June 4, 1997 97-23 RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ============ _______________ PRODUCT Knaub's Cakes, « lemon pound. Recall #F-257-7. CODE All codes with manufacture date of earlier than 10/1/96 that are in commercial channels. MANUFACTURER Knaub's Cakes, Inc., York, Pennsylvania. RECALLED BY Manufacturer, by telephone on or about October 4, 1996. Ongoing recall resulted from sample analysis and followup by the New York State Department of Agriculture and Markets. DISTRIBUTION New York. QUANTITY 478 cases (12 cakes per case) were distributed. REASON Product contained undeclared FD&C Yellow #5. _______________ PRODUCT Pecan Chips, net weight 2 ounces. Recall #F-413-7. CODE Date code: 11-24-97, 11-25-97, 11-26-97, 11-27-97, 11-28-97, 12-1-97, 12-4-97, 12-8-97, 12-10-97, 12-12-97 - The date code is stamped on the bottom right corner of each package. MANUFACTURER Planters Company, Suffolk, Virginia. RECALLED BY Nabisco Inc., Parsippany, New Jersey, by letter dated February 3, 1997. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 23,338 cases (12 bags per case) were distributed; firm estimated that 3% of product remained on market at time of recall initiation. REASON Product contains undeclared milk. RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III =========== _______________ PRODUCT Isomil brand Soy Protein Infant Formula with Iron. Recall #F-414-7. CODE All lot numbers. Product expires in February 1998. MANUFACTURER Abbott Laboratories, The Netherlands. RECALLED BY First National Supermarkets, Inc., doing business as Finast Inc., Maple Heights, Ohio, by fax on September 10 and 16, 1996. Firm-initiated recall complete. DISTRIBUTION Ohio. QUANTITY 104 cases (6 cans per case) were distributed. REASON The infant formula does not contain the labeled amount of inositol, a nutrient required under 21 CFR section 107.100. This product was originally formulated for distribution in the United Kingdom which does not require the addition of inositol. _______________ PRODUCT Sunsweet Chopped Dates, in 10 ounce canisters. Recall #F-415-7. CODE Julian Date: Exp. Date: 3166 11MAY98 3176 12MAY98 3186 13MAY98 3196 14MAY98 3206 15MAY98 3406 05JUN98 3416 06JUN98 3446 09JUN98 0108 08JUL98 0107 10JUL98 0137 13JUL98 0157 15JUL98. MANUFACTURER Sunsweet Growers, Inc., Stockton, California. -2-RECALLED BY Manufacturer, by telephone on February 3, 1997. Firm initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 46,105 cases were distributed; 23,880 cases remained on market at time of recall initiation. REASON Product contains undeclared dextrose. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ============ _______________ PRODUCT Norpace Disopyramide Phosphate Capsules, 150 mg, in bottles of 100 and 1,000, Rx oral antiarrhythmic. Recall #D-182-7. CODE Lot numbers: 6B75B and 6B758A EXP 2/89. MANUFACTURER Searle, Caguas, Puerto Rico. RECALLED BY Searle, Skokie, Illinois, by letter dated May 8, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 9,000 100-capsule bottles and 1,668 1000-bottles were distributed; firm estimated that 10-25% of the product remained on market at time of recall initiation. REASON Some capsules may be partially filled. RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III =========== _______________ PRODUCT Panafil Ointment, in 1 pound jars, and 1 ounce tubes, Rx product intended for the treatment of acute or chronic lesions and infected wounds. Recall #D-181-7. CODE LOT PKG SIZE EXP DATE 0719P-1 pound jars Exp Aug 99 0719P-1 ounce tubes Exp Aug 99 0816P-1 ounce tubes Exp Sep 99. MANUFACTURER Rystan Company, Inc., Little Falls, New Jersey. RECALLED BY Manufacturer, by letter on October 30, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY Firm estimates none remains on the market. REASON Subpotent at stability testing. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======== _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-803/804-7. CODE Unit #24LH23822. -3-MANUFACTURER American Red Cross, Louisville, Kentucky. RECALLED BY Manufacturer, by letters dated October 16 and 20, 1995 and December 7, 1995. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 1 unit of each component REASON Blood products had undergone atypical viral testing for HIV and were then tested into compliance with no confirmatory test. