March 12, 1997 97-11 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============ _______________ PRODUCT President's Choice brand: (a) Bittersweet Chocolate Bars, 17.6 ounces; (b) Milk Chocolate Bars, 17.6 ounces. Recall #F-252/253-7. CODE All Lots. MANUFACTURER Societe Alimentaire du Forez, St. Etienne, France. RECALLED BY President's Choice International, Toronto, Ontario, Canada, by E-mail followed by letter dated December 30, 1996. Firm-initiated recall ongoing. DISTRIBUTION Illinois, Massachusetts, New York, Oregon, Texas. QUANTITY (a) 1,277 cases (24 bars per case); (b) 895 cases (24 bars per case) were distributed. REASON Some candy bars may contain undeclared hazelnuts or almonds. _______________ PRODUCT Snow Crab Clusters, frozen, in 20 pound cases. Recall #F-254-7. CODE Master carton coded JA120796. MANUFACTURER P Janes & Sons Ltd., Hants Harbour, Newfoundland, Canada. RECALLED BY Slade Gorton & Company, Inc., Boston, Massachusetts, by letter issued December 26, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 1,337 cases were distributed. REASON Product may be contaminated with Listeria monocytogenes. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT Glory Foods brand Southern Style String Beans, & Potatoes, pre-seasoned, in 27 ounce cans. Recall #F-243-7. CODE Lot numbers: KD16X/KPGL, KD17X/KPGL, KD18X/KPGL. MANUFACTURER McCall Farms, Inc., Effingham, South Carolina. RECALLED BY Manufacturer, by press release on May 10, 1996, and by telephone and letter on or about May 2, 1996. Firm-initiated recall complete. DISTRIBUTION Georgia, Kentucky, Ohio, Michigan, Tennessee, North Carolina, Maryland, New Jersey. QUANTITY 3,678 cases, 24 cans per case were distributed. REASON Product was contained in swollen cans and was underprocessed. _______________ PRODUCT Seagull brand Green Mango Sliced in Brine, in 16 ounce glass jars. Recall #F-244-7. CODE All codes including TG-10. MANUFACTURER Thai World Import & Export Company Ltd., Yannawa Bangkok, Thailand. RECALLED BY Hong Thai Foods Corporation, Brooklyn, New York (importer), by letter January 10, 1997. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets. DISTRIBUTION New York, New Jersey, Illinois, District of Columbia. QUANTITY 40 cases (24 jars per case) were distributed. REASON Product contains undeclared sulfites and undeclared FD&C Yellow No. 5. _______________ PRODUCT Crystal Springs Pure Drinking Water, in 1 gallon plastic jugs. Recall #F-245-7. CODE 35496, 36696, 00297, 00697, 00797, 00997, 01097, 01497, 01597, and 01697. MANUFACTURER Crystal Springs Bottled Water Company, Inc., Hillsboro, Oregon. RECALLED BY Manufacturer, by telephone beginning on January 10, 1997, followed by fax, and by press release on January 31, 1997. Firm- initiated recall complete. -2-DISTRIBUTION Oregon, Washington state, Idaho, Nevada, California. QUANTITY Product Code Cases Produced 35496 4,434 36696 4,584 00297 2,688 00697 2,622 00797 4,986 00997 2,058 01097 300 01497 2,952 01597 5,436 01697 3,660. REASON Product contains excessive levels of chlorine. _______________ PRODUCT Key Lime Sherbet and Tangerine Sherbet packaged in 1 quart size clear plastic containers with labeling on the lid. Recall #F-255/256-7. CODE None. All product with undeclared FD&C Yellow No. 5 is under recall. MANUFACTURER Coleman's Ice Cream, Inc., Lancaster, Pennsylvania. RECALLED BY Manufacturer, by relabeling product beginning on or about February 11, 1997. Firm-initiated field correction ongoing. DISTRIBUTION Pennsylvania. QUANTITY Approximately 25 quarts were distributed. REASON Products contain undeclared FD&C Yellow No. 5. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ========== _______________ PRODUCT MW Polar brand Baby Clams, in 10 ounce metal cans. Recall #F-251-7. CODE Four 3-line codes are involved: H14 H14 H14 H14 940615 940616 940617 940618 555S 555S 555S 555S. MANUFACTURER State Run, Rongcheng Canning Factory, China. RECALLED BY MW Polar Foods, Inc., doing business as Milky Way Int'l Trading Corporation, Buena Park, California, by letter on November 11, 1994. Firm-initiated recall complete. DISTRIBUTION Eastern United States. QUANTITY Approximately 3,000 cases were distributed; firm estimates none remains on the market. REASON Product was decomposed and was held in swollen cans. -3-RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT Platelets. Recall #B-385-7. CODE Unit numbers: 2488424, 2488425, 2488246, 2488431, 1802383, 1902931, 1902937, 1902936, 1902938, 1902939. MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana. RECALLED BY Manufacturer, by telephone on June 11, 1996. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 10 units were distributed. REASON Blood products were prepared from units of whole blood which were shipped at unacceptable temperatures. _______________ PRODUCT Plasma Apheresis Bowl, Model 00625B, with Ultra-Sonic Weld & Sterile Fluid Path, used with Haemonetics Plasma Collection System. Recall #B-432-7. CODE Lot numbers T96 (starts with T96001), U96, V96, W96 (ends W96069): T96001-T96009; T96012-T96030; T96032-T96038; T96040-T96069; T96071; T96073-T96085; T96088-T96089; T96092-T96095; T96098-T96099; T96102-T96107; T96110; T96112-T96114; T96116-T96119; T96121-T96125; T96129-T96131; T96134; T96136-T96137; T96141; T96143; T96144; T96147-T96149; T96152-T96154; T96158. U96015-U96027; U96029-U96037; U96039-U96042; U96044-U96045; U96048-U96051; U96053-U96062; U96064-U96070; U96072-U96078; U96080-U96082; U96084-U96112. V96001-V96007; V96010-V96012; V96014-V96019; V96021-V96022; V96026-V96028; V96031-V96032; V96034-V96035; V96037-V96039; V96041; V96043-V96050; V96052-V96056; V96058-V96062; V96064-V96065; V96067-V96087; V96091-V96092; V96094; V96096-V96098; V96100-V96106; V96108-V96139; V96141-V96145; V96147-V96153; V96155- V96159; V96163. W96001-W96004; W96007-W96008; W96010; W96012-W96013; W96015; W96017-W96022; W96024-W96030; W96032-W96037; W96039-W96042; W96044-W96045; W96047-W96049; W96051-W96058; W96060-W96080; W96085-W96086; W96088-W96089; W96093-W96094; W96097-W96101; W96105-W96106; W96108-W96110; W96113-W96115; W96117; W96120; W96123; W96138; W96146; W96148; W96151; W96154; W96157; W96160; W96161; W96163; W96164. -4-MANUFACTURER Haemonetics Corporation, Leetsdale, Pennsylvania. RECALLED BY Haemonetics Corporation, Braintree, Massachusetts, by fax on February 20, 1997. Firm-initiated recall ongoing. DISTRIBUTION California, Florida, Georgia, Iowa, Indiana, Massachusetts, New York, Oklahoma, Pennsylvania, South Carolina, Tennessee. QUANTITY 2,073,099 bowls were distributed. REASON Plasma Apheresis Bowls, determined to have an incomplete seal in the ultrasonic weld joint causing the bowl to leak during normal plasmapheresis operations. _______________ PRODUCT Platelets. Recall #B-434-7. CODE Unit #20262-0505. MANUFACTURER Blood Systems, Inc., doing business as United Blood Services, Lafayette, Louisiana. RECALLED BY Manufacturer, by telephone on January 22, 1996. Firm-initiated recall complete. DISTRIBUTION Louisiana. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit which was collected from a donor who had taken aspirin within three days of donation. _______________ PRODUCT Platelets. Recall #B-435-7. CODE Unit #4515053. MANUFACTURER Central Indiana Regional Blood Center, Indianapolis, Indiana. RECALLED BY Manufacturer, by telephone on January 10, 1996, followed by letter dated January 18, 1996. Firm-initiated recall complete. DISTRIBUTION Utah. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit which was collected from a donor who had taken aspirin within three days of donation. _______________ PRODUCT BayRab brand, Rabies Immune Globulin (Human). Recall #B-459-7. CODE Lot #618R01A, EXP 21MAR98 (2 ml vials), 618R01B, EXP 21MAR98 (10 ml vials). MANUFACTURER Bayer Corporation, Clayton, North Carolina. RECALLED BY Manufacturer, by letter on December 2, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Approximately 6,000 doses of single dose vials were distributed. -5-REASON Product was labeled as preservative free but contained low levels of thimerosal. _______________ UPDATE Fluogen (Influenza Virus Vaccine, Trivalent, Types A & B), an extension of Recall #B-117-7, which appeared in the December 11, 1996 Enforcement Report. CODE Syringes: Lot #00296P. Vials: Lot numbers: 00376P, 00476P, 00596P, 00696P, 01186P, 01286P, 01386P. MANUFACTURER Warner-Lambert Company, Parke-Davis, Sterile Products Division, Rochester, Michigan. RECALLED BY The Parke-Davis Division of Warner-Lambert Company, Morris Plains, New Jersey, letter on February 12, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Approximately 551,000 units were distributed. REASON Parke-Davis Fluogen showed a decrease in potency of one component of the vaccine after distribution. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT Platelets, Pheresis. Recall #B-433-7. CODE Unit #53LT50303. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated July 22, 1996. Firm-initiated recall complete. DISTRIBUTION District of Columbia. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with an unacceptable health history. _______________ PRODUCT Monoclate-P Antihemophilic Factor (Human), Factor VIII:C Pasteurized, Monoclonal Antibody Purified. Recall #B-436-7. CODE Lot P68201 EXP 01/18/98. MANUFACTURER Centeon L.L.C., Kankakee Industrial Operations, Kankakee, Illinois. RECALLED BY Centeon L.L.C., A Company of Armour and Behring, King of Prussia, Pennsylvania, by letter dated February 19, 1997. Firm- initiated recall ongoing. See also FDA talk paper T96-67, October 4, 1996. DISTRIBUTION Nationwide. -6-QUANTITY 1,908 vials were distributed; firm estimated that little if any product remained on market at time of recall initiation. REASON Reconstitution difficulties in that vials failed to transfer all of the diluent into a lyophilized product. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Sensi-Touch Regional Anesthesia Delivery System, Spinal Anesthesia Tray, Catalog #8888- 828111, 22 ga plastic hub, diamond point, Marcaine. Recall #Z-297-7. CODE Lot #801685. MANUFACTURER Kelsar S.A., Tijuana, B.C., Mexico. RECALLED BY Sherwood Davis & Geck, St. Louis, Missouri, by letter on January 31, 1997. Firm-initiated recall ongoing. DISTRIBUTION Michigan, Missouri, Connecticut, Texas, New Jersey, Kentucky, Minnesota, Pennsylvania, Massachusetts. QUANTITY 400 trays were distributed between 8/25/96 and 1/27/97. REASON The tray incorrectly identifies the contents as product/catalog No. 8888-826115 containing Tetracaine, however, it actually contains Marcaine. _______________ PRODUCT Imatron CT Scanner, a component of the patient table potentiometer assembly (Y-potentiometer): (a) Imatron C100 CT Scanner; (b) Imatron C150 Series Scanners. Recall #Z-298/299-7. CODE Various model numbers and serial numbers are involved. MANUFACTURER Imatron, Inc., South San Francisco, California. RECALLED BY Manufacturer, by sending an "Advance Letter" in July 1996, and issuing its own Field Modification Instructions, followed by visit. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 81 units were distributed. REASON The table would go beyond its limits and could not be driven back due to a blown fuse. _______________ PRODUCT Model CRC Laser Profilometer, used to determine the surface characteristics of paper. Recall #Z-300-7. CODE None. -7-MANUFACTURER International Paper Company, Tuxedo, New York. RECALLED BY Manufacturer. FDA approved the firm's corrective action plan on March 1, 1997. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY 2 units were distributed. REASON Noncompliance with performance standards for laser products in that the products failed to incorporate required safety interlocks on the operator access door. _______________ PRODUCT EEG Tend Monitor, Model OEE-7102B, intended for long term EEG monitoring and analysis. Recall #Z-303-7. CODE Serial numbers: 00003, 00004, 00006-00016, 00020-00023, 00031, 00033-00035, 00038, and 00043. MANUFACTURER Nihon Kohden Corporation, Shinjuku-Ku, Tokyo, Japan. RECALLED BY Nihon Kohden America, Inc., Irvine, California, by letter dated October 16, 1996. Firm-initiated recall ongoing. DISTRIBUTION Arizona, California, Illinois, Kansas, Louisiana, South Dakota, Texas, Utah. QUANTITY 23 units were distributed. REASON When the 12V DC power supply conductor is broken, and the main power is turned on, a higher than acceptable current leakage is applied to the monitoring electrodes and a chemical reaction is generated with EEG paste, which can discolor the patient's skin when the electrodes are placed on the patient skin. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT Neurosign Straight Concentric Bipolar Probe with Touch Proof Connectors, Catalog #7033- 0919, an accessory to the Neurosign 100 Motor Nerve Monitor. Recall #Z-293-7. CODE Serial numbers: 076, 078, 079, 080, 081, 082, 083, 084, 085, 087. MANUFACTURER The MAGSTIM Company Ltd., United Kingdom. RECALLED BY Smith & Nephew ENT, Smith & Nephew Richards, Inc., Bartlett, Tennessee, by fax on October 16, 1996. Firm-initiated recall complete. DISTRIBUTION Arizona, Kentucky, New York, Texas, Washington state, Wisconsin. QUANTITY 8 units were distributed and are accounted for. -8-REASON The device is subject to possible extrusion of silicone from the end of the probe when the device was autoclaved by the manufacturer. _______________ PRODUCT Incstar VCA IgG Clin-ELISA Test Kit, Product #4590, an in-vitro diagnostic test kit for detecting antibodies in human serum to Epstein-Barr Viral Capsid Antigen (VCA). Recall #Z-294-7. CODE Lot #395406. MANUFACTURER Incstar Corporation, Stillwater, Minnesota. RECALLED BY Manufacturer, by letter on February 3, 1997. Firm-initiated recall complete. DISTRIBUTION California, New Jersey, New York, international. QUANTITY 131 kits were distributed. REASON Some negative samples may yield a positive assay response. _______________ PRODUCT Cytomegalovirus IgM ELISA Test Kit, Product #2325250, used for the qualitative determination of IgM antibody to cytomegalovirus in human serum. Recall #Z-302-7. CODE Lot numbers 108 and 109. MANUFACTURER Clark Laboratories, Inc., Jamestown, New York. RECALLED BY Manufacturer, by letter January 23, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 495 kits were distributed. REASON The absorbance values for controls and specimens are lower than expected. _______________ PRODUCT C-150XP CT Scanner Installed with Software Version 12.22. Recall #Z-304-7. CODE All models with 12.22 version software. MANUFACTURER Imatron, Inc., South San Francisco, California. RECALLED BY Manufacturer, by "Software Notice" letter on August 28, 1996. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 30 units were distributed. REASON The device's software version 12.22 contains an error which prevents it from detecting an unexpected stop in table motion during certain low velocity Continuous Volume Studies (CVS), resulting in unnecessary x-ray radiation exposures to the patient. -9-________________ PRODUCT Software Versions 11.53 and 12.13 installed in computed tomography scanners: (a) Model C-100; (b) Model C-150XP; (c) Model C-150L. Recall #Z-305/307-7. CODE Models C100, C150XP, and C150L. MANUFACTURER Imatron, Inc., South San Francisco, California. RECALLED BY Manufacturer, by sending Software Notice #20 on or about November 16, 1995. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 37 units were distributed. REASON During reconstruction of images, the Fast Reconstruction System software (FSR) may produce an error condition which the computer may interpret as a warning, causing the computer to display erroneous data for the image. _______________ PRODUCT Nellcor Symphony N-3000 Pulse Oximeter, Model N-3000. Recall #Z-308-7. CODE 111 units with suspect printed circuit boards, each with an individual serial number. MANUFACTURER Nellcor Puritan Bennett, Inc., Chula Vista, California. RECALLED BY Nellcor Puritan Bennett, Inc., Carlsbad, California, by letter on October 23, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 111 units were distributed. REASON The device may be potentially subject to printed circuit board damage which can result in the monitor reporting Sp02 values slightly outside the normal accuracy range stated in the Operations Manual. MEDICAL DEVICE SAFETY ALERTS: ============================== _______________ PRODUCT Sherpa Vector and Sherpa Vector X Coronary Guiding Catheters, designed to provide a pathway through which therapeutic devices are introduced: (a) Vector 6F, Catalog numbers PA5xx; (b) Vector 7F, Catalog numbers AS7xxx; (c) Vector 8F, Catalog numbers AS8xxx; (d) Vector X 6F, Catalog numbers S26xxx; (e) Vector X 7F, Catalog numbers S27xxx; (f) Vector X 8F, Catalog numbers S28xxx. Safety Alert #N-007/012-7. -10-CODE All lots. MANUFACTURER Medtronic Interventional Vascular Inc., Danvers, Massachusetts. ALERTED BY Manufacturer, by letter on November 25, 1996. DISTRIBUTION Nationwide. QUANTITY Approximately 38,796 units were distributed. REASON Resistance may be experienced while passing interventional devices through the lumen of the guiding catheter, which may result in the inability to move the interventional device within the lumen of the guiding catheter. -11- END OF ENFORCEMENT REPORT FOR MARCH 12, 1997. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for