March 8, 2000 00-10
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________ PRODUCT Alfalfa Seeds, in 50-pound white woven nylon fabric bags. Recall #F-160-0. CODE COA98. MANUFACTURER L. Stewart Company, Inc., Hennessey, Oklahoma. RECALLED BY International Specialty Supply, also known as Prime Seed Company, Cookeville, Tennessee, by mail and fax on October 25, 1999, followed by letter. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 12,500 pounds were distributed. REASON Product was associated with an outbreak of Salmonella Muenchen in Wisconsin. ________ PRODUCT Pleasant Hill Grain Sprouting Seeds in clear plastic zip-lock bags, approximately 2 pounds. Recall #F-161-0. CODE No codes on labels. MANUFACTURER Pleasant Hill Farm, Inc., Aurora, Nebraska (repacker) International Specialty Supply, also known as Prime Seed Company, Cookeville, Tennessee (seed supplier). RECALLED BY Repacker, by E-mail on October 24, 1999. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY Approximately 150 pounds of seeds were distributed. REASON Product was associated with an outbreak of Salmonella Muenchen in Wisconsin. ________ PRODUCT Alfalfa Seeds in 5-gallon plastic buckets. Recall #F-162-0. CODE None. MANUFACTURER Joseph Company Ltd., Laurel, Montana (repacker). International Specialty Supply, also known as Prime Seed Company, Cookeville, Tennessee (seed supplier). RECALLED BY Repacker, by telephone on October 29, 1999, and by letter dated October 29, 1999. Firm-initiated recall complete. DISTRIBUTION Pennsylvania, Louisiana, Kentucky. QUANTITY 40 pounds were distributed. REASON Product was associated with an outbreak of Salmonella Muenchen in Wisconsin. ________ PRODUCT Alfalfa Sprouts in 5-pound and 2-pound clear unlabeled plastic bags, and in 4-ounce retail containers. Recall #F-163-0. CODE None. MANUFACTURER Spring Valley Gardens, Inc., Xenia, Ohio (grower); International Specialty Supply, also known as Prime Seed Company (seed supplier). RECALLED BY Grower, by telephone and fax on October 23, 1999. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 504 pounds were distributed. REASON Product was associated with an outbreak of Salmonella Muenchen in Wisconsin. ________ PRODUCT Alfalfa Sprouts in 4-ounce clear plastic retail containers. Recall #F-164-0. CODE There were no codes on the containers. The affected seed alfalfa sprouts were distributed until 10/14/99. This product has a 10-day shelf life. MANUFACTURER Sproutstation, Inc., Jackson, Mississippi (grower); Innternational Specialty Supply, also known as Prime Seed Company, Cookeville, Tennessee (seed supplier). RECALLED BY Grower, by telephone on October 22, 1999. Firm-initiated recall complete. DISTRIBUTION Mississippi. QUANTITY 320 4-ounce containers were distributed; firm estimates none remain on the market. REASON Product was associated with an outbreak of Salmonella Muenchen in Wisconsin. ________ PRODUCT Alfalfa Sprouts in 5-ounce, 1-pound, 2-pound, and 2 1/2-pound clear plastic bags labeled in part "Pennington Sprouts"; and Various weights in plastic bags labeled in part "Boise Co-Op". Recall #F-165-0. CODE Product labeled with the Pennington label is not coded. Product labeled with the Boise Co-Op label bearing a date of 10/20/99 or earlier. MANUFACTURER Pennington Greens, Nampa, Idaho (grower). International Specialty Supply, also known as Prime Seed Company, Cookeville, Tennessee (seed supplier) RECALLED BY Grower, by visit on October 28, 1999. Firm-initiated recall complete. DISTRIBUTION Idaho. QUANTITY Approximately 2,200 pounds of sprouts were distributed. REASON The product was associated with an outbreak of Salmonella Muenchen in Wisconsin. ________ PRODUCT a) Alfalfa Sprouts (1) Living Foods Alfalfa Sprouts, in 4-ounce plastic tubs (2) Living Foods Alfalfa Sprouts, in 5-pound clear plastic bags. (3) Aunt Mid's Alfalfa Sprouts, in 4-ounce plastic tubs. (4) Aunt Mid's Alfalfa Sprouts, Naturally Grown, in 4-ounce plastic bags. (5) Living Foods Alfalfa Sprouts, in 4-ounce plastic bags. b) Living Foods Spicy Sprouts, in 4-ounce plastic bags. c) Living Foods Alfalfa and Onion Sprouts, in 4-ounce plastic bags d) Living Foods Alfalfa and Garlic Sprouts, in 4-ounce plastic tubs. e) Living Foods Sprout Salad, in 4-ounce plastic tubs. f) Living Foods Alfalfa and Radish Sprouts, in 4-ounce plastic tubs. Recall #F-170/175-0. CODE Products bear expiration dates from 9/3/99 to 11/3/99 in form 11 03 on white stick-on label. No other codes are used. MANUFACTURER Living Foods, Ionia, Michigan (grower) International Specialty Supply, also known as Prime Seed Company, Cookeville, Tennessee (seed supplier). RECALLED BY