NRAC Issue # 1282 March 7, 2000 NATIONAL RECALL ALERT CENTER - IMMEDIATE WARNING ALERT NOTIFICATION THE FOLLOWING HAVE BEEN RECALLED OR ARE SUBJECT TO FIELD CORRECTION THIS LISTING IS ISSUED BY - NATIONAL RECALL ALERT CENTER, WASHINGTON, D.C. --------------------------------------------------------------------------- PRODUCT Premier Platinum HPSA, an ELSIA assay for the detection of Helicobacter pylori antigens in stool, Product #601348. Recall NUMBER #Z-411-0. CODE Lot #601348.024 MANUFACTURER Meridian Diagnostics, Inc., Cincinnati, Ohio. RECALLED BY Manufacturer DISTRIBUTION Alabama, Arizona, California, Georgia, Iowa, Kansas, Michigan, Montana, New Jersey, New York, Ohio, Oregon, Texas, Utah, Wisconsin, Florida, Honduras, Chile, Japan, German, Italy. QUANTITY 457 test kits were distributed. REASON The kits may contain microwells intended for detection of C. difficile Toxin A. --------------------------------------------------------------------------- PRODUCT Tecan Genesis Disposable Tip. Recall NUMBER #Z-309-0. CODE Catalog #71-705, Lot Numbers: 15169, 16169, 17169, 11179, 25169, 26169, 27169, 35169, 36169, 37169. MANUFACTURER Eppendorf, Hamburg, Germany. RECALLED BY Tecan U.S. Inc., Durham, North Carolina DISTRIBUTION Arizona, California, Florida, Illinois, Wisconsin. QUANTITY 2,720 boxes were distributed. REASON Manufacturing error - Crack in 1000ul tip. --------------------------------------------------------------------------- PRODUCT Deltec Port-A-Cath II Polysulfone/Titanium Venous System, Product #21-4065-01. The product trays each contain a portal, a catheter and an introducer set, for the delivery of fluids and drugs. Recall NUMBER #Z-415-0. CODE Lot numbers: 66947, 67687, 67946 and 68378. MANUFACTURER Sims Deltec, Inc., St. Paul, Minnesota. RECALLED BY Manufacturer DISTRIBUTION Nationwide. REASON Separation of the catheter from the drug portal can result in leaks. --------------------------------------------------------------------------- PRODUCT Smit Sleeves, an accessory to various applicators used with the Nucletron mHDR afterloader, a plastic tube with drainage holes inserted into endometrium and may be sutured into place to allow cervix to remain dilated for easier reinsertion of intrauterine tube for subsequent treatment. Part #'s 086.047 and 086.048. Recall NUMBER #Z-413/414-0. CODE Lot #'s 480301 to 490908. MANUFACTURER NUCLETRON BV, The Netherlands. RECALLED BY Nucletron, Columbia, Maryland DISTRIBUTION Nationwide. QUANTITY 1,061 units were distributed REASON Brachytherapy applicator sleeve may become disconnected during treatment. --------------------------------------------------------------------------- PRODUCT Chemical-Shift Imaging (CSI) Spectroscopy, Model 90LNI. Recall NUMBER #Z-412-0. CODE Serial Numbers: AF212E, BA109P, BA218P, BA103P, AF165E, AF157EU, BA183P, BA118P, BA182P, BA164D, BA178P, BA114P, BA225P, BA187P, AF113EU, BB104P, BA110P, BA131D, and BA192D. MANUFACTURER Marconi Medical Systems, Inc., Highland Heights, Ohio. RECALLED BY Manufacturer DISTRIBUTION Florida, Maryland, Massachusetts, Utah, Arizona, Australia, Italy, Germany, Japan, China and England. REASON Due to a software anomaly, the device acquires data from a slice thicker than intended, and may not be at isocenter. --------------------------------------------------------------------------- PRODUCT EBI XFIX Dynafix DFS Hybrid Fixator, designed for the stabilization of intra and