December 26, 1996 96-52 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========== _______________ PRODUCT Piaxtla Mexican Style Corn Tortillas (Blue/Green), in 32 ounce plastic bags. Recall #F-130-7. CODE None. MANUFACTURER Tortilleria Piaxtla, Inc., Brooklyn, New York. RECALLED BY Manufacturer, by letter dated October 18, 1996, followed by visit. Completed recall resulted from inspection and followup by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY 30 cases were distributed; firm estimates none remains on the market. REASON Product contains undeclared and unapproved food coloring. _______________ PRODUCT Holiday Candy Wreath, unlabeled, made of foil- wrapped cherry and lime hard candies, braided together. Recall #F-131-7. CODE None. MANUFACTURER Montes, Guadalahara, Mexico. RECALLED BY Harry and David Corporation, Medford, Oregon (distributor), by letter on November 26, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 113 wreaths were distributed. REASON Product was shipped without an ingredient statement and contained FD&C Yellow No. 5. _______________ PRODUCT Ceramic Mugs, Garden Fresh Tableware Pattern: (a) Carrot Design; (b) Corn Design; (c) Peas Design; (d) Radish Design. Recall #F-148/151-7. CODE Sticker affixed on the bottom of the mugs read in part: "*** Garden Fresh Mug Tabletops Unlimited Made In China ***". MANUFACTURER Jiangsu Yixing Ceramic Corporation, Yixing City, Jiangsu, China. RECALLED BY Tabletops Unlimited, Inc., Gardena, California (importer), by letter on November 20, 1996. Firm-initiated recall ongoing. DISTRIBUTION California, Kentucky, and international. QUANTITY 14,040 mugs were distributed. REASON The mugs contain excessive levels of leachable lead. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ========== _______________ PRODUCT Holsum 100% Pure Corn Oil, in 24 fluid ounce plastic containers. Recall #F-132-7. CODE H0796. MANUFACTURER Ventura Foods, LLC (formerly Holsum Foods), Waukesha, Wisconsin. RECALLED BY Manufacturer telephone on September 20, 1996. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 174 cases (12 bottles per case) were distributed. REASON The product, labeled as 100% pure corn oil, actually contains a blend of corn oil and canola and/or soybean oil. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ========== _______________ PRODUCT Amantadine Hydrochloride Capsules, USP, 100 mg, in bottles of 100 and 500, Rx indicated in the treatment of idiopathic Parkinson's disease. Recall #D-055-7. CODE Lot #824959. MANUFACTURER Chase Laboratories, Newark, New Jersey (responsible firm). RECALLED BY Banner Pharmacaps, High Point, North Carolina, by letters on or about October 21, 1996. Firm-initiated recall complete. -2-DISTRIBUTION Nationwide. QUANTITY 5,584 bottles were distributed. REASON Product fails dissolution at 9 month stability timepoint. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma. Recall #B-079/081-7. CODE Unit #36L20568. MANUFACTURER American Red Cross, Columbia, South Carolina. RECALLED BY Manufacturer, by telephone and by letter dated October 2, 1995. Firm-initiated recall complete. DISTRIBUTION South Carolina, Virginia. QUANTITY 1 unit of each component was distributed. REASON Blood products were incorrectly tested for anti-HBc. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma; (d) Recovered Plasma. Recall #B-147/150-7. CODE Unit numbers: (a) 1203886, 1263762, 1270937, 1285581, 1525012, 1541822, 1550335; (b) 1270937; (c) 1270937; (d) 1203886, 1263762, 1541822, 1525012, 1285581. MANUFACTURER Mississippi Blood Services, Inc., Jackson, Mississippi. RECALLED BY Manufacturer, by letters between the dates of September 20, 1995, and July 18, 1996. Firm- initiated recall complete. DISTRIBUTION Mississippi, California, Switzerland. QUANTITY (a) 7 units; (b) 1 unit; (c) 1 unit; (d) 5 units were distributed. REASON Blood products tested negative for antibody to the human immunodeficiency virus type 1 (anti- HIV-1), but were collected from donors who previously tested repeatedly reactive for anti-HIV-1. _______________ PRODUCT Red Blood Cells. Recall #B-156-7. CODE Unit #53LV19980. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated June 5, 1996. Firm-initiated recall complete. DISTRIBUTION District of Columbia. -3-QUANTITY 1 unit was distributed. REASON Blood product was collected in a manner which could have compromised the sterility of the collection system. _______________ PRODUCT Red Blood Cells. Recall #B-162-7. CODE Unit #6E9304. MANUFACTURER Puget Sound Blood Center, Seattle, Washington. RECALLED BY Manufacturer, by telephone on April 11, 1996. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY 1 unit was distributed. REASON Blood product was positive for the Fya antigen; was transfused to a patient with an anti-Fya antibody. _______________ PRODUCT Red Blood Cells. Recall #B-163-7. CODE Unit #6E6336. MANUFACTURER Puget Sound Blood Center, Seattle, Washington. RECALLED BY Manufacturer, by telephone on January 21, 1995. Firm-initiated recall complete. DISTRIBUTION Washington state. QUANTITY 1 unit was distributed. REASON Blood product was positive for the Kell (K) antigen; was transfused to a patient with an anti-K antibody. _______________ PRODUCT Red Blood Cells. Recall #B-171-7. CODE Unit #1530228. MANUFACTURER Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, Oklahoma. RECALLED BY Manufacturer, by fax on February 22, 1996. Firm-initiated recall complete. DISTRIBUTION Oklahoma. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria. _______________ PRODUCT Recovered Plasma. Recall #B-175-7. CODE Unit 1K1614. MANUFACTURER Puget Sound Blood Center and Program, Seattle, Washington. RECALLED BY Manufacturer, by letter dated December 27, 1995. Firm-initiated recall complete. -4-DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a possible history of jaundice. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT Platelets, Pheresis. Recall #B-146-7. CODE Split Unit #49P29381. MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma. RECALLED BY Manufacturer, by telephone on May 7, 1996, followed by fax. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit was distributed. REASON Blood products were labeled with extended expiration dates. _______________ PRODUCT (a) Platelets, Pheresis; (b) Plasma. Recall #B-164/165-7. CODE Unit #53P62891. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by telephone on April 4, 1996, followed by letter dated April 10, 1996. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected by apheresis, using a blood cell separator which had an unacceptable quality control value for the Whole Blood Anticoagulant pump speed. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-172/173-7. CODE Unit numbers: (a) 9531986; (b) 9529667, 9529668, 9529682, 9531874, 9531954. MANUFACTURER Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, Oklahoma. RECALLED BY Manufacturer, by fax on July 11 or 12, 1996. Firm-initiated recall complete. DISTRIBUTION New York, Texas, Oklahoma. QUANTITY (a) 1 unit; (b) 5 units were distributed. REASON Blood products were collected from donors who reported receiving Rubella vaccine within four weeks of donation. -5-_______________ PRODUCT Recovered Plasma. Recall #B-174-7. CODE Unit #1035913. MANUFACTURER Scott & White Blood Center, Temple, Texas. RECALLED BY Manufacturer, by letter dated April 18, 1996, and by fax on April 19, 1996. Firm-initiated recall complete. DISTRIBUTION Arizona. QUANTITY 1 unit was distributed. REASON Blood product tested negative for antibody to the human T lymphotropic virus type 1 (anti- HTLV-1); but was collected from a donor who previously tested repeatedly reactive for anti-HTLV-1, Western blot indeterminate. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Sims/Intertech brand Manual Resuscitators with PEEP Valve Bonded to the Exhalation Port: (a) Product Code R1093; (b) Product Code R1094; (c) Product Code R1095. Recall #Z-049/051-7. CODE Product codes: R1093, R1094, R1095. MANUFACTURER Sims Medical Systems/Intertech, Fort Myers, Florida. RECALLED BY Manufacturer, by telephone on September 17, 1996. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 5,352 units were distributed. REASON The positive end expiratory pressure (PEEP) valve may be inoperable on some of the manual resuscitators because the solvent used to bond the PEEP valve dripped on the disk, which may have made the disk difficult or impossible to move. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Medtronic Synchromed Programmable Pumps, indicated for the intraspinal infusion of morphine sulfate to treat chronic intractable pain and baclofen for spasticity and the intravascular infusion of drugs to treat metastatic cancer and clindamycin for the treatment to osteomyelitis: (a) Medtronic Synchromed Programmable Pump, Model 8611, Series (8611H, 8611HL); (b) Medtronic Synchromed Programmable Pump, Model 8615, Series (8615S, 8615LS, 8615L); -6- (c) Medtronic Synchromed Programmable Pump, Model 8616, Series (8616-10, 8616-18); (d) Medtronic Synchromed Programmable Pump, Model 8617, Series (8617-18, 8617L-18); (e) Medtronic Synchromed Programmable Pump, Model 8631. Recall Z-152/156-7. CODE The units identified below by model and serial numbers were retrieved by Medtronic Sales Representatives. These units had not been implanted, and are not past their expiration dates: Model 8615S: Serial numbers NBM007041R, NBM007150R, NBM007170R, NBM008869R, NBM007467R, NBM008226R, NBM008392R, NBM008554R, NBM008942R, NBM008760R, NBM008927R, NBM008507R, NBM007454R Model 8615LS: Serial numbers NBM006888R, NBM007549R Model 8617L18: Serial number NDA000274R Model 861718: Serial numbers NCY000808R, NCY000811R, NCY000739R, NCY000938R, NCY001358R. The units identified below by model and serial numbers are subject to retrieval by Medtronic Sales Representatives, but have not been retrieved because they cannot be located. These units have not been registered as implanted, and are not past their expiration dates: Model 8615S: Serial numbers NBM007177R, NBM007469R, NBM008604R Model 8615LS: Serial number NBM006889R Model 8617L18: Serial number NDA000247R Model 861718: Serial numbers NCY000640R, NCY000980R Medtronic recommended that the units identified below by model and serial numbers be returned. These units are past their expiration dates. The first 53 serial numbers listed below are of units that have been located by Medtronic representatives, and the following 37 numbers are the serial numbers of units that have not been located. Located: Model 8615S/Serial numbers NBM005054R, NBM005237R, NBM005272R, NBM005309R, NBM005348R, NBM005323R, NBM005494R, NBM005552R, NBM005553R, NBM005656R, NBM005751R, NBM005818R, NBM005829R, NBM005859R, NBM005883R, NBM005930R, NBM005957R, NBM005961R, NBM005994R, NBM006036R, NBM006048R, NBM006249R, -7- NBM006459R, NBM006464R, NBM006472R, NBM006620R, NBM006645R, NBM006648R, NBM006703R, NBM006623R, NBM006955R, NBM006960R, NBM007008R, NBM007015R, NBM007062R, NBM007070R, NBM007079R, NBM007105R, NBM007134R Model 8615LS/Serial numbers NBM004993R, NBM005519R, NBM005789R, NBM005974R, NBM006190R, NBM006290R, NBM006333R, NBM006445R, NBM006756R, NBM006897R Model 8611H: Serial number SJ1303852R, SJ1303747R Model 8616-18: Serial number NCV000051R Model 8631: Serial number DAB130095R Not located: Model 8615S/Serial numbers NBM004738R, NBM005052R, NBM005136R, NBM005312R, NBM005550R, NBM005300R, NBM005396R, NBM005468R, NBM005477R, NBM005560R, NBM005628R, NBM005780R, NBM005842R, NBM005871R, NBM005863R, NBM005932R, NBM005911R, NBM006012R, NBM006394R, NBM006506R, NBM006512R, NBM006692R, NBM006705R, NBM006918R, NBM006983R Model 8615LS/Serial numbers NBM004970R, NBM004967R, NBM005522R, NBM006130R, NBM006132R, NBM006134R, NBM006136R, NBM006163R, NBM006524R, NBM006563R, Model 8611H: Serial numbers SJ1303879R, SJ1303963R Medtronic suspects that many of the unlocated units with serial numbers listed above, are implanted but not registered by physicians as implanted. These unlocated units are to be returned only if they have not been implanted. MANUFACTURER Medtronic, Inc., Neurological Division, Minneapolis, Minnesota. RECALLED BY Medtronic, Inc., Neurological Division, Columbia Heights, Minnesota, by sending a technical brief to sales representatives on November 1, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 118 pumps were distributed. REASON The affected pumps have a failure rate of about 1.6% due to motor stall caused by open electrical circuits within the first 10 months of use after implant. -8-_______________ PRODUCT XiScan 1000 12x12, a diagnostic x-ray device. Recall #Z-162-7. CODE Various serial numbers. MANUFACTURER Xi-Tec, Inc., Windsor Locks, Connecticut. RECALLED BY Manufacturer. FDA approved the firm's corrective action plan on December 13, 1996. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY 37 units were distributed. REASON Device was found to be in noncompliance with the Federal Performance Standard for Diagnostic X-Ray Systems and Their Major Components 21 CFR 1020.32(g), in that the label on the systems prior to granting the Variance 94V0330/VAR 1 was not correct because the variance referred to on it (85V-0330) was for another system. _______________ PRODUCT Gesco brand Per-Q-Kit catheter kits: (a) Per-Q-Kit 3 Fr. Single Lumen PICC Insertion Kit with Guidewire Reorder Number 4133107 ; (b) Per-Q-Kit 4 Fr. Single-Lumen PICC Insertion Kit with Guidewire Reorder Number 4134107. Recall #Z-173/174-6. CODE Lot Numbers (a) 51EG1023; (b) 51EG1024. MANUFACTURER Gesco International, Inc., San Antonio, Texas. RECALLED BY Bard Access Systems, Inc., Salt lake City, Utah, by letter dated November 11, 1996; firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY 984 kits were distributed. REASON The expiration date is incorrectly labeled. _______________ PRODUCT Gent-L-Kare Sterile Procedure Trays, sterile, single-use disposable trays packaged with gloves and Tyvek lids: (a) Urethral Catherization Trays, Catalog nos. 2498, 2499, 2502, 2503; (b) Foley Catherization Trays, Catalog nos. 2510, 2512, 2513, 2524, 2526; (c) I.V. Start Kits, Catalog No. 2608, reorder nos. 51-2592, 3108033, 3008050, 3108044, 3108060, 3108031, 3108016, 51-2591; (d) Tracheostomy Care Trays, Catalog Nos. 4118 (reorder no. RW031), 4120 (reorder nos. 3010028 & 3010037), 4128. Recall #Z-177/180-7. -9-CODE All lots beginning with "J", "K", "L" and "M". MANUFACTURER Sterling Disposable Products, Inc., Chicago, Illinois (tray assembler). RECALLED BY Premium Plastics, Inc., Chicago, Illinois (distributor), by letter dated October 11, 1996, and by telephone on October 16, 17, 23, 24, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 89,682 cases were distributed; firm estimated that 3,000 cases remained on market at time of recall initiation. REASON Some of the trays may have part of the glove sealed between the Tyvek lid and the tray, therefore compromising the package integrity, resulting in a lack of assurance of sterility. _______________ PRODUCT Intraocular Lens, AMO Model PS-53ANB. Recall #Z-181-7. CODE Serial numbers 9408416245 through 9408416252. MANUFACTURER Allergan Medical Optics Puerto Rico, Anasco, Puerto Rico. RECALLED BY Allergan, Inc., Irvine, California, by fax on July 30, 1996, followed by letter dated September 5, 1996. Firm-initiated recall complete. QUANTITY 17 lenses from two production lots. DISTRIBUTION Washington state, Canada, England, Germany. REASON The 16.0 diopter lenses are labeled as 11.0 diopter lenses which would result in a refractive error if implanted. _______________ PRODUCT VENTAK MINI AICD Automatic Implantable Cardioverter Defibrillators, Model 1746. Recall #Z-182-7. CODE Serial numbers 602154, 602157, and 602164. MANUFACTURER Guidant Corporation, Cardiac Pacemakers, Inc., St. Paul, Minnesota. RECALLED BY Manufacturer, by telephone on November 21, 1996, and by letter dated November 22, 1996. Firm-initiated recall complete. DISTRIBUTION Florida, New Jersey, New York. QUANTITY 3 units were distributed. REASON Devices do not have the required medical adhesive applied in the device's lead connector block. -10-_______________ UPDATE Recall #Z-147-7 which appeared in December 11, 1996, Enforcement Report should read: PRODUCT: 3M Model 3000 Modular Infusion Pump. REASON The pumps can disconnect from their modular connection systems and can fall to the floor. -11- END OF ENFORCEMENT FOR DECEMBER 26, 1996. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for