Grower, by telephone on October 30 and 31, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan and Ohio. QUANTITY Approximately 30,000 pounds were distributed. REASON Products were associated with an outbreak of Salmonella Muenchen in Wisconsin. ________ PRODUCT Cadbury Eggs Variety 18 Pack, containing 12 Cadbury Creme Eggs, 3 Cadbury Chocolate Creme Eggs, and 3 Cadbury Caramel Eggs. Recall #F-176-0. CODE Item #01153 is for the pallet display and Item #01155 is for the cases. Codes 25A through 42S are involved in the recall. These codes represent production from April 1, 1999 through December 31, 1999, as an entire season. MANUFACTURER Cadbury Schweppes, PLC, Birmingham, England. RECALLED BY Hershey Foods Corporation, Hershey, Pennsylvania, by telephone, E-mail, and voice mail on January 28, 2000, followed by visit beginning January 29, 2000, and letter dated February 3, 2000. The firm also contacted the Food Allergy Network and issued a press release on February 11, 2000. Firm-initiated field correction (relabeling) ongoing. DISTRIBUTION Nationwide. QUANTITY 20,568 mislabeled units remained in commercial channels at time of recall initiation. REASON Product's outer label fails to declare egg whites as an ingredient.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT All styles and sizes of Frozen Cheesecakes and Frozen Key Lime Pies manufactured and distributed by this firm prior to January 7, 2000: a) Chocolate Fudge Cheesecake; b) Mango Cheesecake; c) Strawberry Cheesecake; d) Cheesecake; e) Key Lime Pie. Recall #F-111/115-0. CODE All products which do not bear an ingredient statement. MANUFACTURER T&W, Inc., doing business as Cheesecake, etc., Dessert, Miami Springs, Florida. RECALLED BY Manufacturer, by telephone beginning on January 12, 2000, and by visit. Firm-initiated field correction (relabeling) complete. DISTRIBUTION Florida and Pennsylvania. QUANTITY Approximately 900 cases per month of various recalled products were distributed. REASON The products do not bear ingredient statements and contain ingredients which can elicit reactions in sensitive individuals and/or contain undeclared certified colors. All varieties of cheesecake contain egg and milk ingredients. The Chocolate Fudge Cheesecake also contains undeclared FD&C Yellow No. 5, FD&C Yellow No. 6, and FD&C Red No. 40. The Strawberry Cheesecake also contains FD&C Red No. 40. The Key Lime Pie contains whole condensed milk, FD&C Yellow No. 5, FD&C Yellow No. 6 and FD&C Red No. 40. ________ PRODUCT Ice cream and tofu, in 1-pint containers: a) Woo City ORGANIC Mint Marble Ice Cream b) Woo City ORGANIC WOO FU Banana Fu (banana tofu) Recall #F-120/121-0. CODE None. All products distributed from November 1999 through mid-January 2000. MANUFACTURER Woo City Ice Cream Company, Wooster, Ohio. RECALLED BY Manufacturer, by telephone beginning February 1, 2000. Firm-initiated recall ongoing. DISTRIBUTION Ohio. QUANTITY a) 193 units; b) 266 units were distributed. REASON Products "a" and "b" contain undeclared FD&C Yellow No. 5. Product "b) contain undeclared FD&C Red No. 3, FD&C Red No. 40 and/or FD&C Blue No. 1.RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
________ PRODUCT a) Woo City ORGANIC SORBETO Ruby Grapefruit (sorbet) b) Woo City ORGANIC SORBETO Lime & Coconut (sorbet). Recall #F-122/123-0. CODE None. All products distributed from November 1999 through mid-January 2000. MANUFACTURER Woo City Ice Cream Company, Wooster, Ohio. RECALLED BY Manufacturer, by telephone beginning February 1, 2000. Firm-initiated recall ongoing. DISTRIBUTION Ohio. QUANTITY a) 378 units; b) 93 units were distributed. REASON Products contain undeclared FD&C Red No. 3, FD&C Red No. 40 and/or FD&C Blue No. 1. ________ PRODUCT Sodium Nitrite, granular, free flowing, food grade, in 10-pound packages. Recall #F-159-0. CODE Lot #SY9215. MANUFACTURER Newly Weds Foods, Inc., Yorkville, Illinois. RECALLED BY Manufacturer, by telephone on January 20, 2000. Firm-initiated recall complete. DISTRIBUTION Iowa. QUANTITY 6 boxes were distributed. REASON Sodium nitrite was substituted for sodium nitrate.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
________ PRODUCT Techni-Care(R) Surgical Scrub/Prep Broad-Spectrum Topical Antiseptic Microbicide for Professional Degerming, in 4-fluid ounce bottles, OTC for wound care, general skin cleansing, and preoperative skin preparation. NDC #46706-222-01. Recall #D-221-0. CODE Lot #1723 EXP 06/02. MANUFACTURER Care-Tech Labs, Inc., St. Louis, Missouri. RECALLED BY Manufacturer, by telephone on January 17, 2000, followed by letter dated January 21, 2000, and by telephone and fax beginning January 18, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 24,322 bottles were distributed between 6/30/99-12/23/99. REASON Microbial contamination - Pseudomonas aeruginosa.