Home  | About mdi |  Services  | Industries | News & Information | Partners | Contact| Site Map

FDA Recalls

January 5, 2000 - March 29, 2000

Attention all mdi Clients:

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 29, 2000:

CLASS II

MANUFACTURER: Bionx Implants Ltd., Tampere, Finland

PRODUCT: Literature for BioSorb FX 2.0/2.4 Bioabsorbable Fixation System. Recall #Z-449-0.

REASON: Device is labeled for unintended use. Firm's sales literature misbrands the device for mandibular indications.

MANUFACTURER: Medtronic, In., Minneapolis, Minnesota; Medtronic Med Rel, Inc., Humacao, Puerto Rico; Medtronic, Switzerland

PRODUCT: Implantable Cardiovascular Defibrillators, used to detect ventricular arrhythmias and deliver therapy for the detected arrhythmia. The devices are designed to treat ventricular fibrillation, ventricular tachycardia, and bradycardia: a) GEM II VR Single Chamber Implantable defibrillator, Model No. 7229CX; b) GEM II DR Dual Chamber Implantable Cardiovascular Defibrillator, Model No. 7273. Recall #Z-452/453-0.

REASON: A fracture of a soldered connection in the devices could result in loss of telemetry and device output.

MANUFACTURER: St. Jude Medical, Inc., St. Paul, Minnesota.

PRODUCT: Various Heart Valves and Annuloplasty Rings: a) St. Jude Medical Masters Series Rotatable Aortic Mechanical Heart Valve with Silzone Catalog, Cuff Type, models: Standard Polyester19AS-601, 21AS-601, 21AS-601, 23AS-601, 25AS-601, 27AS-601, 29AS-601, 31AS-601. Expanded Polyester: 19AECS-602, 21AECS-602, 23AECS-602, 25AECS-602, 27AECS-602, 29AECS-602, 31AECS-602. Hemodynamic Plus Cuff: 17AHPS-605, 19AHPS-605, 21AHPS-605, 23AHPS-605, 25AHPS-605, 27AHPS-605. Expanded HP Cuff: 17AEHPS-605, 19AEHPS-605, 21AEHPS-605, 23AEHPS-

605, 25AEHPS-605, 27AEHPS-605. B) ST. Jude Medical Masters Series Rotatable Mitral Mechanical Heart Valve with Silzone Coating, Cuff Type, models: Standard Expanded Polyester: 19MS-601, 21MS-601, 23MS-601, 25MS-601, 27MS-601, 29MS-601, 31MS-601, 33MS-601, 35MS-601, 37MS-601. Expanded Polyester: 19MECS-602, 21MECS-602, 23MECS-602, 25MECS-602, 27MECS-602, 29MECS-602, 31MECS-602, 33MECS-602. Hemodynamic Plus: 17MHPS-605, 19MHPS-605, 21MHPS-605, 23MHPS-605 25MHPS-605, 27MHPS-605. Expanded HP Cuff: 17MEHPS-605, 18MEHPS-605, 21MEHPS-605, 23MEHPS-6-5, 25MEHPS-605, 27MEPHS-605. C) St. Jude Medical Regent Rotatable Aortic Mechanical Heart Valve with Standard Polyester Cuff having Silzone Coating, models: 17-AG-701, 19-AC-701, 21-AG-701, 23-AG-701, 25-AC-701, 27-AG-701, 29-AG-701; D) St. Jude Medical Regent Rotatable Aortic Mechanical Heart Valve with Flex/Polyester Cuff Having Silzone Coating, models: 17AGF706, 19AGF706, 21AGF706, 23AGF706, 25AGF706, 27AGF706, 29AGF706; E) St. Jude Medical Seguin Annuloplasty Ring for Mitral Valve Repair with Silzone Coating, models: SARS-M24, SARS-M26, SARS-M28, SARS-M30, SARS-M32, SARS-M34, SARS-M36, SARS-M38, SARS-M40; F) St. Jude Medical Tailor Annuloplasty Ring with Silzone Coating, models: TAR-25, TAR-27, TAR-29, TAR-31, TAR-33, TAR-35; G) St. Jude Medical Epic Porcine Aortic Bioprosthetic Heart Valve, models: ELS-21A, ELS-23A, ELS-25A, ELS-27A, ELS-29A, ELS-31A; H) ST. Jude Medical Epic Porcine Mitral Bioprosthetic Heart Valve, models: ELS-21M, ELS-23M, ELS-25M, ELS-27M, ELS-29M, ELS-31M. Recall #Z-454/461-0.