peri-articular fractures where the fracture pattern and available bone stock precludes the introduction of larger diameter bone screws: a) Variable Wire Carriage (Part No. 13070); b) Variable Bone Screw (Part No. 13080). Recall NUMBER #Z-409/410-0. CODE All lot numbers - Products produced from 8/11/97 to 6/23/99. MANUFACTURER EBI, L.P., Parsippany, New Jersey. RECALLED BY Manufacturer NOTE THIS IS A FIELD CORRECTION DISTRIBUTION Nationwide, Spain, Puerto Rico. QUANTITY a) 7,000 units; b) 3,241 units were distributed. REASON The carriage locking bolt component for both devices can break, potentially resulting in the loss of fracture reduction/ distraction postoperatively. --------------------------------------------------------------------------- PRODUCT a) 2-way MainFrame Interface Software Version 22.20; b) Pediatric Therapy Guide Version 4.10. Recall NUMBER #Z-405/406-0. CODE Part Numbers: 9800-2666 and 9800-0630; Catalog Numbers: B1018-15 and B1011-30. MANUFACTURER Dade Microscan Inc., West Sacramento, California. RECALLED BY Manufacturer NOTE THIS IS A FIELD CORRECTION DISTRIBUTION Nationwide and international. REASON Potential for incorrect Pediatric Reports--A software problem. --------------------------------------------------------------------------- PRODUCT Chrome plated brass circumcision clamps, gomco like, made in Pakistan, individually packaged clamps in boxes labeled only with the catalog number, description, size and quantity. Recall NUMBER #Z-402/404-0. CODE All units of the following clamps Catalog #83928, 1.1 cm, Extra Small Catalog #83929, 1.3 cm, Newborn Catalog #83930, 1.6 cm, Child. MANUFACTURER Gogi Enterprises, Sialkot, Punjab, Pakistan. RECALLED BY Medco Instruments, Inc., Crestwood, Illinois DISTRIBUTION Nationwide. QUANTITY 2,000 clamps were distributed. REASON Lack of 510(k) approval, inadequate instructions for use, and failure to file MDRs. --------------------------------------------------------------------------- PRODUCT Infinity Modular Bedside Monitors, Models SC7000, SC8000, SC9000, SC9000XL, intended for adult, pediatric, and neonatal monitoring of clinical environment. Recall NUMBER #Z-399/401-0. CODE Infinity Modular Monitors: SC7000, SC8000, SC9000, SC9000XL with software versions VEO, VEO.1 or VEO.2 MANUFACTURER Siemens Medical Systems, Inc., Danvers, Massachusetts. RECALLED BY Manufacturer NOTE THIS IS A FIELD CORRECTION DISTRIBUTION Arkansas, Arizona, California, Florida, Kentucky, Georgia, Illinois, Michigan, New Mexico, New York, Ohio, South Dakota, Tennessee, Texas. DISTRIBUTION 140 units were distributed. REASON Failure to correctly re-calculate drug dosage using saved Drug Dosage Data. --------------------------------------------------------------------------- PRODUCT a) Single Channel b) Triple Channel Volumetric Infusion Pumps, for continuous or intermittent fluid delivery through clinically acceptable routes of administration. Recall NUMBER #Z-397/398-0. CODE All serial numbers of the following pumps a) Colleague Infusion Pump - Single Channel Product code 2M8151 - U.S. Distribution; 2M8151R - Refurbished, U.S. Distribution; 2M8151K - CE Marked, English language; FKM8151 - English language; HNM8151 - CE marked, German language; PNM8151 - CE marked, Spanish language; DNM8151 - CE marked, French language; b) Colleague 3 Infusion Pump - Triple Channel Product code 2M8153 - U.S. distribution; 2M8153R - Refurbished, U.S. distribution. MANUFACTURER