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FDA Recalls

July 2001 - September 2001

Attention all mdi Clients:

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 26, 2001:

CLASS II

MANUFACTURER: Abbott Diagnostics Division Santa Clara, CA

PRODUCT: Z-1187-1/Z-1188-1
Abbott Cell-Dyn 3200 CS
Abbott Cell-Dyn 3200 SL
Abbott Cell-Dyn 3200 systems manufactured after
06/23/00 that contain 486-microprocessing chips.
List No./Serial Number:
Abbott Cell-Dyn 3200 CS 04H59-01
Includes Serial Numbers 29983AH-29993AH
Abbott Cell-Dyn 3200 SL 04H60-01
Includes Serial Numbers 60873AF-60906AF

REASON: Analyzers may exhibit fluctuation in hematology
results under certain parameters

MANUFACTURER: Abbott Laboratories, Inc. Abbott Park, IL

PRODUCT: Z-1186-1, Architect Free T3 Controls, list 06C48-10; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064; The kit contains 3 bottles (8mL each) of T3 in human serum at the following levels: L = 3.1, M = 6.0, and H = 10.5 pg/mL.

REASON: High Control concentrations read below package insert specifications

MANUFACTURER: Alba-Waldensian, Inc. Rockwood, TN

PRODUCT: Z-1189-1/Z-1190-1, Pulstar Anti-Embolism Wrap,

REASON: Tearing at the sewn seam of an anti embolism wrap (compression sleeve)

MANUFACTURER: Master Home Products Morton Grove, IL

PRODUCT: Z-1191-1, Adapta MC-100 Massage Chair

REASON: Massage chair frames break under the weight of massage clients

MANUFACTURER: Asahi Optical Co., Ltd. (AOC) Tokyo, Japan

PRODUCT: Z-1196-1/Z-1197-1, Pentax brand Video Colonoscopes and Fiber Colonoscopes. The Angle Wire Receptacle component is the affected part.

REASON: Angle Wire Connecting Receptacle component was observed to be cracking, resulting in a loss of angulation control for the direction in which the part was applied (up, down).

MANUFACTURER: Depuy Orthopaedics, Inc. Warsaw, IN

PRODUCT: Z-1198-1/Z-1199-1
Gemini Hip Stem, Catalog Nos. 1374-12-000 and 1374-13-000

REASON: Incorrect size number etched into hip stems

MANUFACTURER: Depuy Orthopaedics, Inc. Warsaw, IN

PRODUCT: Z-1200-1/Z-1201-1, LCS Total Knee Meniscal Bearing Tibial insert.

REASON: Outer boxes labeled with incorrect product code and description

MANUFACTURER: Hitachi Instruments Division Iari-ken, Japan

PRODUCT: Z-1202-1, Roche/Hitachi 917 Rack System connected to CLAS.

REASON: Potential sample/results mismatch

MANUFACTURER: Synthes (USA) West Chester, PA

PRODUCT: Z-1203-1/Z-1204-1
Split Tissue Protection Sleeve

REASON: Mislabeled protection sleeves

MANUFACTURER: Polysciences, Inc. Warrington, PA

PRODUCT: Z-1205-1, Save-A-Tooth Emergency Tooth Preserving System. The product is shipped in cases of 24 units. A unit is a complete preserving system. The unit is a plastic jar filled with preserving solution.

REASON: Product leaking, compromising sterility.

MANUFACTURER: Abbott Laboratories, Inc. Abbott Park, IL

PRODUCT: Z-1206-1, IMx Glycated Hemoglobin Ion Capture Component Set, list 1A86-88; the set is composed of the IMx Gylcated Hemoglobin Ion Capture Reagent Pack, list 1A86-20, which contains 1 bottle (10.5 mL) Polyanion Affinity Reagent, 1 bottle (11.1 mL) Lysis Reagent, 1 bottle (10.5 mL) Sorbitol in buffer and 1 bottle (28.0 mL) Wash Buffer, and 1 box (100) Ion Capture Reaction Cells, list 5A57-01; Abbott Laboratories

REASON: Imprecise results (low) on patient specimens

CLASS III

MANUFACTURER: Repro-Med Systems, Inc. Chester, NY

PRODUCT: Z-0643-1, Freedom60 Tubing Set, 2 mL per hour. Intended for use with Freedom60 Syringe Infusion Pump System. Individual packaged and sterilized. Sold in boxes of 50.

REASON: Separation of the female luer connector.

MANUFACTURER: Ansell Healthcare Products, Inc. Dothan, AL

PRODUCT: Z-1192-1/Z-1193-1, Sensation Plus Lubricated and Sensation Plus Spermicidal Lubricant, Codes: Product No. Sensation Plus Lubricated: Lot Nos. 0007900889, (Exp 07/2003), 03/99/C (Exp 02/2002), and 02/00/A (Exp 01/2003)

REASON: Retail packaging error, condoms were packaged into wrong retail boxes

MANUFACTURER: Abbott Health Products, Inc. Barceloneta, PR

PRODUCT: Z-1194-1, X-SYSTEMS Methadone Controls, list 09676-10; an in-vitro diagnostic used for the verification of calibration of the TDxFLx, TDx or ADx System when used for the semi-quantitative determination of methadone in human urine. Distributed in Europe by Abbott, Germany

REASON: Methadone Controls manufactured at methadone concentrations below target value

MANUFACTURER: Abbott Laboratories, Inc. Abbott Park, IL

PRODUCT: Z-1195-1, X-SYSTEMS Multiconstituent Controls for Abused Drug Assays, list 09687-12; an in-vitro diagnostic used for the verification of calibration of the Abused Drug assays on the AxSYM, TDxFLx, TDx or ADx Systems. Distributed in Europe by Abbott, Germany

REASON: Methadone Controls manufactured at methadone concentrations below target value

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 19, 2001:

CLASS II

MANUFACTURER: Valleylab, Inc., Boulder, CO

PRODUCT: Z-1041-1, Valleylab LigaSure vessel sealing system,

REASON: Previously recalled product, not released for distribution, was distributed.

MANUFACTURER: SIEMENS MEDICAL SYSTEMS, INC. HOFFMAN ESTATES, IL

PRODUCT: Z-1106-1 - Z-1108-1
Programmable Multi-Axis Controller (PMAC 2 Lite) circuit board installed in E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures;

REASON: Resistor Packs installed backward causes software errors.

MANUFACTURER: Avid Medical, Inc., Toano, VA

PRODUCT: Z-1116-1/Z-1148-1
Various sterile surgical convenience kits and trays, including biopsy, pacemaker, and cardiac catheterization procedural trays manufactured and labeled by AVID Medical, Inc., identified by catalog, lot number and date of manufacture on each product, and containing vialed injectables:
Ephedrine Sulfate 1 ml/50mg
Heparin Sodium, 10 ml vial
Heparin Injection 10 ml 1000 unit/ml
Heparin Lock 10 ml, 100 u/ml
Z Heparin Lock, 1 ml, 100 units
Lidocaine, 1% 30 mL MDV
Lidocaine, 50 mL 2% Vial M-Dose
Lidocaine 30 ml 2% Vial
Lidocaine, 30ml 1% VL Sng Dose
Lidocaine, 2%hcl 20 ml
Lidocaine, 50 ml 1% multidose
Lidocaine, 20 ml 1% multidose
Polocaine, 50 ml, 2% vial
Sensorcaine, .5% w/EPI 30 ml
Sodium Bicarbonate, 4%, 5ml VL
Sodium Chloride, 30 ml .9% vial
Sodium Chloride, 5cc vial

REASON: Stability and potency of kit injectable components cannot be assured after sterilization

MANUFACTURER: Abiomed, Inc., Danvers, MA.

PRODUCT: Z-1149-1,BVS 5000i Bi-Ventricular Support Console
S/N's: 1599, 1601, 1602, 1609, 1611-1646

REASON: Leaking Compressor gaskets may cause low flow

MANUFACTURER: Cryolife, Inc. Kennesaw, GA

PRODUCT: Z-1150-1 - Z-1151-1,CryoValve Allograft (Heart Valve)

REASON: Does not meet current guidelines regarding serodilution of plasma.

MANUFACTURER: Olympic Medical Corp. Seattle, WA

PRODUCT: Z-1152-1 - Z-1153-1
Olympic Medical Vac Pac - primarily used to assist in maintaining patient position during surgery.

REASON: Weak Seam Seal - Product not remaining firm as intended

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN

PRODUCT: Z-1154-1, Roche/Hitachi Modular P Laboratory Clinical Chemistry Analyzer,Catalog No. 766-4019, All Serial Numbers;

REASON: Incorrect results are obtained if the wash rack is placed on the instrument before placing the instrument in standby or stop mode.

MANUFACTURER: Abbott Laboratories, Inc. Laurinburg, NC

PRODUCT: Z-1170-1 - Z-1183-1
Intravenous Administration Sets for use with Gemstar infusion pumps.
Z-1170-1: 13009-01 Latex-Free GemStar Pump Set-SL, Non-Vented, 110 " (w/ Yellow Striped Tubing)
Z-1171-1: 13012-01 GemStar Pump Set with 0.2 Micron Filter, LIFESHIELD Prepierced Reseal Y Site, Non-Vented, 96 Inch- SL
Z-1172-1: 13013-01 GemStar Nonphthalate Pump Set with 1.2 Micron, Filter, LIFESHIELD Prepierced Reseal Y Site Nonvented, 96"-SL
Z-1173-1: 13014-01 GemStar Primary Pump Piggyback Set, with Convertible Piercing Pin, 110 inch with Backcheck Injection Site, Prepierced/Prepierced Y-Injection Site SL
Z-1174-1: 13015-01 LifeShield Latex-Free GemStar Pump Set-SL, Nonvented, 96 inch (with Orange Polyethylene-lined resistant Tubing)
Z-1175-1: 13016-01 Latex-Free GemStar I.V. Pump Set w/ PCA Extension-SL, Nonvented, 110 inch
Z-1176-1: 13030-01 GemStar HEMA II Y-Type Blood Pump Set
Z-1177-1: 13042-01 LifeShield Latex-Free Microdrip Soluset GemStar 150 mL Burette Pump Set - SL, Convertible Pin, 110 inch
Z-1178-1: 13043-01 GemStar Primary Pump Set
Z-1179-1: 13044-01 GemStar Pump I.V. Set
Z-1180-1: 13046-01 Latex-Free GemStar Pump Set-SL, Nonvented, 96 inches
Z-1181-1: 13242-01 LifeShield Latex-Free Microdrip Soluset GemStar 150 mL Burette Pump Set-OL, Convertible Pin, 110 inch with 3 Clave Ports
Z-1182-1: 13243-01 LifeShield Latex-Free GemStar Piggyback Pump Set-OL, Convertible Pin, 110 inch with 0.2 Micron Filter and 3 Claves
Z-1183-1: 13245-01 LifeShield Latex-Free GemStar Primary Piggyback Pump Set - OL, Convertible Pin, 110 inch with 2 Claves

REASON: Sets over infuse with user error during setup

MANUFACTURER: Abbott Laboratories, Inc. Abbott Park, IL

PRODUCT: Z-1184-1 - Z-1185-1
AxSYM Troponin-I; a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I in human serum or plasma on the AxSYM System. Troponin-I values are used to assist in the diagnosis of acute myocardial infarction (AMI). Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

REASON: Falsely high results

CLASS III

MANUFACTURER: Mattioli Engineering Corporation, SRA, Firenze Italy.

PRODUCT: Z-1115-1
Disposable Glass Tip (P/N 10,010,142), a single use component used with Dermabrader DMS1000 handpiece, for scar revision and tattoo removal. Instrument is classified as a Dermatome, class I device. Disposable tips packaged in cartons, 24 pieces/carton.

REASON: Burr on plastic tip of dermabrasion instrument could cause injury to skin.

MANUFACTURER: STERIS CORP. MENTOR, OH

PRODUCT: Z-1155-1
Steris Quick Connect, Model C1665, is designed to process the Olympus 20D Series and BF-XT20 Bronchoscopes in STERIS SYSTEM I Sterile Processing System, with C1160 Universal Processing Tray.

REASON: The tubing in the kits are labeled with an incorrect endoscope model number.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 12, 2001:

CLASS I

MANUFACTURER: Macropore, Inc. San Diego, CA

PRODUCT: Z-1082-1
Sterile product is packaged in a white Tyvek pouch labeled in part, "MacroPore Instrument***StarBurst Screw Driver***Sterile***Catalog No. 02090***LOT 50489***05-2005***MacroPore Inc.***San Diego, CA 92121***".

Non-sterile product is packaged in a white Tyvek pouch labeled in part, "MacroPore Instrument***StarBurst Screw Driver***Non-Sterile***Catalog No. 02090***LOT 50489***05-2005***MacroPore Inc.***San Diego, CA 92121***".

Labeling for the product is labeled in part, "Instructions For Use***MacroPore Craniomaxillofacial (CMF) and Neurological (Neuro) Surgery Products***DESCRIPTION***INDICATIONS*** CONTRAINDICATIONS***WARNINGS AND PRECAUTIONS***STORAGE AND HANDLING***POSSIBLE ADVERSE EFFECTS***PROCEDURE***CLEANING AND STERILIZATION*** CAUTIONS***MACROPORE***San Diego, CA 92121***".

REASON: False perception of sterility on part of users.

CLASS II

MANUFACTURER: Kurt Manufacturing Company, Minneapolis, MN

PRODUCT: Z-647-1
Laser Product/Custom Gaging System;
Model name and number: Custom gaging system.

REASON: The products did not comply with the warning logotype, aperture label, identification and certification label requirements.

MANUFACTURER: Dynarad Corp., Deer Park, NY.

PRODUCT: Z-0844-1
Dynarad Model HF-110A Mobile X-Ray System;

REASON: Cracks may occur in the yoke supporting the generator

MANUFACTURER: Sabratek Corp. Skokie, IL.

PRODUCT: Z-0845-1 - Z-0846-1
Multi-Therapy Ambulatory Infusion Pumps sold under the following labels:
a) Sabratek 6060 Homerun Infusion Pump, product codes 606000-40 (English), 606000-40L (loaner pump), 606000-40I (International), 606000-41 (Spanish), 606000-42 (Portugal), 606000-43 (France), 606000-44 (JMS), 606000-45 (Sweden), 606000-46 (Dutch) and 606000-47 (German)
b) Baxter 6060 Multi-Therapy Ambulatory Infusion Pump, product code 2M9832

REASON: The infusion pump may overinfuse in the PCA mode of operation.

MANUFACTURER: Baxter Healthcare PTE Ltd. Singapore, SN

PRODUCT: Z-0847-1 and Z-0848-1
Colleague Single Channel Volumetric Infusion Pumps, product code 2M8151 and 2M8151R (refurbished); for continuous or intermittent fluid delivery through clinically acceptable routes of administration such as intravenous, intra-arterial, subcutaneous, epidural or irrigation of fluid spaces applications; Made in Singapore.

REASON: Damaged power cord may result in arcing and potential burning

MANUFACTURER: Medela A.G. CH-6340 Baar, SZ

PRODUCT: Z-0849-1
Medela BiliBed Phototherapy Lamp, Model 0383009; used for the treatment of newborns with neonatal jaundice (hyperbilirubinemia);

REASON: Failure of the internal housing fan allows temperature to rise around infant.

MANUFACTURER: Wesley Jessen Corporation, Des Plaines, IL

PRODUCT: Z-0850-1
FreshLook (phemfilcon A) Toric for Astigmatism Soft Contact Lenses with Handling Tint; the soft contact lenses are individually packaged in sterile foil-sealed plastic packages, 6 packs per box.

REASON: Mislabeled for corrective power, cylinder & axis

MANUFACTURER: Siemens Medical Systems, Inc., Hoffman Estates, IL

PRODUCT: Z-0851-1
ICON Profile Processing Software used on the ICON P workstations designed for use with E.CAM Gamma Camera Systems to conduct cardiac Tomo and SPECT applications; 60195-5203.

REASON: Artifacts on images from profile scans

MANUFACTURER: Manufactured by Althin Medical, Inc., Miami Lakes, FL

PRODUCT: Z-0852-1/Z-0854-1
Cellulose Diacetate Hemodialyzers; a single use sterile device for hemodialysis of patients with acute or chronic renal failure; 12 units per case; marketed under the following brand names:
a) Mera Meltra Nova 110 Hemodialyzer Cellulose Diacetate-N Membrane, cat. #277-451G
b) Altra Nova 170 Cellulose Acetate-N Hemodialyzer, cat. #201-472
c) Altra Nova 200 Cellulose Acetate-N Hemodialyzer, cat. #211-484G. Manufactured by Althin Medical AB, 37221 Ronneby, Sweden
d) Althin A-15 Althane Capillary Dialyzer, cat. #237-015 Codes: Meltra Nova Model 110, product code 277-451G, lot 451-980911C
Altra Nova Model 170, product code 201-472, lots 472-980825A, 472-980923E, 472-981113B Model 200, product code 211-484G, lots 484-981009A, 484-981009C, 484-981012B, 484-990224B, 484-990311A, 484-990318C A Series Althane Model 1.5, product code 237-015, lots 1998M02R, 1998M02R1, 1998M02Z

REASON: Iritis patient reactions

MANUFACTURER: Siemens Medical Systems, Inc., Hoffman Estates, IL

PRODUCT: Z-0855-1/Z-0856-1
E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures;

REASON: Potential loss of engagement in radial drives.