REASON: There is a statistically significant higher rate of paravalvular leaks with the silver ion (Siilzone) coated sewing cuffs leading to valve explants.

MANUFACTURER: Abbott Laboratories, Inc., Irving, Texas.

PRODUCT: Alycon Analyzers, automated chemistry analyzers for in-vitro diagnostic use: a) Alycon Analyzer 300; b) Alycon Analyzer 300i.

REASON: Software program errors cause incorrect association between patient and the patient results.

MANUFACTURER: Roche Diagnostics GmbH, Mannheim, Germany.

PRODUCT: COBAS Integra Ammonia (NH3L) Cassettes, contains an in-vitro diagnostic reagent intended for use on COBAS Integra 400 and 700 for the quantitative determination of the ammonia concentration in plasma: a) Catalog #076682; b) Catalog #0737453.

REASON: Lithium heparin plasma may give erratic results compared to EDTA plasma using the ammonia assay.

MANUFACTURER: Guidant Corporation, St. Paul, Minnesota.

PRODUCT: Ventak Prism Automatic Implantable Cardioverter Defibrillator, VR Models 1850 and 1855, and DR Models 1951 and 1856. These cardioverter defibrillators are intended for use in patients who are at high risk of sudden cardiac death due to ventricular arrhythmias. Recall #Z-469/470-0.

REASON: Defect in an integrated circuit that can result in device failure.

CLASS III

MANUFACTURER: Medical Graphics Corporation, St. Paul, Minnesota.

PRODUCT: Software for Pulmonary Function Testing System: a) BreezePF v3.9 Software, Catalog No. 147536-003; b) BreezePF v3.8A Software, Catalog No. 147570-003. Recall #Z-450/451-0.

REASON: An anomaly has been discovered in the software that can cause confusion on the selection of which FEV1 /FVC ratio is selected for diagnostic reporting. The problem only occurs when using the Quality Review or Bronchial Provocation Review software to select best composite efforts.

MANUFACTURER: Avanti Polar Lipids, Inc., Alabaster, Alabama.

PRODUCT: VDRL (Venteral Disease Research Laboratory) Test Kit-5.0 mL ampoule, slide test provides both qualitative and semi-quantitative results. Recall #Z-466-0.

REASON: The device was labeled with an incorrect expiration date.

MANUFACTURER: Nobel Biocare USA, Inc., Yorba Linda, California.

PRODUCT: Steri-Oss, HL Treaded Implant, HA Coated, endosseous dental implant: Part #56`12HL, 5 mm x 12 mm; b) Part #4610HL, 4.5 mm x 10 mm. Recall #Z-467/468-0.

REASON: Healing screws were mismatched between the two sizes during production assembly.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 22, 2000: 

CLASS II

MANUFACTURER: Roche Diagnostics Corporation, Germany.

PRODUCT: Elecsys Troponin T Immunoassay for the in-vitro quantitative determination of troponin T in human serum and plasma: a) Catalog # 2017423, Elecsys Tronponin T STAT Immunoassay, 100 Tests; b) Catalog 2017644, Elecsys Tronponin T Immunoassay, 100 test. Recall #Z-426/427-0.

REASON: The devices may give test results lower than actual troponin T results when heparinized plasma samples are used. 

MANUFACTURER: Wyntek Diagnostics, Inc., San Diego, California.

PRODUCT: Strep A Tests, an in-vitro diagnostic medical device intended for the qualitative detection of group "A" Streptococcal antigen from throat swabs or confirmation of presumptive group "A" Streptococcal colonies recovered from culture: a) OSOM Strep A Test (Brand for Wyntek); b) Signify Strep A Test (Brand for Abbott Labs.); c) ACCEAVA Strep A Component-Test Sticks (Brand for Biostar). Recall #Z-444/446-0.

REASON: The devices may sporadically show color trace with the negative control, producing a false positive reading on an external negative control.

MANUFACTURER: Medtronic Mexico, S. de R.L. de C.V., Tijuana, Mexico.

PRODUCT: Blood Collection Reservoirs, indicated for use with patients undergoing cardiopulmonary bypass or autotransfusion procedures: a) Blood Collection Reservoirs, Models EL240 and EL2120 b) Cardiotomy Reservoirs, Models EL400, EL402, and EL404.

