May 21, 1997 97-21 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ============ _______________ PRODUCT Island Oasis Frozen Strawberry Daiquiri Cocktail Mix, packed in quart cardboard containers. Recall #F-407-7. CODE Julian codes on or before: 2786 (ie. 2776, 2766, 2756, to 0016). (From product produced at Florida Juice Plant). Product coded as: 2226*, 2228*, 2229*, 2232*, 2270*, 2327* (From product produced at J.R. Wood Plant). Note: * refers to shift code (only the first four numbers are relevant). MANUFACTURERS Florida Juice, Lakeland, Florida; J.R. Wood, Inc., Atwater, California. RECALLED BY Island Oasis Frozen Cocktail Company, Inc., Walpole, Massachusetts, by telephone on April 11, 1997, followed by fax. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 40,154 cases (12 32-ounce containers per case) were distributed. REASON The product was processed from strawberry lots that were associated with a March 1997 illness outbreak of hepatitis A in Michigan. _______________ PRODUCT New West Foods brand Frozen Sliced Strawberries in 30 pound and 6.5 pound plastic pails. Recall #F-408-7. CODE Lot numbers: 30 pound pails: NW100662, NW011573, NW011574, N100461, N100462, N100463, N011572, N011573, and N011574; 6.5 pound pails: N072161, N072162, N072163, N072261, N072262, N072263, N072061, N072062, and N072063. MANUFACTURER New West Foods, Watsonville, California. RECALLED BY Manufacturer, by telephone followed by letters sent April 1 and 2, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and Canada. QUANTITY 89,432 30-pound containers and 26,360 6.5-pound containers were distributed. REASON The product was packed from strawberry lots that were associated with a March 1997 illness outbreak of hepatitis A in Michigan. _______________ PRODUCT (a) Frozen Strawberry Fruit Bar in 4 fluid ounce packs; (b) Frozen Strawberry Drink Mix in 64 fluid ounce containers. Recall #F-409/410-7. CODE The shipping cartons have the code which is a six digit date code. The date codes for the frozen fruit bars are: 10-07-96; 10-08-96; 10-10-96; 10-31-96 and 11-04-96. The date code for the drink mix is 10-14-96. MANUFACTURER Natural Fruit Corporation, Hialeah, Florida. RECALLED BY Manufacturer, telephone by telephone on or before April 16, 1997, followed by letter. Firm-initiated recall ongoing. DISTRIBUTION Nationwide, Puerto Rico, Canada. QUANTITY (a) 14,272 boxes (24 bars per box); (b) 172 cases (6-gallon jugs per case) were distributed. REASON These products were processed from one of the strawberry lots that was associated with a March 1997 illness outbreak of hepatitis A in Michigan. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ========== _______________ UPDATE Medeva's (Rochester, New York) Zaroxolyn Tablets (Metolazone Tablets USP), 2.5 unit dose, Recall #D-158-7, which appeared in the April 23, 1997 Enforcement Report has been extended to include lot #60750. -2-RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======= _______________ PRODUCT Source Plasma. Recall #B-456-7. CODE Unit #NF076782. MANUFACTURER Sera-Tec Biologicals Limited Partnership, Nutter Fort, West Virginia. RECALLED BY Sera-Tec Biologicals Limited Partnership, Harrisburg, Pennsylvania, by letter dated March 12, 1997. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported body piercing the day prior to donation. _______________ PRODUCT Red Blood Cells. Recall #B-457-7. CODE Unit #4524558. MANUFACTURER Life Source, Glenview, Illinois. RECALLED BY Manufacturer, by telephone on January 14, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor with a history of hepatitis A. _______________ PRODUCT Cryoprecipitate AHF. Recall #B-561-7. CODE Unit #2185159. MANUFACTURER Central Indiana Regional Blood Center, inc., Indianapolis, Indiana. RECALLED BY Manufacturer, by telephone on January 18, 1996. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON Blood product had an extended expiration date. _______________ PRODUCT Red Blood Cells. Recall #B-644-7. CODE Unit numbers: 55H43486, 55S69176, 55H39267, 55H36074. MANUFACTURER American Red Cross Blood Services, Little Rock, Arkansas. RECALLED BY Manufacturer, by telephone on September 5, 1996. Firm-initiated recall complete. DISTRIBUTION Arkansas. QUANTITY 4 units were distributed. REASON Blood products tested negative for the antibody to the hepatitis C virus encoded antigen (anti-HCV), but were collected from a donor who previously tested repeatedly reactive for anti-HCV. -3-_______________ PRODUCT (a) Red Blood Cells; (b) Cryoprecipitated AHF. Recall #B-652/653-7. CODE Unit #21GJ69700. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letter dated March 14, 1997. Firm-initiated recall complete. DISTRIBUTION California and Washington state. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with a history of Hodgkins Disease. _______________ PRODUCT Red Blood Cells. Recall #B-671-7. CODE Unit #6012121. MANUFACTURER Southern Oklahoma Blood Institute, Ardmore, Oklahoma. RECALLED BY Oklahoma Blood Institute, Oklahoma City, Oklahoma, by telephone and fax on November 24, 1995. Firm-initiated recall ongoing. DISTRIBUTION New York. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor who emigrated from an area considered endemic for malaria. _______________ PRODUCT Platelets, Pheresis. Recall #B-674-7. CODE Unit numbers: 53GP00989, 53GP00587. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated October 31, 1996. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 2 units were distributed. REASON Blood products were collected from a donor who traveled in an area considered endemic for malaria. _______________ PRODUCT Red Blood Cells. Recall #B-675-7. CODE Unit #7172108. MANUFACTURER Carter Blood Center, Fort Worth, Texas. RECALLED BY Manufacturer, by telephone on January 27, 1997, followed by letter dated February 4, 1997. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had been deferred for ear piercing within the previous 12 months. -4-_______________ PRODUCT Red Blood Cells. Recall #B-676-7. CODE Unit numbers: 11001932, 11001936, 11001941, 11001942, 14000273, 30000810, 30000811, 30000831, 31002929, 33001270, 33001308, 34002807, 34002815, 34002816, 34002820. MANUFACTURER W.E. and Lela I. Stewart Blood Center, Inc., Tyler, Texas. RECALLED BY Manufacturer, by telephone on October 29, 1996. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 15 units were distributed. REASON Blood products were prepared in a manner that could compromise the sterility of the products. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma. Recall #B-677/679-7. CODE Unit #8135810. MANUFACTURER LifeSource, Glenview, Illinois. RECALLED BY Manufacturer, by letter dated January 16, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois and Switzerland. QUANTITY 1 unit of each component. REASON Blood products were collected from a donor who reported a history of cancer. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma. Recall #B-680/682-7. CODE Unit #7461857. MANUFACTURER LifeSource, Glenview, Illinois. RECALLED BY Manufacturer, by letter dated February 12, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who reported a history of cancer. _______________ PRODUCT Red Blood Cells. Recall #B-683-7. CODE Unit #8530570. MANUFACTURER LifeSource, Glenview, Illinois. RECALLED BY Manufacture, by letter dated February 12, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. Quantity 1 unit was distributed. REASON Blood product was collected from a donor who reported a