Baxter Healthcare PTE., Ltd., Singapore. Namiki Precision Jewel Company Ltd., Tokyo, Japan (motors). RECALLED BY Baxter Healthcare Corporation, Round Lake, Illinois DISTRIBUTION Nationwide and international. QUANTITY 78,000 pumps were distributed. REASON Motors burn out at 15-18 months of age. --------------------------------------------------------------------------- PRODUCT Tina System 1000 and Altra Touch 1000 Single Patient Hemodialysis Delivery Systems. Recall NUMBER #Z-395/396-0. CODE All serial numbers 12,500 and below. MANUFACTURER Althin Medical, Inc., Miami Lakes, Florida. RECALLED BY Manufacturer DISTRIBUTION Nationwide and international. QUANTITY 4,972 units were distributed nationally and 695 units were distributed internationally. REASON Linear clamp may not achieve proper occlusion. --------------------------------------------------------------------------- PRODUCT Konica MD-100 Mammography Screens, indicated for use as an accessory to a cassette to convert x-ray energy into light energy. Recall NUMBER #Z-382-0. CODE Lot Numbers 8J**** and 5A****. MANUFACTURER Konica Medical Imaging, Inc., Wayne, New Jersey. RECALLED BY Manufacturer DISTRIBUTION California, Connecticut, Florida, Missouri, New York, Oregon, Texas. REASON The screens cause negative densities on the x-ray film, which could result in a misreading. --------------------------------------------------------------------------- PRODUCT Vitalcom ST Segment Arrhythmis Detection Software Option, an Optional ECG software feature used in conjunction with the Critikon Observer Central Station on which is installed. There are 12 models or catalog numbers of the software option involved as follows: 88951-8 Patient Arrhythmia, S-T, 24 hour Disclosure Software (Hardwire) 88961-8 Patient Arrhythmia, S-T, 1 hour Disclosure Software (Hardwire) 88971-4 Patient Arrhythmia, S-T, 24 Hour Disclosure Software (Hardwire) 88991-4 Patient Arrhythmia, S-T, 1 Hour Disclosure Software (Hardwire) 88911-8 Patient Arrhythmia, S-T, 24 Hour Disclosure Software (900MHz) 88921-8 Patient Arrhythmia, S-T, 1 Hour Disclosure Software (900 MHz) 88931-4 Patient Arrhythmia, S-T, 24 Hour Disclosure Software (900 MHz) 88941-4 Patient Arrhythmia, S-T, 1 Hour Disclosure Software (900 MHz) 88821-8 Patient Arrhythmia, S-T, 24 Hour Disclosure Software (VHF) 88831-8 Patient Arrhythmia, S-T, 1 Hour Disclosure Software (VHF) 88841-4 Patient Arrhythmia, S-T, 24 Hour Disclosure Software (VHF) 88851-4 Patient Arrhythmia, S-T, 1 Hour Disclosure Software (VHF). Recall NUMBER #Z-383/394-0. CODE The only reference numbers are the Catalog Numbers listed here. MANUFACTURER Vital Com, Tustin, California (software). RECALLED BY Critikon Company LLC, Tampa, Florida (distributor) NOTE THIS IS A FIELD CORRECTION DISTRIBUTION Tennessee, Texas, Missouri, Georgia, Wisconsin, Illinois, South Carolina, Ohio, Alabama, Egypt. REASON The software validation of version 4.01R1 a software anomaly was found that affected the proper function of a print option. --------------------------------------------------------------------------- PRODUCT NC-4 Microscope Stand. Recall NUMBER #Z-372-0. CODE Non-sequential Serial Numbers 31352 through 313654. MANUFACTURER Carl Zeiss, Inc., Oberkochen, Germany. RECALLED BY Carl Zeiss, Inc., Thornwood, New York DISTRIBUTION Nationwide and international REASON The vertical carrier arm has the potential to break causing the device to become