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-809/810-7. CODE Unit #24GV21975. MANUFACTURER American Red Cross, Louisville, Kentucky. RECALLED BY Manufacturer, by letters dated December 21, 1995, and January 5, 1996. Firm-initiated recall complete. DISTRIBUTION Indiana and New Jersey. QUANTITY 1 unit of each component was distributed. REASON Blood products had undergone atypical viral testing for HBsAg and were then tested into compliance with no confirmatory test. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-811/812-7. CODE Unit #24LK21280. MANUFACTURER American Red Cross, Louisville, Kentucky. RECALLED BY Manufacturer, by letters dated December 16 and 20, 1995. Firm-initiated recall complete. DISTRIBUTION Indiana and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products had undergone atypical viral testing for HBsAg and were then tested into compliance with no confirmatory test. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-813/815-7. CODE Unit #24GV22380. MANUFACTURER American Red Cross, Louisville, Kentucky. RECALLED BY Manufacturer, by letters dated January 24 and 30, 1996. Firm-initiated recall complete. DISTRIBUTION Indiana and California. QUANTITY 1 unit of each component was distributed. REASON Blood products had undergone atypical viral testing for HBsAg and were then tested into compliance with no confirmatory test. -4-_______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-816/817-7. CODE Unit #24LX03326. MANUFACTURER American Red Cross, Louisville, Kentucky. RECALLED BY Manufacturer, by letters dated January 24 and 30, 1996. Firm-initiated recall complete. DISTRIBUTION Indiana and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products had undergone atypical viral testing for HBsAg and were then tested into compliance with no confirmatory test. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-818/819-7. CODE Unit #24GV22325. MANUFACTURER American Red Cross, Louisville, Kentucky. RECALLED BY Manufacturer, by letters dated January 24 and 30, 1996. Firm-initiated recall complete. DISTRIBUTION Indiana and California. QUANTITY 1 unit of each component was distributed. REASON Blood product had undergone atypical viral testing HIV and were then tested into compliance with no confirmatory test. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-820/821-7. CODE Unit #24LK22310. MANUFACTURER American Red Cross, Louisville, Kentucky. RECALLED BY Manufacturer, by letters dated January 24 and 30, 1996. Firm-initiated recall complete. DISTRIBUTION Indiana and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products had undergone atypical viral testing for HBsAg and were then tested into compliance with no confirmatory test. _______________ PRODUCT Red Blood Cells. Recall #B-822-7. CODE Unit #24LQ05996. MANUFACTURER American Red Cross, Louisville, Kentucky. RECALLED BY Manufacturer, by letter dated February 13, 1996. Firm-initiated recall complete. DISTRIBUTION Tennessee. QUANTITY 1 unit was distributed. REASON Blood product had undergone atypical viral testing for HBsAg and was then tested into compliance with no confirmatory test. -5-_______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-826/828-7. CODE Unit #24GS05529. MANUFACTURER American Red Cross, Louisville, Kentucky. RECALLED BY Manufacturer, by letter dated February 28, 1996. Firm-initiated recall complete. DISTRIBUTION Kentucky, Indiana, Illinois. QUANTITY 1 unit of each component was distributed. REASON Blood products had undergone atypical viral testing for HBsAg and were then tested into compliance with no confirmatory test. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-829/830-7. CODE Unit #24LC02286. MANUFACTURER American Red Cross, Louisville, Kentucky. RECALLED BY Manufacturer, by letter dated February 28, 1996. Firm-initiated recall complete. DISTRIBUTION Kentucky and Pennsylvania. QUANTITY 1 unit of each component was distributed. REASON Blood products had undergone atypical viral testing for HBsAg and were then tested into compliance with no confirmatory test. _______________ PRODUCT Red Blood Cells. Recall #B-831-7. CODE Unit #24LJ18935. MANUFACTURER American Red Cross, Louisville, Kentucky. RECALLED BY Manufacturer, by letter dated April 2, 1996. Firm-initiated recall complete. DISTRIBUTION Kentucky. QUANTITY 1 unit was distributed. REASON Blood product had undergone atypical viral testing for HBsAg and was then tested into compliance with no confirmatory test. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-832/833-7. CODE Unit #24LS15937. MANUFACTURER American Red Cross, Louisville, Kentucky. RECALLED BY Manufacturer, by letter dated March 29, 1996. Firm-initiated recall complete. DISTRIBUTION Kentucky and Pennsylvania. QUANTITY 1 unit of each component was distributed. REASON Blood products had undergone atypical viral testing for HBsAg and were then tested into compliance with no confirmatory test. -6-_______________ PRODUCT Red Blood Cells. Recall #B-834-7. CODE Unit #24GS13484. MANUFACTURER American Red Cross, Louisville, Kentucky. RECALLED BY Manufacturer, by letter dated April 2, 1996. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON Blood product had undergone atypical viral testing for HBsAg and was then tested into compliance with no confirmatory test. _______________ PRODUCT a) Whole Blood; b) Red Blood Cells; c) Recovered Plasma. Recall #B-835/837-7. CODE Unit numbers: a) 24LR01232; b) 24GW12345, 24LK19071, 24LZ09016, 24LE07707, 24LE30261, 24LE08409; c) 24GW12345, 24LK19071, 24LZ09016, 24LE07707, 24LE30261, 24LE08409. MANUFACTURER American Red Cross, Louisville, Kentucky. Recalled by Manufacturer, by letters dated October 17, and 23, 1996. Firm-initiated recall complete. DISTRIBUTION Indiana, Kentucky, California, Switzerland. QUANTITY a) 1 unit; b) 6 units; c) 6 units were distributed. REASON Blood products had undergone atypical viral testing for HBsAg and units were then tested into compliance with no confirmatory test. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Cryoprecipitate; e) Recovered Plasma. Recall #B-838/842-7. CODE Unit numbers: a) 24KM09887, 24LL34069, 24LK16585, 24LG55854; b) 24LL34069, 24LK16585; c) 24LK16585; d) 24KM09887, 24LG55854; e) 24KM09887, 24LL34069, 24LG55854. MANUFACTURER American Red Cross, Louisville, Kentucky. RECALLED BY Manufacturer, by letter dated April 8, 1996. Firm-initiated recall complete. DISTRIBUTION Indiana, Kentucky, California. QUANTITY a) 4 units; b) 2 units; c) 1 unit; d) 2 units; e) 3 units were distributed. REASON Blood products tested negative for antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1, Western Blot negative and was incorrectly reentered. -7-_______________ PRODUCT Red Blood Cells. Recall #B-843-7. CODE Unit #21FL15804. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by telephone on October 7, 1996. Firm-initiated recall complete. DISTRIBUTION Oregon. 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 anti-HCV. _______________ PRODUCT Platelets, Pheresis. Recall #B-844-7. CODE Unit #03LQ10771. MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia. RECALLED BY Manufacturer, by telephone on January 16, 1997. Firm-initiated recall complete. DISTRIBUTION Georgia. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an incorrect platelet yield. _______________ PRODUCT Red Blood Cells. Recall #B-845-7. CODE Unit #T72600. MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois. RECALLED BY Manufacturer, by telephone on March 26, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had been deferred for ear piercing. _______________ PRODUCT Red Blood Cells. Recall #B-847-7. CODE Unit #29FK22697. MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia. RECALLED BY Manufacturer, by letters dated February 21, 1997, and March 4, 1997. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit was distributed. -8-REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria. _______________ PRODUCT Red Blood Cells. Recall #B-848-7. CODE Unit #53FM16771. MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland. RECALLED BY Manufacturer, by letter dated March 4, 1997. Firm-initiated recall complete. DISTRIBUTION Maryland. 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-849-7 CODE Unit #18R64035. MANUFACTURER American Red Cross Blood Services, Lansing, Michigan. RECALLED BY Manufacturer, by letter dated October 19, 1995. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria. _______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-851/852-7. CODE Unit #81-03425. MANUFACTURER Michigan Community Blood Center, Traverse City, Michigan. RECALLED BY Manufacturer, by letter dated March 20, 1996. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria. ______________ PRODUCT Platelets. Recall #B-853-7. CODE Unit #38FC06170. MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana. RECALLED BY Manufacturer, by letter dated December 14, 1995. Firm-initiated recall complete. -9-DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====== _______________ PRODUCT Abbott HTLV-1 2.0 EIA diagnostic Kit, Human T-Lymphotropic Virus Type 1. Recall #B-735-7. CODE Lot #25685M301 EXP 7/11/97. MANUFACTURER Abbott Laboratories, Diagnostic Division, Abbott Park, Illinois. RECALLED BY Manufacturer, by telephone on April 25, 1997, and by letter dated April 28, 1997. Firm-initiated recall ongoing. DISTRIBUTION Arizona, Louisiana, New York, North Carolina, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Texas. QUANTITY 2 kits and 237 bulk tests were distributed. REASON HTLV-1 2.0 coated bead bottles contain inappropriate Corzyme beads. _______________ PRODUCT Streptokinase Kabikinase, a sterile purified preparation of bacterial protein elaborated by group C B-hemolytic streptococci: a) Streptokinase Kabikinase 250,000 IU; b) Streptokinase Kabikinase 1,500,000 IU. Recall #B-781/782-7. CODE Lot numbers: a) 14476A51, 14476B51, 14476C51; b) 14304A51, 14304D51. MANUFACTURER Pharmacia AB, Stockholm, Sweden. RECALLED BY Pharmacia & Upjohn Company, Kalamazoo, Michigan, by letter dated May 5, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY Approximately 16,000 vials were distributed. REASON Streptokinase Kabinase did not meet potency specification throughout the labeled shelf-life. _______________ PRODUCT a) HIV-1 Western Blot Kit; b) OraSure HIV-1 Western Blot Kit. Recall #B-783/784-7. CODE Lot numbers: a) M0613601, M0617602, M0625601, M0709601, M0719602, M0725601, M0813601, M0814601, M0815602, M0815603, M0910601, M0916601, M0919601, M1004602, M1009601, M1022601, M1101604 -10- b) M0730601, M0910602, M1016601, M1205601, M0117703. MANUFACTURER Epitope, Inc., Beaverton, Oregon. RECALLED BY Manufacturer, by letter on February 27, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY a) 3,654 kits; b) 712 kits were distributed. REASON High positive control vials were mislabeled as the conjugate vials for the test kits. _______________ PRODUCT Whole Blood. Recall #B-796-7. CODE Unit #C19760. MANUFACTURER South Bend Medical Foundation, Inc., South Bend, Indiana. RECALLED BY Manufacturer, by telephone on January 5, 1996. Firm-initiated recall complete. DISTRIBUTION Indiana. QUANTITY 1 unit was distributed. REASON Blood product tested positive for syphilis and was not labeled with "Biohazard" label. _______________ PRODUCT Red Blood Cells. Recall #B-797-7. CODE Unit #38W02971. MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana. RECALLED BY Manufacturer, by letter in February 1996. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled in an area considered endemic for malaria. _______________ PRODUCT Red Blood Cells. Recall #B-799-7. CODE Unit #FY70981. MANUFACTURER Inova Health Care Services, Annandale, Virginia. RECALLED BY Manufacturer, by telephone on October 22, 1996, followed by letter dated October 23, 1996. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit was distributed. REASON Blood product tested initially reactive for the hepatitis B surface antigen (HbsAg), and was not repeated in duplicate. -11-_______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B- 805/807-7. CODE Unit #13FN15443. MANUFACTURER American Red Cross, Detroit, Michigan. RECALLED BY Manufacturer, by letter dated February 26, 1997. Firm-initiated recall complete. DISTRIBUTION Michigan. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who exceeded the donation acceptance criterion for body temperature. _______________ PRODUCT Coulter HIV-1 p24 Antigen Elisa Test System. Recall #B-808-7. CODE Lot #2065J376. MANUFACTURER Coulter Corporation, Miami, Florida. RECALLED BY Manufacturer, by letter dated April 2, 1996. Firm-initiated recall complete. DISTRIBUTION California, Florida, Louisiana, Maryland, New York, Pennsylvania, Tennessee, Texas, Washington, state. QUANTITY 53 kits were distributed. REASON Antigen Test system with higher optical density (OD) negative control values than originally obtained, however, results were within labeled specifications. _______________ PRODUCT Fresh Frozen Plasma. Recall #B-846-7. CODE Unit #55C04488. MANUFACTURER American Red Cross Blood Services, Little Rock, Arkansas. RECALLED BY Manufacturer, by telephone on March 10, 1997. Firm-initiated recall complete. DISTRIBUTION Arkansas. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of whole blood with an extended collection time. _______________ PRODUCT Platelets for further manufacture. Recall #B-850-7. CODE Unit #18R64035. MANUFACTURER American Red Cross Services, Lansing, Michigan. RECALLED BY Manufacturer, by letter dated October 19, 1995. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. -12-REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria. _______________ PRODUCT Red Blood Cells for Further Manufacture. Recall #B-854-7. CODE Unit #38FC06170. MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana. RECALLED BY Manufacturer, by letters dated December 14, 1995, March 18, 1996, and April 12, 1996. Firm-initiated recall complete. DISTRIBUTION California. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ========== _______________ PRODUCT E.C.C. Neonatal Percutaneous Catheters and Trays: a) Fr. E.C.C. Neonatal Percutaneous Catheter Order No. 2184.00, b) Fr. E.C.C. Neonatal Percutaneous Catheter Tray Order No. 218400K,. Recall #Z-464/465-7. CODE a)Lot No. E28A51; b) Lot No. 3464 and Lot No. 4029. MANUFACTURER Vygon GmbH & Company, KG, Germany. RECALLED BY Vygon Corporation, East Rutherford, New Jersey, by telephone and by fax on July 19, 1996, and by letter on July 22, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide. QUANTITY 3,068 catheters were distributed. REASON Leaks are occurring at the integral section sets, at the point where the female luer lock hub is bonded to the extension. _______________ PRODUCT Multinex Plus ID, used to monitor gases in a patient: a) Multinex Plus ID b) Multinex Plus ID c) Multinex Plus ID d) Multinex Plus ID Recall #Z-586/589-7. CODE a) Model No. 0998-00-00071-17 b) Model No. 0098-00-00071-18 c) Model No. 0098-00-00071-19 -13- d) Model No. 0098-00-00071-20. MANUFACTURER Datascope Corporation, Paramus, New Jersey. RECALLED BY Manufacturer, by letter August 2, 1996. Firm-initiated field correction complete. DISTRIBUTION Nationwide and international. QUANTITY 876 units were distributed. REASON The labeling for the devices does not state that the Agent Identification mode should be disabled prior to injection of anesthesia gases. Failure to do so will cause erroneous CO2, N2O, and Agent readings. _______________ PRODUCT Vail Enclosed Bed System, used for the containment of patients who have been identified as being at risk and in need of physical, or chemical restraints: a) Vail 1000 Enclosed Bed System b) Vail 2000 Enclosed Bed System. Recall #Z-580/581-7. CODE Lot numbers: a) 100-194; b) 100-289. MANUFACTURER Vail Products, Inc., Toledo, Ohio. RECALLED BY Manufacturer, by mailing questionnaires on July 3, 1996 and by letter on April 9, 1997. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide. QUANTITY a) 131 bed systems; b) 262 bed systems were distributed. REASON Possible breakage of the spring mechanism within the bed side rails. This breakage may hinder the protective side rails from being placed in the upright position, and remain in that position. _______________ PRODUCT Vision FX Series Digital Nuclear Imaging systems, used to produce tomographic images of the body which can aid in the diagnosis of ailments such as cancer and heart disease: a) Model FX-40; b) Model FX-80. Recall #Z-626/627-7. CODE Serial numbers 93-96, 100-173, P2, and PP3. All vision FX series model numbers are affected. MANUFACTURER SMV America, Twinsburg, Ohio. RECALLED BY Manufacturer, by letter on March 19, 1997. Firm-initiated field correction ongoing. DISTRIBUTION Nationwide and international. QUANTITY 79 units were distributed. -14-REASON The collimator of the devices was sliding off the collimator server because it was difficult for the operator to determine when the collimator was properly engaged on the collimator server. This falling collimator problem may result in potential injuries to the operator and/or patient. _______________ PRODUCT Acromioplasty Electrode Basic Kit, Catalog #9801B, used in the shoulder area when performing an Acromioplasty. Recall Z-628-7. CODE Lot numbers: 58738 and 60683. MANUFACTURER Linvatec, Inc., Largo, Florida. RECALLED BY Manufacturer, by letter dated April 29, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and England. QUANTITY 