June 7, 2000 00-23RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________ PRODUCT Chef's Choice Chicken Stir Fry, in 36 ounce packages. Recall #F-468-0. CODE X9363N, X0040N, X0091N. MANUFACTURER National Custom Packing Castroville, California (component assembler); Choice One Foods, Los Angeles, California (chicken component manufacturer). RECALLED BY Sea Coast Foods, Inc., A subsidiary of Aurora Foods, Inc., St. Louis, Missouri (responsible firm), by fax on April 19, 2000, by telephone on April 21, 2000, followed by letter on April 25, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 2,991 12-bag cases were distributed. REASON The product's outer label fails to declare whey protein as an ingredient. ________ PRODUCT Hiland Vitamin A & D Lowfat Milk 1% Milkfat, half-pint. Recall #F-473-0. CODE EXP APR 09, Plant Code 20-434. MANUFACTURER Hiland Dairy Foods Company, Wichita, Kansas. RECALLED BY Manufacturer, by telephone or visits on April 3, 2000. Firm-initiated recall complete. DISTRIBUTION Kansas. QUANTITY Firm estimates none remains on the market. Product expired. REASON Product was contaminated with chlorine. _______ UPDATE Recall F-461-0, Fresh Made Kefir Strawberry-Banana (Fresh Made, Inc., Philadelphia, Pennsylvania), which appeared in the May 30, 2000 Enforcement Report should read: CODE Product is coded with expiration dates through 5/12/00. RECALLED BY Manufacturer, by telephone starting on May 1, 2000 followed by visit. Firm-initiated recall complete.________ PRODUCT RO*TEL brand Diced Tomatoes and Green Chilies, packed in 10-ounce can. Recall #F-471-0. CODE Top Line Can Code: 9_RTX259A1; Case Code: 28243X259AXA1; Label Code: 6414428243. MANUFACTURER Pacific Coast Producers, Inc., Lodi, California. RECALLED BY International Home Foods, Inc., Parsippany, New York, by letter on April 21, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 642,816 cans were distributed. REASON Product may contain metal fragments. ________ PRODUCT Liquid Vitamin Product under two labels: Rugby Daily Vitamins and H-T Dalyvite Liquid, in 8 and 16-ounce bottles. Recall #F-472-0. CODE Lot number appearing on both labels is 910624 EXP 12/01. Product number specific to the Rugby label is 602-0412. The Hi-Tech label erroneously lists NDC #50383-624-16, This is not a drug. MANUFACTURER Hi-Tech Pharmacal Company, Inc., Amityville, New York. RECALLED BY Manufacturer, by telephone on March 8, 2000, followed by letter sent on March 9, 2000. Firm-initiated recall ongoing. DISTRIBUTION The Hi-Tech labeled product was distributed to the following states: Maine, Indiana, New York, California, North Carolina, Michigan, Texas, New Jersey, Ohio, Alabama, Missouri, Connecticut, Florida, Washington state, Oregon, Utah, Puerto Rico. The Rugby labeled product was distributed to Alabama only. QUANTITY 16,857 bottles were distributed; firm estimated that 60 percent of the product remained on the market at time of recall initiation. REASON Product is contaminated with yeast.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________ PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF. Recall #B-640/641-0. CODE Unit #21GS04909. MANUFACTURER American Red Cross Blood Services, Pacific Northwest Regional Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letter dated January 5, 2000, or by telephone on December 27, 1999, followed by letter dated January 5, 2000 Firm- initiated recall complete. DISTRIBUTION California and Oregon. QUANTITY 1 unit of each component was distributed.. REASON Blood products were collected from a donor who reported a history of Systemic Lupus. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-658/659-0. CODE Unit Numbers: 29FJ29503 and 29KM06374. MANUFACTURER American Red Cross, Norfolk, Virginia. RECALLED BY Manufacturer, by letters dated August 2, 1999, and September 1, 1999. Firm-initiated recall complete. DISTRIBUTION North Carolina, Puerto Rico. QUANTITY 2 units of each component were distributed. REASON Blood products were collected from a donor who reported having lived in an area designated as endemic for malaria. ________ PRODUCT Platelets, Pheresis. Recall #B-670-0. CODE Unit 20LR08395 (split unit). MANUFACTURER American Red Cross Blood Services, Boise, Idaho. RECALLED BY Manufacturer, by letter dated October 29, 1999. Firm-initiated recall complete. DISTRIBUTION Idaho. QUANTITY 1 split unit was distributed. REASON Blood product was collected from a donor who was previously implicated in an adverse reaction due to a high plasma titer of anti-A-B. ________ PRODUCT a) Red Blood Cells, Irradiated; b) Platelets; c) Recovered Plasma. Recall #B-675/677-0. CODE Unit #X69387. MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois. RECALLED BY Manufacturer, by letters dated February 18 or 21, 2000. Firm-initiated recall complete. DISTRIBUTION Illinois and Switzerland. 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 Corneas. Recall #B-678-0. CODE Identification Numbers: 0100-00-01, 0100-00-02, 0145-00-01, 0145-00-02. MANUFACTURER Lions Medical Eye Bank and Research Center of Eastern Virginia, Norfolk, Virginia. RECALLED BY Manufacturer, by letter dated April 14, 2000, followed by telephone. Firm-initiated recall on-going. DISTRIBUTION Virginia, Massachusetts, Texas. QUANTITY 4 corneal tissues. REASON Human tissues for transplant were collected from two donors who tested repeatedly reactive for the antibody to the Hepatitis B core antigen (anti-HBc). ________ PRODUCT Red Blood Cells. Recall #B-679-0. CODE Unit #29KL13497. MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia. RECALLED BY Manufacturer, by letter dated January 3, 2000. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a history of jaundice. ________ PRODUCT Red Blood Cells. Recall #B-680-0. CODE Unit #M29524. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by telephone and letter on March 6, 2000. Firm-initiated recall complete. DISTRIBUTION Virginia. 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) Recovered Plasma. Recall #B-681/683-0. CODE Unit #53Y80153. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated February 8, 2000. 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. ________ PRODUCT a) Red Blood Cells; b) Red Blood Cells for Manufacturing Use; c) Recovered Plasma. Recall #B-684/686-0. CODE a) 29FW34389, 29FL53852; b) 29FG76506; c) 29FG76506, 29FW34389, 29FL53852. MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia. RECALLED BY Manufacturer, by letters dated January 10 or 11, 2000. Firm-initiated recall complete. DISTRIBUTION North Carolina, Michigan, California. QUANTITY a) 2 units; b) 1 unit; c) 3 units were distributed. REASON Blood product was collected from a donor with a history of having tested positive for hepatitis C. ________ PRODUCT Platelets, Apheresis, Leukoreduced. Recall #B-687-0. CODE Unit Numbers: C02178 and C02013. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by letter dated February 3, 2000. Firm-initiated recall ongoing. DISTRIBUTION Virginia. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor taking the drug Diclofenac Sodium. ________ PRODUCT Red Blood Cells, Leukocytes Reduced. Recall #B-689-0. CODE Unit #17190-3588. MANUFACTURER United Blood Services, McAllen, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on December 20, 1999. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had previously been deferred due to exposure to HIV-1. ________ PRODUCT Red Blood Cells. Recall #B-694-0. CODE Unit #02FH57229. MANUFACTURER American Red Cross Blood Services, Wichita, Kansas. RECALLED BY Manufacturer, by telephone on February 19, 1999. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was distributed after receiving post donation information indicating that the donor received a tattoo within 12 months of donation. ________ PRODUCT Red Blood Cells. Recall #B-695-0. CODE Unit Numbers: 02FQ01001, 02FL01116, 02FC50049. MANUFACTURER American Red Cross Blood Services, Wichita, Kansas. RECALLED BY Manufacturer, by telephone on January 5, 1999. Firm-initiated recall complete. DISTRIBUTION Kansas. QUANTITY 3 unit was distributed. REASON Blood products may have remained at room temperature greater than 30 minutes. ________ PRODUCT Red Blood Cells. Recall #B-699-0. CODE Unit Numbers: 4778038 and 4778046. MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo, Texas. RECALLED BY Manufacturer, by telephone on October 8, 1999. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 2 units were distributed. REASON Blood products may have remained at room temperature for greater than 30 minutes. ________ PRODUCT Red Blood Cells. Recall #B-700-0. CODE Unit #01GX05339. MANUFACTURER American Red Cross Blood Services, Albany, New York. RECALLED BY Manufacturer, by telephone on July 11, 1997. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 1 unit was distributed. REASON Blood product may have been air contaminated during collection. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-705/706-0. CODE Unit #25GH23846. MANUFACTURER American Red Cross Blood Services, Albany, New York. RECALLED BY Manufacturer, by letter dated September 14, 1999, and by fax. Firm- initiated recall complete. DISTRIBUTION New York and California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of IV drug use and exchanging money for sex. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-707/708-0. CODE Unit #20FJ03374. MANUFACTURER American Red Cross Blood Services, Missoula, Montana. RECALLED BY American Red Cross Blood Services, Boise, Idaho, by letter dated January 18, 2000, and by fax on January 19, 2000. Firm-initiated recall complete. DISTRIBUTION California and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of jaundice. ________ PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c) Plasma. Recall #B-709/711-0. CODE Unit #16LY67389. MANUFACTURER American Red Cross Blood Services, Columbus, Ohio. RECALLED BY Manufacturer, by letter dated March 13, 2000. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of jaundice. ________ PRODUCT Red Blood Cells. Recall #B-715-0. CODE Unit #1542846. MANUFACTURER New York Blood Services (Center West), A Division of New York Blood Center, Inc., New York, New York. RECALLED BY Manufacturer, by letter dated March 10, 2000. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who previously tested repeatedly reactive for anti-HIV-1, Western blot negative. ________ PRODUCT Red Blood Cells. Recall #B-717-0. CODE Unit #L52124. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by telephone on March 7, 2000. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit was distributed. REASON Blood product was collected in a manner that could compromise the sterility of the product. ________ PRODUCT Platelets, Pheresis. Recall #B-718-0. CODE Unit #W62845. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by telephone and letter on March 22, 2000. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria. ________ PRODUCT Red Blood Cells. Recall #B-719-0. CODE Unit #C02847. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by telephone on March 13, 2000, followed by letter dated March 21, 2000. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who previously tested positive for hepatitis. ________ PRODUCT Red Blood Cells. Recall #B-720-0. CODE Unit Numbers: 02FC60049 and 02FC60050. MANUFACTURER American Red Cross Blood Services, Wichita, Kansas. RECALLED BY Manufacturer, by telephone on July 14, 1999. Firm-initiated recall complete. DISTRIBUTION Kansas. QUANTITY 2 units were distributed. REASON Blood products which tested CMV positive, were labeled CMV negative. ________ PRODUCT a) Red Blood Cells b) Platelets. Recall #B-722/723-0. CODE Unit #01FF14578. MANUFACTURER American Red Cross Blood Services, Binghampton, New York. RECALLED BY Manufacturer, by letter dated May 20, 1999. Firm-initiated recall complete. DISTRIBUTION New York. 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-724/725-0. CODE Unit #18218-7352. MANUFACTURER United Blood Services, Cheyenne, Wyoming. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated March 3, 1999. Firm-initiated recall complete. DISTRIBUTION Wyoming and North Carolina. 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-729-0. CODE Unit #11GJ14597. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated January 18, 2000, and by telephone on January 19, 2000. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 1 unit was distributed. REASON Blood product may have been stored at an unacceptable temperature was redistributed. ________ PRODUCT Plasma, Cyroreduced. Recall #B-730-0. CODE Unit Numbers: 50E16846, 50F86608, 50F86662, 50F86667, 50LG17641, 50LG17667, 50LH12643, 50F86595, 50F86663, 50F86668, 50LG17647, 50LG17657, 50LG17669, 50F86612, 50F86666, 50LG17636, 50LG17648, 50LG17671, 50LH12640, 50E16824, and 50LJ14290. MANUFACTURER American Red Cross Blood Services, Toledo, Ohio. RECALLED BY Manufacturer, by telephone on February 16, 2000. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 21 units were distributed. REASON Blood products were labeled with extended expiration dates. ________ PRODUCT Red Blood Cells. Recall #B-731-0. CODE Unit #1635466. MANUFACTURER Central Kentucky Blood Center, Lexington, Kentucky. RECALLED BY Manufacturer, by telephone on February 17, 2000. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 1 unit was distributed. REASON Blood product which was incorrectly tested for syphilis. ________ PRODUCT a) Red Blood Cells; b) Platelets, outdated, for further manufacture of non-injectable products; c) Recovered Plasma. Recall #B-733/735-0. CODE Unit #31LM08547. MANUFACTURER American Red Cross Blood Services, Jamestown, New York. RECALLED BY Manufacturer, by letters dated September 28, 1999, and November 5, 1999. Firm-initiated recall complete. DISTRIBUTION Pennsylvania and California. QUANTITY 1 unit of each component was distributed. REASON Blood products tested negative for anti-HCV, but were collected from a donor who reported previously testing positive for hepatitis C. ________ PRODUCT Platelets, Pheresis. Recall #B-736-0. CODE 12433-2383, 12433-7515, 12434-2505, 12434-8529, 12433-2356-01, 12433-2356-02, 12433-7481, 12433-7494, 12434-2418-01, 12434-2418-02, 12434-2456-01, and 12434-2456-02. MANUFACTURER United Blood Services, Albuquerque, New Mexico. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated January 7, 1999. Firm-initiated recall complete. DISTRIBUTION Arizona and New Mexico. QUANTITY 12 units were distributed. REASON Blood products exceeded the maximum criteria for platelet yield. ________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-737/739-0. CODE Unit #29FF31530. MANUFACTURER American Red Cross Blood Services, Mid-Atlantic Regional Blood Services, Norfolk, Virginia. RECALLED BY Manufacturer, by letters dated February 10, 2000, March 14, 2000, and by fax February 14, 2000. Firm-initiated recall complete. DISTRIBUTION Virginia, North Carolina, California. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of jaundice. ________ PRODUCT Source Plasma. Recall #B-744-0. CODE Unit Numbers: LP81867, LP80593, LP80199, LP79270, LP78891, LP78156, and LP77713. MANUFACTURER Interstate Blood Bank, Inc., St. Louis, Missouri. RECALLED BY Manufacturer, by fax on June 29, 1998. Firm-initiated recall complete. DISTRIBUTION Germany. QUANTITY 7 units were distributed. REASON Blood products were collected from a donor who was previously deferred for repeatedly reactive viral marker test results. ________ PRODUCT a) Platelets, Pheresis. Recall #B-750-0. CODE Unit Numbers: 8794184A and 8795799B. MANUFACTURER New York Blood Services (Center West), A division of New York Blood Center, Inc., New York, New York. RECALLED BY Manufacturer, by letter dated March 9, 2000. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 2 units were distributed. REASON Blood products, which did not meet the minimum criteria for platelet yield, were distributed, labeled as standard products. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-757/758-0. CODE Unit #11KE00826. MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri. RECALLED BY Manufacturer, by letter dated July 23, 1999. Firm-initiated recall complete. DISTRIBUTION Missouri and Switzerland. 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) Recovered Plasma. Recall #B-759/761-0. CODE Unit Numbers: a) 1535646, 0802322; b) 0802322; c) 1535646 and 0802322. MANUFACTURER Central Kentucky Blood Center (CKBC), Lexington, Kentucky. RECALLED BY Manufacturer, by letters dated January 10, 2000, February 21, 2000, March 21 or 22, 2000. Firm-initiated recall complete. DISTRIBUTION Kentucky, Maryland, California. QUANTITY a) 2 units; b) 1 unit; c) 2 units were distributed. REASON Blood products were collected from a donor with a history of having tested positive for hepatitis. ________ PRODUCT Red Blood Cells. Recall #B-764-0. CODE 11KE11993, 11KE11997, 11KE11967. MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri. RECALLED BY Manufacturer, by telephone on June 11, 1999. Firm-initiated recall complete. DISTRIBUTION Missouri. QUANTITY 3 units were distributed. REASON Blood products were collected in a manner that could compromise their sterility. ________ PRODUCT Red Blood Cells. Recall #B-766-0. CODE Unit #L96963. MANUFACTURER HCSC Blood Center, trading as Miller Memorial Blood Center, Bethlehem, Pennsylvania. RECALLED BY Manufacturer, by telephone on July 22, 1998. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 1 unit was distributed. REASON Blood product was collected in a manner that could compromise the sterility of the product. ________ PRODUCT Platelets, Pheresis. Recall #B-767-0. CODE R24753. MANUFACTURER HCSC Blood Center, trading as Miller Memorial Blood Center, Bethlehem, Pennsylvania. RECALLED BY Manufacturer, by letter dated June 4, 1999. Firm-initiated recall complete. DISTRIBUTION Pennsylvania. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose medical history screening was inadequately performed.RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________ PRODUCT Red Blood Cells, Leukoreduced. Recall #B-672-0. CODE Unit #0333131A. MANUFACTURER Inland Northwest Blood Center, Spokane, Washington. RECALLED BY Manufacturer, by telephone on December 21, 1999. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY 1 unit was distributed. REASON Blood product was stored at unacceptable temperatures. ________ PRODUCT Red Blood Cells, Leukoreduced. Recall #B-673-0. CODE Unit Numbers: 18FW04586, 19FW04603, 18FW04605, 18FW04608. MANUFACTURER American Red Cross, Lansing, Michigan. RECALLED BY Manufacturer, by telephone on December 9, 1999. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 4 units were distributed. REASON Blood products were stored at unacceptable temperatures. ________ PRODUCT Red Blood Cells. Recall #B-693-0. CODE Unit #02FJ41157. MANUFACTURER American Red Cross Blood Services, Wichita, Kansas. RECALLED BY Manufacturer, by telephone on December 17, 1998. Firm-initiated recall complete. DISTRIBUTION Kansas. QUANTITY 1 unit was distributed. REASON Blood product was distributed after receiving information concerning a post donation illness. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-726/727-0. CODE Unit #01GC27670. MANUFACTURER American Red Cross Blood Services, Syracuse, New York. RECALLED BY Manufacturer, by letter dated October 7, 1999. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of Idiopathic Thrombocytopenic Purpura. ________ PRODUCT Red Blood Cells. Recall #B-728-0. CODE Unit Numbers: 40GH32143, 40GR48803, and 40GF31566. MANUFACTURER American Red Cross Blood Services, Peoria, Illinois. RECALLED BY Manufacturer, by telephone on April 4, 2000, and on April 11, 2000, followed by letter dated April 17, 2000. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 3 units were distributed. REASON Blood products were labeled with extended expiration dates. ________ PRODUCT Platelets. Recall #B-732-0. CODE Unit #1442279. MANUFACTURER New York Blood Services (Center West), A Division of New York Blood Center, Inc., New York, New York. RECALLED BY Manufacturer, by letter dated March 3, 2000. Firm-initiated recall complete. DISTRIBUTION New York. 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) Single Donor Plasma. Recall #B-740/741-0. CODE Autologous Unit H75524. MANUFACTURER Northern Illinois Blood Bank, Rockford, Illinois. RECALLED BY Manufacturer, by telephone on February 22, 2000, followed by letter dated February 28, 2000. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit of each component was distributed. REASON Autologous blood products which tested repeatedly reactive for anti-HBc were distributed without biohazard labels. ________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-742/743-0. CODE Unit Numbers: 26141-0336, 26142-6245, 26142-9119. MANUFACTURER United Blood Services, Rogers, Arkansas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated February 25, 1999. Firm-initiated recall complete. DISTRIBUTION Arkansas, North Carolina, Switzerland. QUANTITY 3 units were distributed. REASON Blood products were collected from a donor who was previously deferred for an elevated ALT on two separate occasions. ________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-762/763-0. CODE Unit #R32305. MANUFACTURER HCSC Blood Center, trading as Miller Memorial Blood Center, Bethelhem, Pennsylvania. RECALLED BY Manufacturer, by telephone on September 7, 1999, or by letter dated September 23, 1999. Firm-initiated recall complete. DISTRIBUTION New Jersey and Pennsylvania. QUANTITY 1 unit of each component. REASON Blood products, with no documented syphilis or antibody screen test results, were distributed.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
________ PRODUCT Human Wrist Restraints, used in a hospital setting to restrain the limbs of patients that may be a harm to themselves or attendants: a) Connected Wrist Restraint, Catalog Numbers 2204 and 2205 b) Locking Synthetic Strap, Catalog Numbers 2212 and 2213. Recall #Z-693/694-0. CODE Serial Numbers: Julian Date 00006-000067 and Julian Date 00006-000067. MANUFACTURER J.T. Posey Company, Arcadia, California. RECALLED BY Manufacturer, by letter on March 17, 2000, followed by telephone. Firm- initiated recall ongoing. DISTRIBUTION Nationwide, Puerto Rico, France, The Netherlands. QUANTITY a) 152 units; b) 4 units were distributed. REASON The devices were manufactured with materials that did not meet specifications. ________ PRODUCT Cordis French, Mutipacs, Primopacs, Propacs and other modified Angio Catheters and certain Endovascular 6 Fr Supertorque models: a) 6 Fr Supertorque; b) 