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________ PRODUCT Levothyroxine Sodium, USP, 25 mcg (0.025 mg) tablets, in 100 and 1,000 unit bottles, Rx used as a replacement or supplemental therapy in patients with hypothyroidism and as a pituitary TSH suppressant in the treatment or prevention of various types of euthyroid goiters. Recall #D-222-0. CODE Lot Numbers: 024107C, 113038A, 113038D, 071128A, 071128B, 071128C, 071128D. MANUFACTURER Vintage Pharmaceuticals, Inc., Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated August 3, 1999. Firm-initiated recall ongoing. DISTRIBUTION Alabama. QUANTITY 6,013 1000-tablet bottles and 6,455 100-tablet bottles were distributed. REASON Subpotency prior to labeled expiration date.RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________ PRODUCT a) Acyclovir Sodium Injection, Rx antiviral used to treat herpes viruses: a) 500 mg/20mL (25mg/mL),20 mL single dose vial; b) 1g/40mL (25mg/mL),40 mL single dose vial. Recall #D-223/224-0. CODE All lot codes. NDC Numbers: 61703-311-21 (20 ml/vial) and 61703-311-43 (40 ml/vial). MANUFACTURER F.H. Faulding & Company, Mulgrave, Victoria, Australia. RECALLED BY Faulding Pharmaceutical Company, Cranford, New Jersey, by letter dated December 22, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Amount shipped: a) 49,498 (10 units/carton) = 494,980 units total b) 7,857 (10 units/carton) = 78,570 units total. REASON Product fails visible particulate matter specification (calcium sterate particles) prior to expiration date. ________ PRODUCT Seroquel (Quetiapine Fumarate) 25 mg Tablets, in 100-tablet bottles/12 bottles per case, Rx oral medication for the management of the manifestations of psychotic disorders, including schizophrenia. NDC # 0310-0275-10. Recall #D-225-0. CODE 4750B EXP 10/01. MANUFACTURER AstraZeneca, Newark, Delaware. RECALLED BY AstraZeneca Pharmaceutcials, Wilmington, Delaware, by letter February 11, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 26,316 bottles were distributed. REASON Some tablets may have become wet during packaging. ________ PRODUCT Sodium Iodide Capsules, Rx for diagnosing thyroid irregularities, packaged in 5-capsule packs: a) I-123, 7.4 MBq (200 microCi) Capsules; b) I-123, 3.7 MBq (100 microCi) Capsules. Recall #D-226/227-0. CODE Lot. Numbers: a) I-3306-1C2; b) I-3306-1C1 MANUFACTURER Syncor Pharmaceuticals, Inc. Golden, Colorado. RECALLED BY Manufacturer, by telephone on December 28, 1999, and by letter on January 4, 2000. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY a) 60 5-packs; b) 127 5-packs were distributed. REASON Incorrect date of calibration printed on labeling.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT Red Blood Cells. Recall #B-383-0. CODE Unit #35GG57199. MANUFACTURER American Red Cross, Roanoke, Virginia. RECALLED BY Manufacturer, by letter on May 5, 1999, and June 11, 1999. Firm-initiated recall complete. DISTRIBUTION Puerto Rico. 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) Fresh Frozen Plasma; b) Cryoprecipitated AHF. Recall #B-385/386-0. CODE Unit Numbers: a) K89013, K89011, K89010, G85428, L38575, L38577, L38582, J07304, L38541, L38317; b) K86989, K87000, K87005, K87014. MANUFACTURER HCSC Blood Center, doing business as Miller Memorial Blood Center, Bethlehem, Pennsylvania. RECALLED BY Manufacturer, by letter dated April 23, 1997. Firm-initiated recall complete. DISTRIBUTION New Jersey and Pennsylvania. QUANTITY a) 10 units; b) 4 units were distributed. REASON Blood products were not tested for the HIV-1 antigen. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Red Blood Cells for Further Manufacture. Recall #B-387/390-0. CODE Unit Numbers: a) 22LN56388, 22GZ47635, 22KP09257; b) 22KP09257, 22LN56388, 22GZ47635, 22KP02044 c) 22KP09257, 22LN56388, 22GZ47635, 22KP02044; d) 22KP02044. MANUFACTURER American National Red Cross, Philadelphia, Pennsylvania. RECALLED BY Manufacturer, by letters January 23, 1998, and March 12, 1998. Firm-initiated recall complete. DISTRIBUTION Michigan, New Jersey, Pennsylvania. QUANTITY a) 3 units; b) 4 units; c) 4 units; d) 1 unit. REASON Blood products tested negative for anti-HCV, but was collected from a donor who previously tested reactive for anti-HCV. ________ PRODUCT Platelets. Recall #B-394-0. CODE Unit Numbers: 0331215, 0331216, 0331217, 0331222, 0331232, 0331233, 0331249. MANUFACTURER Inland Northwest Blood Center, Spokane, Washington. RECALLED BY Manufacturer, by telephone on October 18, 1999, and by letter dated October 22, 1999. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY 7 units were distributed. REASON Blood products had unacceptable platelet counts, were distributed. ________ PRODUCT Platelets. Recall #B-406-0. CODE Unit #LR33630. MANUFACTURER The Blood Center of Central Iowa, Des Moines, Iowa. RECALLED BY Manufacturer, by letter dated January 29, 1999. Firm-initiated recall complete. DISTRIBUTION Iowa. QUANTITY 1 unit was distributed. REASON Platelets were prepared from a unit collected from a donor who had taken aspirin within three days of donation. ________ PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c) Recovered Plasma. Recall #B-407/409-0. CODE Unit Numbers: a) KS30659; b) LC29185; c) KS30659 and LC29185. MANUFACTURER The Blood Center of Central Iowa, Des Moines, Iowa. RECALLED BY Manufacturer, by letter or fax dated October 26, 1998. Firm-initiated recall complete. DISTRIBUTION Iowa and Switzerland. QUANTITY a) 1 unit; b) 1 unit; c) 2 units were distributed. REASON Blood products were collected from a donor with a history of Multiple Sclerosis. ________ PRODUCT Stein 4 Molds, allergenic extract containing A. terreus/ Hormodendrum/A. alternata/P. chrysogenum, 50 ml vials, labeled as containing 2,500 PNU/mL of each of the molds. Recall #B-411-0. CODE Lot E9007188. MANUFACTURER Allergy Laboratories of Ohio, Inc., Columbus, Ohio. RECALLED BY Manufacturer, by telephone on October 15, 1999. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 1 vial distributed. REASON Allergenic extract was labeled with a concentration of 2,500 PNU/ml for each of the four molds present, actually contains 308 PNU/ml of A. alternaria. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-424/426-0. CODE Unit Numbers: a) 53G33713, 53GN26570; b) 53GN26570; c) 53G33713, 53GN26570. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated October 6, 1999. Firm-initiated recall complete. DISTRIBUTION Maryland and California. QUANTITY a) 2 units; b) 1 unit; c) 2 units were distributed. REASON Blood products were collected from a donor who had been deferred for high risk behavior. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-428/429-0. CODE Unit #35FH28525. MANUFACTURER American Red Cross, Roanoke, Virginia. RECALLED BY Manufacturer, by letters dated September 14, 1999 and October 22, 1999, and by fax on September 3, 1999. Firm-initiated recall complete. DISTRIBUTION Puerto Rico and New York. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of Hepatitis. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-430/432-0. CODE Unit Numbers: a) KR30855, KR30905, KM46781; b) KL89328; c) KR30855. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by telephone on February 18-20, 1999, and by letter on March 11, 1999. Firm-initiated recall complete. DISTRIBUTION Virginia and Switzerland. QUANTITY a) 3 units; b) 1 unit; c) 1 unit. REASON Blood products were collected from donors who had identified the donations for confidential self exclusion. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-433/434-0. CODE Unit #LT12895. MANUFACTURER The Blood Center of Central Iowa, Des Moines, Iowa. RECALLED BY Manufacturer, by letter dated September 20, 1999, or by fax dated September 21, 1999. Firm-initiated recall complete. DISTRIBUTION Iowa and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of cancer. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-435/436-0. CODE Unit Numbers: a) 29FN27984, 29KM06306, 29KL11239 b) 29KM06306, 29KL11239. MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia. RECALLED BY Manufacturer, by letters dated August 2, 1999, and September 1, 1999. Firm-initiated recall complete. DISTRIBUTION North Carolina, Virginia, Puerto Rico. QUANTITY a) 3 units; b) 2 units were distributed. REASON Blood products were collected from a donor who reported having lived in area designated as endemic for malaria. ________ PRODUCT a) Red Blood Cells; b) Platelets, Pooled; c) Platelets, Pheresis. Recall #B-437/439-0. CODE Unit Numbers: a) KT86360, LC22518; b) LP26654, LP27481; c) P17560. MANUFACTURER The Blood Center of Central Iowa, Des Moines, Iowa. RECALLED BY Manufacturer, by letter February 1, 1999. Firm-initiated recall complete. DISTRIBUTION Iowa and Pennsylvania. QUANTITY a) 2 units; b) 2 units; c) 1 unit. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. ________ PRODUCT Platelets, Pheresis. Recall #B-440-0. CODE Unit #P19202. MANUFACTURER The Blood Center of Central Iowa, Des Moines, Iowa. RECALLED BY Manufacturer, by telephone on July 19, 1999, and by letter dated July 26, 1999. Firm-initiated recall complete. DISTRIBUTION Iowa. QUANTITY 1 unit was distributed. REASON Blood product had an unacceptable platelet count. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Plasma. Recall #B-441/443-0. CODE Unit # 53FK36823. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated July 14, 1999. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of having tested positive for HCV. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-444/445-0. CODE Unit #53GE21328. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter on September 20, 1999 and November 2, 1999. Firm-initiated recall complete. DISTRIBUTION Maryland and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of having tested positive for Hepatitis C. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-446/447-0. CODE Unit #53LL42947. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated July 19, 1999. Firm-initiated recall complete. DISTRIBUTION Maryland. 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-448/449-0. CODE Unit Numbers: LT12134 and LR32002. MANUFACTURER The Blood Center of Central Iowa, Des Moines, Iowa. RECALLED BY Manufacturer, by letter or fax dated May 21, 1999. Firm-initiated recall complete. DISTRIBUTION Iowa and Switzerland. QUANTITY 2 units of each component were distributed. REASON Blood products were collected from a donor with a history of polycyhthemia. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-450/451-0. CODE Unit #29GZ07670. MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia. RECALLED BY Manufacturer, by letter dated August 27, 1999. Firm-initiated recall complete. DISTRIBUTION North Carolina and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from an unsuitable donor. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-452/453-0. CODE Unit Numbers: a) LT15150, LT16581, LT18133; b) LT18133. MANUFACTURER The Blood Center of Central Iowa, Des Moines, Iowa. RECALLED BY Manufacturer, by letter or fax dated July 13, 1999. Firm-initiated recall complete. DISTRIBUTION Iowa, New York, Switzerland. QUANTITY a) 3 units; b) 1 unit. REASON Blood products were collected from an unsuitable donor. ________ PRODUCT a) Red Blood Cells; b) Platelets, Pooled; c) Fresh Frozen Plasma; d) Recovered Plasma. Recall #B-456/459-0. CODE Unit Numbers: a) KW31142, KW31143, LR35855, LR35858, LR35859, KW31138, KW31145, KW31139, KW31147, KW31140; b) LP33699. LP33698, LP33689, LP33694; c) KW31142, LR35855, KW31139; d) LR35858, KW31144, KW31138, KW31145 KW31147, KW31140. MANUFACTURER The Blood Center of Central Iowa, Des Moines, Iowa. RECALLED BY Manufacturer, by letter sent March 16, 1999, or by telephone on or about March 16, 1999 followed by letter or fax on March 31, 1999. Firm- initiated recall complete. DISTRIBUTION Iowa, Texas, New York, Switzerland. QUANTITY a) 10 units; b) 4 units; c) 3 units; d) 6 units were distributed. REASON Blood products were not properly tested for HIV-p24 antigen. ________ PRODUCT Red Blood Cells. Recall #B-460-0. CODE Unit Numbers: 36252-5774 and 36253-2058. MANUFACTURER United Blood Services, Ventura, California. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letters dated March 3, 1999, June 11, 1999, October 25, 1999, and/or December 13, 1999. Firm- initiated recall complete. DISTRIBUTION California. 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 Red Blood Cells. Recall #B-461-0. CODE Unit #1434310. MANUFACTURER Central Kentucky Blood Center (CKBC), Lexington, Kentucky. RECALLED BY Manufacturer, by letter dated December 8, 1999. Firm-initiated recall complete. DISTRIBUTION Kentucky. 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 Platelets. Recall #B-462-0. CODE Unit #01GC29190. MANUFACTURER American Red Cross Blood Services, Syracuse, New York. RECALLED BY Manufacturer, by letter dated July 15, 1999. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a history of cancer. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-463/464-0. CODE Unit #1608032. MANUFACTURER Central Kentucky Blood Center (CKBC), Lexington, Kentucky. RECALLED BY Manufacturer, by letter dated December 8, 1999. Firm-initiated recall complete. DISTRIBUTION Kentucky. 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 Red Blood Cells. Recall #B-465-0. CODE Unit #35GG72834. MANUFACTURER American Red Cross, Roanoke, Virginia. RECALLED BY Manufacturer, by telephone on November 9, 1999, and by letter dated November 17, 1999. Firm-initiated recall complete. DISTRIBUTION West Virginia. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a history of cancer. ________ PRODUCT Platelets. Recall #B-467-0. CODE Unit #1604105. MANUFACTURER Central Kentucky Blood Center (CKBC), Lexington, Kentucky. RECALLED BY Manufacturer, by letter dated November 24, 1999. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 1 unit was distributed. REASON Platelets were prepared from a unit collected from a donor who had taken aspirin on the day of donation. ________ PRODUCT Platelets. Recall #B-468-0. CODE Unit #W03724. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by telephone on October 6, 1999. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 was distributed. REASON Blood product was not quarantined after receiving information concerning a post donation illness. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-469/470-0. CODE Unit #16LY68491. MANUFACTURER American Red Cross Blood Services, Columbus, Ohio. RECALLED BY Manufacturer, by letter dated November 10, 1999. Firm-initiated recall complete. DISTRIBUTION Ohio and California. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor with a history of jaundice and mononucleosis. ________ UPDATES The following recalls which appeared in the March 1, 2000 Enforcement Report are being corrected as follows: B-272/274-0, (Class II) Red Blood Cells, Platelets, Plasma, and Recovered Plasma, should read: RECALLED BY: Manufacturer, by letters sent on May 11, 13, and 14 1999. DISTRIBUTION Virginia, California, Switzerland. B-395/402-0 (Class II) should read: RECALLED BY: Manufacturer, by letters on September 15 and 17, 1999. B-013/014-0 (Class III) CODE: Under b) the last number listed should be changed from 13P72150 to 13P72152.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT Image X 70 Dental X-Ray System, used in dental radiography. Recall #Z-361-0. CODE Model Image X 70. MANUFACTURER De Gotzen S.r.l. Legnano, Italy. RECALLED BY AFP Imaging Corporation, Elmsford, New York. FDA approved the firm's corrective action plan on February 14, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY Approximately 2,400 units. REASON The diagnostic x-ray devices were found defective under 21 CFR 1003.11. The defect occurs as a result of incomplete equipment specifications and labeling on equipment manufactured by de Gotzen S.r.l., Legnano, Italy for DENTX (a subsidiary of AFP). ________ PRODUCT NC-4 Microscope Stand. Recall #Z-372-0. CODE Non-sequential Serial Numbers 31352 through 313654. MANUFACTURER Carl Zeiss, Inc., Oberkochen, Germany. RECALLED BY Carl Zeiss, Inc., Thornwood, New York, by letter July 20, 1999. Firm-initiated recall complete. DISTRIBUTION Nationwide and international QUANTITY 189 units were distributed. REASON The vertical carrier arm has the potential to break causing the device to become inoperative. ________ PRODUCT Konica MD-100 Mammography Screens, indicated for use as an accessory to a cassette to convert x-ray energy into light energy. Recall #Z-382-0. CODE Lot Numbers 8J**** and 5A****. MANUFACTURER Konica Medical Imaging, Inc., Wayne, New Jersey. RECALLED BY Manufacturer, by letter dated September 24, 1999, and December 28, 1999, followed by telephone. Firm-initiated recall ongoing. DISTRIBUTION California, Connecticut, Florida, Missouri, New York, Oregon, Texas. QUANTITY 38 units (size 18cm X 24 cm,) and 13 units (size 24 cm X 30cm) were distributed. REASON The screens cause negative densities on the x-ray film, which could result in a misreading. ________ PRODUCT Vitalcom ST Segment Arrhythmis Detection Software Option, an Optional ECG software feature used in conjunction with the Critikon Observer Central Station on which is installed. There are 12 models or catalog numbers of the software option involved as follows: 88951-8 Patient Arrhythmia, S-T, 24 hour Disclosure Software (Hardwire) 88961-8 Patient Arrhythmia, S-T, 1 hour Disclosure Software (Hardwire) 88971-4 Patient Arrhythmia, S-T, 24 Hour Disclosure Software (Hardwire) 88991-4 Patient Arrhythmia, S-T, 1 Hour Disclosure Software (Hardwire) 88911-8 Patient Arrhythmia, S-T, 24 Hour Disclosure Software (900MHz) 88921-8 Patient Arrhythmia, S-T, 1 Hour Disclosure Software (900 MHz) 88931-4 Patient Arrhythmia, S-T, 24 Hour Disclosure Software (900 MHz) 88941-4 Patient Arrhythmia, S-T, 1 Hour Disclosure Software (900 MHz) 88821-8 Patient Arrhythmia, S-T, 24 Hour Disclosure Software (VHF) 88831-8 Patient Arrhythmia, S-T, 1 Hour Disclosure Software (VHF) 88841-4 Patient Arrhythmia, S-T, 24 Hour Disclosure Software (VHF) 88851-4 Patient Arrhythmia, S-T, 1 Hour Disclosure Software (VHF). Recall #Z-383/394-0. CODE The only reference numbers are the Catalog Numbers listed above. MANUFACTURER Vital Com, Tustin, California (software). RECALLED BY Critikon Company LLC, Tampa, Florida (distributor), by telephone on October 27, 1999. Firm-initiated