904 kits were distributed. REASON Some kits may contain a Meniscectomy Electrode instead of the labeled Acromioplasty Electrode. ______________ PRODUCT Force Argon II Gas Delivery System (includes regulator) GR200 Pressure Regulator (for second argon bottle, used to provide energy delivery for argon-enhanced electrosurgery. Recall #Z-629/630-7. CODE Force Argon II System, Serial Nos. G6L101U through G7D160U; GR200 Regulator, Lot Nos. PCA563-03, 97095322, 9705322G, 9705323. MANUFACTURER Tescom, Minneapolis, Minnesota (regulator unit). RECALLED BY Valleylab, Inc., Boulder, Colorado, by telephone on May 2, 1997, followed by fax with confirming letters sent on May 2, 1997. Firm-initiated recall ongoing. DISTRIBUTION International. QUANTITY 3 units. REASON Under certain conditions, the high pressure regulator may fail and cause the hose on the low pressure side of the regulator to rupture, which could cause injury to patients, surgical personnel or service technicians. -15-_______________ PRODUCT AL-800PA Sp02 Module, used with the Nihon Kohden Multi-Parameter Patient Monitor, for pulseoxymetry monitoring in patients. Recall #Z-631-7. CODE All modules bearing serial number 06354 and below. MANUFACTURER Nihon Kohden, Inc., Irvine, California. RECALLED BY Manufacturer, by letter dated January 24, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide and international. QUANTITY 3,109 units were distributed. REASON Crosstalk (noise) between the LED driver circuit and the SpO2 sensing circuit is due to spatial limitations of the printed circuit board layout which caused an increase of the SpO2 sensing circuit offset current to give incorrect readings. _______________ PRODUCT Sensicare Non-Sterile Medical Examination Gloves, powder free. Recall #Z-632-7. CODE Catalog #484302A, Lot #0121637, Sublot #63753N (on individual boxes). MANUFACTURER Maxxim Medical, Inc., Los Gatos, California. RECALLED BY Manufacturer, by letter on April 16, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 819 cases of lot #0121637 and 59 cases of sublot #63753N were distributed. REASON The gloves are mislabeled as "Powder Free," which indicates the gloves do not contain powder. The gloves appear to have powder dusted on the interior surface. RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========= _______________ PRODUCT Hydron Proactive 55 (Ocufilcon D) Disposable Contact Lenses, in blister package that is put into a box. Recall #Z-625-7. CODE 2400516503, 2400516937, 2400516838, 2400516210, 2400516747, 2400517385, 2400516638, 2400517066, 2400516936, 2400516946, 2400516592, 2400516805, 2400517482, 2400516738, 2400516522, 2400516996, 2400517202, 2400516128, 2400516878, 2400516503. MANUFACTURER Ocular Science/American Hydron, San Francisco, California. -16-RECALLED BY Manufacturer, by telephone and by letter on April 24, 1997. Firm-initiated recall ongoing. DISTRIBUTION Nationwide. QUANTITY 1,577 boxes are subject to recall. REASON The wrong label on the blister is for the HYDRON PROACTIVE FW (POLYMACON) contact lens, however, the lens in the blister is a HYDRON PROACTIVE 55 contact lens. _______________ PRODUCT Measles (Rubeola) IgG ELISA Test Kit, an in-vitro diagnostic test kit for the detection of IgG antibody to the measles virus. Recall #Z-633-7. CODE Lot #2326000-114 EXP 5/97. MANUFACTURER Clark Laboratories, Inc., Jamestown, New York. RECALLED BY Manufacturer, by letter dated July 9, 1996. Firm-initiated recall complete. DISTRIBUTION Nationwide and international. QUANTITY 126 kits were distributed. REASON The calibrator was incorrectly labeled "Herpes simplex virus type 2 IgG ELISA" instead of "Measles (Rubeola) IgG ELISA". _______________ PRODUCT 2.5 mm Disposable Optical Valvulotome, Model #A5205, used for valve incision during in-situ saphenous vein arterial bypass procedures. Recall #Z-639-7. CODE Lot numbers: 95L268, R5N009, 96B137. MANUFACTURER Applied Medical Resources, Laguna Hills, California. RECALLED BY Manufacturer, by telephone followed by fax on on August 1, 1996. Firm-initiated recall ongoing. DISTRIBUTION Florida, Illinois, New Mexico, Spain. QUANTITY 9 units were distributed. REASON The product labeled as 2.5 mm disposable angioscopes but contain 2.5 mm disposable optical valulotomes. -17- END OF ENFORCEMENT REPORT FOR JUNE 4, 1997. BLANK PAGES MAY FOLLOW. ####End of Enforcement Report for