inoperative. --------------------------------------------------------------------------- PRODUCT Image X 70 Dental X-Ray System, used in dental radiography. Recall NUMBER #Z-361-0. CODE Model Image X 70. MANUFACTURER De Gotzen S.r.l. Legnano, Italy. RECALLED BY AFP Imaging Corporation, Elmsford, New York. NOTE THIS IS A FIELD CORRECTION DISTRIBUTION Nationwide. QUANTITY Approximately 2,400 units. REASON The diagnostic x-ray devices were found defective under 21 CFR 1003.11. The defect occurs as a result of incomplete equipment specifications and labeling on equipment manufactured by de Gotzen S.r.l., Legnano, Italy for DENTX (a subsidiary of AFP). --------------------------------------------------------------------------- PRODUCT Sodium Iodide Capsules, Rx for diagnosing thyroid irregularities, packaged in 5-capsule packs: a) I-123, 7.4 MBq (200 microCi) Capsules; b) I-123, 3.7 MBq (100 microCi) Capsules. Recall NUMBER #D-226/227-0. CODE Lot. Numbers: a) I-3306-1C2; b) I-3306-1C1 MANUFACTURER Syncor Pharmaceuticals, Inc. Golden, Colorado. RECALLED BY Manufacturer DISTRIBUTION Nationwide. REASON Incorrect date of calibration printed on labeling. --------------------------------------------------------------------------- PRODUCT Seroquel (Quetiapine Fumarate) 25 mg Tablets, in 100-tablet bottles/12 bottles per case, Rx oral medication for the management of the manifestations of psychotic disorders, including schizophrenia. NDC #0310-0275-10. Recall NUMBER #D-225-0. CODE 4750B EXP 10/01. MANUFACTURER AstraZeneca, Newark, Delaware. RECALLED BY AstraZeneca Pharmaceutcials, Wilmington, Delaware DISTRIBUTION Nationwide. QUANTITY 26,316 bottles were distributed. REASON Some tablets may have become wet during packaging. --------------------------------------------------------------------------- PRODUCT a) Acyclovir Sodium Injection, Rx antiviral used to treat herpes viruses: a) 500 mg/20mL (25mg/mL),20 mL single dose vial; b) 1g/40mL (25mg/mL),40 mL single dose vial. Recall NUMBER #D-223/224-0. CODE All lot codes. NDC Numbers: 61703-311-21 (20 ml/vial) and 61703-311-43 (40 ml/vial). MANUFACTURER F.H. Faulding & Company, Mulgrave, Victoria, Australia. RECALLED BY Faulding Pharmaceutical Company, Cranford, New Jersey DISTRIBUTION Nationwide. QUANTITY Amount shipped: a) 49,498 (10 units/carton) = 494,980 units total b) 7,857 (10 units/carton) = 78,570 units total. REASON Product fails visible particulate matter specification (calcium sterate particles) prior to expiration date. --------------------------------------------------------------------------- PRODUCT Techni-Care(R) Surgical Scrub/Prep Broad-Spectrum Topical Antiseptic Microbicide for Professional Degerming, in 4-fluid ounce bottles, OTC for wound care, general skin cleansing, and preoperative skin preparation. NDC #46706-222-01. Recall NUMBER #D-221-0. CODE Lot #1723 EXP 06/02. MANUFACTURER Care-Tech Labs, Inc., St. Louis, Missouri. RECALLED BY Manufacturer DISTRIBUTION Nationwide. QUANTITY 24,322 bottles were distributed between 6/30/99-12/23/99. REASON Microbial contamination - Pseudomonas aeruginosa. --------------------------------------------------------------------------- PRODUCT Levothyroxine Sodium, USP, 25 mcg (0.025 mg) tablets, in 100 and 1,000 unit bottles, Rx used as a replacement or supplemental therapy in patients with hypothyroidism and as a pituitary TSH suppressant in the treatment or prevention of various types of euthyroid