgG to Helicobacter pylori in human serum, plasma, or whole blood. Recall #Z-576-0. CODE Catalog #710030, Lot #710030.089, EXP 1/22/01; and Lot #710030.090, EXP 1/30/01. MANFACTURER Meridian Diagnostics, Inc., Cincinnati, Ohio. RECALLED BY Manufacturer, by certified mail, fax and telephone on March 28, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Canada, Japan, Italy, Germany. QUANTITY 546 kits were distributed. REASON Variations of the positive control and test ports may lead to invalid results. ________ PRODUCT Boehringer Mannheim Systems Creatinine Plus, for the quantitative determination of creatinine in serum, plasma, and urine: a) Catalog No. 1775685; b) Catalog No. 1775642; c) Catalog No. 1775677. Recall #Z-606/608-0. CODE Lot Numbers: a) 60054701, Exp. Date 03/2000, 60173701, Exp. 04/2000; b) 60375601, Exp. Date 04/2000; c) 60217901, Exp. Date 06/2000. MANFACTURER Roche Diagnostics GmbH, Mannheim, Germany. RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana, by letter dated February 23, 2000. Firm-initiated recall ongoing. 00DISTRIBUTION Nationwide. QUANTITY Approximately 1,500 kits were distributed. REASON These lots exhibit positive interference from lactate. The lactate interference is undetectable in samples containing normal levels of lactate. ________ PRODUCT Carolon Trinity Pneumatic Pump, Model 480000. Recall #Z-615-0. CODE Serial Numbers 1011 through 1510. MANFACTURER MJS Healthcare, Ltd., Barton, Bedfordshire, England. RECALLED BY Carolon Company, Rural Hall, North Carolina, by letter during December 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide QUANTITY 499 pumps were distributed. REASON A plug portal area with a hairline crack and recession of receptor prong into casing could result in a potential fire hazard within the cord. END OF ENFORCEMENT REPORT FOR MAY 3, 2000. ####
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