field correction (software retrofit) complete. DISTRIBUTION Tennessee, Texas, Missouri, Georgia, Wisconsin, Illinois, South Carolina, Ohio, Alabama, Egypt. QUANTITY There are 15 OBSEVER Central Stations with the VitalCom ST Segment Arrhythmia Detection Software Option installed in commerce. REASON The software validation of version 4.01R1 a software anomaly was found that affected the proper function of a print option. ________ PRODUCT Tina System 1000 and Altra Touch 1000 Single Patient Hemodialysis Delivery Systems. Recall #Z-395/396-0. CODE All serial numbers 12,500 and below. MANUFACTURER Althin Medical, Inc., Miami Lakes, Florida. RECALLED BY Manufacturer, by letter on December 6, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 4,972 units were distributed nationally and 695 units were distributed internationally. REASON Linear clamp may not achieve proper occlusion. ________ PRODUCT a) Single Channel b) Triple Channel Volumetric Infusion Pumps, for continuous or intermittent fluid delivery through clinically acceptable routes of administration. Recall #Z-397/398-0. CODE All serial numbers of the following pumps a) Colleague Infusion Pump - Single Channel Product code 2M8151 - U.S. Distribution; 2M8151R - Refurbished, U.S. Distribution; 2M8151K - CE Marked, English language; FKM8151 - English language; HNM8151 - CE marked, German language; PNM8151 - CE marked, Spanish language; DNM8151 - CE marked, French language; b) Colleague 3 Infusion Pump - Triple Channel Product code 2M8153 - U.S. distribution; 2M8153R - Refurbished, U.S. distribution. MANUFACTURER Baxter Healthcare PTE., Ltd., Singapore. Namiki Percision Jewel Company Ltd., Tokyo, Japan (motors). RECALLED BY Baxter Healthcare Corporation, Round Lake, Illinois, by letter dated February 7, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 78,000 pumps were distributed. REASON Motors burn out at 15-18 months of age. ________ PRODUCT Infinity Modular Bedside Monitors, Models SC7000, SC8000, SC9000, SC9000XL, intended for adult, pediatric, and neonatal monitoring of clinical environment. Recall #Z-399/401-0. CODE Infinity Modular Monitors: SC7000, SC8000, SC9000, SC9000XL with software versions VEO, VEO.1 or VEO.2 MANUFACTURER Siemens Medical Systems, Inc., Danvers, Massachusetts. RECALLED BY Manufacturer, by letter dated February 15, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Arkansas, Arizona, California, Florida, Kentucky, Georgia, Illinois, Michigan, New Mexico, New York, Ohio, South Dakota, Tennessee, Texas. DISTRIBUTION 140 units were distributed. REASON Failure to correctly re-calculate drug dosage using saved Drug Dosage Data. ________ PRODUCT Chrome plated brass circumcision clamps, gomco like, made in Pakistan, individually packaged clamps in boxes labeled only with the catalog number, description, size and quantity. Recall #Z-402/404-0. CODE All units of the following clamps Catalog #83928, 1.1 cm, Extra Small Catalog #83929, 1.3 cm, Newborn Catalog #83930, 1.6 cm, Child. MANUFACTURER Gogi Enterprises, Sialkot, Punjab, Pakistan. RECALLED BY Medco Instruments, Inc., Crestwood, Illinois, by fax on February 16, 2000.
Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 2,000 clamps were distributed. REASON Lack of 510(k) approval, inadequate instructions for use, and failure to file MDRs. ________ PRODUCT a) 2-way MainFrame Interface Software Version 22.20; b) Pediatric Therapy Guide Version 4.10. Recall #Z-405/406-0. CODE Part Numbers: 9800-2666 and 9800-0630; Catalog Numbers: B1018-15 and B1011-30. MANUFACTURER Dade Microscan Inc., West Sacramento, California. RECALLED BY Manufacturer, by letter on February 4, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 90 copies were distributed. REASON Potential for incorrect Pediatric Reports--A software problem. ________ PRODUCT EBI XFIX Dynafix DFS Hybrid Fixator, designed for the stabilization of intra and peri-articular
fractures where the fracture pattern and available bone stock precludes
the introduction of larger diameter bone screws: a) Variable Wire Carriage (Part No. 13070); b) Variable Bone Screw (Part No. 13080). Recall #Z-409/410-0. CODE All lot numbers - Products produced from 8/11/97 to 6/23/99. MANUFACTURER EBI, L.P., Parsippany, New Jersey. RECALLED BY Manufacturer, by memorandum and letter dated June 23, 1999. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide, Spain, Puerto Rico. QUANTITY a) 7,000 units; b) 3,241 units were distributed. REASON The carriage locking bolt component for both devices can break,