6 French Supertorque Plus; c) 7 French Supertorque Plus; d) 6 French Plus TL Diagnostic Catheters; e) Multipac Kit (with preceding catheters); f) Propac Kit (with preceding catheters); g) Primopac Kit(with preceding catheters); h) Modified Special Product (with preceding catheters). Recall #Z-695/702-0. CODE All unexpired codes of the listed Cordis products as listed above which include Model Numbers manufactured from 1997 to present are under recall. Also 142 additional Endovascular catheters. In this case ONLY the listed model AND LOT NUMBERS are under recall because these lots contain recalled catheters. Endovascular 6Fr Supertorques: Standard Catalog #'s, Lot #'s affected by recall Item Lot Item Lot 455611T S0199292 455611T S0799745 455611T R098299 455613E R0799884 455613S R0999428 455660D W1198082 455662 S1298554 455665 R0299589 Item Lot Units Item Lot Units TS63810000HS E0198004 5 ST63810000SIM2 E0198025 20 520000 08876 E0198045 5 ST63810002SIM2 E0198054 60 520000 13228 E0199002 5 520000 09327 E0199012 5 520000 09327 E0199020 5 ST63810000SIM3 E0199021 10 520000 13228 E0199027 10 MODC18065 E0200005 10 ST63810002SIM2 E0298051 50 ST63810002SIM2 E0299019 15 MODC18065 E0300001 10 ST63810000SIM2 E0398031 20 520000 08876 E0398040 5 520000 13228 E0398041 5 520000 13228 E0398051 5 TS63810000HS E0399002 20 ST63810000SIM3 E0399003 10 ST63810002SIM2 E0399009 20 ST63810000SIM3 E0498011 15 ST63810000SIM2 E0498020 5 ST63810002SIM2 E0499004 30 TS63810000HS E0499017 15 520000 13764 E0597010 5 ST63810000SIM4 E0597015 30 ST63810000SIM3 E0597022 15 ST63810000SIM2 E0597061 10 520000 08876 E0597076 5 ST63810000SIM4 E0598041 5 520000 08876 E0697037 5 TS63810000HS E0698013 5 520000 13764 E0698024 10 520000 13764 E0698028 5 ST63810000SIM2 E0698041 10 ST63810000SIM3 E0698061 5 MODC13764 E0699008 5 MODC18065 E0699020 10 ST63810000SIM2 E0797056 10 TS63810000HS E0797109 20 520000 13228 E0798014 5 ST63810000SIM2 E0798026 5 ST63810000SIM2 E0798031 45 520000 09327 E0897034 15 TS63810000HS E0897074 5 520000 13764 E0898008 5 ST63810002SIM2 E0898015 30 520000 13228 E0898034 5 TS63810000HS E0997007 5 TS63810000HS E0997010 5 520000 13764 E0997063 25 TS63810000HS E0997064 10 520000 13228 E0998016 5 TS63810000HS E0998017 10 520000 13764 E0998026 5 520000 08876 E0998032 5 ST63810000SIM1 E0998033 5 TS63810000HS E0998034 10 520000 13764 E0998038 10 520000 09327 E1097005 5 ST63810000SIM3 E1097016 20 520000 09189 E1097035 20 TS63810000HS E1097055 5 520000 13764 E1098005 5 ST63810000SIM3 E1098045 20 MODC18065 E1099003 10 MODC18065 E1099016 10 TS63810000HS E1197028 25 TS63810000HS E1198021 15 TS63810000HS E1198025 10 520000 09189 E1198030 10 520000 09189 E1198035 10 520000 08876 E1198042 5 TS63810000HS E1198043 5 ST63810000SIM2 E1297026 15 ST63810000SIM3 E1297036 10 520000 09327 E1298001 5 MODC18065 E1299004 10 MODC13052 K0100077 5 TS73808000C2 K0199004 5 TS73806500STR K0199096 5 MODC08876 K0200197 5 MODC17857 K0200274 10 MODC17857 K0200386 5 ST63812500SIM1 K0299238 5 ST63812500H1 K0299239 5 TS73806500STR K0299263 5 520000 17428 K0299266 40 TS73806500STR K0398145 10 TS73808000C2 K0398257 5 520000 17428 K0398312 10 TS73808000C2 K0398347 5 520000 17429 K0398358 10 520000 17417 K0498054 5 TS73808000C2 K0498238 5 TS73808000C2 K0498239 5 TS73808000C2 K0499006 20 ST63812500SIM1 K0499021 5 TS73808000C2 K0598040 5 MODC13052 K0599104 5 MODC17924 K0599186 5 MODC13052 K0599358 15 MODC12147 K0599482 10 ST63806502C3 K0698115 5 MODC12147 K0699112 10 MODC18045 K0699128 5 MODC18076 K0699340 5 MODC17857 K0699415 5 MODC17857 K0798249 25 MODC17857 K0799089 15 TS73808000C2 K0898159 5 TS73806500SIM2 K0898164 10 ST63806506STR K0898195 10 MODC17848 K0899310 20 MODC17428 K0899351 5 TS73808000C2 K0998213 5 ST63806502C2 K0998257 5 MODC17848 K0999152 20 MODC13052 K0999232 25 MODC17857 K0999422 15 TS63808000SIM2 K1097050 10 ST63806506STR K1098116 10 ST63806502C2 K1098117 5 520000 17428 K1098134 5 TS73808000C2 K1098262 5 MODC18328 K1099245 5 MODC08101 K1099430 45 TS73808000C2 K1198268 5 MODC18390 K1199326 5 MODC13052 K1199338 15 ST63810000VER K1298168 5 MODC08101 K1299065 5 MODC08101 K1299074 5. MANUFACTURER Cordis Corporation, Miami Lakes, Florida. RECALLED BY Manufacturer, by letters on April 20 and 28, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 6,573 lots and 6,451,609 catheter units were distributed since 1997. REASON The catheters may have unexpected fibers in inner lumen which may loosen into the blood. _______ PRODUCT CML, Inc. Kits and Trays for particular medical procedures. Most of the kits and trays are custom products, manufactured differently for individual customers: CVC Dressing Change Kits, product number 02-138 CVC Dressing Change Trays, product numbers 1918, 02-004, 02-005, 02-008, 02-012, 02-014, 02-020, 02-021, 02-023, 02-026, 02-028, 02-029, 02-030, 02-034, 02-036, 02-039, 02-052, 02-105, 02-106, 02-122, 02-123, 02-130, 02-131, 02-133, 02-135, 02-140, 02-141, 02-143, 02-146, 02-148, 02-150, 02-152, 02-153, 02-154, 02-156, 02-158, 02-161, 02-162, 02-164, 02-165, 02-167, 02-168, 02-175, 02-176, 02-177, 02-178, 02-179, 02-185, 02-187, 02-402, 02-403, 02-423, 02-42B, 02-445, 02-610, 02-008A, 02-026A, 02- 402B; 2006, 2025, 5050, 5062, 5068, 6010HP, 6010-2, 6011, 6012-1, 6013, 6016, 6017, 6018, 6019, 6021, 6022, 6028, 6029, 6030-1, 6033, 6036, 6037, 6038, 6042, 6046, 6048, 6051, 6052, 6053, 6059, 6063, 6066, 6067, 6071, 6072, 6076, 6077 Central Line Dressing Change Kits, product numbers 02-157, 02-159 PICC/Central Line Dressing Change Kit, product #02-183 Central Line Change Trays, product numbers 02-121, 02-145, 02-182, 4550 RJDT 2820 Central Line Dressing Change Tray TPN Tray, product number 9002 TPN/CVP Dressing