August 9, 2000 00-32RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT Sandwich and salad products Fresh Sandwiches and Salad a) Ham Salad Wedge Sandwich, 5 oz. b) Chicken Salad Wedge Sandwich, 5 oz. c) Egg Salad Wedge Sandwich, 5 oz. d) Corned Beef Wedge Sandwich, 5 oz. e) Ham & Cheese Wedge Sandwich, 5 oz. f) Turkey & Swiss Wedge Sandwich, 5 oz. g) Roast Beef & Swiss Wedge Sandwich, 5 oz. h) Ham & Turkey Club Wedge Sandwich, 5 oz. i) Salami & Cheese Wedge Sandwich, 5 oz. j) Bologna & Cheese Wedge Sandwich, 5 oz. k) Chuckwagon Wedge Sandwich, 5 oz. l) Deli Ham Wedge Sandwich, 5 oz. m) Hamburger, 5.10 oz. n) BBQ Bacon Cheeseburger, 5.60 oz. o) Cheeseburger, 5.85 oz. p) Chili Cheeseburger, 5.85 oz. q) Cheddar & Onion Burger, 6.20 oz. r) Pepper Jack Burger, 5.45 oz. s) Double Burger w/ Cheese, 8.45 oz. t) Breaded Steak Biscuit, 4.75 oz. u) Sausage Cheese Omelet Biscuit, 5.50 oz. v) Sausage Cheese Omelet English Muffin, 4.50 oz. w) Bacon & Cheese English Muffin, 3.75 oz. x) Tuna Salad Croissant, 5.00 oz. y) Chicken Salad Croissant, 5.00 oz. z) Egg Salad Croissant, 5.00 oz. aa) Ham & Cheese Croissant, 5.00 oz. bb) Roast Beef & Swiss Croissant, 5.00 oz. cc) Ham & Turkey Club Croissant, 5.00 oz. dd) Chicken & Swiss Croissant, 6.00 oz. ee) Sausage & Cheese Omelet Croissant, 5.50 oz. ff) Canadian Bacon Omelet Croissant, 5.25 oz. gg) Ham & Cheese Bun Sandwich, 5.00 oz. hh) Roast Beef & Cheddar Bun Sandwich, 5.00 oz. ii) Ham & Turkey Club Bun Sandwich, 5.00 oz. jj) Chuckwagon Bun Sandwich, 5.00 oz. kk) Meatloaf w/ Ketchup Bun Sandwich, 6.00 oz. ll) Deli Roasted Chicken Bun Sandwich, 5.25 oz. mm) Smoked Turkey Parmesan Bun Sandwich, 5.25 oz. nn) Chicken Fried Steak Bun Sandwich, 7.00 oz. oo) Double Pork Chop Bun Sandwich, 7.84 oz. pp) Hickory BBQ Chicken Bun Sandwich, 6.10 oz. qq) Sloppy Joe Bun Sandwich, 6.00 oz. rr) Pork Rib w/ BBQ Bun Sandwich, 5.75 oz. ss) Chicken & Mushroom Bun Sandwich, 6.50 oz. tt) Fish & Cheese Bun Sandwich, 6.00 oz. uu) BBQ Beef Bun Sandwich, 5.50 oz. vv) Frisco Chicken Bun Sandwich, 6.50 oz. ww) Roast Beef w/ Horseradish Bun Sandwich, 5.50 oz. xx) Salisbury w/ A-1 Bun Sandwich, 7.50 oz. yy) Buffalo Chicken Bun Sandwich, 6.00 oz. zz) Cajun Chicken Bun Sandwich, 6.00 oz. aaa) Grilled Ham & Cheese Sandwich, 6.50 oz. bbb) Grilled BBQ Club Sandwich, 6.75 oz. ccc) Grilled Turkey & Raspberry Sandwich, 5.50 oz. ddd) Grilled Western Omelet Sandwich, 6.50 oz. eee) Grilled Cheese Sandwich, 6.00 oz. fff) Jumbo Hot Dog, 6.25 oz. ggg) Twin Chili & Cheese Dog, 7.70 oz. hhh) Polish Sausage, 5.45 oz. iii) Jalapeno Cheese Dog, 6.95 oz. jjj) Monster Sub Sandwich, 7.75 oz. kkk) Philly & Swiss Sub Sandwich, 6.75 oz. lll) CheeseSteak w/ Onions Sub Sandwich, 6.75 oz. mmm) Deluxe Sub Sandwich, 6.05 oz. nnn) Pepperoni Melt Bun Sandwich, 5.50 oz. ooo) Submarine Sandwich, 6.00 oz. ppp) Ham & Turkey Club Bun Sandwich, 6.00 oz. qqq) Ham & Swiss Sub Sandwich, 6.60 oz. rrr) Peppered Turkey & Swiss Sub Sandwich, 6.00 oz. sss) Roasted Chicken & Swiss Sub Sandwich, 6.50 oz. ttt) Macaroni Salad, 6.00 oz. (Note: Products a) - ttt) above were distributed under the following labels: Grand Deli; Snack Plus; Sweets and Eats on Sixth; T-S Vending; Apple Automatic; Breaktime Beverage; C&C Vending’s Sweets and Eats; D&R Vending; Davidson’s Vending Systems; HUB Vending, Inc.; jji (Jimmy Jingle) Deli Classics; Sedexho Marriott Services; Midwest Vending; NorVend, Inc.; Vendrite, Inc.; Venstar; Colonel Lea Sandwiches; Omega Trading; Royal Vending; Ryer Food Service; Theisen Vending Company; Quality Service North, Inc.; and Sunrise Vending.) uuu) SuperMom’s Recipe brand Tangy Turkey Mozzarella Sandwich, Net Wt. 5.4 oz. vvv) Signature Dining brand Chicken Salad Wedge Sandwich, 5 oz. www) Signature Dining brand Egg Salad Wedge Sandwich, 5 oz. xxx) Signature Dining brand Ham & Turkey Club Wedge Sandwich, 5 oz. Frozen Sandwiches: yyy) Ham & Cheese Sandwich, 4 oz. zzz) Turkey & Swiss Sandwich, 4 oz. aaaa) Ham & Turkey Club Sandwich, 4 oz. bbbb) Cheeseburger, 4.75 oz. cccc) Ham Omelet English Muffin, 4.5 oz. dddd) Sausage English Muffin, 4.5 oz. eeee) Ham & Cheese Croissant, 5 oz. ffff) Turkey & Swiss Croissant, 5 