REASON: There are holes in some of the sterile packages.

CLASS III

MANUFACTURER: Chemicon International, Inc., Temecula, California.

PRODUCT: Light Diagnostics Simulfluor HS/VZV immunofluorescence Assay, intended for the simultaneous detection and identification of herpes Simplex (HSV) 1 and 2 and Varicella-Zoster Virus (VZV) form patients with vesicular, oral, or skin lesions, using direct specimens and culture confirmation. Recall #Z-443-0.

REASON: Labeling error - The primary reagent, labeled in part "SimuFlour HSV/VZV ***EXP 12/00" should bear the expiration date "02/01: as indicated on the box end label.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 15, 2000:

CLASS II

MANUFACTURER: Organogenesis, Inc., Canton, Massachusetts.

PRODUCT: APLIGRAF (GRAFTSKIN) Apligraf is indicated for use with standard therapeutic compression for the treatment of non-infected partial or full-thickness skin ulcers. Recall #Z-416-0.

REASON: Product was contaminated with Burkholderia cepecia.

MANUFACTURER: Siemens-Elema AB, Solna, Sweden.

PRODUCT: Servo Ventilator 300 and Servo Ventilator 300A, an intensive care ventilator that can be used on patients ranging from neonates to adults. Recall #Z-417/418-0.

REASON: Higher trigger sensitivity than expected in neonate setting and frozen alpha value.

MANUFACTURER: Stryker Endoscopy, Santa Clara, California

PRODUCT: Stryker Endoscopy Cholangiogtram Kit, a catheter used to introduce dye into the common bile duct to facilitate an X-ray to check for bilestones. Recall #Z-419-0.

REASON: Failure to include latex and natural rubber disclosure statement.

MANUFACTURER: Bio-Laser Response Corporation, Castle Rock, Colorado.

PRODUCT: Biolaser, used for biostimulation: a) Model 1000; b) Model 2000. Recall #Z-421/422-0.

REASON: The devices are adulterated, misbranded, and failed to comply with 21 CFR 1040.10 and 11 in that the models have numerous noncompliance.

MANUFACTURER: Sunrise Medical Inc., Fresno, California.

PRODUCT: Mechanical Wheelchair. Recall #Z-428-0.

REASON: Poor design - User can fall backwards and there is potential for injury.

MANUFACTURER: Cryolife, Inc., Kennesaw, Georgia.

PRODUCT: Allograft Heart Valves: Model PV05, PV00 and AV05. Recall #Z-435/436-0.

REASON: Donors did not meet current guidelines regarding serodilution of plasma.

MANUFACTURER: Cryolife, Inc., Kennesaw, Georgia.

PRODUCT: Allograft Heart Valve, Model PV05. Recall #Z-437-0.

REASON: Donors did not meet current guidelines regarding serodilution of plasma.

MANUFACTURER: Cryolife, Inc., Kennesaw, Georgia.

PRODUCT: Allograft Heart Valve, Models PV00 and AV00. Recall #Z-438/439-0.

REASON: Donors did not meet current guidelines regarding serodilution of plasma.

MANUFACTURER: Lifenet, Virginia Beach, Virginia.

PRODUCT: Human Heart Valves, frozen and processed for transplantation. Recall #Z-440-0.

REASON: Sera from donors of human tissues were not tested using validated methods.

CLASS III

MANUFACTURER: Intratherapeutics, Inc., St. Paul, Minnesota.

PRODUCT: IntraStent Biliary Endoprosthesis, 36 mm in length. The product was labeled for foreign distribution as IntraStent Peripheral Stent, 36 mm in length, Product Number S10-36 on both labels, intended for permanent implant. Recall #Z-420-0.

REASON: The Stent length was incorrectly identified on the product labels as 36 mm, rather than the actual length of 26 mm.

MANUFACTURER: Nucletron BV, The Netherlands.

PRODUCT: Trocar Needle for use in interstitial treatment prior to brachytherapy of patient: Part Numbers: 083.914, 083.918, 083.920, 083.922, 083.924, 093.926. Recall #Z-429/434-0.

REASON: Trip of trocar needle separated from body of needle leaving tip in the patient.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 8, 2000:

CLASS II

MANUFACTURER: De Gotzen S.r.1. Legnano, Italy

PRODUCT: Image X 70 Dental X-Ray System, used in dental radiography. Recall #Z-361-0.