potentially resulting in the loss of fracture reduction/ distraction postoperatively. ________ PRODUCT Chemical-Shift Imaging (CSI) Spectroscopy, Model 90LNI. Recall #Z-412-0. CODE Serial Numbers: AF212E, BA109P, BA218P, BA103P, AF165E, AF157EU, BA183P, BA118P, BA182P, BA164D, BA178P, BA114P, BA225P, BA187P, AF113EU, BB104P, BA110P, BA131D, and BA192D. MANUFACTURER Marconi Medical Systems, Inc., Highland Heights, Ohio. RECALLED BY Manufacturer, by letter dated February 3, 2000. Firm-initiated recall ongoing. DISTRIBUTION Florida, Maryland, Massachusetts, Utah, Arizona, Australia, Italy, Germany, Japan, China and England. QUANTITY 19 units were distributed. REASON Due to a software anomaly, the device acquires data from a slice thicker than intended, and may not be at isocenter. ________ PRODUCT Smit Sleeves, an accessory to various applicators used with the Nucletron mHDR afterloader, a plastic tube with drainage holes inserted into endometrium and may be sutured into place to allow cervix to remain dilated for easier reinsertion of intrauterine tube for subsequent treatment. Part #ís 086.047 and 086.048. Recall #Z- 413/414-0. CODE Lot #ís 480301 to 490908. MANUFACURER NUCLETRON BV, The Netherlands. RECALLED BY Nucletron, Columbia, Maryland, by letter dated December 13, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 1,061 units were distributed REASON Brachytherapy applicator sleeve may become disconnected during treatment. ________ PRODUCT Deltec Port-A-Cath II Polysulfone/Titanium Venous System, Product #21-4065-01. The product trays each contain a portal, a catheter and an introducer set, for the delivery of fluids and drugs. Recall #Z-415-0. CODE Lot numbers: 66947, 67687, 67946 and 68378. MANUFACTURER Sims Deltec, Inc., St. Paul, Minnesota. RECALLED BY Manufacturer, by letter dated February 10, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 187 access systems were distributed. REASON Separation of the catheter from the drug portal can result in leaks.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT Tecan Genesis Disposable Tip. Recall #Z-309-0. CODE Catalog #71-705, Lot Numbers: 15169, 16169, 17169, 11179, 25169, 26169, 27169, 35169, 36169, 37169. MANUFACTURER Eppendorf, Hamburg, Germany. RECALLED BY Tecan U.S. Inc., Durham, North Carolina, by letter on October 4, 1999. Firm-initiated recall ongoing. DISTRIBUTION Arizona, California, Florida, Illinois, Wisconsin. QUANTITY 2,720 boxes were distributed. REASON Manufacturing error - Crack in 1000ul tip. ________ PRODUCT Premier Platinum HPSA, an ELSIA assay for the detection of Helicobacter pylori antigens in stool, Product #601348. Recall #Z-411-0. CODE Lot #601348.024 MANUFACTURER Meridian Diagnostics, Inc., Cincinnati, Ohio. RECALLED BY Manufacturer, by letter dated February 16, 2000. Firm-initiated recall ongoing. DISTRIBUTION Alabama, Arizona, California, Georgia, Iowa, Kansas, Michigan, Montana, New Jersey, New York, Ohio, Oregon, Texas, Utah, Wisconsin, Florida, Honduras, Chile, Japan, German, Italy. QUANTITY 457 test kits were distributed. REASON The kits may contain microwells intended for detection of C. difficile Toxin A.RECALLS AND FIELD CORRECTOINS: VETERINARY PRODUCTS -- CLASS II
________ PRODUCT Sanitizing Teat Dip packaged in 1-gallon, 5-gallon, 30-gallon, and 55- gallon plastic containers: a) Pre-Vail Sanitizing Teat Dip; b) Tandem Sanitizing Teat Dip. Recall #V-062/063-0. CODE All codes. MANUFACTURER Webco Chemical Corporation, Dudley, Massachusetts. RECALLED BY IBA, Inc., Millbury, Massachusetts, by letter on October 21, 1999. Firm- initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY a) 500 gallons; b) 1,200 gallons were distributed. REASON Product is sub-potent after 1 year shelf life. Shelf life is stated at 2 years. Firms does not do finished product testing or stability testing. Firm also does not have any stability data to support the 2 year expiration date. ________ PRODUCT Friskies Fancy Feast Roasted Turkey Feast, cat food in 3-ounce pull open aluminum cans. Recall #V-079-0. CODE 9326KM1 FRT 0140 THROUGH 0220 9326KM2 FRT 0140 THROUGH 0220 9326KM3 FRT 0140 THROUGH 0220 ALL CANS STATED 'BEST BEFORE NOV2001'. MANUFACTURER Friskies Pet Care Division, St Joseph, Missouri. RECALLED BY Nestle USA, Inc., Glendale, California, by memorandum on January 20, 2000. Firm-initiated recall ongoing. DISTRIBUTION Colorado, Florida, Indiana, Kansas, Missouri, Mississippi, South Carolina, Tennessee, Georgia, Iowa, Illinois, Kentucky, Michigan, Minnesota, North Carolina, North Dakota, Ohio, Wisconsin. QUANTITY 5,500 cans were distributed. REASON Product is adulterated - Cans were not properly retorted. END OF ENFORCEMENT REPORT FOR MARCH 8, 2000.####
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