MANUFACTURER: Applicare Medical Imaging, B.V. ZEIST

PRODUCT: Z-0857-1/Z-0858-1
RadWorks Software Version 5.1 with Software Patch 5 or 7, and RadWorks WebViewer Software Verion 5.1 running on RadWorks 5.1 Software Patch 5 or 7; picture archival and communications system; Applicare Medical Imaging B.V., Zeist, The Netherlands Codes: RadWorks Software Version 5.1 with Software Patch 5 or 7 and RadWorks Webviewer Software 5.1 running on RadWorks 5.1 Software Patch 5 or 7

REASON: Software anomaly causes image to be associated with wrong DICOM header

MANUFACTURER: Raven Biological Laboratories, Inc. Omaha, NE

PRODUCT: Z-866-1
Raven Prospore2 Biological Indicator Intended for
steam Sterilization (121 degrees C) Contains Bacillus
stearothermophilus spores, packaged 50 tests per box;
and Raven Prospore ii Biological Indicators (same
product) packaged 10-tests per box. (NOTE: The label
for the 10-test boxes is an old label which was in use
for this lot.).

REASON: Inappropriate color change.

MANUFACTURER: Becton Dickinson Microbiology Systems, Sparks, MD.

PRODUCT: Z-867-1. VDRL Test Control Serum Set, Catalog No. 235201,Lot Nos. 149027LA and 149484LA;

REASON: The VDRL Weakly Reactive Serum Control demonstrates
reactivity comparable to or stronger than the VDRL
Reactive Control Serum. The unexpected reactivity of
the control invalidates the assay and the users cannot
qualify the antigen present in the sample.

MANUFACTURER: Medical Components, Inc., Harleysville, PA.

PRODUCT: Z-0872-1 - Z-0879-1
Ash Split Catheter, Bio-Flex Continuous/CAVH, Duo-Flow XTP, Hemo-Cath, Soft Line, and Tesio Hemodialysis and Apheresis Catheters. These products are hemodialysis catheters; the three types affected are: long term (chronic), short term (acute) and femoral
(hemofiltration)catheters.

REASON: Unapproved for pediatric use as stated in literature.

MANUFACTURER: Alaris Medical Systems, Inc., San Diego, CA

PRODUCT: IVAC MedSystem III Infusion Pump:
Z-899-1 - Model No. 2860 (110V);
Z-900-1 - Model No. 2863 (110V);
Z-901-1 - Model No. 2865 (220V);
Z-902-1 - Model No. 2866 (220V);
Z-903-1 - MiniMed MMT 9500 (110V).

REASON: The motor drive is subject to premature wear which can cause alarms and error notices which may affect fluid delivery.

MANUFACTURER: Prizm Medical, Inc., Duluth, GA

PRODUCT: Touch-Proof Leadwires, Black and Red Wire, Micro-Z
Neuromuscular Stimulators:
Z-904-1 Black Wire, Part No. 0-24-ML WBLK-0-0,
Lot No. 99H007
Z-905-1 Red Wire, Part No. 0-24-ML WRED-0-0,
Lot No. 99H008.

REASON: A design flaw (untapered pins) may cause an intermittent failure to conduct electrical energy from the stimulator to the electrode.

MANUFACTURER: Dade Behring Marburg GMBH Marburg

PRODUCT: Z-0906-1
Behring Coagulation System (BCS) software

REASON: Leak of piston pump valve introduces air bubbles.

MANUFACTURER: Dade Behring, Inc., Newark, DE.

PRODUCT: Z-0907-1
Dimension RxL integrated chemistry system. Prostate Specific Antigen (PSA) Flex Reagent Cartridge.

REASON: False positive results - increased number.

MANUFACTURER: False positive results - increased number.
Medex, Inc. Hilliard, OH

PRODUCT: Z-0931-1
Medex Bifurcated Set, with SmartSite Valve, 25 sets per case.

REASON: The device is labeled as Latex Free, however it actually contains latex

MANUFACTURER: Sunquest Information Systens, Inc. Tucson, AZ

PRODUCT: Z-0939-1 - Z-0940-1
FlexiLab Laboratory Information System, Versions 5.23 and 5.3 with Microbiology Module.

REASON: Incorrect printing of lab test results.

MANUFACTURER: Sunquest Information Systems, Inc. Tucson, AZ

PRODUCT: Z-0941-1 - Z-0942-1
FlexiLab

REASON: Incorrect data is filed to patient file.

MANUFACTURER: Vidamed, Inc. Fremont, CA

PRODUCT: Z-0943-01
VidaMed Transurethral Needle Ablation (TUNA) System VTS PROVu ground pad Model Number(s): 7002

REASON: Potential burn of a return electrode following a TUNA procedure.

MANUFACTURER: Mack Technologies, Westford, MA

PRODUCT: Z-0944-01
FluidSense FS-01 Infusion Pump

REASON: Keyboard may malfunction with stuck keys or provide no response to touch

MANUFACTURER: Medisense UK Limited, ABINGDON

PRODUCT: Z-0950-01
Precision PCx Blood Glucose Test Strips

REASON: Assigned High and Normal Control Ranges are incorrect

MANUFACTURER: Instrumentation Laboratory Co. Ann Arbor, MI

PRODUCT: Z-0952-01 - Z-0953-01
GEM Premier 5300
GEM Premier Plus 5500

REASON: Inaccurate pO2 reading

MANUFACTURER: Bebig Isotopentechnik GmBh Berlin,

PRODUCT: Z-0954-01
Symmetra I-125 Brachytherapy Sources
Sealed source, Radionuclide

REASON: Labeled with wrong activity levels

MANUFACTURER: Agilent Technologies Inc., Andover, MA

PRODUCT: Z-0955-01 - Z-0957-01
a) Agilent Model M3500B Heartstream XLT Defibrillator, also labeled as: Laerdal Heartstart 4000 Model M5500B Dibrillator/Monitor
b) Heartstream XL Model M4735A Defibrillator/Monitor

REASON: Defibrillator may shut down or fail to power on.

MANUFACTURER: Medsource Technologies Newton, MA

PRODUCT: Z-0958-01 - Z-0965-01
Superview Speedband Multiple Band Ligator and Injection
Superview Speedband Multiple Band Ligator Sterile

REASON: Band ligator fails to deploy

MANUFACTURER: LaserStar Technology, Division of Crafford Precision Products Company, Riverside, RI

PRODUCT: Model Nos. 501-4, 501-5, 501-6 Series, Deluxe LaserStar 501-4002 Nd:Yag, Hi Performance LaserStar Model 501-4002HP and Standard LaserStar Model No. 501-4003 Nd:Yag; laser welding products which are not medical devices:
Z-967-1 - Model No. 501-4xxx Series;
Z-968-1 - Model No. 501-5xxx Series;
Z-969-1 - Model No. 501-6xxx Series.

REASON: The products failed to have a readily available remote
interlock connector.

MANUFACTURER: Bio-Rad Laboratories, Inc., Irvine, CA.

PRODUCT: Z-0970-1 - Z-0971-1
Wako Lyophilized Chemistry 2, Product Code 7707A, Lot 7707A01, MFD Mar-00, Exp Date 31 Mar 2003; Wako Lyophilized Chemistry 1, Product Code 1104A,Lot 7704A01, MFD Mar-00, Exp Date 31 Mar 2003.

REASON: Unit recalled by component manufacturer due to positive for anti-HCV.

MANUFACTURER: Abbott Laboratories Abbott Park, IL

PRODUCT: Z-0972-1 - Z-0973-1
Plum A+ Infusion Pump List No. 11973
Plum A+ Peripheral Card List No. 12380-04-05/06

REASON: There is a potential for error in delivery if Duration is changed while in "Titration Mode".

MANUFACTURER: Tosoh Medics, Inc. South San Fransisco, CA

PRODUCT: Z-0975-1
Tosoh AIA-PACK brand Troponin I, Immunoassay Test Cups

REASON: False positive and false negative results.

MANUFACTURER: Mallinckrodt Medical Athlone, Ireland,

PRODUCT: Z-0979-1
TracheoSoft, 8.0mm Shiley, XLT Distal Extension - Tracheostomy tube and tube cuff. The product is an extended length tracheostomy tube that has a disposable inner cannula. It is available in four sizes V 5, 6, 7 and 8mm and four different SKUs. There are cuffed and uncuffed versions and proximal and distal versions of the above sizes. Only the 8.0mm Shiley TracheoSoft XLT with Distal Extension - Cuffed Tracheostomy Tube is the subject of this recall.

REASON: Device components can become disconnected or dislodged, leading to ineffective ventilation.

MANUFACTURER: Hamilton Co., Reno, NV.

PRODUCT: Z-0980-1 - Z-0981-1
Hamilton Disposable Precision Tips, A Microlab AT Series A pipette

REASON: A defect in the molding of the tip barrel.

MANUFACTURER: AMERIWATER DAYTON, OH

PRODUCT: Z-0982-1
Dialysis Reverse Osmosis (RO) Water System, a water treatment system used in hemodialysis applications.

REASON: The fuse holder may fail prematurely, heat up, and result in a potential fire.

MANUFACTURER: Neurocontrol Corp. Valleyview, OH

PRODUCT: Z-0983-1
Freehand System, Implantable Receiver-Stimulator (IRS) Electrodes for the NeuroControl FreeHand System. The system uses electrical muscle stimulation which is intended to improve a patient's ability to grasp, hold, and release objects.

REASON: The electrode device may fail to deliver proper stimulation to the patient.

MANUFACTURER: Steris Corp. Mentor, OH

PRODUCT: Z-0984-1
STERIS 20 Sterilant Concentrate, used with the STERIS SYSTEM 1 PROCESS. STERIS 20 is packaged in a cup consisting of two parts: 35% peracetic acid liquid and a dry powdered formulation (sterilant builders). 20 cups per carton.

REASON: Metal particles may lodge in endoscope lumen and result in ineffective sterilization and/or may dislodge into patient during a surgical procedure.

MANUFACTURER: Ethicon Endo-Surgery, Inc. Ciudad Juarez Cihuahua, Mexico,

PRODUCT: Z-0985-1 - Z-0996-1
ENDOPATH Non-Bladed Obturator Trocar, with smooth or stability sleeve, handled or non-handled. Sizes: 5mm, 10/11mm, and 10/12mm. Lengths: 100mm and 75mm. The defective Trocars are packaged as 6 per single sales unit per box or 2 to 5 units per procedure kit/tray.

REASON: The lens tip of the trocar may separate from the obturator during surgery.

MANUFACTURER: Meridian Diagnostics, Inc. Cincinnati, OH

PRODUCT: Z-0997-1 - Z-1022-1
Product Name / Catalog Number / Lot Number:
1) Premier CMV IgG; Cat # CME100
Lots: CME100.003, CME100.004, CME100.005
2) Premier CMV IgM; Cat # CME150
Lots: CME150.002, CME150.003, CME150.004
3) Premier EBV Early Antigen IgG; Cat # EAI101
Lots: EAI101.005, EAI101.007, EAI101.008
4) Premier EBV VCA IgG; Cat # EBE100
Lots: EBE100.004, EBE100.005, EBE100.008,
EBE100.009,EBE100.010
5) Premier EBV VCA IgG Semi Quantitative; Cat #EBE101
Lots: EBE101.009, EBE101.011, EBE101.012
6) Premier EBV VCA IgM; Cat # EBE150 Lots:
EBE150.005, EBE150.009,EBE150.011, EBE150.012
7) Premier EBV EBNA-1 IgG; Cat # ENE102
Lots: ENE102.004, ENE102.007, ENE102.008
8) Premier EBV VCA/EA IgM; Cat # EVE150
Lots: EVE150.005, EVE150.006
9) Premier HSV Type 1 IgM; Cat # H1E150
Lots: H1E150.008
10) Premier Type Specific HSV-1 IgG; Cat # H1I101
Lots: H1I101.008, H1I101.009
11) Premier Type Specific HSV-1 IgG; Cat # H1S100
Lots: H1S100.007, H1S100.008, H1S100.009
12) Premier HSV Type 2 IgM; Cat # H2E150
Lots: H2E150.004, H2E150.007, H2E150.008,H2E150.009, H2E150.010
13) Premier Type Specific HSV-2 IgG; Cat # H2I101
Lots: H2I101.005, H2I101.007, H2I101.008
14) Premier Type Specific HSV-2 IgG; Cat # H2S100
Lots: H2S100.005, H2S100.007
15) Premier Type Specific HSV-1 & 2 IgG; Cat # H3I101
Lots: H3I101.002, H3I101.003
16) Premier Lyme IgM; Cat # LDE150
Lots: LDE150.004, LDE150.005, LDE150.006
17) Premier Rubeola IgG; Cat # RBE100
Lots: RBE100.003, RBE100.004
18) Premier Rubeola IgM; Cat # RBE150
Lots: RBE150.004, RBE150.005
19) Premier Rubella IgG; Cat # RUE100
Lots: RUE100.004, RUE100.005
20) Premier Rubella IgM; Cat # RUE150
Lots: RUE150.002, RUE150.003
21) Premier Rubella IgG; Cat # RUE101
Lots: RUE101.003, RUE101.004
22) Premier Toxoplasma IgG; Cat # TXE100
Lots: TXE100.002, TXE100.003
23) Premier Toxoplasma IgG; Cat # TXE101
Lots: TXE101.001
24) Premier Toxoplasma IgM; Cat # TXE150
Lots: TXE150.001, TXE150.002
25) Premier VZV IgG; Cat # VZE101
Lots: VZE101.005, VZE101.006

REASON: The kits are not properly validated, which may give variable or inaccurate test results.

MANUFACTURER: OSTEOMED CORP. ADDISON, TX

PRODUCT: Z-1022-1
2.4mm Locking Screws, component/accessory of the Osteomed Rigid Fixation System - Mandibular Frature/Reconstruction System.

REASON: The locking screw can fracture/break during surgical procedure.

MANUFACTURER: Aaron Medical Industries, St. Petersburg, FL

PRODUCT: Z-1027-1 - Z-1030-1
a) Aaron Ball Electrode, 5mm;
b) PSS Ball Electrode 5mm;
c) Sklar Ball Electrode 5mm;
d) Apple Medical Ball Electrode 5 mm.

REASON: Electrode fell apart during use.

MANUFACTURER: Hill-Rom, Inc. Charleston, SC

PRODUCT: Z-1031-1/
Clinitron At-Home Air Fluidized Therapy

REASON: Power cords overheating, smoking, or melting during normal operations.

MANUFACTURER: Datascope Corp. Collagen Products Division Mahwah, NJ

PRODUCT: Z-1033-1/
VasoSeal VHD Device
Bascular Hemostasis device
Catalog number 75304

REASON: Portion of VasoSeal VHD lot shipped prior to receipt of complete pyrogen testing.

MANUFACTURER: DataScope Corp. Fairfield, NJ.

PRODUCT: Z-1034-1 - Z-1041-1
Datascope's Percor STAT-DL and True Sheathless 9.5 Fr.Intra-Aortic Balloon Catheter for optional Sheathless Insertion.

REASON: Defect in the Y-fitting component which could cause slow gas leak.

MANUFACTURER: Valleylab, Inc., Boulder, CO

PRODUCT: Z-1042-1
Valleylab LigaSure vessel sealing system,

REASON: Previously recalled product, not released for distribution, was distributed.

MANUFACTURER: BD Critical Care Systems PTE LTD Singapore,

PRODUCT: Z-1043-1
All products bearing the Hydrocath trademark. Products manufactured from 1996 until 1998 were labeled as Ohmeda Hydrocath Central Venous Catheters. In 1998, BD acquired Ohmeda and labeling will indicate BD Hydrocath Central Venous Catheters.

REASON: Immediate-type hypersensitivity reactions, primarily in pediatric/infant patient

MANUFACTURER: The Kendall Co. LP Argyle, NY

PRODUCT: Z-1044-1 - Z-1045-1
a) Kendall SCD Clear Sequel/SCD Response Tubing Assembly used with Model 6325 and 7325;
b) Kendall SCD Blue Quick-Lock Tubing Assembly used with Models 5320 and 5325

REASON: Tubing Assemblies assembled incorrectly and compression sleeves may not inflate properly.

MANUFACTURER: LifeScan, Inc, Milpitas, CA

PRODUCT: Z-1046-1
Lifescan brand One Touch Hospital Blood Glucose Test Strips, 50-count test strips in a package.

REASON: The product was assigned an incorrect calibration code ("calcode").

MANUFACTURER: Sanguin Intl., Inc. Staffordshire DE 13 8AX,

PRODUCT: Z-1048-1
Medusa 2000 MED20SP Link Software Versions 1.2 and 1.3
The software Medusa 2000 is an interface link to the Ortho Summit Processor (OSP) which is a mass processing device for microplate based assays [tests for viral markers by ELISA]. The software is responsible for conveting OSP files into a format for use by Medusa 2000.

REASON: Software may process result instead of invalidating the plate

MANUFACTURER: Welch Allyn Protocol, Inc. Beaverton, OR

PRODUCT: Z-1049-1
Acuity Central Monitoring Stations with software versions 4.03.00, 4.03.01, 4.03.02, 4.03.03, 4.03.04, and 4.03.05 when connected to VHF/UHF telemetry units CODES: software versions 4.03.00, 4.03.01, 4.03.02, 4.03.03, 4.03.04, and 4.03.05

REASON: Incorrect Visual Display

MANUFACTURER: USSC Puerto Rico, Inc. Mercedita, PR

PRODUCT: Z-1050-1 - Z-1052-1
AutoSuture [Single use Staplers]

REASON: Stapler may fire without the staples being completely formed into the tissue

MANUFACTURER: Maquet Aktiengesellschaft Rastatt, Germany,

PRODUCT: Z-1053-1
Maquet Alphamaxx Surgical Tables, Model 1133

REASON: Table did not elevate when the Table-Up function was activated

MANUFACTURER: ALM Orleans CEDEX 2, France,

PRODUCT: Z-1054-1
Maquet Surgical Table, Model C-Max

REASON: There is a potential of allowing the patient's head to drop.