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.1/. Legnano, Italy for DENTX (a subsidiary of AFP)

MANUFACTURER: Carl Zeiss, Inc., Oberkochen, Germany.

PRODUCT: NC-4 Microscope Stand. Recall #Z-372-0.

REASON: The vertical carrier arm has the potential to break causing the device to become inoperative.

MANUFACTURER: Konica Medical Imaging, Inc., Wayne, New Jersey.

PRODUCT: Konica MD-100 Mammography Screens, indicated for use as an accessory to a cassette to convert x-ray energy into light energy. Recall #Z-382-0.

REASON: The screens cause negative densities on the x-ray film, which could result.

MANUFACTURER: Vital Com, Tustin, California (Software).

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: 88951-9 Patient Arrhythmia, S-T, 23 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) 88851-4 Patient Arrhythmia, S-T, 1 Hour Disclosure Software (VHF). Recall #Z-383/394-0.

REASON: The software validation of version 4.91R1 a software anomaly was found that affected the proper function of a print option.

MANUFACTURER: Althin Medical, Inc., Miami Lakes, Florida.

PRODUCT: Tina System 1000 and Altra Touch 1000 Single Patient Hemodialysis Delivery Systems. Recall #Z-395/396-0.

REASON: Linear clamp may not achieve proper occlusion.

MANUFACTURER: Baxter Healthcare PTE., Ltd., Singapore Namiki Percision Jewel Company Ltd., Tokyo, Japan (motors)

PRODUCT: a) Single Channel b) Triple Channel Volumetric Infusion Pumps, for continuous or intermittent fluid delivery through clinically acceptable routes of administration. Recall #Z-395/396-0

REASON: Motors burn out at 15-18 months of age.

MANUFACTURER: Siemens Medical Systems, Inc., Danvers, Massachusetts.

PRODUCT: Infinity Modular Bedside Monitors, Models SC7000, SC8000, SC9000, SC9000XL, intended for adult, pediatric, and neonatal monitoring of clinical environment. Recall #Z-399/401-0.

REASON: Failure to correctly re-calculate drug dosage using saved Drug Dosage Data.

MANUFACTURER: Gogi Enterprises, Sialkot, Punjab, Pakistan.

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 #Z-402/404-0

REASON: Lack of 510 (k) approval inadequate instructions for use, and failure to file MDRS.

MANUFACTURER: Dade Microscan Inc., West Sacramento, California.

PRODUCT: a) 2-way MainFrame Interface Software Version 22.20; b) Pediatric Therapy Guide Version 4.10. Recall #Z-405/406-0.

REASON: Potential for incorrect Pediatric Reports-A software problem.

MANUFACTURER: EBI, L.P., Parsippany, New Jersey

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 #Z-409/410-0.

REASON: The carriage locking bolt component for both devices can break, potentially resulting in the loss of fracture reduction/distraction postoperatively.

MANUFACTURER: Marconi Medical Systems, Inc., Highland Heights, Ohio.

PRODUCT: Chemical-Shift Imaging (CSI) Spectroscopy, Model 90LNI. Recall #Z-412-0.

REASON: Due to a software anomaly, the device acquires data from a slice thicker than intended, and may not be at isocenter.

MANUFACTURER: NUCLETRON BV, The Netherlands.

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 suturred into place to allow cervix to remain dilated for easier reinsertion of intrautherine tube for subsequent treatment. Part #'s 086.047 and 086.048. Recall #Z-413/414-0.

REASON: Brachytherapy applicator sleeve may become disconnected during treatment.

MANUFACTURER: Sims Deltec, Inc., St. Paul, Minneosota.

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 an drugs. Recall #Z-415-0.

REASON: Separation of Catheter from the drug portal can result in leaks.

CLASS III

MANUFACTURER: Eppendorf, Hamburg, Germany.

PRODUCT: Tecan Genesis Disposable Tip. Recall #Z-309-0.

REASON: Manufacturing error - Crack in 1000ul tip. 

MANUFACTURER: Meridian Diagnostics, Inc., Cincinnati, Ohio.

PRODUCT: Premier Platinum HPSA, an ELSIA assay for the detection of Helicobacter pylori antigens in stool, Product #601348. Recall #Z-411-0

REASON: The kits may contain microwells intended for detection of C. difficile Toxin A.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 1, 2000:

CLASS II

MANUFACTURER: Abbott Laboratories, Inc., North Chicago, Illinois

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 #Z-407-0

REASON: The kits may not quantitate the %Ghb or give imprecise results.