Change Kits, product nos. 02-001, 02-003 CVP/TPN Dressing Change Trays, product #6027 CVC/TPN Dressing Change Tray, product number 02-124 IMS CVC Dressing Change Tray, product number 02-169 Wausau VNA CVC Dressing Change Tray, product number 02-181 BMR-160 CVP Dressing Change Tray HCA 02-402 CVC Dressing Change Tray Dressing Change Kits, product number 01-160, 02-192, 02-198, 02-457, 2150 Dressing Change Kit with Island Dress, product #02-190 Dressing Change Trays, product numbers 01-162, 01-163, 02-032, 02-033, 02-134, 02-163, 02-180, 02-188, 2011, 2190DC, A371-83, 6065, 6079 Dress Change Hard Tray, product number 02-196 CD Dressing Change Kit, product number 2023 Amicare Dressing Change Tray, product number 5000 CD02121 Dressing Change Tray, product number D2133 RJ2133 Dressing Change Tray SJH1000 Dressing Change Kit St. Joseph's Dressing Change Tray, product number 02-184 VAD Access Kits, 02-050, 02-051, 02-053, 02-058, 02-116, 7020 VAD Insertion Trays, product numbers 02-114 Catheter Insertion Trays, product numbers 02-101, 02-102, 02-103, 02-112, 02-117, 6043 Catheter Insertion Kit, product number 02-115 PICC Tray, product number 6026 PICC Line Tray, product number 6020, 7022 PICC Dressing Tray, product number 60201 PICC Dressing Change Kits, product number 02-137 PICC Dressing Change Trays, product number 02-108, 02-109, 02-111, and 02-136 BMR145-1 PICC Line Tray RJDT3555 PICC Line Tray, Latex-Free Midline Kit, product number 02-274 Midline Trays, product numbers 02-221 and 02-270 Midline Insertion Trays, product numbers 02-271, 02-279 PICC Kit, product numbers 2062, 2064 PICC Midline Tray, product number 02-222 Midline Catheter Prep Tray, product number 7012 Midline Catheter Support Tray, product number 02-151 Midline Catheter Care Kit, product number 02-273 Peritoneal Kit, product number 02-189 Port Access Trays, product number 02-194 TPN Dressing Change Kits, product numbers 02-126, 02-191 TPN Dressing Change Trays, product numbers 02-128, 02-193 CVC/TPN Dressing Tray with Drape, product number 02-02T CVC/TPN Dressing Change Tray, product number 02-124 C.V.P. Dressing Change Tray, product number D2133 CHM2500 Urethral Catheter Tray CHM2500A Urethral Catheter Tray Urethral Catheterization Tray, product number 3022015 CHM2000 Foley Insertion Kit IV Start Kits, product numbers 01-147, 5056, 6008, 6080 Chow Change Tray, product number 02-425 Chow Dressing Change Tray, product number 02-025, 02-031, 02-427 Chow Dressing Change Kits, product numbers 1910, 02-431 RJDT2825 Chow Dressing Change Tray IU Medium Dressing Change Trays, product numbers 02-037, 6068 Home Care Kit, product number 02-055 Home Care Kit with B-D Syringe, product number 02-054 SJH3000 Sub Q Port Kit IV Dressing Change Kits, product numbers 5054, 6024 IV Dressing Change Tray, product number 02-110 Children Dressing Change Tray, product number 02-127 Option Care D.C. Kit, product number 02-197 Dialysis Dressing Change Tray, product number 02-223 Wound Care Tray, product number 2270 Deridement Tray, product number A37182 Oncology Tray, product number 6075 A1796L-1 Lesion Removal Pack BB-27 Groshong Prep Kit. Recall #Z-703-0. CODE All lots of the products are to be checked for the Clinipad swabsticks. MANUFACTURER Continental Medical Laboratories, Inc., Waterford, Wisconsin. RECALLED BY Manufacturer, by letter dated March 28, 2000, requesting that the Clinipad products be removed form the kits or trays and be destroyed. Firm-initiated recall ongoing. COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hills, Connecticut. DISTRIBUTION Nationwide. QUANTITY Approximately 2,000 kits. REASON Kits contain Clinipad products labeled as sterile for which Clilnipad is unable to assure the sterility. ________ PRODUCT Vas-Cath Hemodialysis Catheters (Opti-Flow, Soft-Cell, Flexxicon, Flexxicon II, Trialysis, Vaccess, Niagara, and Hemofiltration. Recall #Z-713/720-0. CODE OPTI-FLOW PERMANENT DIALYSIS CATHETERS Product Code Lot Number 5631190 - - - - 22KJ1419, 22LJX030 5631230 - - - - 22KJ1418, 22LJX016 5631690 - - - - 22BK1820, 22KJ1427, 22LJX033, 22LJX045 5631692 - - - - 22LJM011 5631730 - - - - 82EJ0111, 82GJ0007 5632190 - - - - 22KJ1426 5632192 - - - - 22KJ1407 5632230 - - - - 22LJM010 5632232 - - - - 22LJM012 5633190 - - - - 22KJ1425, 22LJX031, 82BJ0074, 82CJ0114, 82KJ0002 5633192 - - - - 82BJ0072, 82CJ0117 5633230 - - - - 22KJ1423, 22LJX017, 82CJ0116 5633232 - - - - 82BJ0073, 82JJ0009 5633690 - - - - 22KJ1431, 22LJM006, 82CJ0053, 82DJ0149, 82GJ0002 5633690 - - - - 82KJ0003 5633692 - - - - 22DJ0111, 22HJM707, 22HJM708, 22JJO758, 22KJM002, 82DJ0035, 82DJ0150, 82DJ0151, 82GJ0003, 82IJ0004, 82IJ0005, 82IJ0031, 82IJ0033, 82JJ0005 5633730 - - - - 22BK1823, 22IJM726, 22KJ1428, 22LJM007, 82BJ0075, 82EJ0112, 82GJ0006, 82HJ0007, 82JJ0008. 5633732 - - - - 22IJM734, 22LJM009, 22LJM016, 22LJM017, 82DJ0037, 82EJ0113, 82GJ0004, 82GJ0005. 5633732 - - - - 82IJ0006, 82IJ0007, 82JJ0007, 82JJ0008. 5634190 - - - - 22BK1822, 22KJ1430, 82DJ0034, 82EJ0109, 82EJ0110, 82FJ0004, 82GJ0008, 82GJ0009, 82HJ0011, 82KJ0001. 5634192 - - - - 22AKM021, 22AKM022, 22AKM024, 22BK1833, 22BK1834, 22BK1835, 22LJM005, 82CJ0054, 82DJ0036, 82EJ0043, 82EJ0044, 82HJ0002, 82HJ0003, 82IJ0001, 82IJ0002, 82IJ0003, 82JJ0001, 82JJ0002, 82JJ0003. 5634230 - - - - 82FJ0002, 82HJ0004, 82HJ0008. 5634232 - - - - 82CJ0055, 82FJ0003, 82HJ0005, 82HJ0006, 82HJ0009, 82HJ0010, 82IJ0008, 82IJ0030, 82JJ0033. 5635192 - - - - 36FJ0156. 5635232 - - - - 36BJ0130, 36DJ0208, 36DJ0212. 5635692 - - - - 36AK0036, 36BJ0131, 36CJ0184, 36DJ0206. 5635732 - - - - 36BJ0132, 36DJ0232, 36LJ0048. 5636192 - - - - 36AK0035, 36DJ0207, 82EJ0044. 