MANUFACTURER: Respironics Colorado, Inc. Westminster, CO

PRODUCT: Z-1056-1
Respironics Noninvasive Extrathoracic Ventilator NEV-100

REASON: Faulty RFI filter may cause device to stop, reset and/or exhibit a smoky odor.

MANUFACTURER: Welch Allyn Protocol, Inc. Beaverton, OR

PRODUCT: Z-1057-1
Acuity Central (Monitoring) Station

REASON: System crashes and lock-up.

MANUFACTURER: Siemens Elema AB/Electromedical Division SOLNA,

PRODUCT: Z-1058-1
Siemens Compressor Compact,115V/60Hz

REASON: Defective clutch in the compressor may result in low pressure alarm or noisy units

MANUFACTURER: Catheter Innovations, Inc. Salt Lake City, UT

PRODUCT: Z-1061-1/ - Z-1066-1
Catheter Innovations PASV Implantable Port (plastic)
Single or Dual port.

REASON: Implantable plastic catheter ports may leak due to cracking.

MANUFACTURER: Abbott Laboratories, Inc., Laurinburg, NC

PRODUCT: Z-1067-1
Enteral Feeding Tube, Preassembled with Stylet, size 10 French 45 inch (114 cm), non-sterile, 10 feeding tube units per case.

REASON: Stylet may extend beyond the tip of the tube and cause tissue damage.

MANUFACTURER: Medron, Inc. Salt Lake City, UT

PRODUCT: Z-1068-1 - Z-1069-1
Bard Access Opti-Flow Pre-Curved Dual Lumen Catheters, and Bard Access Opti-Flow Straight Chronic Dual Lumen Catheters

REASON: Catheter tips may separate during use.

MANUFACTURER: Medex, Inc. Hilliard, OH

PRODUCT: Z-1070-1
Medex 60-inch Low-Vol Extension Set with Female Luer Lock, Male Luer Lock, and Non-Removable Slide Clamp. The product is packaged as 50 units per case, and labeled in part, ' ** Medex - A Furon Company Hilliard, OH 43026 USA ** PRODUCT 536035 ** 60in/152cm Ext. W/M/FLL Clamp APV 1.0 ml ** Latex Free ** STERILE ** '

REASON: The immediate container is labeled with the incorrect product number/priming volume.

MANUFACTURER: STERIS CANADA CORP. BEAUPORT, QUEBEC,

PRODUCT: Z-1071-1
Amsco Reliance 444 Washer-Disinfector, single-chamber.

REASON An electrical shock hazard may exist due to improper ground wiring.

MANUFACTURER: Tandem Medical San Diego, CA

PRODUCT: Z-1073-1
AutoDose Pump, Model P4120, an External Infusion Pump

REASON: Rollers in pump may pinch fingers of caregiver.

MANUFACTURER: Elcam Paltics Merom Hagali, Israel

PRODUCT: Z-1074-1 - Z-1077-1
FluidSense Sterile Administration Sets as follows:
The sets are used with the FluidSense Fluid Delivery System [FS-01].

REASON: Core Y-Site may separate from plastic housing and dislodge

MANUFACTURER: GE Medical Systems, Information Technologies, Milwaukee, WI

PRODUCT: Z-1078-1
Clinical Information Center Software. The brand name was Marquette when the product was initially distributed.

REASON Device can improperly restart resulting in no alarms or information at the central station for 2 minutes.

MANUFACTURER: MACROPORE, INC. SAN DIEGO, CA

PRODUCT: Z-1082-1
StarBurst Screw Driver. This medical device is a screwdriver designed for use with the firm's MacroPore System. The MacroPore System consists of resorbable implants and accessories for bone healing applications.
The catalog numbers affected are 02090. The devices from this catalog number were sold in sterile and non-sterile forms. Only the sterile units were subject to the removal.

REASON: False perception of sterility on part of users.

MANUFACTURER: CRYOLIFE, INC. KENNESAW, GA

PRODUCT: Z-1083-1 - Z-1084-1
Allograft Heart Valve

REASON: Failure to meet curent guidelines regarding serodilution of plasma.

MANUFACTURER: BAXTER HEALTHCARE CORP. MOUNTAIN HOME, AR

PRODUCT: Z-1086-1 - Z-1087-1
Polysynthane Hemodialyzers; 24 units per case; The products were distributed under both the Baxter label: Baxter Healthcare Corporation, Renal Division, Deerfield, IL 60015, and the Gambro label: the following models are affected:
a) Model PSN-170, 1.7 m2 surface area x 229 mm length product code 5M1817
- Baxter label, global multi-language
5Q6123 - Baxter Japanese label
5M4117 - Gambro label
b) Model PSN-210, 2.1 m2 surface area x 229 mm length product code 5M1818
- Baxter label, global multi-language
5Q6124 - Baxter Japanese label
5M4118 - Gambro label

REASON: Fiber blood leaks

MANUFACTURER: MEDTRONIC, INC. MINNEAPOLIS, MN

PRODUCT: Z-1088-1/Z-1092-1
Medtronic Activa Tremor Control Systems, also called Medtronic Activa Systems For Deep Brain Stimulation (DBS). Each consists of a neurostimulator or pulse generator, an extension, and a lead, which are used for the treatment of tremor due to Parkinson's Disease and Essential Tremor. Identified below are the specific pulse generators, extensions, and leads that can be used:
Medtronic Generators Itrel I, II and 3 Implantable Pulse Generators Models 7420, 7421, 7424, 7425.

Medtronic Soletra Quadripolar Neurostimulator for Deep Brain Stimulation, Model 7426

Medtronic Model 7495 DBS Extension For Stimulation of the Brain,

REASON Using diathermy to treat patients with neurostimulation devices can cause injury

MANUFACTURER: Becton Dickinson Infusion Therapy Systems Inc. Sandy, UT

PRODUCT: Z-1093-1 - Z-1094-1
Becton Dickinson Saf-T-Intima IV Catheter. Catalog No. 383323, Lot 101322, and Catalog No. 383336, Lot 101328 and 101329.

REASON: The telescoping needle shield would not function as designed due to improper epoxy application during manufacture. As a needle is withdrawn, the needle shield is supposed to telescope over the needle to prevent the possibility for needle sticks.

MANUFACTURER: SARL CODMAN LELOCLE SWITZERLAND,

PRODUCT: Z-1095-1 - Z-1099-1
a) Codman SiphonGuard CSF Control Device
S/N 883944
b) CodmanHakim Programmable Valve, In-Line Reservoir
Separable
Distal Catheter with SiphonGuard Device
c) CodmanHakim Programmable
Valve, with Right Angle Reservoir, Separable Distal Catheter with SiphonGuard Device
d) CodmanHakim Programmable Valve, In-Line Reservoir
Unitized Distal Catheter with SiphonGuard Device
e) CodmanHakim Programmable Valve with Right Angle
Reservoir Unitized Distal Catheter with SiphonGuard
Device

REASON Device may activate at lower than intended flow rates

MANUFACTURER: Howmedica Osteonics Corp. Rutherford, NJ

PRODUCT: Z-1100-1 - Z-1105-1
Brand Name: Dall Miles Vitallium Cable Crimp Sleeve Common Name:Cable Crimp Sleeve Classification Name: Appliance, fixation, nail/blade/plate combination Multiple Component

REASON: Cable crimp sleeves not heat treated which can cause fracture during crimping

MANUFACTURER: Siemens Medical Systems, Inc. Hoffman Estates, IL

PRODUCT: Z-1105-1/Z-1107-1
Programmable Multi-Axis Controller (PMAC 2 Lite) circuit board installed in E.CAM Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures.

REASON: Resistor Packs installed backwards cause software errors

MANUFACTURER: Arrow Intl., Inc. Reading, PA

PRODUCT: Z-1109-1 - Z-1110-1,
MAC Two Lumen Central Venous Access Kit/Set.

REASON: Potential for leakage of fluid or air from hemostasis valve w/obturator in place

MANUFACTURER: Kendall/Div. of Tyco Healthcare Group LP Norfolk, NE

PRODUCT: Z-1111-1
"Reli On" Insulin Syringe, 3/10 cc, 30 gauge 5/16" (8mm) Needle (sterile).Labeled: "ULTRA COMFORT SHORT NEEDLE Insulin Syringes Reli On U-100 Insulin for 30 Units or Less***3/10cc***". Packed in boxes of 100 Single Use Syringes

REASON: Insulin Syringes Mislabeled as 3/10cc, 30 unit instead of 1/2cc, 50 unit

MANUFACTURER: World of Medicine Gmbh Ludwigsstadt

PRODUCT: Z-1112-1
Olympus Uteromat Fluid Control model A4058. Designed for infusion of low viscosity distension media during hysteroscopic procedures to distend the cavum uteri (uterine cavity). Device provides constant monitoring and display of inflow fluid volume and fluid loss, permanent measuring of fluid consumption automatic calculation of the total amount of fluid loss, additional warning for rapid absorption.

REASON: Software malfunction.

MANUFACTURER: Lifenet Virginia Bbeach VA

PRODUCT: Z-1113-1 - Z-1114-1
Human Heart Valves, processed and frozen, for transplantation

REASON: Sera from donor of human tissues were tested with unapproved method.

CLASS III

MANUFACTURER: Abbott Laboratories, Inc. Abbott Park, IL

PRODUCT: Z-0861-1
lMx Glycated Hemoglobin Calibrators; list 1A86-01; an In Vitro diagnostic for calibration of the IMx Analyzer when used for the determination of Glycated Hemoglobin in human anticoagulated whole blood; each kit consists of 6 vials, Calibrators A - F, 0 -2.4 GHb;

REASON: Elevated Low Control values

MANUFACTURER: Nobel BioCare USA, Inc. Yorba Linda, CA

PRODUCT: Z-0863-01
Steri-Oss HL Threaded Implant, HA-Coated 4.5D x 10mm, Endosseous Implant,

REASON: Label on cap does not match labels on inner and outer vials.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 05, 2001:

CLASS II

MANUFACTURER: Guidant Corporation, Cardiac Pacemakers, St. Paul, MN.

PRODUCT: Z-0613-1 - Z-0618-1
Ventak Prism Automatic Implantable Cardioverter Defibrillators, VR Model 1850, VR HE Models 1852 and 1857, DR Model 1851, and DR HE Models 1853 and 1858. Several serial numbers.

REASON: Devices could inappropriately go into Safety Mode limiting therapy.

MANUFACTURER: Alaris Medical Systems, Inc., San Diego, CA.

PRODUCT: Z-748-1, Infusion Pump. Model PC-1, 220V CE, with software versions 8.12 and 8.13, Marked "International Only".

REASON: The devices have the potential for a motor stall thereby affecting fluid delivery.

MANUFACTURER: Stryker Corp., Kalamazoo, MI.

PRODUCT: Z-757-1 Stryker Secure Med/Surg Bed, Model No. 3000-AC powered Hospital Bed; all units with serial numbers beginning with the first four digits 9505 through 9610.

REASON: The fasteners which hold the side rails can loosen over time and make the side rail unstable, which may allow a patient to fall out of bed.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA.

PRODUCT: Z-759-1 Cryovale Allograft Heart Valve.

REASON: The firm's donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA

PRODUCT: Z-760-1 - Cryovalve Allograft Heart Valve,
Model No. AV00, Serial No. 3942406;
Z-761-1 - Cryovalve Allograft Heart Valve,
Model No. PV00, Serial No. 3942392.

REASON: The firm's donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA.

PRODUCT: Z-762-1 - Cryovalve Allograft Heart Valve,
Model No. AV00, Serial No. 6064264;
Z-763-1 - Cryovalve Allograft Heart Valve, Model No. PV00, Serial No. 6064272

REASON: The firm's donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA.

PRODUCT: Z-764-1 Cryovalve Allograft Heart Valve;
Model No. PV00, Serial No. 6197116.

REASON: The firm's donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA

PRODUCT: Z-765-1 Cryovalve Allograft Heart Valve, Model No. AV00, Serial No. 6105661.

REASON: The firm's donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA

PRODUCT: Z-766-1 Cryovalve Allograft Heart Valve;
Model No. AV00. Serial No. 3988317.

REASON: The firm's donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

MANUFACTURER: Sybaritic Inc./Symedex LLC, Minneapolis, MN

PRODUCT: Z-767-1 Model SkinMaster System;
CODE: SkinMaster MD7 Skin Rejuvenation System and SkinMaster Beauty Pro 5 System.

REASON: The device failed to comply with 21 CFR 1040.11(a)(2) in that the units were introduced into commerce without safety labels and user information that comply with the Federal laser product performance standard, 21 CFR 1040.10 and 11.

MANUFACTURER: North American Drager, Telford, PA.

PRODUCT: Z-768-1 Gas machine for anesthesia.

REASON: Reports of unintended PEEP greater than 20 cmH20, all occurring at same hospital.

MANUFACTURER: Siemens Medical Systems, Inc. Hoffman Estates, IL.

PRODUCT: Z-0769-1 - Z-0771-1
E.CAM Emission Imaging Computed Tomography Systems
used for all common nuclear medicine procedures; Siemens Medical Systems, Inc., Nuclear Medicine Group, Hoffman Estates, IL 60195-5203
CODES:
a) E.CAM+ models with e.soft workstations, e.soft software versions 1.0 and above
b) E.CAM Duet models with e.soft workstations, e.soft software versions 1.0 and above
c) E.CAM+ models with ICON workstations, ICON software versions 8.0 and above all serial numbers with Coincidence mode package installed.

REASON: Incorrect orientation of acquired patient data

MANUFACTURER: Baxter Products Medicos Ltd. Cartago, CR

PRODUCT: Z-0772-1/Z-0807-1
Baxter Interlink and Regular I.V. Sets; sterile, nonpyrogenic fluid path. Several product codes and lot numbers.

REASON: Pinholes in protector cap of luer lock.

MANUFACTURER: Abbott Laboratories, Inc. Abbott Park , IL

PRODUCT: Z-0859-1/Z-0860-1
Abbott LCx Probe System Chlamydia trachomatis Assay Amplification & Detection Kit; an in-vitro diagnostic. list 09B11 - U.S. labeling and list 07A91 - rest of world labeling CODES: list no.09B11 - several U.S. labeling lotnumbers

REASON: High negative control rates resulting in invalid runs and non-repeating positive.

MANUFACTURER: Abbott Laboratories, Inc. Abbott Park, IL

PRODUCT: Z-0862-1 AxSYM B12 Reagent Pack (Dual Pack), list 3C79-20; an In Vitro diagnostic assay for the quantitative determination of vitamin B12. Codes: list 3C79-20, lots 71097M100 and 71098M100

REASON: Calibration failures and nonreproducible results.

MANUFACTURER: Medical Components, Inc., Harleysville, PA

PRODUCT: Z-0880-1
7F BioFlex Tesio Long Term Hemodialysis or Apheresis Catheter Set.

REASON: Mislabeled - incorrect priming volume

MANUFACTURER: Medical Components, Harleysville, PA

PRODUCT: Z-0881-1-Z-0889-1,
MEDCOMP BIO-FLEX CS CATHETER (CS100)

REASON: Longitudinal slits

MANUFACTURER: Medical Components, Inc., Harleysville, PA

PRODUCT: Z-0890-1 - Z-0892-1, Silicone catheters

REASON: Resent instructions for silicone catheters - not to use iodine

MANUFACTURER: Dade Behring, Inc., Newark, DE

PRODUCT: Z-0913-1, Dimension RxL, Clinical Chemical Analyzer, RxL/HM with software, 5.1

REASON: Incorrect low results for a number of patient samples.

MANUFACTURER: Pride Mobility Products Corp., Exeter, PA

PRODUCT: Z-0914-1 - Z-0918-1
Pride Jazzy Scooter.

REASON: Tire exploded

MANUFACTURER: Shanghai Global Fabtech Plastic Products, Shanghai, China,

PRODUCT: Z-0919-1, Z0921-1, Revo Scooter.

REASON: Scooter drive system may engage while parking brake is inactive.

MANUFACTURER: Drager Medizintechnik GmBh Luebeck

PRODUCT: Z-0922-1
Drager Vapor 2000 Sevoflurane Vaporizers

REASON: Mislabeled - Sevoflurane labeled as Isoflurane

MANUFACURER: ARROW INTL., INC., READING, PA

PRODUCT: Z-0923-1 - Z-0926-1
Percutaneous Sheath Introducer Kit.

REASON: Valve may leak under certain conditions

MANUFACTURER: Baxter Healthcare Corporation, Singapore, SN.

PRODUCT: Z-929-1 Colleague Single Channel Volumetric Infusion Pumps,

REASON: Battery related failures.

MANUFACTURER: ZNC International Inc., Port Chester, NY.

PRODUCT: Z-0932-1, Disposable Scalpels labeled as sterile.

REASON: Packaging defect (weld seals)/sterility may be compromised.

MANUFACTURER: Unknown

PRODUCT: Z-0934-1-Z-0937-1, Surgical accessories used for orthopedic or trauma surgery: saw blades, twist drill bits, burrs, and high speed burrs. All products contain a label that states "SSIS Inc. Date **Lot # ** Hos Part # ** Part Description: ** Product has been EO Gas sterilized.***"

REASON: Sterility may be compromised.