oz. gggg) Roast Beef & Swiss Croissant, 5 oz. hhhh) Ham & Turkey Club Croissant, 5 oz. iiii) Sausage, Egg & Cheese Croissant, 5.5 oz. jjjj) Chuckwagon, 5 oz. kkkk) Cheesesteak Hoagie, 4.5 oz. llll) Chicken Sandwich, 5 oz. mmmm) Rib Hoagie, 4.5 oz. nnnn) Grilled Panini - Salami & Pepper, 5 oz. oooo) Cheese Sandwich pppp) Fish Sandwich with Tarter Sauce, 6.5 oz. qqqq) Pork Tenderloin Sandwich, 4.5 oz. rrrr) Grilled Ham & Cheese, 6.2 oz. (Note: Products yyy) - rrrr) were distributed frozen under the Grand Foods brand.) Recall #F-658/753-0. CODE Refrigerated fresh sandwiches with pull dates of 4/30 - 5/7, or Julian dates of 0109-0119, were recalled. Most of the fresh sandwiches are labeled with pull dates. Fresh sandwiches with the following brands have Julian dates, rather than pull dates: Grand Deli, Snacks Plus, Davidson's Vending Systems, Vendrite, Inc., Colonel Lea Sandwiches, Royal Vending. Sunrise Vending. Sandwiches, having these brands, were distributed as fresh sandwiches by Grand Foods, but may have been frozen after receipt by consignees. Frozen sandwiches, coded 0109 through 0119, were also recalled. All macaroni salad on market at time of recall initiation. MANUFACTURER Grand Foods, Inc., Minneapolis, Minnesota. RECALLED BY Manufacturer, by telephone on April 27 and 28, by letter dated April 27, 2000, and by press release on April 28, 2000. Completed recall resulted from sample analysis and follow-up by the Minnesota Department of Agriculture. DISTRIBUTION Minnesota, North Dakota, South Dakota. QUANTITY Approximately 20,000 refrigerated sandwiches and 2,500 frozen sandwiches were distributed. REASON Products may be contaminated with Listeria monocytogenes. ________ PRODUCT Breakstone's Free Small Curd Fat Free Cottage Cheese, in 16-ounce containers. Recall #F-762-0. CODE 06 JUN00/W. MANUFACTURER Kraft Foods, Inc., Walton, New York. RECALLED BY Kraft Foods, Inc., Northfield, Illinois, by fax/E-mail on June 1, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY Firm estimates none remains on the market. REASON Product was contaminated with E. coli O157.H7. ________ PRODUCT Astragalus Root Powder, package size varies from 1 pound bags to 100 pound lined paper drum. Recall #F-763-0. CODE Lot HI-029. MANUFACTURER China Jiangsu Medicines and Health Products Import and Export Corporation, China. RECALLED BY Herbco International, Inc., Kenosha, Wisconsin, by letter dated June 22, 2000. Firm-initiated recall complete. DISTRIBUTION Nebraska, New Jersey, New York, Canada. QUANTITY 576 pounds were distributed. REASON Product is contaminated with Salmonella.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT BJ's Assorted Sugar-Free Cookies, 1.87 pound (850g). Recall #F-635-0. CODE All product purchased on or before June 23, 2000. MANUFACTURER The Cookie Jar/Century Cookies/Div. Of Boca Foods, Harrison, New Jersey. RECALLED BY BJ's Wholesale Club, Inc., Natick, Massachusetts, by E-mail on June 23, and by letter on June 26, 2000. Firm-initiated recall complete. DISTRIBUTION Connecticut, Florida, Massachusetts, Maryland, Maine, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia. QUANTITY 422 units were distributed. REASON Product contained undeclared soy nuts. _______ PRODUCT Peacock brand Coconut Candy in 500 gram flexible plastic bags. Recall #F-754-0. CODE None. EXPORTER Aquatic Products Trading Company, Ho Chi Minh City, Vietnam. RECALLED BY Hong Lee Trading, Inc., Brooklyn, New York (importer), by placing a notice in customer area of store on January 4, 2000. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION Undetermined. QUANTITY 60 cases (40 packages per case) were distributed. REASON Product contained the uncertified color additive tartrazine (certifiable as FD&C Yellow No. 5).RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT Dried Cuttlefish, in 6-ounce flexible plastic packages. Recall #F-758-0. CODE None. MANUFACTURER Daxin Hua Feng Food Company, Ltd., Taishan City, Guangdong, China. RECALLED BY Blooming Import Company, Inc., Brooklyn, New York, by letter dated December 7, 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. QUANTITY 47 cases (50 units per case) were imported. REASON Product is misbranded because it does not declare the ingredient star anise.