5636232 - - - - 36BJ0130, 36DJ0208, 36LJ0066. NIAGARA TEMPORARY DIALYSIS CATHETERS 5577121 - - - - 22AK1472, 22IJ0742, 22JJ0773, 82CJ0003, 82CJ0004. 5577202 - - - - 22BK1851, 22KJ1401, 82CJ0169, 82CJ0170. 5577224 - - - - 22AK1445, 22FJ0378, 22IJ0744, 22LJ1434, 22LJX044, 82CJ0008, 82CJ0168. 5678122 - - - - 22BK1825, 82CJ0002. 5678155 - - - - 22FJ0404, 22IJ0746, 22KJ0787, 22KJ0794, 82CJ0005, 82CJ0010, 82CJ0173. 5678202 - - - - 82CJ0006. 5591150 - - - - 22AK1441, 22FJ0400, 22IJ0740, 22JJ0774, 82CJ0167. 5591200 - - - - 22AK1477, 22BK1853, 22CJ0085, 22CJ0101, 22FJ0375, 22HJ0704, 22JJ0760, 22KJ0795, 22KJ1400, 22LJX026. 5591240 - - - - 22IJ0737. 5592120 - - - - 22BK2108, 22DJ0147. 5592150 - - - - 22AK1443, 22BK1847, 22CJ0080, 22DJ0157, 22FJ0401, 22HJ0702, 22IJ0745, 22JJ0759, 22JJ0776, 22LJX022. 5592200 - - - - 22AK1444, 22AK1484, 22AK1491, 22CJ0081, 22CJ0100, 22GJ0452, 22KJ0789, 22KJ0790, 82CJ0171. 5593150 - - - - 22AK1442, 22AK1809, 22BK1846, 22DJ0162, 22EJ0327, 22GJ0453, 22IJ0741, 22JJ0754, 22KJ1402, 22LJX004. 5593200 - - - - 22AK1808, 22BK1852, 22DJ0163, 22EJ0328, 22FJ0409, 22JJ0749, 22LJX027. 5593240 - - - - 22AK1812, 22DJ0161, 22FJ0377, 22IJ0738, 22KJ1414, 22LJ1435, 22LJX043. 5594120 - - - - 22AK1813, 22DJ0165, 22FJ0402, 22KJ1403, 22KJ1411. 5594150 - - - - 22BK1849, 22BK1850, 22FJ0403, 22IJ0747, 22JJ0777, 22KJ1408, 22LJX001, 82BJ0056. 5594200 - - - - 22AK1492, 22AK1814, 22FJ0405, 22GJ0454, 22KJ0791, 22LJX036. 5595150 - - - - 36AK0033, 36BJ0125, 36CJ0158, 36DJ0210, 36FJ0152, 36GJ0112, 36HJ0179, 36KJ0011, 36LJ0008. 5595200 - - - - 36AK0051, 36BJ0126, 36CJ0161, 36FJ0153, 36GJ0115, 36HJ0182, 36HJ0183, 36JJ0067, 36KJ0012, 36LJ0010, 36LJ0065. 5595240 - - - - 36BJ0127, 36CJ0159, 36GJ0113, 36HJ0180, 36KJ0014. 5596120 - - - - 36CJ0163, 36DJ0209, 36FJ0155, 36GJ0117, 36HJ0184, 36KJ0010, 36LJ0007. 5596150 - - - - 36AK0032, 36AK0050, 36BJ0128, 36CJ0160, 36DJ0210, 36GJ0114, 36HJ0181, 36LJ0009. 5596200 - - - - 36AK0034, 36BJ0129, 36CJ0162, 36DJ0211, 36FJ0154, 36GJ0116, 36HJ0183, 36KJ0013, 36LJ0011. FLEXXICON II TEMPORARY DIALYSIS CATHETERS 5521150 - - - - 22AK1457, 22BJ0046, 22BK1827, 22BK2113, 22CJ0099, 22EJ0171, 22FJ0367, 22GJ0425, 22KJ1405. 5521200 - - - - 22AK1436, 22BJ0047, 22BK2103, 22EJ0172, 22EJ0348. 5521240 - - - - 22BJ0048, 22DJ0117, 22EJ0173, 22EJ0349. 5522120 - - - - 22CJ0055. 5522150 - - - - 22AK1454, 22BJ0028, 22BK1838, 22CJ0056, 22EJ0169, 22EJ0174, 22GJ0423, 22LJX023. 5522200 - - - - 22CJ0057, 22EJ0170, 22FJ0368, 22GJ0424, 22IJ0715, 22IJ0722, 22IJ0723. 5522650 - - - - 22BK2100. 5522700 - - - - 22DJ0129. 5523150 - - - - 22AK1468, 22BK1841, 22BK2114, 22CJ0069, 22CJ0098, 22EJ0179, 22FJ0384, 22GJ0432. 5523200 - - - - 22AK1437, 22BK2104, 22CJ0097, 22EJ0181, 22EJ0356. 5523240 - - - - 22CJ0068, 22EJ0183. 5524120 - - - - 22CJ0089, 22EJ0176. 5524150 - - - - 22BK1839, 22CJ0090, 22DJ0132. 5524200 - - - - 22DJ0131, 22LJX006, 82CJ0073. 5524620 - - - - 22EJ0175, 82CJ0056. 5524650 - - - - 22BK2101, 22BK2115, 22CJ0067, 22EJ0177, 22GJ0429. 5524700 - - - - 22BK1836, 22DJ0130, 22GJ0430, 82CJ0072. 5525150 - - - - 22DJ0136, 22DJ0137, 22EJ0187, 22FJ0410, 22LJX020. 5525200 - - - - 22DJ0138, 22DJ0139, 22EJ0311, 22EJ0313, 22GJ0436. 5525240 - - - - 22DJ0140, 22EJ0188, 22FJ0385, 82BJ0080. 5526120 - - - - 22DJ0141, 22EJ0186, 22GJ0434. 5526150 - - - - 22DJ0156, 22FJ0397, 82BJ0077. 5526200 - - - - 22DJ0155, 22FJ0398, 22GJ0435, 22LJX014, 82CJ0075. 5526650 - - - - 22DJ0148, 82BJ0076. 5526700 - - - - 82CJ0074. 5577105 - - - - 22BK2117, 22FJ0394. 5577115 - - - - 22BK1840, 22CJ0087, 22FJ0370, 82BJ0064. 5577135 - - - - 22CJ0058, 22EJ0178, 22FJ0396, 22GJ0431. 5577215 - - - - 22AK1458, 22CJ0063, 22EJ0180, 22FJ0372, 22KJ1406. 5577220 - - - - 22AK1439, 22BK2105, 22CJ0062, 22DJ0119, 22EJ0182, 22EJ0357, 22GJ0433. 5577324 - - - - 22AK1446, 22AK1453, 22AK1469, 22CJ0061, 22DJ0120, 22EJ0184, 22FJ0371, 22JJ0756, 22KJ0780, 22LJX007. SOFT CELL PERMANENT DIALYSIS CATHETERS 5500100 - - - - 22CJ0070, 22KJ0796, 22LJX032. 5531120 - - - - 22BJ0008. 5531190 - - - - 22DJ0102. 5531230 - - - - 22BJ0010, 22FJ0412, 22IJ0711. 5531620 - - - - 22BJ0007, 22BK1815, 22FJ0379. 5531690 - - - - 22GJ0470. 5531730 - - - - 22AK1478, 22AK1496, 22CJ0083. 5532120 - - - - 22BJ0004. 5532190 - - - - 22DJ0103, 22EJ0196, 22FJ0366. 5532230 - - - - 22BJ0054 5533120 - - - - 22DJ0128, 22EJ0198. 5533190 - - - - 22BK1816, 22DJ0108, 22EJ0301, 22FJ0382, 22KJ0798. 5533230 - - - - 22AK1497, 22CJ0073, 22DJ0116, 22FJ0413, 22LJX041. 5533620 - - - - 22DJ0127. 5533690 - - - - 22AK1450, 22DJ0107, 22EJ0300, 22FJ0381, 22GJ0471. 5533730 - - - - 22DJ0110, 22FJ0383. 5534120 - - - - 22DJ0105, 22EJ0199, 22GJ0468. 5534190 - - - - 22AK1449, 22AK1479, 22BK1817, 22CJ0072, 22DJ0109, 22FJ0407. 5534230 - - - - 22CJ0071, 22DJ0111, 22FJ0414, 22LJX024, 82JJ0005. 5536190 - - - - 22DJ0145. VACCESS SINGLE-LUMEN DIALYSIS CATHETERS 5541150 - - - - 22BJ0005, 22BK1832, 22EJ0307, 22EJ0345, 22GJ0426. 5541200 - - - - 22BJ0006, 22EJ0308, 22EJ0346, 82DJ0157. 5541650 - - - - 22EJ0309. 5541700 - - - - 22EJ0310, 22EJ0347, 82DJ0154, 82ADJ0155, 82DJ0156. 5542150 - - - - 22EJ0302, 22EJ0314, 22EJ0341. 5542240 - - - - 22CJ0082, 22DJ0123, 22EJ0304, 22EJ0343. 5542650 - - - - 22EJ0303, 22EJ0342, 22IJ0712, 22IJ0713, 22IJ0714. 5542700 - - - - 22AK1447, 22DJ0113, 22EJ0305. 5543150 - - - - 22DJ0152, 22EJ0320. 5543200 - - - - 22EJ0321. 5543650 - - - - 22DJ0114, 22EJ0322, 22EJ0354. 5543700 - - - - 22DJ0115, 22EJ0323, 82DJ0153. 5544150 - - - - 82BJ0081. 5544200 - - - - 22DJ0126, 22EJ0317, 22EJ0352. 5544650 - - - - 22DJ0125, 22EJ0315. 5544700 - - - - 22EJ0353. 5577250 - - - - 22GJ0442. 5577265 - - - - 22DJ0149. 5577270 - - - - 22DJ0158, 82DJ0152. 