history of cancer. -5-_______________ PRODUCT Samplink Access Device, used during the blood donation process to obtain a sample of the donors blood from the bloodline. Recall #B-684-7. CODE Catalog #4R4215. All lots. MANUFACTURER Migada Ltd., Kiryat Shmona, Israel. RECALLED BY Migada, Inc., Englewood Cliffs, New Jersey, by letters dated March 10 and 12, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY Approximately 1,800,000 units were distributed. REASON When the latex cover is being retracted down past the lip that holds the cover onto the needle, the lip then prevents the latex cover from sliding back into place when the vacuum tube is removed from the needle. This leaves the needle unsealed, allowing blood to leak from the tip of the needle. Also, the needle is puncturing the side of the latex cover. This leaves the needle unsealed, allowing blood to leak from the tip of the needle. _______________ PRODUCT Red Blood Cells. Recall #B-685-7. CODE Unit numbers: 53FQ38126, 53GQ39718, 53GZ77973, 53GZ77977, 53GE04251, 53GE04252, 53GE04254, 53FC47822, 53FJ27576, 53GN84210, 53GZ78681. MANUFACTURER American Red Cross, Baltimore, Maryland. RECALLED BY Manufacturer, by telephone on July 7, 13, 14, 18, 1995, and by letters dated July 27, August 2, 24, and 28, 1995. Firm-initiated recall complete. DISTRIBUTION Maryland, Pennsylvania, District of Columbia. QUANTITY 11 units were distributed. REASON Blood products carried an extended expiration date due a computer error. _______________ PRODUCT (a) Red Blood Cells; (b) Red Blood Cells, Leukocyte free; (c) Platelets; (d) Recovered Plasma. Recall #B-686/689-7. CODE Unit numbers: (a) 152-9633, 214-6277, 300-2130, 300-2452, 300-2620, 300-2782, 300-3050, 300-3902, 300-4349, 300-4856, 300-5616, 321-0134, 321-0436, 321-2456, 321-4277, 321-4907, 321-7307; -6- (b) 300-4267, 300-4279, 300-4810, 300-4528, 300-4832, 300-5436, 300-5625, 300-5636, 300-5714, 300-5734; (c) 152-9633, 300-2782, 300-4279, 300-4528, 300-4922, 300-5636, 300-5714, 300-5734; (d) 152-9633, 214-6277, 321-2456, 321-4277, 321-4907, 321-7307. MANUFACTURER Sylvan N. Goldman Center, Doing business as Oklahoma Blood Institute, Oklahoma City, Oklahoma. RECALLED BY Manufacturer, by fax on September 3-5, 1996, followed by letter dated February 24, 1997. Firm-initiated recall complete. DISTRIBUTION Oklahoma, Massachusetts, Rhode Island, Texas, Switzerland. QUANTITY (a) 17 units; (b) 10 units; (c) 8 units; (d) 6 units were distributed REASON Blood products were mistakenly collected from permanent deferred donors and inappropriately released. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma. Recall #B-690/692-7. CODE Unit #1890155. MANUFACTURER LifeSource, Glenview, Illinois. RECALLED BY Manufacturer, by letter dated March 10, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit of each component. REASON Blood products were collected from a donor who reported a history of cancer. _______________ PRODUCT Red Blood Cells. Recall #B-694-7. CODE Unit #9746022. MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, Ohio. RECALLED BY Manufacturer, by letter dated November 20, 1996. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported emigrating from an area considered endemic for malaria. _______________ PRODUCT Red Blood Cells. Recall #B-695-7. CODE Unit #21GF94751. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by telephone on January 23, 1997. Firm-initiated recall complete. DISTRIBUTION Washington state. -7-QUANTITY 1 unit was distributed. REASON Blood product had a satellite bag attached in a manner that could compromise the sterility of the product. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma. Recall #B-696/698-7. CODE Unit #8406414. MANUFACTURER Community Blood Centers of South Florida, Inc., Lauderhill, Florida. RECALLED BY Manufacturer, by fax or by telephone on February 13, 1995. Firm-initiated recall complete. DISTRIBUTION Florida, New York, Massachusetts. QUANTITY 1 unit of each component. REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 2 (anti-HIV-2), but was collected from a donor who previously tested initially reactive for anti-HIV-2. _______________ PRODUCT (a) Red Blood Cells; (b) Red Blood Cells - Leukocytes Reduced; (c) Platelets; (d) Fresh Frozen Plasma. Recall #B-699/702-7. CODE Unit numbers: (a) 8472505, 8472511, 8472517, 8472552; (b) 8472484; (c) 8472484, 8472505, 8472511, 8472517, 8472552; (d) 8472484, 8472505, 8472511, 8472517, 8472552. MANUFACTURER Community Blood Centers of South Florida, Inc., Lauderhill, Florida. RECALLED BY Manufacturer, by fax or telephone between May 23-26, 1995. Firm-initiated recall complete. DISTRIBUTION Florida and New York. QUANTITY (a) 4 units; (b) 1 unit; (c) 5 units; (d) 5 units were distributed. REASON Blood products, corresponding to Platelets which were contaminated with a gram negative bacteria suspected to be Serratia marcescens, were distributed. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT Red Blood Cells. Recall #B-458-7. CODE Unit #3551326. MANUFACTURER LifeSource, Glenview, Illinois. RECALLED BY Manufacturer, by telephone on February 21, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. -8-REASON Blood product was labeled with an extended expiration date. _______________ PRODUCT (a) Coulter HIV-1 p24 Antigen Neutralization Kit; (b) Coulter HIV-1 p24 Antigen Assay; (c) Coulter HIV-1 p24 Antigen ELISA Test System. Recall #B-564/566-7. CODE All lots, MANUFACTURER Coulter Corporation, Miami, Florida. RECALLED BY Manufacturer, by letter February 10, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 25,187 kits were distributed. REASON The reconstituted Positive Antigen Reagent product may not remain stable over the period indicated in the product labeling. _______________ PRODUCT Red Blood Cells. Recall #B-641-7. CODE Unit #2669075. MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas. RECALLED BY Manufacturer, by fax on February 15, 1995. Firm-initiated recall complete. DISTRIBUTION Texas and Florida. QUANTITY 1 unit was distributed. REASON Blood product tested negative for the antibody to the hepatitis C virus encoded antigen (anti-HCV), but was collected from a donor who previously tested repeatedly reactive for the anti-HCV. _______________ PRODUCT Blood Transfer Bag (150 ml Quad Set with attached 600 ml bag). Recall #B-664-7. CODE Catalog #T3605, Lot #954045. MANUFACTURER CharterMed, Inc., Lakewood, New Jersey. RECALLED BY Manufacturer, by telephone followed by letter on December 29, 1995. Firm-initiated recall complete. DISTRIBUTION Indiana, New York, Virginia. QUANTITY 1,848 units were distributed. REASON Improper assembly of blood collection bags resulted in unrestricted blood flow into the wrong blood bag. _______________ PRODUCT Red Blood Cells. Recall #B-693-7. CODE Unit numbers: 53Y64165, 53LN09976, 53LN09977, 53F08187, 53F08186. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. -9-RECALLED BY Manufacturer, by telephone on July 26, 1996. Firm-initiated recall complete. DISTRIBUTION Maryland. QUANTITY 5 units were distributed. REASON Blood products were labeled with an extended expiration date. _______________ PRODUCT Red Blood Cells, Irradiated. Recall #B-717-7. CODE Unit 29442-3339. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Manufacturer, by letter dated March 4, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit. REASON Blood product was held at an unacceptable temperature and was released for distribution. _______________ PRODUCT Platelets, Pheresis. Recall #B-719-7. CODE Unit numbers: LP11046-P51, LP11046-P52, LP11049-P51, LP11049-P52, LP11052-P51, LP11052-P52, LP11058-P52, LP11064-P52, LP11068-P51, LP11068-P52. MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri. RECALLED BY Manufacturer, by telephone on September 9, 1996. Firm-initiated recall complete. DISTRIBUTION Missouri. QUANTITY 10 units. REASON Unlicensed blood products were distributed, labeled with the firm's license number. _______________ PRODUCT Platelets, Pheresis. Recall #B-720-7. CODE Unit #03FH05603. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by telephone on December 16, 1996. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY 1 unit was distributed. REASON Blood product was stored at an unacceptable temperature. _______________ PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-723/724-7. CODE Unit #9316269. MANUFACTURER Florida Blood Services, Inc., St. Petersburg, Florida. RECALLED BY Manufacturer, by telephone/orally on May 9, 1996. Firm-initiated recall complete. -10-DISTRIBUTION Florida. QUANTITY 1 unit of each component was distributed. REASON Blood products tested negative for the antibody to the hepatitis B core antigen (anti-HBc), but were collected from a donor who previously tested repeatedly reactive for anti-HBc. _______________ PRODUCT Fraction IV-1 Paste (Plasma Fraction Intermediate). Recall #B-744-7. CODE Lot #963002. MANUFACTURER V.I. Technologies, Inc. (VITEX), also konwn as Melville Biologicals, Inc., Melville, New York. RECALLED BY Manufacturer, by telephone on August 23, 1996, followed by letter on March 25, 1997. Firm-initiated recall ongoing. DISTRIBUTION North Carolina. QUANTITY 42.1kg was distributed. REASON Fractionated products with detectable levels of ethylene glycol were distributed. .RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========= _______________ PRODUCT Vacutainer brand Lok-on Needle Disposal Container, designed to lock the needle and needle holder onto the container. Recall #Z-462-7. CODE Catalog #366223, involve Lot #'s 5H602, 5H603, 5J604, 5J605, 5J606, 5K600, 5L600, 5L601, 5L602, 5M600, 6A600, 6A601, 6A602, 6C600, 6C601, 6D602, 6D603, 6E600, 6E601, 6F601. MANUFACTURER Becton Dickinson Vacutainer Systems, Sumter, South Carolina. RECALLED BY Becton Dickinson Vacutainer Systems, Franklin Lakes, New Jersey, by letters on October 21 and 31, 1996. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 58,350 units were distributed. REASON The device to be adulterated in that some of the containers have been manufactured with a defective needle removal device (blue insert) which may break, causing the needle holder to permanently lock to the container. _______________ PRODUCT BMW Clampless Valved Venous Catheters: (a) Clampless Valved Catheter-Tunneled (CVC-T ) Catalog Nos.: CVC421 CO, CVC421 1K, CVC661 CO,CVC661 1K, CVC961 CO, CVC961 1K; -11- (b) Clampless Valved-PICC (CV-PIC) Catalog Nos.: PIC401 1K, PIC501 1K; (c) Clampless Valved Midline-Catheter (CV-MLC) Catalog Number: MLC401 1K. Recall #Z-466/468-7. CODE All lots. MANUFACTURER BMW Medical Inc., Salt Lake City, Utah. RECALLED BY Manufacturer, by letter on April 2, 1997, followed by fax on April 8, 1997. Firm-initiated recall ongoing. DISTRIBUTION Alabama, California, Colorado, Indiana, New Jersey, Massachusetts, Maryland, Michigan, Missouri, Pennsylvania, South Carolina, Texas, Washington state. QUANTITY 53 cases (10 units per case) were distributed. REASON The catheters have potentially defective molded female hubs which can result in a crack developing after repeated cleaning with alcohol. _______________ PRODUCT Diagnostic X-Ray System - CompuGen Systems, used for general purpose radiography: (a) Model No. WWG0301 X-Ray