UPDATE

RECALL #z-374-0, Fourex Natural Skin Condoms, which appeared in the February 23, 2000 Enforcement Report was incorrectly assigned a recall number and was published prior to appropriate review and evaluation.

CLASS III

MANUFACTURER: Maillefer Instruments SA, Ballaigues, Switzerland.

PRODUCT: Endontic File.

REASON: Mislabeled – The wrong size Endostar Files were packaged in part number 259446.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 9, 2000:

CLASS II

MANUFACTURER: Olympic Medical, Seattle, Washington

PRODUCT: Olympic Mini Bili-Lite (halogen phototherapy light), Models 77 and 78. Recall #Z-331/332-0.

REASON: Potential for light to fall due to a broken spring.

MANUFACTURER: Datascope Corporation, Patient Monitoring Division, Paramus, New Jersey.

PRODUCT: System 98 Intra-Aortic Balloon Pumps containing software Revision B, used to inflate and deflate intra-aortic balloons; several model numbers. Recall #Z-337/347-0.

REASON: Some units may fail to power-up and displays "Electrical Code Failure #5" on the pump screen.

CLASS III

MANUFACTURER: Genzyme Diagnostics, San Carlos, California.

PRODUCT: Contrast hCG Urine/Serum Test, a rapid immunoassay for the qualitative detection of Human Chorionic Gonadotropin in urine or serum for the early detection of pregnancy. Recall #Z-325-0.

REASON: Increase incidence of false positive results using serum specimens.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 2, 2000:

CLASS II

MANUFACTURER: CryoLife, Inc., Kennesaw, Georgia

PRODUCT: CryoValve Allograft, Model AVOO and PVOO. Recall #Z-330-0.

REASON: Donor unsuitability.

MANUFACTURER Schneider (Europe) A.G., Bulach, Switzerland.

PRODUCT: AMS Urolume Endoprostheses, stents for recurrent bulbar urethral stricture and prostatic obstruction secondary to benign prostatic hyperplasia: a) AMS Urolume Endoprostheses, Models 72402010 (2.0 cm) and 72402011 (2.5 cm); by) AMS Urolume Endourethral Prosthesis Plus Stricture, Models 72401841 (2.0 cm) and 72401843 (3.0 cm); c) AMS Urolume Endourethral Prosthesis Plus Prostate, Models 72401800 (1.5 cm), 72401801 (2.0 cm) and 72401802 (2.5 cm). Recall #Z-322/324-0.

REASON: The delivery tool of the devices, which is supposed to place the stent in the urethra, could fail to deploy and place the stent in position.

MANUFACTURER: Hewlett-Packard GmbH, Boeblingen, Baden-WTTBG, Germany

PRODUCT: Hewlett-Packard Model M1026A Anesthetic Gas Module with Watertrap Option, used in operating rooms to measure concentration of anesthetic agent and 02 in the breathing circuit to supplement indications given on the anesthesia machine and other monitors. Recall #Z-326-0.

REASON: Values of C02 and anesthetic agents may be lower than actual due to dilution.

MANUFACTURER: Zimmer, Inc., Warsaw, Indiana.

PRODUCT: Versys Cemented Hip Stem: a) Versys Cemented Plus Hip Stem, Size 15, Catalog No. 00-7852-015-00; b) Versys Cemented Hip Stem, Size 15, Catalog No. 00-7853-015-01. Recall #Z-328/329-0.

REASON: An anomaly in the vendor forging die created an intermittent flaw in the mid-section region that could reduce the ultimate fatigue strength.

CLASS III

MANUFACTURER: Baxter Research Medical, Inc., also known as Research Medical, Inc., Midvale, Utah.

PRODUCT: Duraflow II Heparin Treated Thin-Flex Single Venous Return Cannula Wire Reinforced Open Lighthouse Tip, Model No. DII-TF-036-L.

REASON: The size 30 French was found in the 36 French package.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 26, 2000:

CLASS II

MANUFACTURER: Toshiba Corporation, Otawara-Shi, Tochigi-Ken, Japan.

PRODUCT: Toshiba Powervision 6000 Diagnostic Ultrasound Device. Recall #Z-321-0.