MANUFACTURER: Siemens Elema AB Solna,

PRODUCT: Z-0946-01, Z-0947-01, Servo Ventilator, 300/300A

REASON: Failure of front panel potentiometers due to oxidation.

MANUFACTURER: Agilent Technologies(Hewlett-Packard GmbH) Boeblingen, Baden-WTTBG,

PRODUCT: Z-0948-01/Z-0949-01
Agilent Technologies (formerly Hewlett Packard Co.)
(A) Anesthesia Monitoring Systems, M1165A, M1166A,
M1167A, M1175A, M1176A, M1177A with Release C.0 software and Options A74, A76, A84, A86 specifying Care Models: 74S, 76S, 84S, 86S Firmware Revision level: Only EEPROM Nos.: M1059-81242 or M1059-81262
(B)Upgrade kits M1160A and M1170A with option LO1
Anesthesia Monitoring Systems, Models: M1165A, M1166A,
M1167A, M1175A, M1176A, M1177A with Released C.0
software and Options A74, A76, A84, A86 specifying
Care Models: 74S, 76S, 84S, 86S Firmware Revision
level: Only EEPROM Nos.: M1059-81242 or M1059-81262
Upgrade kits M1160A and M1170A with option LO1

REASON: Monitoring and alarm functions maybe temporarily disabled

MANUFACTURER: Medical Components, Inc., Harleysville, PA

PRODUCT: Z-0976-1, Ash Split Catheter with cuffs. Several codes and batch numbers.

REASON: Catheter fails to remain anchored to patient.

MANUFACTURER: Animas Corporation, Frazer, PA

PRODUCT: Z-1032-1, Animas R1000 Insulin Pump, Several serial numbers

REASON: Infusion pumps may have defective vents causing unintentional dose of insulin.

CLASS III

MANUFACTURER: Medi-Physics, Inc.

PRODUCT: Z-699-1 OncoSeed Iodine 125 Seeds; a welded titanium capsule containing Iodine-125 absorbed onto a silver rod.

REASON: Mislabeled seeds.

MANUFACTURER: Zimmer, Inc., Statesville, NC.

PRODUCT: Z-751-1
A.T.S. Reusable Tourniquet Cuffs, Velcro Component, Part No. 650199, several lot numbers

REASON: The Velcro hook fastener component tore during use. Internal tensile strength testing showed that the Velcro component had approximately half of the tensile strength of a normal product.

MANUFACTURER: Colin Corp. Komaki City, Japan

PRODUCT: Z-758-1 PRESS MATE Advantage Vital Sign Monitor. Models 9861, 9871

REASON: The monitor may display erratic respiration rates and cause a false or no alarm.

MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Rochester, NY.

PRODUCT: Z-864-1 Vitros Clinical Chemistry Cholesterol (CHOL) Slides, Coating 0309, Catalog No. 1669829, several lot numbers

REASON: The use of the referenced product may result in positively biased results at high concentrations.

MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Rochester, NY.

PRODUCT: Z-865-1 Vitros Clinical Chemistry Specialty Diluent,
Catalog No. 8559825, Lot No. Y1844.

REASON: Product is labeled with the incorrect expiration date of 31 May 2003. The correct expiration date is 31 May 2002.

MANUFACTURER: Polymer Technology (A Bausch & Lomb, Inc. Co.) Rochester, NY.

PRODUCT: Plastic Material (Buttons) used to make Rigid Gas Permeable Contact Lenses:
Z-893-1 - Boston II (oprifocon A) Green. Product No.1000-A, Lot No. 00264PTC001, Rigid Gas Permeable Lens for Daily Wear;
Z-894-1 - Boston Equalens II (itafocon A) Green wit UV, Product No. 1500-A, Lot Nos. 00214PTC003, 99279PTC004, 99279PTC005, 99279PTC006, Rigid Gas Permeable Contact Lenses for Daily Wear or Extended Wear;
Z-895-1 - Boston ES (enflufocon A) Green with UV, Product No. 2200-A, Lot Nos. 00236PTC001, 00264PTC002, Rigid Gas Permeable Contact Lenses;
Z-896-1 - Boston ES (enflufocon A) Gray with UV, Product No. 2200-G, Lot No. 00236PTC002, Rigid Gas Permeable Contact Lenses;
Z-897-1 - Boston XO (hexafocon A) Green with UV, Product No. 2300-A, Lot Nos. 00040PTC013, 00040PTC014, 00040PTC015, 00165PTC008, 00278PTC006, Fluoro Silicone Acrylate Rigid Gas Permeable Contact Lenses for Daily Wear;
Z-898-1 - Boston EO (enflufocon B) Green with UV, Product No. 2600-A, Lot Nos. 00222PTC006, 00313PTC002, Rigid Gas Permeable Contact Lenses.

REASON: The contact lenses contained D&C Yellow No. 11 which is not approved for contact lens use.

MANUFACTURER: Dade Behring Marburg GMBH Marburg

PRODUCT: Z-0906-1 Behring Coagulation System (BCS) software version 2.2. CODES: Model OVIO03 Version 2.2

REASON: Leak of piston pump valve introduces air bubbles.

MANUFACTURER: Dade Behring, Inc., Newark, DE.

PRODUCT: Z-0908-1/ Z-0912/1 Five Dimension RxL Flex Reagent Cartridges. The product is composed of 1) Ferritin (FERR), 2) Human Chorionic Gonadotropin (HCG), 3) Mass Creatine Kinase MB Isoenzyme (MMB), 4) Myoglobin, and 5) Prostate Specific Antigen (PSA). FERR has 120 tests/carton; 30 tests/cartridge. HCG has 120 tests/carton; 30 tests/cartridge. MMB has 160 tests/carton; 40 tests/cartridge. MYO has 120 tests/carton; 30 tests/cartridge. PAS has 120
tests/carton; 30 tests/cartridge. The product is sold by the cartridge or 4 cartridges per carton.

REASON: Decline in stability following hydration.

MANUFACTURER: Canon U.S.A., Inc., Lake Success, NY.

PRODUCT: Z-930-1 Canon CXDI-22 X-Ray Digital Radiography System;

REASON: The exposure function may fail due to a blown fuse.

MANUFACTURER: Euro DPC United Kingdom.

PRODUCT: Z-0933-1 IMMULITE 2000 Antithyroid peroxidase (Anti TPO) kit, Catalog Number L2KTO2 121.

REASON: Component mix-up. Wrong bead lot.

MANUFACTURER: MicroBioLogics, Inc., St. Cloud, MN.

PRODUCT: Z-0938-1 MicroBioLogics Streptococcus bovis,
Derivative of ATCC# 49147, Catalog Numbers
0631V,0631S, and 0631P. This product was packaged into
3 packaging configurations under the MicroBioLogics
brand name:
1. Catalog number 0631V - A single vial that contains 10 individual LYFO-Disk pellets streptococcus bovis.
2. Catalog number 0631S - A canster with 10 individual KWIK-STIK units of streptococcus bovis.
3. Catalog number 0631P - A wrapped set that contains 2 individual KWIK-STIK units of streptococcus bovis. Packaging configurations 2 and 3 are labeled for a private label distributor, PML Microbiologicals, Wilsonville, OR. That name and address appears at the top of the label, with the product identification below.

Recalled product in a fourth packaging configuration was made and labeled for HealthLink. It is individually-wrapped Kwik-Stik labeled
"HealthLink***Cat # HL3480 (49147) S. bovis". HealthLink is located in Jacksonville, FL. CODE: Lot numbers 63131 and 63132.

REASON: The product contains the wrong bacteria strain.

MANUFACTURER: Medica Corp., Bedford, MA.

PRODUCT: Z-0951-1 EasyBlood Gas Analyzer.

REASON: PCO2 and PO2 values are incorrect if displayed in SI units instead of mmHg.

MANUFACTURER: Becton Dickinson Infusion Therapy Systems, Inc., Sandy, UT.

PRODUCT: Z-0966-01 Vaxcel 5F SL PICC(Peripherally Inserted Central Cannula), Clampable Hub Catalog #45-443, Lot Number 005827

REASON: Product may not have a clampable hub.

MANUFACTURER: Bio-Rad Laboratories, Inc. Irvine, CA.

PRODUCT: Z-0970-1/Z-0971-1
Wako Lyophilized Chemistry 2, Product Code 7707A, Lot 7707A01, MFD Mar-00, Exp Date 31 Mar 2003;
Wako Lyophilized Chemistry 1, Product Code 1104A, Lot Number 7704A01, MFD Mar-00, Exp Date 31 Mar 2003

REASON: Unit recalled by component manufacturer due to positive for anti-HCV

MANUFACTURER: Bard Glens Falls Operation, Queensbury, NY.

PRODUCT: Z-0978-1 Bard InLay Ureteral Stent, 4.7 Fr. Diameter.

REASON: Packaged with wrong guidewire.

MANUFACTURER: Diamedix Corp, Miami, FL.

PRODUCT: Z-1023-1 Diamedix/immunosimplicity brand of anti-Sm/RNP Enzyme Immunoassay Test Kit, For in Vitro Diagnostic Use, 96 test kit, catalog No. 720-270.

REASON: Positive control failed to recover within its assigned range.

MANUFACTURER: Sunsoft Corp., Albuquerque, NM.

PRODUCT: Z-1024-1 / Z-1026-1 Sunsoft Additions contact lenses, Sunsoft Multiples Toric, and Sunsoft Sphere Multiples.

REASON: Contact lenses may vary from the labeled power by as much as 0.75 diopters.

MANUFACTURER: Meridian BioScience, Inc., Cincinnati, OH.

PRODUCT: Z-1047-1 Premier Human Lyme EIA, an in-vitro diagnostic test kit. The kits should contain 2 microplates containing 96 test wells per plate. Kits are packaged and sold individually.

REASON: The kits are packaged with less test wells than labeled.

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

PRODUCT: Z-1055-1 Premier EBV IgG ELISA, in-vitro diagnostic
test kits, packaged under the Gull label.

REASON: Microwells that are washed automatically may result in an invalid test assay.

MANUFACTURER: Ameriwater, Dayton, OH.

PRODUCT: Z-1059-1 MRO Reverse Osmosis (RO) Water Treatment System.

REASON: Defective sensor will result in a false high conductivity reading and trigger alarm.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 29, 2001:

CLASS II

MANUFACTURER: Shanghai Global Fabtech Plastic Products, Shanghai, China,

PRODUCT: Z-919-1 to Z-921-1, Revo Scooter. The product is a three wheeled motorized scooter. The product has been designed for both indoor and outdoor use to clean and dry conditions. Model Information: SC60RRED, SC60RBLU, and SC60RYEL Models: SC60RRED (red), SC60RBLU (blue), and SC60RYEL (yellow)

REASON: Scooter drive system may engage while parking brake is inactive.MANUFACTURER: Medical Components, INC., Harleysville, PA.

PRODUCT: Z-976-1, Ash Split Catheter with cuffs, Several Batch/Lot Numbers

REASON: Catheter fails to remain anchored to patient.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 22, 2001:

CLASS I

MANUFACTURER: MAXXIM MEDICAL, INC., Clearwater, FL

PRODUCT: Z-688-1, VARIOUS CUSTOM SURGICAL PROCEDURE TRAYS-see specific listing under "codes" below. These are all Maxxim kits that contain Clinipad Products implicated as Class I although the specific lot number included in the kits cannot be determined until they are opened. Various tray names, kit items and clinipad items.

REASON: Sterile Surg.Kits May Contain Nonsterile Clinipad Products

MANUFACTURER: MAXXIM MEDICAL, INC. North Clearwater, FL

PRODUCT: Z-689-1, Various Sterile Surgical Procedure Trays (custom), Code Information: ALL SURGICAL TRAYS MANUF. AND LABELED WITH MAXXIM MEDICAL OF CLEARWATER FL. ARE COVERED BY THIS RECALL ACTION, ALL PRODUCT NUMBERS AND LOT NUMBERS

REASON: STERILE KITS MAY CONTAIN CLINIPAD PRODUCT-LACK OF ASSUR OF STER.

CLASS II

MANUFACTURER: Alcon Laboratories, Fort Worth, Texas

PRODUCT: Z-698-1, AcrySofô Brand Intraocular Lenses

REASON: Pin holes in the sterile pouches of the intraocular lenses.

MANUFACTURER: SONOSITE, INC., Bothell, WA

PRODUCT: Z-868-1, Sonosite 180 - portable, software controlled ultrasound system intended for use with a variety of transducers to perform a variety of scans and measurements/calculations for the abdomen, pediatric scans, general cardiac, GYN/infertility, obstetrics. Code: Sonosite units with the following software versions: 01.xx.003.00 to 01.xx.003.067 and 01.xx.002.yyy and 01.xx.001.yyyxx is 40, 60, or 80; and yyy is 000 through 999

REASON: Potential for miscalculation of estimated delivery date

MANUFACTURER: Disetronic Medical Systems, St. Paul, MN

PRODUCT: Z-709-1, H-TRONplus V100 Insulin Infusion Pump

REASON: Claim of waterproofing was not cleared.

MANUFACTURER: Alaris Medical Systems, Inc., San Diego, CA

PRODUCT: Z-748-1, Model PC-1 A one channel, general purpose, infusion pump, 220V CE Marked, International only (Software version 8.12 and 8.13)

REASON: Motor stall

MANUFACTURER: Sunquest Iinformation Systems, Inc., Tucson AZ

PRODUCT: Z-0735-1, FlexiLab Laboratory Information System, Version 5.23

REASON: Software anomaly

MANUFACTURER: Surgical Instrument Service & Savings, Inc., Sisters, OR

PRODUCT: Z-736-1, Inflatable Leg compression wraps used to maintain cardiovascular circulation of the legs of a bed-ridden patient. All parts are packed and labeled in part "SISS Inc. Date** Lot # ** Hos Part # ** Part Description: # ** Sisters, OR ** Product has been EO Gas sterilized ***", Inflatable leg compression wraps DVT 30 product - 3574

Z-737-1,Inflatable Leg compression wraps used to maintain cardiovascular circulation of the legs of a bed-ridden patient. All parts are packed and labeled in part "SISS Inc. Date** Lot # ** Hos Part # ** Part Description: # ** Sisters, OR ** Product has been EO Gas sterilized ***", Inflatable leg compression wraps DVT 40 product - 3575

REASON: PRODUCTS ERRONEOUSLY LABELED AS STERILE

MANUFACTURER: ALEXON - TREND, INC., Ramsey MN

PRODUCT: Z-0741-1, Intact hCG ELISA Test kit, catalog number KIF4013

REASON: Possible false negative test results

MANUFACTURER: STRUCKMEYER CORP. Dallas, TX

PRODUCT: Z-0750-1, Alumi-hand - a sterile, medical device used to immobilize the patient's hand during hand surgeries. Not implanted - single use. Code: Alumi-Hand, large, Stock #760, Lot #I-4284

REASON: Products may not be sterile - not irradiated at proper dose.

MANUFACTURER: BAUSCH & LOMB SURGICAL, INC., North Clearwater, FL

PRODUCT: Z-0808-1 to Z-0842-1 - Various models and lot numbers of Bausch & Lomb Intraocular Lens. There are 1639 lot numbers for each model.

REASON: Possible compromise of sterility packaging barriers.

MANUFACTURER: White Knight Healthcare, NC

PRODUCT: Z-0749-1, Impervious Labeled, Internally-Reinforced UltraGard Gowns - The affected gowns are labeled as "single use only." The following products/labels are under recall: Several reference and reorder numbers. Some of the products are for bulk, non-sterile components that are intended for use in finished surgical kit devices made by others.

REASON: Gowns may not be impervious

MANUFACTURER: NORTH AMERICAN DRAGER, Telford, PA

PRODUCT: Z-0768-1, gas machine for anesthesia, Code: 4114586-001

REASON: Reports of unintended PEEP greater than 20 cmH2O, all occurring at same hospital.

MANUFACTURER: STELKAST CO., Pittsburgh, PA

PRODUCT: Z-0869-1 Proform Non-Hooded Acetabular Shell Liner and Proven Posterior Stabilized Tibial Tray Insert, CODE: Catalog Number SC1163-5052 Lot 3559-071800
Z-0870-1, 1Proform Non-Hooded Acetabular Shell Liner and Proven Posterior Stabilized Tibial Tray Insert, Catalog Number SC1163-5860 Lot 3600-071800
Z-0871-1, 1Proform Non-Hooded Acetabular Shell Liner and Proven Posterior Stabilized Tibial Tray Insert, Catalog Number SC1586-3-10 Lot 3594-071800

REASON: Overlapped seal

MANUFACTURER: MEDICAL COMPONENTS, INC., Harleysville, PA

PRODUCT: Z-0880-1, 7F BioFlex Tesio Long Term Hemodialysis or Apheresis Catheter Set, Code Information: Catalog # MCTC730K, Lot #M029230

REASON: Mislabeled - incorrect priming volume

MANUFACTURER: Medical Components, Harleysville, PA

PRODUCT: MEDCOMP BIO-FLEX CS CATHETER (CS100)
Z-0881-1, MEDCOMP BIO-FLEX CS CATHETER (CS100)
Catalog #BFL-6 - lots: M813770, M819200, M820840, M902950, M903840, M907780, M915320, M919550, M921320, M929930, M933270 and M936870.

Z-0882-1, MEDCOMP BIO-FLEX CS CATHETER (CS100)
Catalog #BFL-6CTT (left side) - lots: M912540, M919140, M932310 and M934780.

Z-0883-1, MEDCOMP BIO-FLEX CS CATHETER (CS100)
Catalog #BFR-6CTT (right side) - lots: M912550, M915330, M919130, M924550, M932320, M935480, and M937950.