goiters. Recall NUMBER #D-222-0. CODE Lot Numbers: 024107C, 113038A, 113038D, 071128A, 071128B, 071128C, 071128D. MANUFACTURER Vintage Pharmaceuticals, Inc., Charlotte, North Carolina. RECALLED BY Manufacturer DISTRIBUTION Alabama. QUANTITY 6,013 1000-tablet bottles and 6,455 100-tablet bottles were distributed. REASON Subpotency prior to labeled expiration date. --------------------------------------------------------------------------- PRODUCT Endontic File. Recall NUMBER #Z-408-0. CODE Part #259446, Lot Numbers: 100799, 110199, 121899 and 051199. MANUFACTURER Maillefer Instruments SA, Ballaigues, Switzerland. RECALLED BH Den-Tal-EZ, Inc., Lancaster, Pennsylvania DISTRIBUTION Pennsylvania, Georgia, Texas, Florida, Indiana, New York, Illinois, Minnesota, Washington state, Japan. REASON Mislabeled - The wrong size Endostar Files were packaged in part number 259446. --------------------------------------------------------------------------- PRODUCT IMx Glycated Hemoglobin Ion Capture Component Set, list 1A86-88, 100 test kit; an ion capture assay for the quantitative measurement of percent glycated hemoglobin in human anticoagulated whole blood on the IMx Analyzer. Recall NUMBER #Z-407-0. CODE List # 1A86-88. Set Lot Numbers: 56566M200, 56568M200, 57411M200, 58079M100, 58157M400, 58332M200, 59545M200, 60274M300, 60275M300, 60276M300, 60277M300, 60278M300. MANUFACTURER Abbott Laboratories, Inc., North Chicago, Illinois. RECALLED BY Abbott Laboratories, Inc., Abbott Park, Illinois DISTRIBUTION Nationwide and international. QUANTITY 27,444 sets were distributed. REASON The kits may not quantitate the %GHb or give imprecise results. --------------------------------------------------------------------------- PRODUCT Q-V Tussin Elixir (Hydrocodone Bitartrate, Pseudoephedrine HCL and Chlorpheniramine Maleate), in 1-pint bottles, under the Qualitest and Vintage labels. Recall NUMBER #D-220-0. CODE NDC # Lot # EXP 0603-1609-58 038D8A 04/00 0603-1609-58 035F8A 05/00 0254-9403-58 035F8B 05/00 0603-1609-58 004G8A 06/00 0603-1609-58 005G8A 06/00 0603-1609-58 006G8A 06/00 0603-1609-58 034M8A 11/00. MANUFACTURER Vintage Pharmaceuticals, Inc., Huntsville, Alabama. RECALLED BY Manufacturer DISTRIBUTION Nationwide. QUANTITY 7,928 of lot 038D8A 2,856 of lot 035F8A 5,052 of lot 035F8B 7,745 of lot 004G8A 7,773 of lot 005G8A 7,861 of lot 006G8A 7,942 of lot 034M8A. REASON Lack of assurance chlorpheniramine maleate will maintain potency throughout labeled shelf life. --------------------------------------------------------------------------- PRODUCT Procanbid(tm) Extended-Release Tablets (Procainamide HCL), 500 mg, in 60 tablet bottles, Rx for use as an anti-arrhythmic. Recall NUMBER #D-211-0. CODE Product Code: N0071-0562-20, Lot #40697D EXP 7/00. MANUFACTURER Warner Lambert Company, Morris Plains, New Jersey. RECALLED BY The Parke Davis, Division of Warner Lambert Company, Morris Plains, New Jersey DISTRIBUTION Nationwide. QUANTITY 21,251 bottles were distributed. REASON Dissolution failure (2 hour time point). --------------------------------------------------------------------------- UPDATE Recall #Z-374-0, Fourex Natural Skin Condoms, which appeared in the February 22, 2000 Recall Warning Alert (page 4 of 7 - 2nd product on page) was incorrectly assigned a recall number and was published prior to appropriate review and evaluation. ---------------------------------------------------------------------------