REASON: The wheel caster welds can fail causing the caster to fall off, resulting in the machine tilting and/or falling.

MANUFACTURER: Datascope, Collagen products Division, Montvale, New Jersey.

PRODUCT: VasoSeal ES (tm) (Extravascular Security) Device Sterile-Nonpyrogenic. Recall #Z-327-0.

REASON: Some units may contain out of specification locator components.

UPDATE 

Soflex UC-Absorbing Silicone PC Intraocular Lenses which appeared in the November 3, 1999 Enforcement Report is being updated. It should be noted that Model L151U (Recall Z-066-0) is not under recall. PRODUCT Model L161U Soflex UB-Absorbing Silicone PC IOL. Reecall #Z-067-0. CODE Lot Numbers 390T, 4BG1, 4BG1, 4BG7, 4CRA and 4DVI and 4BGB, 4CPB, 4CTJ, 4CUP, 4CUU, 4E2U, 4EN3, 4EPD, 4ERX, 4FUB. RECALLED BY Manufacturer, by letters on September 14, 1999, and October 25, 1999. Firm-initiated recall ongoing.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 19, 2000: 

CLASS II

MANUFACTURER: Kevex Instruments, Inc., Sunnyvale, California.

PRODUCT: X-Ray Fluorescence Spectrometers, used for the qualitative and quantitative elemental analysis of material composition and thickness by x-ray fluorescence spectroscopy: a) Model No. 0700; b) Model No. 770; c) Model No. 771; d) Model No. 0750.

REASON: These analytical X-ray systems are defective as defined by 21 CFR 1003.2. The relay controlling the interlock for the sample chamber, indicator light, and X-ray power can potentially fail.

MANUFACTURER: Stratec Medical, Oberdorf, Switzerland.

PRODUCT: 6.5 mm Cannulated Tap for proximal hip pin, used to tap a hole in the bone prior to the placement of a hop pin (screw). Recall #Z-293-0.

REASON: Product does not meet hardness specifications.

MANUFACTURER: Depuy Orthopaedics Inc., Warsaw, Indiana.

PRODUCT: Depuy LCS Total Knee System Rotating Platform: a) Size STD/LG, Part No. 1278-46-025, b) Size STD+/LG, Part No. 1278-51-025. Recall #Z-310/311-0.

REASON: Two lots were mixed during manufacturing. The difference between the devices is a slight mismatch between the curvature of the femoral and tibial insert (approximately 5mm).

MANUFACTURER: Baxter Healthcare Corporation, Anasco, Puerto Rico.

PRODUCT: Swan-Ganz Bipolar Pacing Catheter Model 97K125F5, designed for temporary transvenous right ventricular endocardial pacing. Recall #Z-312-0.

REASON: The labeling on the box and tray indicates that the product is for femoral insertion rather than for Superior Vena Cava (SVC) insertion.

MANUFACTURER: I-Flow Corporation, Lake Forest, California.

PRODUCT: Management Systems, intended to provide continuous infusion of a local anesthetic directly into an intra-operative site for postoperative pain management: a) ON-Q Pain Management System; b) Pain-Buster Pain Management System. Recall #Z-313/314-0.

REASON: The devices contain natural rubber latex components and the label fails to declare, "Caution: This product contains natural rubber latex which may case an allergic reaction."

MANUFACTURER: Philips Medical Systems Nederland B.V., Best Netherlands.

PRODUCT: Philips BV26 Mobile C-Arm Stand Mobile C-Arm Fluoroscope. The unit consists of a mobile C-arm stand with X-ray generator, medical imaging chain and control. Recall #Z-316-0.

REASON: The wheel plates may fail causing the BV26 to fall.

MANUFACTURER: J-Lloyd Medical, Inc., West Berlin, New Jersey.

PRODUCT: Series 200 5 French Angiographic Balloon Catheter, designed for use in right heart catherization for cardiac angiography, and pulmonary angiography: a) Model No. 252-50; b) Model No. 252-60; c) Model No. 252-80. Recall #Z-317/319-0

REASON: The catheter tip may break just proximal to the balloon.

MANUFACTURER: Electroscope, Inc., Boulder, Colorado.

PRODUCT: ES 4007 Universal Cord, a reusable device that combines the function of a standard electrosurgical active cord with the electroshield cable in one cable. This allows the user to make a single termination of the ESU/EM equipment and a single termination at the surgical instrument. Recall #Z-320-0.