5577275 - - - - 22CJ0084. HEMOFILTRATION CATHETERS 5573110 - - - - 22KJ1095, 82BJ0022, 82CJ0059, 82DJ0039. MANUFACTURER Bard Access Systems, Salt Lake City, Utah. RECALLED BY Manufacturer, by mail on April 18, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 175,034 units were distributed. REASON Cracked luer connectors which could cause air embolisms or blood loss. ________ PRODUCT Cordis Savvy PTA Balloon Catheters: Model: 435200L, 435200S, 435202L, 435202S, 435202T, 435202X,435203L, 435203S, 435203X, 435204L, 435204S, 435204X, 435206L, 435206S, 435250L, 435250S, 435252L, 435252S, 435252X, 435253L, 435253S, 435253X, 435254L, 435254S, 435254X, 435256L, 435256S, 435300L, 435300S, 435302L, 435302S, 435302X, 435303L, 435303S, 435303X, 435304L, 435304S, 435304X, 435306L, 435306S, 435350L, 435350S, 435352L, 435352S, 435352X, 435353L, 435353S, 435353X, 435354L, 435354S, 435354X, 435356L, 435356S, 435499L, 435400S, 435402L, 435402S, 435402X, 435403L, 435403S, 435403X, 435404L, 435404S, 435404X, 435406L, 435406S, 435450L, 435450S, 435450Y, 435452L, 43542S, 435452Y, 435454L, 435454S, 435454Y, 435456L, 435456S, 435456Y, 435500L, 435500S, 435500Y, 435502L, 435502S, 435502Y, 435503L, 435503S, 435503Y, 435504L, 435504S, 435504Y, 435506L, 435506S, 435506Y, 435550L, 435550S, 435550Y, 435552L, 435552S, 435552Y, 435553L, 435553S, 435553Y, 435554L, 435554S, 435554Y, 435556L, 435556S, 435556Y, 435699L, 435600S, 435600X, 435600Y, 435602L, 435602S, 435602Y, 435603L, 435603S, 435603Y, 435604L, 435604S, 435604Y, 435606L, 435606S, 435606X, 435606Y. Recall #Z-728-0. CODE A total of 790 lots are involved which represents all unexpired product produced from May 1998 to present. MANUFACTURER Cordis Corporation, Miami Lakes, Florida. RECALLED BY Manufacturer, by letter dated April 14, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 790 lots or 11,550 units. REASON Hub leakage during flushing of catheters because of cracks. ________ PRODUCT Exacta External Drainage and Monitoring System, used for externally draining cerebrospinal fluid (CSF) from the lateral ventricles of the brain and monitoring intracranial pressure due to head trauma. Recall #Z-730-0. CODE Catalog No. 46700, Lot Nos. R5651 through R5657, R8515, R9255, R9581, R9938, T0419, T1262, T1974, T2528, T2645, T3237, T3515, T4771, and T5140. MANUFACTURER Medtronic PS Medical, Goleta, California. RECALLED BY Manufacturer, by letter and fax on March 3, 2000. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 1,895 units were distributed. REASON The device's sterility may be compromised due to loss of package integrity and which may possibly allow bacteria to enter the patient. ________ PRODUCT Pacesetter Trilogy Pulse Generator, indicted for the treatment of bradycardia: a) Trilogy SR 2250 Pulse Generator; b) Trilogy SR+ 2260 Pulse Generator; c) Trilogy SR+ 2264 Pulse Generator; d) Trilogy DC 2308 Pulse Generator; e) Trilogy DC+ 2318 Pulse Generator; f) Trilogy DR 2350 Pulse Generator; g) Trilogy DR+ 2360 Pulse Generator; h) Trilogy DR+ 2364 Pulse Generator. Recall #Z-731/738-0. CODE Serial Numbers: 53184-53232 53433-53478 53983-54032 54673-54722 55526-55572 55873-55971 56273-56422 58113-58205 58966-59014 59316-59372 59778-59822 61075-61122 61433-61532 61633-61725 62133-62182 63233-63281 66851-66959 66970-66994. MANUFACTURER St. Jude Medical, Cardiac Rhythm Management Division, Sylmar, California. RECALLED BY Manufacturer, by mail on or about March 10, 2000. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY Approximately 144,000 generators. REASON An anomaly with the microprocessor integrated circuit was detected. The anomaly behavior includes: Interrogation/programming difficulties, including the presence of dashes (---) on the programmer screen for some parameter values after interrogation; Unexpected rate variations; Abnormally high battery current drain; Mode changeRECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________ PRODUCT Merge ExamWorks Video Units, used with equipment for connecting diverse diagnostic imaging products: Model/Catalog Numbers 006-04100-00, 006-04100-01, 006-04100-00S, 006- 04100-01S, and 006-04100-02. Recall #Z-721/725-0 CODE All units shipped prior to March 30, 2000. MANUFACTURER Merge Technologies, Inc., West Allis, Wisconsin. RECALLED BY Manufacturer, by "Important Customer Product Advisory" dated April 26, 2000. Firm-initiated field correction ongoing. DISTRIBUTION California, Connecticut, Indiana, Illinois, Kansas, Minnesota, Missouri, Nebraska, Ohio, Oregon, Texas, Brazil, Denmark, The Netherlands, Sweden. QUANTITY 168 units were distributed. REASON Warning label which limits product use was omitted from the cable of the video units. ________ PRODUCT U-100 Insulin Single Use Syringes, 29 G X 1/2 inch and U-100 Insulin Single Use Syringes, 28 G X 1/2 inch. Recall #Z-726/727-0. CODE Lot Number 990427 for the 28 gauge X 1 cc product and Lot Number 990426 for the 29 gauge X 1 cc product MANUFACTURER Medicore, Inc., Hialeah, Florida. RECALLED BY Manufacturer, by telephone on March 17, 2000, or by fax and visit. Firm- initiated field correction ongoing. DISTRIBUTION New Jersey and Florida. QUANTITY 100 cases (100 syringes per case) were distributed. REASON Mislabeled volume on outer shelf cartons, device package is correct. ________ PRODUCT Alycon Reagent Probe LN 05D44-01. Recall #Z-729-0. CODE None. MANUFACTURER Abbott Laboratories, Inc., Diagnostics Division, Irving, Texas. RECALLED BY Manufacturer, by telephone October 22, 1999. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Japan, Puerto Rico. QUANTITY 78 units were distributed. REASON The box labeled as containing a Reagent Probe actually contained an ISE probe. END OF ENFORCEMENT REPORT FOR JUNE 7, 2000.
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