Control Console; (b) Model No. WWG0302 Power Unit; (c) Model No. WWG0303 High Voltage Generator; (d) Model No. WWG0310 Under/Over Power Unit; (e) Model No. WWG4001 X-Ray Control Console; (f) Model No. WWG4002 Power Unit; (g) Model No. WWG4003 High Voltage Generator; (h) Model No. WWG4010 Under/Over Power Unit; (i) Model No. WWG0351 X-Ray Control (50 hz); (j) Model No. WWG0352 Power Unit (50 hz); (k) Model No. WWG0350 Under/Over Power Unit (50 hz); (l) Model No. WWG4051 X-Ray Control Console (50 hz); (m) Model No. WWG4052 Power Unit (50 hz); (n) Model No. WWG4050 Under/Over Power Unit (50 hz). Recall #Z-517/530-7. CODE See Model numbers above. MANUFACTURER Wuestec Medical, Inc., Mobile, Alabama. RECALLED BY Manufacturer. FDA approved the firm's corrective action plan on May 9, 1997. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY All units manufactured prior to March 26, 1996. -12-REASON The diagnostic x-ray devices were found noncompliant with 21 CFR 1010.2 AND 1010.3 of the Federal Performance Standard for Diagnostic X-Ray System and Their Major Components. Some of the devices were improperly identified and certified to the diagnostic x-ray standard. _______________ PRODUCT Mobile Radiographic Systems, intended for portable use in making film radiographs in a hospital environment: (a) Lorad Model RT 125 OEM, Serial Nos. 38001-380068; (b) Philips Model X-Ray 2000, Serial Nos. 1500496001-1500397027; (c) Philips PRACTIX 2000; (d) Bennet HMX (High Frequency Mobile Radiographic System), Model HMX-5, Serial Nos. 94-37-001 through 96-37-467. Recall #Z-550/553-7. CODE Devices manufactured prior to October 1996. (See serial numbers above). MANUFACTURER Lorad Corporation, Danbury, Connecticut. RECALLED BY Manufacturer, by letter on April 14, 1997. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY 70 Lorad RT 125 units; 491 Philips-200/PRACXTIX units; and 22 Bennet HMX-5 units were distributed. REASON The radiographic units may be subject to unanticipated movement. _______________ PRODUCT Vitros Hb DT Slides, used to measure the concentration of hemoglobin in blood. Recall #Z-563-7. CODE Vitros Hb DT Slides, Catalog No. 125 1453, GEN 75 - All lots starting with 2175-00052-xxxx, GEN 76 - All lots starting with 2176-00056-xxxx; GEN 77 - All lots starting with 2177-00057-xxxx. MANUFACTURER Johnson & Johnson Clinical Diagnostics, Inc., Rochester, New York. RECALLED BY Manufacturer, by letter dated March 31, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 23,520 boxes (25 slides per box) were distributed. -13-REASON The hemoglobin results were biased to the reference method. _______________ PRODUCT Kendall Curity Spinal Anesthesia Tray, sterile, Reorder #4761. Recall #Z-566-7. CODE Lot #AD8372KG. MANUFACTURER Especialidades Medicas Kenmex, Tiajuana, Mexico. RECALLED BY Kendall Healthcare Products Company, Mansfield, Massachusetts, by telephone on April 7, 1997, followed by letter dated April 8, 1997. Firm-initiated recall ongoing. DISTRIBUTION Alabama, California, Georgia, Mississippi. QUANTITY 310 units were distributed. REASON The tray contained Xylocaine MPF 5% with Glucose 7.5%, 2 ML instead of Bupivacaine Hydrochloride 0.75 with Dextrose 8.25%, 2ML. _______________ PRODUCT Sentry Medical Products Heparin-Bonded Polyurethane Umbilical Vessel Catheters and Trays with Catheters: (a) 3.5 F Heparin-Bonded Polyurethane Catheter, Reorder Nos. 15000350 and MC0040; (b) 5.0 F Heparin-Bonded Polyurethane Catheter, Reorder Nos. 1500500 and MC00050; (c) Insertion Tray with Catheter (3.5 F), Reorder Nos. 1502350 and MT00010; (d) Insertion Tray with Catheter (5.0 F), Reorder Nos. 1502500 and MT00020. Recall #Z-567/570-7. CODE Sentry LTP Sentry LTP p/n p/n lot # lot # 1500350 MC0040 056649 904641 