REASON: A fatigued active conductor could result in a spark and burning of the cord insulation.

UPDATE

Pelvic Implant Set Graphic Case for Self-Taping Screws was printed in duplicate in the November 3, 1999, Enforcement Report. The correct recall number for this product is Recall #Z-077-0. UPDATE Recall #Z-265/266-0, Ancure Endograft System, which appeared in the December 29, 1999 

Enforcement should be corrected as follows: 
CODE All devices with serial numbers less than 9C12980*, with the following exceptions: 9C12261 T 9C12596 T 9C12605 T 9C12825 T 9C12928 T 9C12955 T 9C12273 T 9C12597 T 9C12598 T 9C12609 T 9C12929 T 9C12956 T 9C12275 T 9C12598 T 9C12609 T 9C12831 T 9C12930 T 9C12957 T 9C12276 T 9C12599 T 9C12610 T 9C12832 T 9C12931 T 9C12958 T 9C12490 T 9C12600 T 9C12611 T 9C12894 T 9C12932 T 9C12567 T 9C12601 T 9C12762 T 9C12895 T 9C12953 T 9C12595 T 9C12704 T 9C12823 T 9C12898 T 9C12954 T

 *The last character is an Alpha character and is not part of the serial number sequence.

MANUFACTURER Guidant Corporation, Cardiac & Vascular Surgery Group, Menlo Park, California. QUANTITY 287 units.

CLASS III

MANUFACTURER: Eppendorf, Barkhausenweg-1, Germany.

PRODUCT: TECAN Genesis Disposable 1000ul Filter DiTi Tips, Catalog No. 71-705. Recall #Z-309-0.

REASON: The device delivers incorrect volumes.

MANUFACTURER: Fresenius Medical Care, North America, CD Reynosa Tamps, Mexico.

PRODUCT: Fresenius Kidney Euro-Collins Perfusion Set, 1 liter. Recall #Z-315-0.

REASON: Outer case label has extended expiration date.

MEDICAL DEVICE SAFETY ALERT:

PRODUCT Endopath ETS45 Endoscopic Linear Cutter, used in general, gynecologic, thoracic, and urologic surgery to delivery staples while simultaneously dividing tissue between rows. Safety Alert #N-005-0. CODE All Endoscopic Linear Cutters, Model ETS45, manufactured since January 1999. MANUFACTURER Ethicon Endo-Surgery, Inc, Cincinnati, Ohio. ALERTED BY Manufacturer, by letter dated December 10, 1999. DISTRIBUTION Nationwide and international. QUANTITY 49,163 UNITS. REASON Surgeons are using the device for tissue thickness beyond the specified range.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 12, 2000:

CLASS II

MANUFACTURER: Sensor Developments, Inc., Lake Orion, Michigan (Contract manufacturer).

PRODUCT: Trans-Lift Resident Sling Scale, used as an accessory to the Trans-Lift Resident Sling which is used to transport immobile patients. Recall #Z-287-0.

REASON: The device failed due to metal fatigue.

MANUFACTURER: Mini-Med, Inc., Sylmar, California.

PRODUCT: Mini-Med MMT-508 Insulin Pump, indicated for the continuous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. Recall #Z-288-9.

REASON: The pump's software has a error in which the current basal rate profile indicated on the pump display, was a rate programmed for earlier in the day and different from the expected current rate based on the pump's present program.

MANUFACTURER: Stryker Ireland, Ltd., Carrigtwohill, County Cork, Ireland.

PRODUCT: Stryker Heavy Duty Blades, Sterile, used by surgeons for cutting bone: a) Sagittal Blades with several part numbers and b) Aggressive Tooth Blades with several part numbers. Recall #Z-290/291-0

REASON: The sterility cannot be assured through the labeled expiration date due to the potential for a package integrity failure.

MANUFACTURER: Valleylab, Inc., Boulder, Colorado.

PRODUCT: Valleylab E2516H-GNSB Electrosurgical Pencils, intended for use in the operating room for surgical procedures requiring cutting and coagulation. Recall # Z-292-0.

REASON: The insulation on the blade electrode may have stress cracks, allowing for the possibility of burns to the patient or surgical personnel.

MANUFACTURER: Stratec Medical, Eimattstrasse, Switzerland.

PRODUCT: Guide Shaft, used as an insertion aide between wrench and screw. Recall #Z-294-0.