Z-0884-1, MEDCOMP BIO-FLEX CS CATHETER (CS100)
Catalog #BFR-6 - lots: M728810, M801970, M809360, M813780, M819050, M819980, M820830, M900800, M902960, M903830, M904290, M904900, M907770, M918790, M918800, M921300, M922780, M924570, M927450, M933260, M936500,
and M937960.

Z-0885-1, MEDCOMP BIO-FLEX CS CATHETER (CS100)
Catalog #BFR-70 - lot: M928700.

Z-0886-1, MEDCOMP BIO-FLEX CS CATHETER (CS100)
Catalog #BFS-6 - lots: M834100, M903280, M912650, M914740, M927830 and M928340.

Z-0887-1, MEDCOMP BIO-FLEX CS CATHETER (CS100)
Catalog #BFS-6CTT - lots: M912560, M931380 and M932530.

Z-0888-1, MEDCOMP BIO-FLEX CS CATHETER (CS100)
Catalog #TRAY 452 - lots: M912380, M916450, M919100, M924370 and M933050.

Z-0889-1, MEDCOMP BIO-FLEX CS CATHETER (CS100)
Catalog #TRAY 453 - lot: M912390

REASON: Longitudinal slits

MANUFACTURER: MEDICAL COMPONENTS, INC., Harleysville, PA

PRODUCT: Z-0890-1 to Z-0892-1
Silicone catheters: Tesio is a long-term hemodialysis Catheter. Schon Duo-Flow is a long-term hemodialysis catheter. Hemo-Cath is a dual lumen catheter.

REASON: Resent instructions for silicone catheters - not to use iodine

MANUFACTURER: Dade Behring, Inc., Newark, DE

PRODUCT: Z-0913-1, Dimension RxL, Clinical Chemical Analyzer, RxL/HM with software version 5.1

REASON Incorrect low results for a number of patient samples

MANUFACTURER: Pride Mobility products Corp., Exeter, PA

PRODUCT: Z-0914-1, Pride Jazzy Scooter. CODE: model number 1100;
Z-0915-1, Pride Jazzy Scooter. CODE: model number 1104;
Z-0916-1, Pride Jazzy Scooter, CODE: model number 1120;
Z-0917-1, Pride Jazzy Scooter. CODE: model number 1170;
Z-0918-1, Pride Jazzy Scooter, CODE: model number PHC1.

REASON: Tire exploded

MANUFACTURER: Dade Behring, Inc., Newark, DE

PRODUCT: Z-0907-1, Dimension RxL integrated chemistry system. Prostate Specific Antigen (PSA) Flex Reagent Cartridge, CODE: catalog number RF450. Lots: JS1284 exp. 10/11/01, IP1265 exp. 9/22/01, IR1265 exp. 9/22/01, HN1240 8/28/01, UA1207 exp. 7/26/01, UB1194 exp. 7/13/01, TC1174 exp. 6/23/01, FN1156 exp. 6/5/01, SA1125 exp. 5/5/01, DP1102 exp. 4/12/01, PC1087 exp. 3/28/01, CP1068 exp. 3/9/01, BM1045 exp. 2/14/01, AR1010 exp. 1/10/01, LS0344 exp. 12/9/00, and KM0327 exp. 11/22/00

REASON: False positive results - increased number

MANUFACTURER: Stryker Endoscopy, Santa Clara, CA

PRODUCT: Z-927-1, Stryker Endoscopy brand 5.5mm 6 Flute Barrel Bur , Model Number(s): (Hooded) 275-951-000)
Z-928-1, Stryker Endoscopy brand 5.5mm 6 Flute Barrel Bur , Model Number(s): (Unhooded) 275-951-200

REASON: The bur tip has a potential to separate from the bur shaft during surgery.

MANUFACTURER: Surgical Instrument Service & Savings, Inc., Sisters, OR

PRODUCT: Z-934-1 to Z-937-1
Surgical accessories used for orthopedic or trauma surgery: saw blades, twist drill bits, burrs, and high speed burrs. All products contain a label that states "SSIS Inc. Date ** Lot # ** Hos Part # ** Part Description: Sisters, OR ** Product has been EO Gas sterilized. ***".

REASON: Sterility may be compromised.

CLASS III

MANUFACTURER: Netra Therapeutics, Inc., St. Paul, MN

PRODUCT: Z-0714-1, IntraCoil Self-Expanding Peripheral Endoprosthesis, Model VT640135, Code: Lot Numbers MF1826, MF1827 and MF1999

REASON: Mislabeled as to french size of the delivery catheter.

MANUFACTURER: MPI, INC., Clear Lake, SD

PRODUCT: Z-0716-1, Innova Pelvic Floor Stimulation System and the touch-proof output jack adapter for the Innova Pelvic Floor Stimulation System.
CODE: All Innova units with the old adapter are affected. The Innova was cleared for market 1/20/95. Innova units were first sold with an adapter on 5/7/00. An old-style (defective) adapter was provided for all Innova units which were originally shipped without an adapter prior to 5/7/00. No Innovas were sold with the old adapter after 9/6/00. The units which have been shipped with the new adapter are not affected. The new adapter can be identified by the word Innova which is printed on it. The old "defective" adapters are only "defective" to the extent that they do not function properly with the Innova device. They do however function appropriately with the firm's other devices which include TENS, powered muscle stimulators, and iontophoresis devices.

REASON: Insufficient electrical contacts in adapter.

MANUFACTURER: SUNQUEST INFORMATION SYSTEMS, INC., TUCSON, AZ

PRODUCT: Z-0732-1, FlexiLab Laboratory Information System version 5.3, release date 2/11/2001.

REASON: Wrong normal ranges reported when age is listed as unknown.

MANUFACTURER: SUNQUEST INFORMATION SYSTEMS, INC., TUCSON, AZ

PRODUCT: Z-0733-1, FlexiLab Laboratory Information System Version 5.2, 5.23, and 5.3 interfaced with Anatomic Pathology Lab Access Transcription Workstation.

REASON: Software glitch

MANUFACTURER: Industrias UnidAs De Baja California, Mesa De Otay, Mexico.

PRODUCT: Z-0727-1, SIMS Deltec, Inc. Gripper Port-A-Cath Needle, 0.9 mm (20 G) x 19 mm (3/4 in.), Re-order Number 21-2947-24. Labeled on some individual needle packages as:
Z-0727-1, SIMS Deltec, Inc. Gripper Port-A-Cath Needle, 0.9 mm (20 G) x 25 mm (1 in.), Re-order Number 21-2948-24. Some of the product has SIMS Graseby Ltd. WD2 4LG UK as the distributor on the label instead of SIMS Deltec Inc.

REASON: Misidentification of needle length on label.

MANUFACTURER: MEDTRONIC, MILACA, MN

PRODUCT: Z-0743-1, Model 3625 Test Stimulator, CODE: S/N# NACO13714P through NACO13717P, NAC013738P through NAC013749P, NACO13752P through NACO13755P and NACO13759P through NACO13761P

REASON: Reversed labels on amplitude and rate knobs.

MANUFACTURER: Reversed labels on amplitude and rate knobs.

PRODUCT: Z-0744-1, StatusFlow Pro CD34 Whole Blood Process Control for Flow Cytometry (CD34 positive cells), Code:Lot FC100-34 (StatusFlow Pro),
Z-0745-1, StatusFlow Lo CD4-Low Whole Blood Process Control for Flow Cytometry (CD4 positive cells), Lot FC100-4L (StatusFlow Lo)

REASON: Values tend to go out of assay range while product is still within expiration.

MANUFACTURER: Dade Behring Marburg, Germany

PRODUCT: Z-0906-1, Behring Coagulation System (BCS) software version 2.2

REASON: Leak of piston pump valve introduces air bubbles

MANUFACTURER: Dade Behring, Inc., NEWARK, DE

PRODUCT: The product is composed of:
1) Z-0908-1, Ferritin (FERR)
2) Z-0909-1, Human Chorionic Gonadotropic (HCG)
3) Z-0910-1, Mass Creatine Kinase MB Isoenzyme (MMB)
4) Z-0911-1, Myoglobin
5) Z-0912-1, Prostate Specific Antigen (PSA).
FERR has 120 tests/carton; 30 tests/cartridge. HCG has 120 tests/carton; 30 tests/cartridge. MMB has 160 tests/carton; 40 tests/cartridge. MYO has 120 tests/carton; 30 tests/cartridge. PSA has 120 tests/carton; 30 tests/cartridge. The product is sold by the cartridge or 4 cartridges per carton.

REASON: Decline in stability following hydration.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 8, 2001:

CLASS I

MANUFACTURER: Maxxim Medical, Inc., North Clearwater, FL.

PRODUCT: Z-0688-1, VARIOUS CUSTOM SURGICAL PROCEDURE TRAYS-see specific listing under "codes" below. These are all Maxxim kits that contain Clinipad Products implicated as Class I although the specific lot number included in the kits cannot be determined until they are opened. Several Kit Items Tray Names Clinipad Items

REASON: Sterile Surgical Kits May Contain Nonsterile Clinipad Products.

CLASS II

MANUFACTURER: Surgimedics, Inc., The Woodlands, TX

PRODUCT: Z-0659-1, 1/4 X 1/2 X 1/2 Clear PAY with Luer Lock. 10 pouched/labeled units per box.

REASON: Nonsterile product labeled non-sterile contained a sterile catalog number and should have been sterile

MANUFACTURER: Datascope Corporation, Mahwah, NJ

PRODUCT: Z-700-1, Passport 2 Vital Signs Monitor

REASON: Power supply fails when the printer/recorder is activated.

MANUFACTURER: Timm Medical Technologies, Inc., Praire, MN

PRODUCT: Z-0715-1, Dura II Concealable Penile Prosthesis (in sterile packaging) with 1 Pair of 10 mm Bodies, Part Number 9310, Lot/Serial Number: 007695,Catalog Number: 9310, Expiration: 2005-10,(stands for October 2005)

REASON: 12 mm hex wrenches put in 10 mm Dura II penile prosthesis kits

MANUFACTURER: BOSTON SCIENTIFIC SCIMED, INC. MAPLE GROVE, MN

PRODUCT: Z-0729-1, ACE 2.0 PTCA Dilatation Catheters (2.0 mm diameter balloon size), Model Number H74902071011
Z-0730-1, Graft ACE 2.0 PTCA Dilatation Catheters (2.0 mm diameter balloon size), Model Number H74903647201
Z-0731-1, ACE 1 cm TIP 2.0 PTCA Dilatation Catheters (2.0 mm diameter balloon size), Model Number 74903628201

REASON: Slow or no balloon deflation was noticed during final functional testing of some of the catheters.

MANUFACTURER: GUIDANT CORPORATION, CARDIAC PACEMAKERS, ST. PAUL, MN

PRODUCT: Ventak Prism Automatic Implantable Cardioverter Defibrillators.

Z-0732-1, Ventak Prizm VR Model 1850: Several Serial numbers

Z-0733-1, Ventak Prizm DR Model 1851: Several Serial numbers

Z-0734-1, Ventak Prizm VR HE Model 1852: Serial numbers: 100000-100507

Z-0735-1, Ventak Prizm DR HE Model 1853: Several Serial numbers

Z-0736-1, Ventak Prizm VR HE Model 1857: Serial numbers: 500000-500123

Z-0737-1, Ventak Prizm DR HE Model 1858: Serial numbers: 600000-600129

REASON: Some of the defibrillators have automatically switched to an integrated Safety Mode because of a rare interaction between the device and a specific memory component.

MANUFACTURER: ST. JUDE MEDICAL, INC., DAIG DIVISION, MINNETONKA, MN

PRODUCT: Seal-Away Coronary Sinus Introducer Kit, Reorder Numbers 407508 & 407510
Z-0738-1, several lot numbers and expiration date.
Reorder Number 407508:
Z-0739-1, several lot numbers and expiration date. Reorder Number 407510:

REASON: It is possible for the Seal-Away CS sheath to split upon insertion.

MANUFACTURER: MEDTRONIC, INC., MINNEAPOLIS, MN

PRODUCT: Z-0740-1, Medtronic GEM Implantable Cardioverter Defibrillators, Model 7227, with Interchangeable Connector, Model 5227

REASON: Even though the devices will continue to provide therapy, the physician is led to believe that a lead failure has occurred. As a result, lead replacement would probably be chosen in some cases when it is unnecessary.

MANUFACTURER: BEEVE PRECISION, RACINE, WI

PRODUCT: Z-0742-1, Silhouette Spinal Fixation System Torque-Limiting T-Handle Driver, Catalog Number: 7010-0019-00. The Torque-Limiting T-Handle Drivers were each distributed in a case of instruments labeled "SILHOUETTE SCREW INSTRUMENT GENERIC CASE COMPLETE SET: 7050-0000-00".

REASON: The calibration of the device can be affected if the adjustment screws are altered.

MANUFACTURER: MEDTRONIC, INC., MINNEAPOLIS, MN

PRODUCT: Myotherm Cardioplegia Delivery System, XP 4:1 (catalog number 61399404996) and XP 4:1B (catalog number 61399405331). The XP 4:1B differs from the XP 4:1 by having a bridge connection which the XP 4:1 does not have.
Z-0746-1, MYOtherm XP 4:1 (catalog number 61399404996): lot number 0006013298 Z0747-1, MYOtherm XP 4:1B (catalog number 61399405331): lot number 0006014173

REASON: Some of the devices are mislabeled as to whether they have a bridge connection.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 1, 2001:

CLASS II

MANUFACTURER: Getinge/Castle, Inc., North Charleston, SC

PRODUCT: Z-639-1 - Castle Model GCL 500 Surgical Light;
Z-640-1 - Castle Model GCL 550 Surgical Light;
Z-641-1 - Castle Model GCL 750 Surgical Light;
Z-642-1 - 500 Series Lamp Head, Serial #GL 9911017 - GL 0003051.

REASON: Excessive force on the surgical lamp head may cause one of the welded joints in the suspension yoke to fail.

MANUFACTURER: Disetronic Medical Systems, St. Paul, MN

PRODUCT: Z-709-1, H-TRONplusV100 Insulin Infusion Pump

REASON: Labeling claims insulin pump is waterproof but some pumps malfunctioned when exposed to water.

MANUFACTURER: MEDTRONIC, INC., MINNEAPOLIS, MN 55432

PRODUCT: Z-0665-2, Medtronic Membrane Oxygenator with Integral Heat Exchangers Model Number I-4500-2A
Z-0666-1, Medtronic Membrane Oxygenator with Integral

REASON: Shorter than specified forced aeration has resulted in higher ETO levels.

MANUFACTURER: Beere Precision, Racine, WI; Metal Craft Machine & Engineering, Inc., Elk River, MN; and Houck Machine Company, Minneapolis, MN.

PRODUCT: Z-0717-1, Silhouette Five-Sided Nut Driver (part 7010-0021-00) for the Sulzer Spine-Tech Silhouette Spinal Fixation System. The Five-Sided Nut Driver is distributed in a case of instruments labeled "SILHOUETTE SCREW INSTRUMENT GENERIC CASE COMPLETE SET: 7050-0000-00".

REASON: The socket of a tool used for locking nuts for a spinal fixation device can slip.

MANUFACTURER: GE MEDICAL SYSTEMS EUROPE, FRANCE

PRODUCT: Z-0720-1, ZOmega IV Angiographic Table, (angiographic x-ray system),
Model: 2120637;
Z-0721-1, ZOmega IV Angiographic Table, (angiographic x-ray system),
Model: 2219154;
Z-0722-1, ZOmega IV Angiographic Table, (angiographic x-ray system),
Model: 2154474;
Z-0723-1, ZOmega IV Angiographic Table, (angiographic x-ray system),
Model: 2219155;
Z-0724-1, ZOmega IV Angiographic Table, (angiographic x-ray system),
Model: 2252036;
Z-0725-1, ZOmega IV Angiographic Table, (angiographic x-ray system),
Model: 2252037
Code Information:
Model Numbers: 2120637, 2219154, 2154474, 2219155 - All units manufactured are to be corrected.
Model Numbers 2252036, 2252037 - All units manufactured prior to May, 2001 are to be corrected.

REASON: Cable that controls table movement could break resulting in uncontrolled motion

MANUFACTURER: Medtronic, Inc., Minneapolis, MN 55432-3576 Medtronic Med Rel, Inc. Rd, Puerto Rico 00791 Medtronic, B.V. European Service and Technology Center, The Netherlands

PRODUCT: Z-0726-1, Medtronic Micro Jewel II Implantable Cardioverter Defibrillator, Model 7223Cx
CODE: There are about 8000 mostly non-consecutive serial numbers which are not in one or a few ranges. The devices were made and distributed in the last month of 1996 and the first half of 1997.

REASON: Extended Charge times, which can delay the delivery of cardioversion and defibrillation therapies, and allow the extension of Ventricular fibrillation or other tachyarrhythmia event.

CLASS III

MANUFACTURER: Carl Zeiss, Inc., Thornwood, N.Y. 10594

PRODUCT: Z-687-1, X-100 Suspension System for Carl Zeiss Dental Surgical Microscope.

REASON: A tertiary screw in the microscope-to-stand coupling may not secure the coupling of two components.

MANUFACTURER: Roche Diagnostics Corps, Indianapolis, IN

PRODUCT: Z-707-1, Roche HbAlc Calibrator, Code: Catalog No. 0755664/47110

REASON: A negative bias of up to 10% may be observed in patient results.