056413 904640 055544 904478 056695 904764 1500500 MC00050 055554 904697 055553 904731 055559 904765 057396 904826 1502350 MT00010 055550 904639 055549 904636 055525 904444 056764 904698 056414 904763 1502500 MT00020 055555 904699 055556 904724 055556 904725 055560 904761 057213 904829. -14-MANUFACTURER Kendall Sheridan, Argle, New York. RECALLED BY Ludlow Technical Products, Chicopee, Massachusetts, by telephone on April 15, 1997, followed by letter issued April 24, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 245 cases were distributed. REASON The lumens of the catheters are occluded by Benzalkonium Heparin Coating and cannot flush correctly. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======== _______________ PRODUCT Comfortec Disposable pH Probes, used for monitoring pH levels in the esophagus. Recall #Z-571-7. CODE Catalog numbers: NIS, NID5, NID10, NID15, NID21, IIS, IID5, IID10, IID15, IID21. Lot numbers: 1996 Lots: 601, 602, 603, 604, 605, 606, 607, 608, 609, 610, 611, 612. 1997 Lots: 701, 702, 703, 704. MANUFACTURER Alpine Biomed Corporation, Santa Ana, California. RECALLED BY Sandhill Scientific, Inc., Highlands Ranch, Colorado, by letter sent on April 29, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Firm estimated that 400-500 probes remained at customer locations at time of recall initiation. REASON A precipitate may form on the probe connector leads and break the signal path between the probe and the data logger, resulting in loss of signal. _______________ PRODUCT All-in-One Laparoscopic Hand Control, Catalog #0055. Recall #Z-582-7. CODE Lot #2400. MANUFACTURER MegaDyne Medical Products, Inc., Draper, Utah. RECALLED BY Manufacturer, by fax on August 19, 1996, followed by letter on August 20, 1996. Firm-initiated recall complete. DISTRIBUTION California, Colorado, Florida, Georgia, Kentucky, Louisiana, Massachusetts, Minnesota, Missouri, Montana, Ohio, Pennsylvania, Texas, Virginia, and international. QUANTITY 825 units were distributed. -15-REASON Device was distributed and labeled as "E-Z CLEAN 2.5" BLADE ELECTRODE FOR ALL-IN-ONE HANDLE, Catalog No. 0066", instead of the correct identification, "ALL-IN-ONE LAPAROSCOPIC HAND CONTROL, Catalog No. 0055". RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III ========== _______________ PRODUCT Vigortone VigorGlo 22 CTC Milk Replacer Medicated, (chlortetracycline) for aid in the prevention of bacterial calf diarrhea. Recall #V-038-7. CODE Lot numbers: 7B06H15, 7B06H14, 7B13H08, 7B20H10, 7B28H11, 7C07H09, 7C10H02-06, 7C11H09, 7C13H14, 7C24H50. MANUFACTURER Milk Specialties Company, Dundee, Illinois. RECALLED BY Manufacturer, by telephone on April 4 and 8, 1997. Firm-initiated recall complete. DISTRIBUTION Iowa, Nebraska, Ohio. QUANTITY 1,867 50-pound bags were distributed. REASON Product was mislabeled -- 1,500 bags were mislabeled to contain 150 g/ton chlortetracycline instead of 20 g/ton chlortetracycline. MEDICAL DEVICE SAFETY ALERTS: ============================== _______________ PRODUCT 3M Sarns Sternal Saw II System, used during chest surgery. Safety Alert #N-014-7. CODE Part #98-0702-0597-0. MANUFACTURER 3M Health Care, Ann Arbor, Michigan. ALERTED BY Manufacturer, by letter of April 24, 1997. DISTRIBUTION Nationwide and international. QUANTITY Undetermined. REASON Use of Komet Medical's KM-278 and KM-278N blades are not to be used with the 3M Starns Sternal Saw II System, because they are not suitable replacement for the 3M Sarns 5589 and 5755 blades, as specified by Komet Medical. These blades do not fit into the chuck properly and may not stay attached to the saw and be expelled during use. -16- END OF ENFORCEMENT REPORT FOR MAY 21, 1997. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for