REASON: Guide Shaft may be outside specified dimensions.

MANUFACTURER: Maxxim Medical, Temecula, California.

PRODUCT: Custom Procedure Trays containing Heparin Sodium Injection a) RDG393 EP STUDY TRAY; b) HCG185A CARDIAC CATH TRA; c) HCF876B SWAN GANZ TRAY. Recall #Z-295/297-0

REASON: The Heparin Sodium Injection ampule may contain particulate matter.

MANUFACTURER: Quidel Corporation, San Diego, California.

PRODUCT: Clinitek hCG Test Strips, for the qualitative determination of human chorionic gonadotropin in urine and are intended for use in the early detection of pregnancy: a) Product No. 2043, CLINITEX hCG Test Strips - 25 Foiled Strips; b) Product No. 2044, CLINITEK hCG Test Strips - 25 Strips. Recall #Z-298/299-0.

REASON: The devices may give false positive results.

MANUFACTURER: Marconi Medical Systems, Inc., Highland Heights, Ohio.

PRODUCT: AcQ Plan, 3-D Radiation Therapy Treatment Planning System (software), a software option for the Computed Tomography (CT) Scanners. Recall #Z-300-0.

REASON: Software anomaly causes the isocenter shift to be labeled incorrectly.

MANUFACTURER: Becton Dickinson VACUTAINER Systems, Franklin Lakes, New Jersey.

PRODUCT: VACUTAINER Brand Sodium Citrate Tubes a) Catalog No. 366392, 0.105M Buffered Sodium Citrate Tube with Conventional Stopper, 1.8mL draw; b) Catalog No. 366393, 0.105M Buffered Sodium Citrate Tube with Conventional Stopper, 2.7nL draw; c) Catalog No. 369711, 0.105M Buffered Sodium Citrate Tube with HEMOGARD Closure, 1.8mL draw; d) Catalog No. 367712, 0.105M Buffered Sodium Citrate Tube with HEMOGARD Closure, 2.7mL draw; e) Catalog No. 366394, 0.129M Buffered Sodium Citrate Tube with Conventional Stopper, 1.8mL draw; f) Catalog No. 366395, 0.129M Buffered Sodium Citrate Tube with Conventional Stopper, 2.7mL draw; g) Catalog No. 369700, 0.129M Buffered Sodium Citrate Tube with HEMOGARD Closure, 1.8mL draw; h) Catalog No. 367703, 0.129M Buffered Sodium Citrate Tube with HEMOGARD Closure, 2.7mL draw. Recall #Z-301/308-0.

REASON: The devices may produce lowered coagulation results for PT's and a PTT's.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 5, 2000:

CLASS II

MANUFACTURER: Drager Medizintechnik GMBH, Luebeck, Germany

PRODUCT: Julian Anesthesia Machine Recall #Z-226-9.

REASON: The oxygen can contaminate the air supply line and/or air can contaminate the oxygen supply line under certain conditions.

MANUFACTURER: Bivona Medical Technologies, Division of UroQuest Medical Corporation, Gary, Indiana.

PRODUCT: Nu-TRAKE Emergency Cricotyrotomy Device, Catalog #B10100. Recall #Z-250-0.

REASON: The cannula body may be missing in unopened packages.

MANUFACTURER: Paceart Associates, L.P. Fairfield, New Jersey.

PRODUCT: Heart Access Plus, a portable, battery-operated, cardiac memory electrocardiogram (ECG) event recorder and a voice diary. Recall #Z-289-0.

REASON: The device fails to comply within performance standard for electrode lead wires and patient cables, 21 CFR 898.

CLASS III

MANUFACTURER: Advanced Medical Designs, Marietta, Georgia.

PRODUCT: Sterile Drape Bag and Coupler for Endoscopic Camera System. Recall #Z-263-0.

REASON: The assembled components were inadequately glued resulting in the plastic lens cap separating from the sterile drape bag.

MANUFACTURER: Meridian Diagnostics, Inc., Cincinnati, Ohio

PRODUCT: IMMUNOCARD TOXIN A, a rapid enzyme immunoassay for the detection of Clostridium difficile Toxin A in human stool. Recall #Z-286-0.

REASON: The substrate reagent exhibits a blue color which may affect final test results.
 

Home  | About mdi |  Services  | Industries | News & Information | Partners | Contact| Site Map