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT Pannaz(tm) Tablets, antihistamine-decongestant (Phenylpropanolamine HCl, 75 mg, Chlorpheniramine Maleate 8 mg, Methscopolamine Nitrate 2.5 mg), in 100-tablet bottles, Rx. NDC #0525-0780-01. Recall #D-443-0. CODE Lot #V6337A01 EXP 5/02. MANUFACTURER Anabolic Laboratories, Inc., Irvine, California. RECALLED BY Manufacturer, by letter dated June 14, 2000. Firm-initiated recall ongoing. DISTRIBUTION Undetermined. QUANTITY 9,493 bottles were distributed. REASON Lack of complete manufacturing process validation. ________ PRODUCT Estratab(r) (Esterified Estrogens Tablets, USP), 2.5 mg, in bottles of 100, Rx intended for hormone replacement. Recall #D-444-0. CODE Lot #90654 exp 6/01. MANUFACTURER Solvay Pharmaceuticals, Inc., Baudette, Minnesota. RECALLED BY Solvay Pharmaceuticals, Inc., Marietta, Georgia, by letter on June 26, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 2,282 bottles were distributed. REASON Tablets did not meet friability specification.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT AntiCoagulant Citrate Phosphate Double Dextrose Solution (CP2D) 200 mL for Collection of blood components with Haemonetics automated apheresis devices only. Recall #B-868-0. CODE Lot Number: CA9M40 (Sub lot D only). MANUFACTURER Pall Medical, Covina, California. RECALLED BY Haemonetics Corporation, Braintree, Massachusetts, by letter dated May 25, 2000. Firm-initiated recall ongoing. DISTRIBUTION California, Florida, Indiana, Kentucky, Kansas, Louisiana, Massachusetts, New Mexico, Nevada, New York, Oklahoma, Pennsylvania, Tennessee, Vermont, Wisconsin, Nevada, Texas. QUANTITY 436 foil pouches were distributed. REASON Foil pouch may have been imprinted with an extended expiration date that varies from the date on the individual solution bags. ________ PRODUCT Red Blood Cells. Recall #B-878-0. CODE Unit #22KQ41400. MANUFACTURER American Red Cross, Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by letter dated May 25, 2000. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor taking the drug Imuran. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-903/905-0. CODE Unit #22FK00641. MANUFACTURER American Red Cross, Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by letters dated December 9 and 14, 1999. Firm-initiated recall complete. DISTRIBUTION Pennsylvania and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who had previously been deferred due to a history of hepatitis. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-906/907-0. CODE Unit Numbers: a) 22KJ46523, 22KJ47123, 22KY38267, 22KJ48819, 22GZ88101; b) 22KJ46523, 22KJ47123, 22KY30142; MANUFACTURER American Red Cross, Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by letters dated December 10 and 30, 1999, January 10, 2000, February 16, 2000, March 27, 2000, and April 5, 2000. Firm- initiated recall complete. DISTRIBUTION Pennsylvania and New Jersey. QUANTITY a) 5 units; b) 3 units were distributed. REASON Blood products were collected from donors who reported having traveled to or having lived in areas designated as endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-910-0. CODE Unit Numbers: 04KT10555 and 04KM77473. MANUFACTURER American Red Cross, Dedham, Massachusetts. RECALLED BY Manufacturer, by letters dated January 25, 2000. Firm-initiated recall complete. DISTRIBUTION Massachusetts. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma; c) Recovered Plasma. Recall #B-912/914-0. CODE Unit Numbers: a) 16340-0912, 16341-7881; b) 16340-0912; c) 16341-7881. COLLECTED BY United Blood Services, Hattiesburg, Mississippi. PROCESSED BY United Blood Services, Meridian, Mississippi. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letters mailed on October 21, 1998, and January 21, 1999, and by fax on July 11, 2000. Firm- initiated recall complete. DISTRIBUTION Mississippi and Switzerland. QUANTITY a) 2 unit; b) 1 unit; c) 1 unit was distributed. REASON Blood products were collected from a donor with a history of hepatitis. ________ PRODUCT Platelets, Pheresis, Leukoreduced. Recall #B-919-0. CODE Unit #W63259. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by telephone on April 12, 2000. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor taking the drug Colchicine. ________ PRODUCT Fenwal Blood-Pack Units with platelet storage containers used in the collection of blood and blood components: a) Product code C4R1464: Baxter Fenwal Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood-Pack Unit; Transfer Pack Container with Adsol Red Cells Preservation Solution; Quadruple for Collection and Processing of 450 ml Blood; with Integral Donor Tube; contains natural rubber latex; for export only. Lots M99I22163, M99I23161 b) Product code 4R1411P: Baxter Fenwal Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood-Pack Unit; Transfer Pack Container with Adsol Red Cells Preservation Solution; Quadruple for Collection and Processing of 450 ml Blood; with Integral Donor Tube. Lots M99I27188, M99122189 c) Product code 4R3433: Baxter Fenwal Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood-Pack Unit; Transfer Pack Container with Adsol Red Cells Preservation Solution; Triple for Collection and Processing of 450 ml Blood; with Lab-Site Sampling Site. Lot M99J14045 d) Product code 4R3448: Baxter Fenwal Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood-Pack Unit; Transfer Pack Container with Adsol Red Cells Preservation Solution; Quadruple for Collection and Processing of 500 ml Blood; with Lab-Site Sampling Site. Lots M99J01059, M99J01059A. Recall #B-928-0. CODE See Above. MANUFACTURER Baxter Healthcare of Puerto Rico, Maricao, Puerto Rico. RECALLED BY Baxter Healthcare Corporation, Deerfield, Illinois, by fax on June 6, 2000. Firm-initiated recall ongoing. DISTRIBUTION Massachusetts, Wisconsin, South Carolina, Florida, Ohio, Texas, South Dakota, Oklahoma. QUANTITY 74,916 units distributed. REASON Platelet containers, labeled with a platelet storage time of five days, was produced in part with a plastic that can not support this expiration period. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-935/937-0. CODE Unit #04J00484. MANUFACTURER American Red Cross, Dedham, Massachusetts. RECALLED BY Manufacturer, by letter dated March 7, 2000. Firm-initiated recall complete. DISTRIBUTION Massachusetts and New Hampshire. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who had engaged in high risk activities. ________ PRODUCT Red Blood Cells, Leukoreduced. Recall #B-939-0. CODE Unit #28LQ19260. MANUFACTURER American Red Cross Blood Services, Charleston, South Carolina (collection site). RECALLED BY American Red Cross Blood Services, Columbia, South Carolina, by letter dated May 26, 1999. Firm-initiated recall complete. DISTRIBUTION South 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 Red Blood Cells. Recall #B-940-0. CODE Unit #28LG04611. MANUFACTURER American Red Cross Blood Services, Myrtle Beach, South Carolina (collection site). RECALLED BY American Red Cross Blood Services, Columbia, South Carolina, by letter dated April 15, 1999. Firm-initiated recall complete. DISTRIBUTION South 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 Red Blood Cells. Recall #B-942-0. CODE Unit #42W10679. MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by letter dated April 28, 2000. Firm-initiated recall complete. DISTRIBUTION Ohio. 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) Platelets; c) Fresh Frozen Plasma; d) Plasma, Cryoreduced; e) Cryoprecipitated AHF; f) Recovered Plasma. Recall #B-943/948-0. CODE Unit Numbers: a) 12R75813, 12GY131242, 12R71435, 12R69329, 12R68076, 12R65466, 12GY01208; b) 12R75813, 12R71435, 12R68076, 12R65466; c) 12R75813, 12GY13242; d) 12R69329; e) 12R69329; f) 12R71435, 12R68076, 12R65466, 12GY01208. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by telephone on September 16 and 22, 1998, followed by letters dated September 25 and 28, 1998, and October 28, 1998. Firm- initiated recall complete. DISTRIBUTION North Carolina, Puerto Rico, South Carolina, Tennessee, California. QUANTITY a) 7 units; b) 4 units; c) 2 units; d) 1 unit; e) 1 unit; f) 4 units were distributed. REASON Blood products, which tested negative for antibody to the Human Immunodeficiency Virus Type 1 (anti-HIV-1), but were collected from a donor who reported previously testing positive for HIV, were distributed prior to receipt of this information. ________ PRODUCT Platelets, Pheresis. Recall #B-949-0. CODE Unit #36FP09047 (split unit). MANUFACTURER American Red Cross Blood Services, Columbia, South Carolina. RECALLED BY Manufacturer, by telephone on July 26, 1999, followed by letter dated July 30, 1999. Firm-initiated recall complete. DISTRIBUTION South Carolina. QUANTITY 1 split unit was distributed. REASON Leukoreduced blood products had unacceptable white blood cell counts. ________ PRODUCT Platelets, Pheresis. Recall #B-953-0. CODE Unit #22KG28227 (split unit). MANUFACTURER American Red Cross Blood Services, Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by letter dated August 5, 1999. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 1 split unit was distributed. REASON Split apheresis products were prepared from a unit with an unacceptable platelet yield. ________ PRODUCT a) Saphenous Vein , Model No. V010 b) Medial Menisus with Bone - Right, Model No. M010 c) Lateral Meniscus with Bone - Left, Model No. M040 d) Achilles Tendon, Model No. T010 e) Patellar Tendon - Hemi, Model No. T030 Recall #B-954-0. CODE a) Serial numbers: 6182275, 6182267, 3873358, 3868354 b) Serial number 4123077 c) Serial number 4124251 d) Serial numbers 4134079, 4124197 e) Serial numbers 4124243, 4124235, 4124227, 4124219 MANUFACTURER CryoLife, Inc., Kennesaw, Georgia. RECALLED BY Manufacturer, by letter on January 28, 2000. Firm-initiated recall ongoing. DISTRIBUTION Arkansas, California, Colorado, Florida, Kentucky, Massachusetts, Tennessee. QUANTITY 12 allografts were distributed. REASON Various tissues for transplant which were collected from donors who had not been properly evaluated. ________ PRODUCT a) Lateral Meniscus with Bone - Right, Model No. M020 b) Medial Meniscus with Bone - Left, Model No. M030 c) Lateral Meniscus with Bone - Left, Model No. M040 d) Achilles Tendon, Model No. T010 e) Patellar Tendon - Hemi, Model No. T030 f) Saphenous Vein , Model No. V010. Recall #B-955-0. CODE a) Serial number 4145852 b) Serial number 4146018 c) Serial number 4146026 d) Serial numbers 4146107, 4146093 e) Serial numbers 4146085, 4146077, 4146069, 4146034 f) Serial numbers 6295134, 6295126. MANUFACTURER CryoLife, Inc., Kennesaw, Georgia. RECALLED BY Manufacturer, by letter dated September 14, 1999. Firm-initiated recall complete. DISTRIBUTION Arkansas, California, Georgia, Illinois, New Jersey, North Carolina, Pennsylvania, Utah, Virginia. QUANTITY 11 allografts. REASON Various tissues for transplant which were collected from a donor who had not been properly evaluated. ________ PRODUCT Pulmonary Artery, Model M030. Recall #B-956-0. CODE Serial #3968944. MANUFACTURER CryoLife, Inc., Kennesaw, Georgia. RECALLED BY Manufacturer, by letter dated November 9, 1999. Firm-initiated recall ongoing. DISTRIBUTION Washington state. QUANTITY 1 unit was distributed. REASON Tissue for transplant was collected from a donor who had not been properly evaluated. ________ PRODUCT a) Red Blood Cells, Leukoreduced; b) Fresh Frozen Plasma. Recall #B-957/958-0. CODE Unit #12FV87215. MANUFACTURER American Red Cross Blood Services, Durham, North Carolina. RECALLED BY American Red Cross Blood Services, Charlotte, North Carolina, by letter dated July 21, 1999, and by telephone on July 16, 1999. Firm-initiated recall complete. DISTRIBUTION North Carolina and South Carolina. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of having tested positive for hepatitis. ________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma. Recall B-959/960-0. CODE Unit #12X79059. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated September 3, 1999, and by telephone on August 12, 1999. Firm-initiated recall complete. DISTRIBUTION Tennessee and North Carolina. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of having tested positive for hepatitis. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Cryoprecipitated AHF; d) Plasma Cryoreduced. Recall #B-961/964-0. CODE Unit #12P04293. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated February 11, 2000, and by telephone of February 10, 2000. Firm-initiated recall complete. DISTRIBUTION Tennessee and North Carolina. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of having tested positive for hepatitis. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-965/966-0. CODE Unit Numbers: a) 3102150, 3108623, 3105929, 1058230; b) 3105929, 1058230. MANUFACTURER Scott & White Memorial Hospital and Scott, Sherwood and Brindley Foundation, Temple, Texas. RECALLED BY Manufacturer, by fax on or about August 24, 1999. Firm-initiated recall complete. DISTRIBUTION Texas and Florida. QUANTITY a) 4 units; b) 2 units were distributed. REASON Blood products tested negative for HBsAg and anti-HBc, but were collected from donors who previously tested repeatedly reactive for HBsAg, and confirmed positive by neutralization, or repeatedly reactive for anti- HBc, followed by a single reactive test result 5 months later. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-969/970-0. CODE Unit #16LY71010. MANUFACTURER American Red Cross Blood Services, Columbus, Ohio. RECALLED BY Manufacturer, by letters dated May 8, 2000, and June 8, 2000. Firm- initiated recall complete. DISTRIBUTION Ohio and New Jersey. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-971/972-0. CODE Unit #42FR78860. MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio. RECALLED BY Manufacturer, by letter dated May 26, 2000. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced; c) Fresh Frozen Plasma; d) Recovered Plasma. Recall #B-976/979-0. CODE Unit Numbers: a) 12FC70974, 12GZ04807, 12FC70051, 12GZ04021, 12FC67792, 12FC66978, 12GZ00744, 12FC65463, 12FC64250, 12FC63419, 12FC60897; b) 12FC73549, 12FC72981, 12GZ06569, 12GZ05939, 12GZ03435; c) 12FC70974, 12GZ04807 d) 12FC73549, 12FC72981, 12GZ06569, 12GZ05939, 12FC70051, 12GZ04021, 12GZ03435, 12FC67792, 12FC66978, 12GZ00744, 12FC65463, 12FC64250, 12FC63419, 12FC60897. MANUFACTURER The American National Red Cross, Charlotte, North Carolina. RECALLED BY Manufacturer, by letters issued between September 29, 1999, and October 1, 1999, and between November 4 and 5, 1999. Firm-initiated recall complete. DISTRIBUTION North Carolina, New York, California, Puerto Rico, and Switzerland. QUANTITY a) 11 units; b) 5 units; c) 2 units; d) 14 units were distributed. REASON Blood products tested negative for the antibody to human immunodeficiency virus (anti-HIV), but were collected from a donor who previously tested repeatedly reactive for anti-HIV. ________ PRODUCT Red Blood Cells, Leukocytes Reduced, Frozen. Recall #B-1000-0. CODE Unit #2238261. MANUFACTURER South Texas Blood and Tissue Center, Victoria, Texas. RECALLED BY South Texas Blood and Tissue Center, San Antonio, Texas, by telephone and fax on February 10, 1999. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had a tattoo within 12 months of donation. ________ PRODUCT Red Blood Cells. Recall #B-1002-0. CODE Unit #49G89711. MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma. RECALLED BY Manufacturer, by telephone on September 27, 1999. Firm-initiated recall complete. DISTRIBUTION Oklahoma. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose hemoglobin was below the acceptable level. ________ PRODUCT a) Red Blood Cells, Leukoreduced; b) Cryoprecipitated AHF. Recall #B-1003/1004-0. CODE Unit #49LG48061. MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma. RECALLED BY Manufacturer, by letter dated April 10, 2000, and by telephone on March 2, 2000. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood products tested negative for anti-HCV, but were collected from a donor who previously tested repeatedly reactive for anti-HCV, and RIBA non-reactive. ________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall #B-1005-0. CODE Unit #4806389. MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo, Texas. RECALLED BY Manufacturer, by letter dated May 4, 2000. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a history of hepatitis. ________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall #B-1006-0. CODE Unit #4806097. MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo, Texas. RECALLED BY Manufacturer, by letter dated April 14, 2000. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was not quarantined after receiving information concerning an illness. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-1008/1009-0. CODE Unit Numbers: 19LQ07112 and 19LY22241. MANUFACTURER American Red Cross Blood Services, Nashville, Tennessee. RECALLED BY Manufacturer, by telephone and letter dated August 20, 1999, or by fax on August 19, 1999. Firm-initiated recall complete. DISTRIBUTION Tennessee and Switzerland. QUANTITY 2 units of each component. REASON Blood products were collected from a donor who reported previously testing positive for hepatitis were distributed prior to receipt of this information.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT Platelets, Pheresis. Recall #B-846-0. CODE Unit #22KG35256. MANUFACTURER American Red Cross, Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by letter dated April 6, 2000. Firm-initiated recall complete. DISTRIBUTION New Jersey. QUANTITY 1 unit was distributed. REASON Unlicensed blood product was distributed in interstate commerce. ________ PRODUCT Platelets. Recall #B-879-0. CODE Unit #36LC13165. MANUFACTURER The American National Red Cross, Columbia, South Carolina. RECALLED BY Manufacturer, by letter dated March 3, 1999. Firm-initiated recall complete. DISTRIBUTION South Carolina. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of whole blood with an extended collection time. ________ PRODUCT Red Blood Cells, Irradiated. Recall #B-902-0. CODE Unit Numbers: 22KJ54920, 22GK74280, 22LY71331. MANUFACTURER American Red Cross, Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by telephone on April 18, 2000, and by letters dated April 28, 2000. Firm-initiated recall complete. DISTRIBUTION New Jersey and Pennsylvania. QUANTITY 3 units were distributed. REASON Blood products were stored at unacceptable temperatures. ________ PRODUCT Red Blood Cells for Further Manufacture. Recall #B-908-0. CODE Unit #22KY30142. MANUFACTURER American Red Cross, Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by letters dated December 10 and 30, 1999, January 10, 2000, February 16, 2000, March 27, 2000, and April 5, 2000. Firm- initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit. REASON Blood product was collected from a donor who reported having traveled to or having lived in areas designated as endemic for malaria. ________ PRODUCT Fresh Frozen Plasma. Recall #B-920-0. CODE Unit Numbers: 19GK34199, 19GK34200, 19GK34202, 19GK34204, 19GK34205,19GK34207, 19GK34208, 19GK34210, 19GK34211, 19GK34212, 19GK34213, 19GK34214, 19GW35262, 19GW35263, 19GW35265, 1GW35267, 19GW35269, 19GW35270, 19GW35271, 19GW35272, 1GW35273, 19GW35274, 19GW35279, 19GW35281, 19GW35282, 19GW35283, 19GW35284. MANUFACTURER American Red Cross Blood Services, Nashville, Tennessee. RECALLED BY Manufacturer, by telephone and fax on April 27, 1999. Firm-initiated recall complete. DISTRIBUTION Tennessee and Kentucky. QUANTITY 27 units were distributed. REASON Blood products had extended expirations. ________ PRODUCT Platelets. Recall #B-921-0. CODE Unit #22KC11156. MANUFACTURER American Red Cross, Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by letter dated September 17, 1999. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a whole blood unit that had discrepant start and end times documented. ________ PRODUCT Fresh Frozen Plasma. Recall #B-951-0. CODE Unit #36Q56305. MANUFACTURER The American National Red Cross, Columbia, South Carolina. RECALLED BY Manufacturer, by telephone on August 25, 1999, and by letter dated September 8, 1999. Firm-initiated recall complete. DISTRIBUTION South Carolina. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of whole blood with an extended collection time. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-973/975-0. CODE Unit #04H88110. MANUFACTURER The American National Red Cross, Dedham, Massachusetts. RECALLED BY Manufacturer, by telephone on January 28, 2000, and by letter on February 7, 2000. Firm-initiated recall complete. DISTRIBUTION Massachusetts. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from an unsuitable donor due to previous elevated test results for alanine aminotransferase (ALT). ________ PRODUCT Platelets. Recall #B-998-0. CODE Unit #49LG44024. MANUFACTURER American Red Cross Blood Services, Waco, Texas. RECALLED BY American Red Cross Blood Services, Tulsa, Oklahoma, by telephone on October 11, 1999. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of whole blood with an extended collection time. ________ PRODUCT Red Blood Cells. Recall #B-1001-0. CODE Unit #33GJ09652. MANUFACTURER American Red Cross, Farmington, Connecticut. RECALLED BY Manufacturer, by letter dated March 13, 2000. Firm-initiated recall complete. DISTRIBUTION Connecticut. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. ________ PRODUCT Red Blood Cells, Leukoreduced. Recall #B-1007-0. CODE 36FK22217, 36FK22200, 36FK22209, 36FK22186, 36FK22189, 36FK22208, 36FK22182, 36FK22183, 36FK22193, 36FK22201, 36FK22202, 36FK22206, 36FK22210, 36FK22187, 36FK22191, 36FK22212. MANUFACTURER American Red Cross Blood Services, Columbia, South Carolina. RECALLED BY Manufacturer, by telephone on May 21, 1999. Firm-initiated recall complete. DISTRIBUTION South Carolina. QUANTITY 16 units were distributed. REASON Blood products were leukoreduced greater than 24 hours after collection.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT Elecsys HGC STAT Immunoassay, a pregnancy test kit for use on Roche Elecsys analyzers. Recall #Z-835-0. CODE Catalog #1731289, All Lots (Lot No. 198859, EXP 02/28/01; 151150, EXP 11/30/01). MANUFACTURER Roche Diagnostics GmbH, Penzburg, Germany. RECALLED BY Roche Diagnostics Corporation, Indianapolis, Indiana, by letter (Customer Bulletin #00-096) dated May 11, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Undetermined. REASON There is an incidence of false elevation in pregnancy test results for the above method that is not related to HAMA (human anti-mouse antibody) interference. This effect manifests as a repeatable positive result that cannot be confirmed by alternative methodologies. ________ PRODUCT Access brand immunoassay Reagent Packs, in-vitro diagnostic medical devices: a) Beckman Coulter Access Troponin I brand Immunoassay System Reagent Pack; b) Beckman Coulter Access CEA brand Immunoassay system reagent pack; c) Beckman Coulter Access PSA brand Immunoassay system reagent pack; d) Beckman Coulter Access Rubella IgG brand Immunoassay system reagent pack; e) Beckman Coulter Access Toxoplasma IgM Brand Immunoassay system reagent pack. Recall #Z-850/854-0. CODE a) Catalog #33320, Lot #993831 EXP 03/01/00, Catalog #993833 EXP 04/15/00; b) Catalog #33200, Lot #997617 EXP 2/15/00 (Int’l only); c) Catalog #33220, Lot #904753 EXP 01/01/00, Catalog #904762 EXP 01/01/00); d) Catalog #34430, Lot #990232 EXP 07/15/00, Catalog #990233 EXP 10/01/00; e) Catalog #34460, Lot #990532 EXP 05/01/00. MANUFACTURER Sanofi Diagnostics Pasteur, Coquette, France. RECALLED BY Beckman Coulter, Inc., Brea, California, by letters beginning on October 1, 1999, followed by telephone. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY a) 5,624 of lot #993831 and 5,686 of lot 993833 b) 222 of lot 97617 c) 1,210 of lot 904753 and 218 of lot 904762 d) 5,102 of lot 990232, and 1,972 of lot 990233 e) 1,636 of lot 990532 were distributed. REASON The above reagent packs may have been improperly filled or contain an incorrect reagent component. ________ PRODUCT Chiron Vision SoFlex Foldable UV-Absorbing Posterior Chamber Silicone Intraocular Lens, Model L151U. Recall #Z-880-0. CODE Lot #2042191. MANUFACTURER Baush & Lomb Surgical, Claremont, California. RECALLED BY Baush & Lomb Surgical, Irvine, California, by telephone on January 10, 1999. Firm-initiated recall complete. DISTRIBUTION Arkansas and Tennessee. QUANTITY 25 lenses were released. REASON The lenses were polished using an incorrectly prepared polishing mixture that resulted in the lens causing a cloudy visual acuity for the patient.END OF ENFORCEMENT REPORT FOR AUGUST 9, 2000 ####
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