MANUFACTURER: Surgical Specialties Corp. 100 Dennis Drive Reading, PA

PRODUCT: Z-712-1, Havel's brand 5-0 Plain Gut Sterile Absorbable Surgical Suture, U.S.P., with CC-77 Needle or C-3 Needle. One needle with suture is packaged in a sterile pouch, 12 pouches per carton.

REASON: The sterile suture needles may be defective with rust-like corrosion.

MANUFACTURER: ABBOTT LABORATORIES, INC. ABBOTT PARK, IL 60064

PRODUCT: Z-0713-1
Architect Anti-HBS Reagent Kitlist 7C18-30. This is an in vitro diagnostic Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of antibody to Hepatitis B surface antigen (anti-HBs) in human serum and plasma used to monitor the success of Hepatitis B vaccination and to monitor the convalescence and recovery of Hepatitis infected individuals.

REASON: Microbial growth

MANUFACTURER: SCANLAN INTL., INC. ST PAUL, MN 55107

PRODUCT: Z-0718-1, Scanlan Diethrich-Potts Scissors, Micro Fine Tips, Super Cut and Ultra Sharp.

REASON: Scissors blades could break in high stress situations (e.g. sterilization).

MANUFACTURER: Ciba Vision Corp., Duluth, GA

PRODUCT: Z-0719-1, Focus Dailies Spherical Contact Lenses, Lot No. 1096004

REASON: The primary label indicated Focus Dailies Spherical, while the secondary label indicates Focus Dailies Progressive.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  July 25, 2001:

CLASS II

MANUFACTURER: Toshiba American Medical System Tustin, CA

PRODUCT: Z-579-1 - X-Ray Generator/Control; KXO-30R
Z-580-1 - X-Ray Generator/Control; KXO-50F
Z-581-1 - X-Ray Generator/Control; KXO-80N

REASON: Noncompliance with 21 CFR 1020.31(a)(2) because exposure non-termination can occur as a result of tube arcing

MANUFACTURER: Dentatus USA, Ltd., New York, NY

PRODUCT: Z-623-1 - Luscent Anchors, Model LUC-K1;
Z-624-1 - Luscent Anchors, Model LUC-4.

REASON: Anchors, for dental restoration, show a reduced light (UV) transmission at the lower tapered end due to incomplete polymerization of surrounding light cured material.

MANUFACTURER: Medtronic Physio-Control Corp., Redmond, WA

PRODUCT: LIFEPAK? 500 Automated External Defibrillator
Z-694-1 - Part No. D3005400-000004;
Z-695-1 - Part No. K3005400-000005;
Z-696-1 - Part No. U3005400-000004;
Z-697-1 - Part No. U3005400-000005;
Z-698-1 - Part No. 30111790-00012;
Z-699-1 - Part No. D3011790-000011; and
Z-700-1 - Part No. D3011890-000012.

REASON: Mis-configured devices will not auto-analyze.

MANUFACTURER: Medtronic Physio-Control Corp., Redmond, WA

PRODUCT: Z-701-1, LIFEPAK? 500 Automated External Defibrillator, Lot/Serial Numbers: 12778268, 12778270-12778275, 12778284, 12778285, 12778296-12778331, 12778403-12778420, 12778422-12778432, 12778749-12778755, and 12778761-12778763;

REASON: Devices will not auto-analyze.

MANUFACTURER: SUNQUEST Information Systems, Inc., Tucson, AZ

PRODUCT: Z-702-1, FlexiLab(r) versions 5.23, Released 2/22/00;

REASON: This software version could file incorrect patient data to the Hospital Information System.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN

PRODUCT: Z-707-1, Roche HbA1c Calibrator, Catalog No. 07555664/47110, Lot No. 61130001.

REASON: Use of the referenced product may result in negatively biased results.

MANUFACTURER: Disetronic Medical Systems, St. Paul, MN

PRODUCT: Z-709-1, H-TRONplus V100 Insulin Infusion Pump, and All Serial Numbers

REASON: Misbranded in that there are labeling claims of the H-TRONplus V100 Infusion Pump being waterproof; however, this claim was not clear.

MANUFACTURER: Arthrotek, A Biomet, Inc. company, Warsaw, IN

PRODUCT: Z-710-1, Arthotek Disposable Infusion Pump, Model No. B074338, Catalog No. 909995. All lots.

REASON: Devices may not deliver the prescribed dose of drug.

CLASS III

MANUFACTURER: Medtronic Sofamor Danek, Memphis, TN

PRODUCT: Z-695-1, Atlas Cable with an Integral Crimp, Product code: 826-213Lots: 07089, 07129, 07130, 07131, 07132 The device is a temporary implant for use in orthopedic and cardiovascular surgery. The system is intended to help provide temporary stabilization, augment the development of solid bony fusion and/or aid in the repair of bone fractures.

REASON: The inner packaging of the product is mislabeled as stainless steel, rather than titanium.

MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Rochester, NY

PRODUCT: Z-708-1,Vitros Calcium Slides, Lot No. 0313-0287-6531,
0313-0287-6582, 0313-0287-6583, 0313-0287-6743,
0313-0287-6749, 0313-0287-7565, 0313-0287-7598,
0313-0287-7611, 0313-0287-7634, 0313-0287-7679,
0313-0287-7685, 0313-0287-8130, 0313-0287-8184,
0313-0287-8278, 0313-0287-8300, 0313-0287-8311;

REASON: Calcium results from plasma samples are negatively biased by approximately 1.5- 3.0 mg/dL (0.37-0.75 mmol/L) when compared to serum.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  July 18, 2001:

CLASS I

MANUFACTURER: Medtronic PS Medical, Goleta, CA

PRODUCT: Z-890-1, Ventriculostomy Kits, Catalog No. 46155, Lot No. T0749,

REASON: Antiseptic products may be contaminated with bacteria.

MANUFACTURER: Life-Tech International, INC., Stafford, TX

PRODUCT: Z-978-0, Various custom Kits containing antiseptic products

REASON: Antiseptic products may be contaminated with bacteria.

MANUFACTURER: I-Flow Corporation, Lake Forest, CA

PRODUCT: Z-1021-0, Custom Epidural Anesthesia Tray, Custom Nerve Block Tray, Custom Spinal Block Tray containing Antiseptic Products

REASON: Antiseptic products may be contaminated with bacteria.

CLASS II

MANUFACTURER: Sulzer Orthopedics, Inc., Austin, TX

PRODUCT: Inter-OP Rim Flare, Hemispherical, Revision, and Protrusio Acetabular Shells for Hip Implants.
Z-404-1
Inter-Op Rim Flare Acetabular Shells: Catalog Numbers: 4361-00- 039/071 Several Lot Numbers.
Z-405-1
Inter-Op Hemispherical Acetabular Shells: Catalog Number 4360-00- 039/065 Several Lot Numbers.
Z-406-1
Inter-Op Revision Acetabular Shells: Catalog Number 4362-00-043/081 Several Lots
Z-407-1
Inter-Op Protrusio Acetabular Shells: Catalog Number 4360-00-053/081 Several Lots.

REASON: Product contains manufacturing oil residue

MANUFACTURER: Welch Allyn, Inc., Skaneateles Falls, NY.

PRODUCT: Z-682-1, Welch Allyn Wall Plug-In Transformer included with otoscopes, episcopes, audioscopes, ophthalmoscopes, & retinoscopes, Model 71034, with date codes 0900c or 1200c;

REASON: There is a design problem that could expose user to electric shock.

MANUFACTURER: Toshiba America Medical Systems, Inc., Tustin, CA

PRODUCT: Z-0690-1, Impax Technology Inc. DDS
Intended use is as Diagnostic Image Display Software
Model/catalog number: DS3000, CS5000, XA3000

REASON: Wrong image presents to radiologist upon database query.

MANUFACTURER: Agilent Technologies, Inc., Heartstream Operation, Seattle, WA

PRODUCT: Z-0683-1, Agilent Heartstream FR2 Automatic External Defibrillator, portable, Model 3860A, Serial No. 1000013120

REASON: Battery insertion test may fail due to a tantalum capacitor with the incorrect voltage rating.

MANUFACTURER: Toshiba America Medical Systems, Inc. (TAMS), Tustin, CA

PRODUCT: Z-0691-1 through Z-0693-1
Software used on the Computerized Tomography Fluoroscopy
CT Fluroscopy option, model numbers TSXF-003A; TSXF-003B; TSXF-003C for Aquilion (Model No. TSX-101A) and Asteion (Model No. TSX-021A) Computed Tomography Scanners

REASON: X-ray generation without operator command using unusual program sequence

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of  July 11, 2001:

CLASS II

MANUFACTURER: Laerdal Medical Corp., Wappingers Falls, NY

PRODUCT: Z-644-1, Suction Unit-Optional Accessory Wall Bracket DC Version Model 78 22 00.

REASON: Charging function of the wall bracket is not adequately being delivered to the suction pump.

MANUFACTURER: SeQual Technologies, Inc., San Diego, CA

PRODUCT: Z-645-1 - Integra Oxygen Concentrator, Model No. 6323;
Z-646-1 - Integra Oxygen Concentrator, Model No.6323OM.

REASON: Restricted air flow can cause the device to overheat, leading to emanation of an odor, excessive noise, and possibly to shutoff of device operation.

MANUFACTURER: Mavig GmbH, Munich Germany

PRODUCT: Z-606-1, Mavig Portegra Ceiling Suspension System Used with Personnel Protective Shields and Injectors, Code: All serial numbers beginning with: "0299" thru "0201". NOTE: The first 4 digits of the s/n represent a date code. "0299" = February 1999. i.e. s/ns beginning with: 0299, 0399, 0499, 0599 through 0201.

REASON: Personnel protective shield can spontaneously separate from the ceiling suspension and fall between the patient and operator.

MANUFACTURER: Sabratek Corp. Skokie, IL

PRODUCT: Z-0629-1, Multi-Therapy Ambulatory Infusion Pumps sold under the following labels
a) Sabratek 6060 Homerun Infusion Pump, product codes 606000-40 (English), 606000-40L (loaner pump) and 606000-40I (International)
b) Baxter 6060 Multi-Therapy Ambulatory Infusion Pump, product code 2M9832

REASON: Potential over infusion in the Auto-Ramp mode with software ver. 3.00 or higher

MANUFACTURER: Baxter Healthcare Corporation Irvine, CA

PRODUCT: Z-0630-1. Seven Day Infusor 0.5 ml/h, Portable Elastomeric Infusion System Product code 2C1082KJ; a single-use disposable elastomeric infusion pump indicated for patients requiring slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications at a constant flow rate; Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015; 4 units per case

REASON: Incorrect flow restrictor allows overinfusion

MANUFACTURER: Eli Lilly and Company, Indianapolis, IN

PRODUCT: Z-621-1, HumaPen Ergo, Model MS8335 (Teal color pen)
Z-622-1, HumaPen Ergo, Model MS8343 (Burgundy color pen)
All Lot Nos.

REASON: Cartridge holder engagement tabs may break off possibly causing delivery of less insulin than intended.

MANUFACTURER: Osmonics, Inc., Kent WA

PRODUCT: ZyzaTech Portable Reverse Osmosis Machines to generate water for use in hemodialysis treatments.
Z-649-1 - S-700 Series, Model No. 14524;
Z-650-1 - S-750 Althin, Model No. 13200;
Z-651-1 - F-801 Fresenius, Model No. 12340;
Z-652-1 - Millenium, Model No. 14714;
Z-653-1 - SOLO II, Model No. 14914.

REASON: The product may not be properly grounded and may cause an electrical shock.

MANUFACTURER: Howmedica Osteonics Corp., Rutherford, NJ

PRODUCT: Z-672-1, Wrought Vitallium Orthopaedic Wire .040 x 18", Catalog No. 6704-1-018, Lot Nos. BZHIOA, BZHIOB, and CAPMR

REASON: Wire was not annealed, so the Ultimate Tensile Strength is greater and the Elongation (%) is less than designed.

MANUFACTURER: Precision Medical, Inc., Northampton, PA

PRODUCT: Easy Dial Oxygen Regulator
Z-673-1 - Model No. 168704DLB;
Z-674-1 - Model No. 168708DB;
Z-675-1 - Model No. 168708DLB;
Z-676-1 - Model No. 168725DB;
Z-677-1 - Model No. 168715DB;
Z-678-1 - Model No. 168715DLB, Lot Nos. 0999 through 0401;
Z-679-1 - Canadian Model Nos. 010R7800 and 010R7900-1.

REASON: The yoke on the regulator is too wide and a nitrogen cylinder may be connected rather than an oxygen cylinder.

MANUFACTURER: Polysciences, Inc. Warrington, PA

PRODUCT: Z-680-1, Save-A-Tooth, The Emergency Tooth Preserving System, Lot No. 512844, serial nos. 32-393.

REASON: The seal under lid, the sterile barrier leaks.

MANUFACTURER: Abbott Laboratories, Inc., South Pasadena, CA

PRODUCT: Z-681-1, Abbott Aeroset Carbon Dioxide Test Reagent, Lot Nos. 43617HW00, 43618HW00, 41458HW00, 46048HW00, 46072HW00, 50032HW00, 53071HW00, 55081HW00, 57094HW00, 58013HW00, 61005HW00, 60010HW00, 63030HW00, 63089HW00, 66007HW00, 69009HW00, and 73046HW00

REASON: There are shifts in values, which can result in low or high bicarbonate/carbon dioxide values.

MANUFACTURER: VitalCom, Inc., Tustin, CA

PRODUCT: Z-684-1, PatientNet(tm) Central Monitoring Station, Part No.056250, Central Station software version 1.01.38B, CD-ROM
Serial No. 01117-001

REASON: Software anomaly with the PatientNet Central Station software part number 056250, revision 1.01.38B. This anomaly only affects the Wireless Medical Telemetry Service (WMTS) configuration.

MANUFACTURER: STAAR Surgical Company, Monrovia, CA

PRODUCT: Z-685-1, COLLAMER? Ultraviolet-Absorbing Posterior Chamber 3-Piece Intraocular Lens, Model No. CQ2005V, All Lot Numbers. Manufactured from October 1, 2000 to February 1, 2001.

REASON: The pouch seals can weaken and cause the packages to open, which may compromise the sterility of the lenses.

MANUFACTURER: IMDS, Inc., Pompano Beach, FL

PRODUCT: Z-0628-1, Medline Sterile Premium Wet Skin Prep Tray, a Latex-free Product; a sterile Rx kit used to prepare the patient's skin at the operative site prior to surgery, Catalog #DYND70660, lot 0J1267, exp. date 08-02

REASON: Devices labeled as Latex Free and found to contain latex. Some of the kits were assembled with latex gloves instead of the labeled vinyl gloves.

MANUFACTURER: Abiomed, Inc., Danvers, MA

PRODUCT: Z-0655-01, Abiomed BVS 5000 Bi-Ventricular Support System 10 mm Arterial Cannula with Hemashield Graft Catalog Number: 0506-0010

REASON: The graft of the 10 mm Arterial cannula separated from the cannula shaft.

MANUFACTURER: Agilent Technologies Inc., Andover, MA

PRODUCT: Z-0657-01, Agilent or Hewlett Packard 40488A, 12V 2.3 Ah Sealed Lead-Acid Battery. Manufacturing Date Codes: 990901 through 991231 and 000101 through 000131. Batteries manufactured between Sept.1, 1999 and Jan. 31, 2000.
Used in:
-Agilent V24/26CT Component Monitoring System
(Model M1205A); and
-Hewlett Packard Component Transport System
(Model M1275A)

REASON: Patient Monitor may shut down as batteries may provide a shorter operating time

MANUFACTURER: Ansell Perry, Inc., Juarez Chih, Mexico

PRODUCT: Z-0660-1 to Z-0661-1
Exam Gloves, Beaded, Powdered, Medium Size, Natural Rubber Latex, Non-Sterile (Style 332 IF) and Sterile (Style 332) Pairs, Ambidextrous.

Glove Style 332 IF, Non-Sterile, Catalogue #5760502, Lot Numbers: 0006372007, 0006371007, 0006370907, 0006371207, 0006371107, and 0006371407;

Glove Style 332, Sterile, Catalogue #57611402, Lot Number: 0006393807.

REASON: A total of 25 non-sterile, bulk gloves out of 294 gloves examined by FDA were found to contain defects/holes.

MANUFACTURER: Rochester Medical Corp., Stewartville, MN

PRODUCT: Z-0662-1 to Z-0664-1
Rochester Medical Personal Catheters identified as follows:

Product Reference Number 63312
12Fr. Male Length Personal Catheter

Product Reference Number 63314
14Fr. Male Length Personal Catheter

Product Reference Number 63316
16Fr. Male Length Personal Catheter

12Fr. Male Length Personal Catheter Lot # 54100604 Lot # 54100898 Lot # 54101025 Lot # 54101114 Catalog #63316 16Fr.

Male Length Personal Catheter Lot # 54100409 Catalog #63314

14Fr. Male Length Personal Catheter Lot # 54100406 Lot # 54100605 Lot # 54100899 Lot # 54101026 Lot # 54101115 Lot # 54100606 Lot # 54100900 Lot
# 54101027 Lot # 54101116

REASON: There is a possibility of a void or unsealed segment in the sterile Tyvek package seal of some packages

MANUFACTURER: Convatec, a Bristol-Myers Squibb Co., Skillman, NJ

PRODUCT: Z-0667-1, Brand Name: ProSys Leg Bag Comfort Straps Common Name: Urine collector and accessories, Catalog Number 650162, Lot 327092

REASON: Lacks latex warning label on product

MANUFACTURER: SRI/Surgical Express, Elk Ridge, MD

PRODUCT: Z-0668-1, Surgical Procedure Pack, containing e.g., basins, towels, cups, and gowns. Sterile Packs 6581D, 120425A, 102433B Lot numbers 97510, 97728, 97732

REASON: Failure of firm's internal process control, which specifies that sterilizer chamber and that of the load's reference temperature probe cannot vary more than +/- 1 degree C.

MANUFACTURER: Microvasive Urology Div./ Boston Scientific Corp., Watertown, MA

PRODUCT: Z-0669-1, Microvasive LeVeen Inflator with Pressure Gauge 20 ml (cc) Catalog #710-112

Z-0670-1, Medi-Tech LeVeen Inflator with Pressure Gauge 20 ml (cc) Catalog #115-102

Z-0671-1, Microvasive Balloon Dilatation Catheter Kits containing the Microvasive LeVeen Inflator with Pressure Gauge 20 ml (cc),Catalog #710-112

Catalog # Product Description UPN/Material # 15-102 LeVeen Inflator with M001151021 Pressure Gauge 20 ml (cc) SEVERAL LOT NUMBERS:

Product distributed by Microvasive Urology Catalog # Product Description UPN/Material # 710-112 LeVeen Inflator M0067101121 with Pressure Gauge 20 ml (cc) SEVERAL LOT NUMBERS:

Product Distributed by: Microvasive Urology
Balloon Dilatation Catheter Kits containing (1) LeVeen Inflator with Pressure Gauge 20 ml (cc) Catalog # Product Description UPN/Material # LeVeen Refer to the specific lots of the LeVeen Inflator, Catalog #710-112 and UPN# M0067101121 that are


included in this recall. 210-151 Tandem(tm) Thin-Shaft M0062101510 210-153 Tandem(tm) Thin-Shaft M0062101530 210-155 Tandem(tm) Thin-Shaft M0062101550 216-140 Carson Zero Tip M0062161400 216-141 Carson Zero Tip M0062161410 216-143 Carson Zero Tip M0062161430 216-144 Carson Zero Tip M0062161440 219-140 UroMax(tm) 20 M0062191400 219-141 UroMax(tm) 20 M0062191410 219-142 UroMax(tm) 20 M0062191420 219-143 UroMax(tm) 20 M0062191430 219-144 UroMax(tm) 20 M0062191440 219-145 UroMax(tm) 20 M0062191450 219-146 UroMax(tm) 20 M0062191460 219-147 UroMax(tm) 20 M0062191470 219-148 UroMax(tm) 20 M0062191480 219-151 UroMax(tm) 20 M0062191510 219-155 UroMax(tm) 20 M0062191550 219-156 UroMax(tm) 20 M0062191560 219-157 UroMax(tm) 20 M0062191570 219-170 UroMax(tm) 20 M0062191700 219-171 UroMax(tm) 20 M0062191710 219-172 UroMax(tm) 20 M0062191720 219-174 UroMax(tm) 20 M0062191740 219-180 UroMax(tm) 20 M0062191800 221-220 Trilogy(tm) M0062212200 221-221 Trilogy(tm) M0062212210 221-222 Trilogy(tm) M0062212220 221-223 Trilogy(tm) M0062212230 221-225 Trilogy(tm) M0062212250 Note: only the specific catalog numbers and lots detailed above are affected.

REASON: During in-house testing of the LeVeen Inflator for tray package integrity, a hole in the Tyvek lid was discovered in a small quantity of trays in one lot of tray material.

CLASS III

MANUFACTURER: D.O. Weaver Co., Aurora, CO

PRODUCT: Z-0654-1, D.O. Weaver & Co., Ten20 Conductive Paste, 4 oz jar, Catalog # 10-20-4, Batch # 535, MAR 2004 07.

REASON: Incorrect expiration date is on label of product.

MANUFACTURER: St. Jude Medical, Inc., Daig Division, Minnetonka, MN

PRODUCT: Z-0565-01, Daig Angio-Seal Vascular Closure Device, 8 French, Product Number 610097, Lot number 00DP59

REASON: Boxes of the product from lot 00DP59 contain incorrect Instructions for Use (IFUs).

MANUFACTURER: Lifestream International, Inc., The Woodlands, TX

PRODUCT: Z-0659-1, 1/4 X 1/2 X 1/2 Clear PAY with Luer Lock. 10 pouched/labeled units per box.

REASON: Non-sterile product labeled non-sterile contained a sterile catalog number and should have been sterile.

MANUFACTURER: Swissray America, Inc., Elmsford, NY

PRODUCT: User and Service Manuals for the ddR (direct digital radiography) Multi-System X-Ray Units, a stationary radiographic system for diagnostic imaging.
Z-648-1, ddRMulti-System User Manual and Service Manual Model No. 6.1030,0002,3.

REASON: The user and service manuals did not adequately identify the manufacturer's recommended automatic exposure control (AEC) settings and cautions regarding changes to these settings.

MANUFACTURER: Diagnostic Products Corp, Los Angeles, CA

PRODUCT: Z-605-1, Immulite 2000 TBG, Catalog No. LKTB2, Lot No. 107

REASON: During routine stability monitoring performed at EURO/DPC, it was identified the potential for a diminished performance in the Immulite TBGT lot 209 and Immulite TBG control.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 4, 2001:

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

MANUFACTURER: Imago Radiology, Abbiategrosso, Italy.

RECALL NUMBER, PRODUCT AND CODE:
Z-327-1, X-Ray Table, XRT 600

REASON: The units were found defective under 21 CFR 1003.2, in that they fail to comply with performance standards with regards to: importation, establishing and maintaining manufacturing records and finished device records, no product report submitted and an inadequate certification program.

RECALLED BY:Wuestec Medical, Mobile AL, telephoned the firm on June 7, 2001.
FIRM INITIATED RECALL:
Ongoing DISTRIBUTION: Nationwide
QUANTITY 2 units

MANUFACTURER/RECALLING FIRM:   PROGENY, INC. Buffalo Grove, IL

RECALL NUMBER, PRODUCT AND CODE:
Z-0631-1, Linear MC150-C Manual Collimator, catalog #70-631xx
Z-0632-1, Linear MC150 Manual Collimator, catalog #70-630xx
Z-0633-1, Linear II Automatic Collimator, catalog #70-4300x
Z-0634-1, Linear III Automatic Collimator, catalog #70-53xxx
Z-0635-1, Linear IV Automatic Continuous SID Collimator, catalog #70-750xx
REASON:
Collimator housing may separate from the tube mounting plate

RECALLED BY:
Recalling Firm, by letters dated 1/24/01.
FIRM INITIATED RECALL:
Ongoing
DISTRIBUTION:
Nationwide, Canada, Turkey
QUANTITY
224 collimators

MANUFACTURER/RECALLING FIRM: OSMONICS, INC. Minnetonka, MN

RECALL NUMBER, PRODUCT AND CODE: 
Z-0636-1, Osmo 23G series reverse osmosis machine with the Permeate
Divert Option. These are intended to purify the water for use in
hemodialysis applications.
REASON:
Potential failure of Permeate valve could allow feed water into permeate
stream

RECALLED BY:
OSMONICS, INC. KENT, WA, on 3/2&5/01 by letters, and by telephone on
3/6/01.
FIRM INITIATED RECALL:
Ongoing
DISTRIBUTION:
Nationwide and Canada
QUANTITY
386

MANUFACTURER/RECALLING FIRM:  STAAR SURGICAL CO., MONROVIA, CA

RECALL NUMBER, PRODUCT AND CODE: Z-0637-01 thru Z-0638-01
Intra-Ocular Lens. Silicone based. These lens are sterile and foldable.
The affected lens come in two styles - plated haptics and a modified C
loop haptic. Various models and diopters are involved. Each IOL is
contained inside a small cardboard box that is labeled in part, "STAAR
IOL FOLDABLE INTRAOCULAR LENS *** FOR SINGLE USE ONLY *** STERILE ***
*** MODEL *** DIOPTER".

510K/PMA PMA P910059 for models AA; and P910060 for models AQ

Only model numbers with a prefix of "AA" (plate haptic)
or "AQ" (loop haptic) may be affected.
Serial numbers are too numerous to list as they are not
consecutive.
REASON:
Increased tear rate of lens 
upon insertion into the eye.

RECALLED BY:
Recalling Firm by First Class letter dated 4/5/2001.
FIRM INITIATED RECALL:
Complete
DISTRIBUTION:
Nationwide. Internationally to Canada, Newfoundland, Puerto Rico, Nova
Scotia.
QUANTITY
25,000 lenses

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 27, 2001:

CLASS II

MANUFACTURER: Imago Radiology, Abbiategrosso, Italy.

PRODUCT: X-ray Tables. Recall # Z-327-1.

REASON: The units fail to comply with performance standards (21 CFR 1003.2) with regard to: importation, establishing and maintaining manufacturing records and finished device records, no product report submitted and an inadequate certification program.

MANUFACTURER: Millennium Medical Systems, Inc., Aurora, IL.

PRODUCT: Veterinary surgical CO2 laser systems.
a) Recall # Z-510-1;
b) Recall # Z-511-1.

REASON: Lacked certification and identification labels and instructional and promotional materials contained implied claims for human use.

MANUFACTURER: Sampo Corporation, Baldwin Park, CA.

PRODUCT: Television Product.
a) Z-568-1; b) Z-569-1; c) Z-570-1.

REASON: X-radiation exceeded the 0.5 mr/hr exposure rate limit.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN.

PRODUCT: a) Roche Cobas Integra 700 Analyzers with a Hewlett-Packard 71 Monitor. Recall # Z-608-1; b) Roche PSD 1 (Primary Sample Distribution System) with a Hewlett-Packard 71 Monitor. Recall # Z-609-1.

REASON: The monitor of the device can result in an electric shock to anyone contacting a certain area on the top of the monitor.

MANUFACTURER: Sunquest Information Systems, Inc., Tucson, AZ.

PRODUCT: FlexiLab Laboratory Information System
Recall # Z-610-1.

REASON: Using devices with these software versions with roll and scroll differential keyboard may miscalculate the absolute blood cell counts.

MANUFACTURER: Becton Dickinson, Franklin Lakes, NJ.

PRODUCT: BD Vacutainer Whole Blood Tube with K3 EDTA.
Recall # Z-611-1.

REASON: An incorrect volume of additive was dispensed into the tubes, causing blood specimen to clot.

MANUFACTURER: Biomet Manufacturing, Inc., Warsaw, IN.

PRODUCT: Ring-Loc Brand Ring Loc Acetabular Liner.
Recall # Z-612-1.

REASON: Device misbranded in that the inner sphere diameter of the product measures 28mm not 32mm as indicated on the labeling.

MANUFACTURER: Guidant Corp., St. Paul, MN.

PRODUCT: Ventak Prism Automatic Implantable Cardioverter Defibrillators
Z-613-1 - Ventak Prizm VR Model No. 1850, Several Serial Numbers. Z-614-1
Ventak Prizm DR Model No. 1851, Several Serial Numbers. Z-615-1 - Ventak Prizm VR HE Model No. 1852, Serial Nos. 100000-100507; Z-616-1 - Ventak Prizm DR HE Model No. 1853, Several Serial Numbers. Z-617-1 - Ventak Prizm VR HE Model No. 1857, Serial No. 500000-500123; Z-618-1 - Ventak Prizm DR HE Model No. 1858, Serial No. 600000-600129.

REASON: Devices switch to the Safety Mode which limits available shock therapy.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA.

PRODUCT: a) Cryovalve Allograft Heart Valve. Recall # Z-619-1;
b) Cryovalve Allograft Heart Valve. Recall # Z-620-1.

REASON: The donor did not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

MANUFACTURER: MAVIG GmbH, Munich, Germany.

PRODUCT: Mavig Portegra Ceiling Suspension System, used with lead shields and injectors. This recall includes all model numbers of shields and injectors. Recall # Z-0606-1.
The following model numbers/descriptions:
PT 6262 - 30 x 40 cm - lead glass shield, 1.5 mm lead equivalent.
PT 6272: Lead acrylic shield, 61 x 76 cm (24 x 30 in.) 0.5 mm lead equivalent.
PT 6272B71: Injector arms
PT 6272B72LF: Injector arms
Model 6272SHB: Side-mounted lead acrylic shield with patient cutout, 61 x 76 cm (24 x 30 in.), 0.5 mm lead equivalent;
Model PT 6274: Smaller size lead acrylic shield, 40 x 50 cm (16 x 20 in.), 0.5 mm lead equivalent;
Model PT 6290: Large size lead acrylic shield with patient contour cutout, 61 x 76 cm (24x30 in.), 0.5 mm lead equivalent;
Model PT6290SHB: Same as PT6272SHB except with ceiling track from Model PT 6290;
Model PT 6294: Lead Acrylic Shield, 40 x 50 cm (16 x 20 in.), 0.5 mm lead equivalent.

REASON: The spring arm may break when used with shield and injector attachments.

MANUFACTURER: Encision Inc., Boulder, CO.

PRODUCT: Encision AEM Fixed-Tip J-Hook Electrode, 5mm, Reusable, Catalog No. ES3510B,
Recall # Z-607-1.

REASON: J-hook electrode tip could break off during use.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 13, 2001:

CLASS II

MANUFACTURER: United States Surgical Corp., North Haven, CT.

PRODUCT: Single Use Staplers as follows:
a) AutoSuture Endo GIA* II 60mm 2.5mm Order Code: 030412. Recall #Z-0590-01
b) AutoSuture Endo GIA* II 60mm 3.5mm Order Code: 030414. Recall #Z-0591-01.

REASON: The units may transect without all of the staples being placed into the tissue.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA.

PRODUCT: a) Cryovalve Allograft. Recall # Z-533-1.
b) Cryovalve Allograft. Recall # Z-534-1.

REASON: The donor did not meet the current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered.

MANUFACTURER: Analogic Corportation, Peabody, MA.

PRODUCT: a) Philips Tomoscan M. Recall # Z-550-1.
b) Philips Tomoscan EG. Recall # Z-551-1.
c) Philips Tomoscan EG. Recall # Z-552-1.

REASON: The diagnostic x-ray devices fail to conform to design specifications relating to the accomplishment of their intended purpose.

MANUFACTURER: DePuy Orthopaedics, Warsaw, IN.

PRODUCT: a) DePuy Acclaim Total Elbow System Humeral 100 MM Component. Recall # Z-558-1.
b) DePuy Acclaim Total Elbow System Bobbin Component. Recall # Z-559-1.

REASON: An incorrect taper angle was used during manufacture.

MANUFACTURER: King Systems Corporation, Noblesville, IN.

PRODUCT: Breathing Circuits (see below);
a) King Systems brand Jackson-Rees Modification Breathing Circuits. Recall # Z-592-1.
b) King Systems brand Mapleson D Breathing Circuit. Recall # Z-593-1.
c) Ped F2 Pediatric Anesthesia Breathing Circuit. Recall #Z-594-1.
d) Norman Elbow, individually packed [VETERINARY DEVICE]: Anesco brand Mapleson C Breathing Circuits. Recall #Z-595-1.

REASON: There is a possible obstruction of the fresh gas inlet of the elbow.

MANUFACTURER: Zimmer, Inc., Warsaw, IN.

PRODUCT: NexGen Knee Threaded Fixation Pin.
Recall # Z-596-1.

REASON: The hex end of the pin is incorrect and will not assemble with the driver to secure the Micro-Mill femoral mounting base instrumentation to the surgical site.

MANUFACTURER: Guidant Corporation, Temecula, CA.

PRODUCT: a) 1000464 5F AtheroCath Bantam Atherectomy Catheter. Recall # Z-597-1.
b) 1000465 6F AtheroCath Bantam Atherectomy Catheter. Recall # Z-598-1.
c) 1000466 7F AtheroCath Bantam Atherectomy Catheter; Recall # Z-599-1.
d) 20344-01 5mm 6F AtheroCath SCA-EX Atherectomy Catheter. Recall # Z-600-1.
e) 20345-01 5mm 7F AtheroCath SCA-EX Shortcutter Atherectomy Catheter. Recall # Z-602-1.
f) 20354-01 6F AtheroCath GTO Atherectomy Catheter. Recall # Z-603-1
g) 20355-01 7F AtheroCath GTO Atherectomy Catheter. Recall # Z-604-1.
h) 20361-01 7FG SCA-EX (Graft) AtheroCath Atherectomy Catheter. Recall # Z-605-1.

REASON: Tip of artherectomy catheter dislodged in a patient during procedure.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 6, 2001:

CLASS II

Recall # Z-533/534-1, which appeared in the May 16, 2001, Enforcement Report has been updated as follows:

PRODUCT: Z-592-1 - King Systems brand Jackson-Rees Modification Breathing
Circuits;
Z-593-1 - King Systems brand Mapleson D Breathing Circuit;
Z-594-1 - Ped F2 Pediatric Anesthesia Breathing Circuit;
Z-595-1 - Norman Elbow, individually packed
[VETERINARY DEVICE]: Anesco brand Mapleson C Breathing Circuits;

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 30, 2001:

CLASS II

MANUFACTURER: DePuy Orthopaedics, Warsaw, Indiana.

PRODUCT: a) Coordinate Knee Cemented Stem, Ref 1968-01-000, all lots.
Coordinate Knee Cemented Stem, Ref 1968-02-000, all lots.
Coordinate Knee Cemented Stem, Ref 1968-03-000, all lots. 
Recall #Z-582-1.

b) Coordinate Knee-Fluted Stem, Ref , 1968-11-000, all lots.
Coordinate Knee-Fluted Stem, Ref 1969-12-000, all lots.
Coordinate Knee-Fluted Stem, Ref 1968-13-000, all lots.
Coordinate Knee-Fluted Stem, Ref 1968-14-000, all lots.
Coordinate Knee-Fluted Stem, Ref 1968-15-000, all lots.
Coordinate Knee-Fluted Stem, Ref 1968-16-000, all lots.
Coordinate Knee-Fluted Stem, Ref 1968-17-000, all lots.
Coordinate Knee-Fluted Stem, Ref 1968-18-000, all lots.
Coordinate Knee-Fluted Stem, Ref 1968-19-000, all lots.
Coordinate Knee-Fluted Stem, Ref 1968-20-000, all lots.
Coordinate Knee-Fluted Stem, Ref 1968-30-000, all lots.
Coordinate Knee-Fluted Stem, Ref 1968-31-000, all lots.
Coordinate Knee-Fluted Stem, Ref 1968-32-000, all lots.
Coordinate Knee-Fluted Stem, Ref 1968-33-000, all lots.
Coordinate Knee-Fluted Stem, Ref 1968-34-000, all lots.
Coordinate Knee-Fluted Stem, Ref 1968-35-000, all lots.
Recall#Z-583-1.

c) Coordinate Ultra Knee Cemented Stem, Ref 1884-21-000, all lots.
Coordinate Ultra Knee Cemented Stem w/Taper, Ref 1884-21-500, all lots.
Coordinate Ultra Knee Cemented Stem, Ref 1884-22-000, all lots.
Coordinate Ultra Knee Cemented Stem, Ref 1884-23-000, all lots.
Recall #Z-584-1.

d) Coordinate Ultra Knee-Fluted Stem, Ref 1884-31-000, all lots.
Coordinate Ultra Knee-Fluted Stem, Ref 1884-32-000, all lots excluding lots VJ7J41 and T5VAMA.
Coordinate Ultra Knee-Fluted Stem, Ref 1884-33-000, all lots excluding lots VJ4EV1 and VD4A7A.
Coordinate Ultra Knee-Fluted Stem, Ref 1884-34-000, all lots excluding lot VJ7JV1.
Coordinate Ultra Knee-Fluted Stem, Ref 1884-35-000, all lots excluding lots VJ4CF1 and VC4NMA.
Coordinate Ultra Knee-Fluted Stem, Ref 1884-36-000, all lots excluding lots VJ4CE1 and VJ4CD1.
Coordinate Ultra Knee-Fluted Stem, Ref 1884-37-000, all lots excluding lots VJ4ES1 and VJ4EM1.
Coordinate Ultra Knee-Fluted Stem, Ref 1884-38-000, all lots excluding lot VJ7KD1.
Coordinate Ultra Knee-Fluted Stem, Ref 1884-39-000, all lots excluding lot VJ7JW1.
Coordinate Ultra Knee-Fluted Stem, Ref 1884-40-000, all lots excluding lot T37K5A.
Coordinate Ultra Knee-Fluted Stem, Ref 1884-41-000, all lots.
Coordinate Ultra Knee-Fluted Stem, Ref 1884-42-000, all lots.
Coordinate Ultra Knee-Fluted Stem, Ref 1884-42-000, all lots excluding lots VJ4EW1, VJ4EWA, U86BLA and U86BLB.
Coordinate Ultra Knee-Fluted Stem, Ref 1884-43-000, all lots excluding lot VD4A8A.
Coordinate Ultra Knee-Fluted Stem, Ref 1884-44-000, all lots.
Coordinate Ultra Knee-Fluted Stem, Ref 1884-45-000, all lots excluding lots VJ4CC1, VJ4CCA, VJ4CB1 and VJ4CA1.
Coordinate Ultra Knee-Fluted Stem, Ref 1884-46-000, all lots, excluding lot VJ7JX1.
Coordinate Ultra Knee-Fluted Stem, Ref 1884-50-000, all lots.
Coordinate Ultra Knee-Fluted Stem, Ref 1884-51-000, all lots.
Coordinate Ultra Knee-Fluted Stem, Ref 1884-80-000, all lots.
Coordinate Ultra Knee-Fluted Stem, Ref 1884-81-000, all lots.
Recall #Z-585-1

REASON: There is a possibility for sterility to be compromised due to packaging failure under routine shipping conditions.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA.

PRODUCT: Access (beta) hCG Reagent Packs. Recall #Z-578-1.

REASON: Low results were obtained with level 1 Quality Control material.

MANUFACTURER: Stryker Corporation, Kalamazoo, MI.

PRODUCT: a) Stryker MedSurg Bed. Recall #Z-575-1;
b) Stryker MedSurg Bed. Recall #Z-576-1.

REASON: The weight readout for the bed exit system may be inaccurate, and the patient exit system may not alarm.

MANUFACTURER: Cardiomedics, Inc., Irvine, CA.

PRODUCT: CardiAssist External Counter Pulsation (ECP) System. Recall #Z-574-1.

REASON: When two patients are hooked up at the same time on the unit the device pumps one patient based on the other patient's ECG signal.

MANUFACTURER: Cardiomedics, Inc., Irvine, CA.

PRODUCT: CardiAssist External Counter Pulsation (ECP)System. Recall #Z-573-1.

REASON: The screen on the unit containing software version 1.4.3 intermittently locks up. Unexpected shutdown; deletion of use for cardiogenic shock.

CLASS III

MANUFACTURER: Applied Medical Resources, Rancho Santa Margarita, CA.

PRODUCT: Clip Applier Handle. Recall #Z-588-1; Recall #Z-589-1.

REASON: There is a potential for inadequate clip retention.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN.

PRODUCT: Creatine Kinase (CK/NAC) R2 Reagent (see below).
Z-586-1 - Catalog No. 1126006, Lot Nos. 143139, 143151, 143219, 143255;
Z-587-1 - Catalog No. 1928929, Lot Nos. 61439901, and 61547401.

REASON: Crystals forming in these lots can lead to erroneous low patient results due to clogging of the reagent tubing.

MANUFACTURER: Instrumentation Laboratory Co., Lexington, MA.

PRODUCT: ACL Futura Coagulation Analyzers. Recall #Z-577-1.

REASON: There is a software error that may cause index file and record information to be mismatched.

MANUFACTURER: Bivona Medical Technologies, Div. UroQuest Medical Corp., Gary, IN.

PRODUCT: Cuffless Adult Tracheostomy Tube.
Recall #Z-572-1.

REASON: Device misbranded due to the container and box was labeled an 8.0 O.D., but the neckplate on the tube was 9.0 O.D.

MANUFACTURER: Bivona Medical Technologies, Div. UroQuest Medical Corp., Gary, IN.

PRODUCT: Cuffless Adult Tracheostomy Tube.
Recall#Z-571-1.

REASON: One of the sealed trays is empty.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 23, 2001:

CLASS II

MANUFACTURER: Prosec Protection Systems, Inc., Lakewood, NJ.

PRODUCT: Infant Umbilical Clamp with Security Transponder Device.
Recall #Z-296-1.

REASON: Device sometimes slips off and may lead to infection
(skin and bacteria) and blood loss.

MANUFACTURER: Midas Rex, Fort Worth, TX.

PRODUCT: Midas Rex MRIV Motor System Catalog #MRIVMO.
Recall #Z-515-1.

REASON: The motor overheats when operating within the active MRI field.

MANUFACTURER: Sulzer Intermedics Inc., Angleton, TX.

PRODUCT: Res-Q Micron Automated Implantable cardioverter.
a) Model No. 101-05. Recall #Z-516-1.
b) Model No. 101-09. Recall #Z-517-1.
c) Model No. 101-10. Recall #Z-518-1.

REASON: The unit indicates an improper end of service message and enters into backup mode disabling defibrillation therapy.

MANUFACTURER: Howmedica Osteonics Corporation, Allendale, N.J.

PRODUCT: a) Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left #9 35mm, Catalog No. 6088-0935-300L. Recall #Z-520-1.
b) Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left #11 40mm, Catalog No. 6088-1140-300L.

REASON: The Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left #9 35mm was labeled as the Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left # 11 40mm, and the Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left # 11 40mm was labeled as the Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left #9 35mm.

MANUFACTURER: EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL.

PRODUCT: Optetrak Total Knee Augmentation Blocks.
Recall #Z-0554-1.

REASON: Sterility barrier failure

MANUFACTURER: Medi-Physics, Inc. dba Nycomed Amersham Imaging, Arlington Heights, IL.

PRODUCT: OncoSeed Iodine-125 Seeds; a welded titanium capsule containing Iodine-125 adsorbed onto a silver rod; Medi-Physics, Inc., Arlington Heights, IL 60004 U.S.A. Recall #Z-0555-1.

REASON: Seeds have a higher radioactivity than stated on the label

MANUFACTURER: Hill-Rom, Inc., Charleston, SC.

PRODUCT: Efica CC (Dynamic Air Therapy Unit).
Recall #Z-560-1.

REASON: Device batteries were alleged to have given off a strong odor.

MANUFACTURER: Zimmer, Inc., Warsaw, IN.

PRODUCT: a) NexGen Knee Threaded Fixation Pin.
Recall #Z-558-1;
b) NexGen Knee Threaded Fixation Pin.
Recall #Z-559-1.

REASON: The hex end of the pin will not assemble with the driver to secure the Micro-Mill femoral mounting base instrumentation to the surgical site.

MANUFACTURER: DYNEX TECHNOLOGIES (THERMO LABSYSTEMS), Chantilly, VA.

PRODUCT: Thermo Labsystemís DSX Automated System.
a) Recall #Z-561-1;
b) Recall #Z-562-1;
c) Recall #Z-563-1;
d) Recall #Z-564-1;
e) Recall #Z-565-1;
f) Recall #Z-566-1;
g) Recall #Z-567-1.

REASON: Incorrect sample volume may be dispensed and therefore produce erroneous test results. In addition, an Electro Magnetic incompatibility in the instrument may cause instrument to report an error and lock-up.

MANUFACTURER: MEDICAL COMPONENTS, INC., Harleysville, PA.

PRODUCT: MedComp 14F Ash Split Cath Long Term, Duo-Flow 400XL, and Duo-Split Cath Short Term Hemodialysi or Apheresis Catheters.
Recall #Z-0549-1.

REASON: Pinch/line clamp not fully occluding tubing when engaged.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 16, 2001:

CLASS II

MANUFACTURER: Terumo Cardiovascular Systems, Inc., Ann Arbor, MI.

PRODUCT: a) Sarns flexible aortic arch cannula 8.00 mm (24 Fr) OD with 3/8î connector. Recall #Z-528-1.
b) Sarns high flow aortic arch cannula with suture flange and luer port, 6.5 mm (20 Fr) OD with 3/8î connector.
Recall #Z-529-1.
c) Sarns 6.5 mm aortic arch cannula with 3/8î connector. Recall #Z-530-1.
d) Sarns 24 Fr flexible arterial cannula 8.5î, NW-soft, cm markings, 3/8î connector with vented cap and luer port. Recall # Z-531-1.
e) Sarns 24 Fr wire-reinforced flex aortic arch 3/8î connector with luer port. Recall #Z-532-1.

REASON: A crack in the connector near the joint between the connector and the cannula tube.

MANUFACTURER: King Systems Corporation, Noblesville, IN.

PRODUCT: a) King Systems brand Jackson-Rees Modification Breathing Circuits. Recall #Z-533-1.
b) King Systems brand Mapleson D Breathing Circuit as follows: Ped F2 Pediatric Anesthesia Breathing Circuit Norman Elbow, individually packed [VETERINARY DEVICE]: Anesco brand Mapleson C Breathing Circuits.
Recall #Z-534-1.

REASON: There is a possible obstruction of the fresh gas inlet of the elbow.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA.

PRODUCT: Access Rubella IgG Reagent Packs.
Recall#Z-535-1.

REASON: Adulterated in under filled reagent wells may produce false negative or false positive test results.

MANUFACTURER: Guidant Corporation, Endovascular Solutions, Menlo Park, CA

PRODUCT: AncureÆ EndograftÆ System. Recall#Z-536-1.

REASON: Problems experienced during the deployment of the graft and the retrieval of the catheter.

MANUFACTURER: Nellcor Puritan Bennett, Inc., Mallinckrodt, Inc.,

PRODUCT: a) Upgradable Achieva Ventilator Models: Achieva Achieva X, Achieva PS, Achieva PSx. Recall #Z-45-1.
b) New Achieva Plus Ventilator Models: Achieva Achieva PS, Achieva PSO2. Recall #Z-546-1.

REASON: The devices may produce over-pressure conditions to the lungs that could place the patient at risk.

MANUFACTURER: Sterile Recoveries, Inc., Long Beach, CA.

PRODUCT: Custom Gown Pack, Sterile.
Recall #Z-553-1

REASON: Device adulterated in that the custom gown pack is possibly non-sterile due to the lack of records showing that the unit received its sterilization cycle.

MANUFACTURER: SYNTHES (USA) PAOLI, PA

PRODUCT: 2.0 mm Universal Drill Guide.
Recall Z-0547-1.

REASON: The device consists of a 1.5 mm drill guide on one end and a 2.0 mm drill guide on the other end. The 1.5 mm end has been etched as 2.0 mm and the 2.0 mm end has been etched as 1.5 mm.

MANUFACTURER: Medical Components, Inc. Harleysville, PA.

PRODUCT: MedComp 14F Ash Split Cath Long Term, Duo-Flow 400XL, and Duo-Split Cath Short Term Hemodialysi or Apheresis Catheters.
Recall#Z-549-1.

REASON: Certain Ash Split Catheters had leaked through the pinch/line clamp immediately following insertion. The recalling firm confirmed that the clamp may not occlude the extensions for the three product lines.

CLASS III

MANUFACTURER: BAYER CORP. OBERLIN, OH

PRODUCT: ADVIA: Centaur Analyzer.
Recall #Z-0548-1.

REASON: A defective 3-way valve, which is used only during the Daily Cleaning Procedure, may cause the hypochlorite cleaning solution to flow into the system water reservoir. As a result, there is a potential for inaccurate test results.

MANUFACTURER: Sunquest Information Systems, Inc., Tucson, AZ.

PRODUCT: Flexilab Versions 5.23 and 5.3 with callback System
Versions 3.0.50.1.
Recall#Z-544-1.

REASON: Device adulterated in that inappropriate output when patients age is unknown may occur.

MANUFACTURER: Autonomous Technologies Corp., Orlando, FL

PRODUCT: LADARVision Excimer System and LADARVision 4000 Excimer Laser System
a) Product No. 6509-0078; Z-537-1.
b) Product No. 6509-4000; Z-538-1.
c) Product No. 6509-0285; Z-539-1.
d) Product No. 6509-0126; Z-540-1.
e) Product No. 6509-0131; Z-541-1.
f) Product No. 6509-0137; Z-542-1.
g) Product No. 6509-0336; Z-543-1.

REASON: Devices adulterated in that unanticipated laser pulses reaching the cornea will cause ablation of the corneal surface, which could result in a central corneal defect of about 1mm in diameter.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 9, 2001:

CLASS II

MANUFACTURER: Fischer Imaging Corporation, Denver, Colorado.

PRODUCT: ISS 2001 X-Ray Imaging System.
Recall # Z-246-1.

REASON: The systems fail to conform to design specifications relating to the emission of electronic product radiation.

MANUFACTURER: GE OEC Medical Systems, UT.

PRODUCT: GE OEC Laser Aimer.
Recall #Z-247-1.

REASON: The laser aimer became disengaged from the image intensifier.

MANUFACTURER: Shimadzu, Kyoto, Japan.

PRODUCT: MobileArt Mobile X-Ray System.
Recall # Z-523-1.

REASON: A failure of a semi-conductor module in the motor drive could result in the out of control movement of the system and the emergency off button may not be effective in removing power to the motorized drive.

MANUFACTURER: Shimadzu, Kyoto, Japan.

PRODUCT: MobileArt Mobile X-ray System,
Recall #Z-524-1.

REASON: A bolt securing a chain inside the third section of the telescoping arm could come out resulting in the unit not being able to be positioned for clinical use.

CLASS III

MANUFACTURER: Applied Medical Resources, Laguna Hills, CA.

PRODUCT: Laparoscopic Clip Applier;
Recall #Z-522-1.

REASON: The handle may not allow proper engagement of the clip applier cartridge, rendering the unit unusable.

MANUFACTURER: GE Medical Systems Europe, Buc Cedex, France.

PRODUCT: GE Senographe 2000D Mammographic X-Ray System. Model Number 2228448. Recall # Z-525-1.

REASON: The spot compression paddle extended beyond the detector front by more than one percent of the source to image distance.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 2, 2001:

CLASS II

MANUFACTURER:     Prosec Protection Systems, Inc., Lakewood, NJ.

PRODUCT:          Infant Umbilical Clamp with Security Transponder Device. 

                  Recall #Z-296-1.

REASON:           Device to be adulterated in that the device sometimes slips off and may lead to infection (skin and bacteria) and blood loss. 

MANUFACTURER:           Midas Rex, Fort Worth, TX.

PRODUCT:          Midas Rex MRIV Motor System Catalog #MRIVMO.  

                  Recall #Z-515-1.

REASON:                 The motor overheats when operating within the active MRI field.

MANUFACTURER:     Sulzer Intermedics Inc. , Angleton, TX 

PRODUCT:          Res-Q Micron Automated Implantable cardioverter

                  a) Model No. 101-05.        Recall#Z-516-1

                  b) Model No. 101-09.      Recall#Z-517-1

                  c) Model No. 101-10.        Recall#Z-518-1

REASON:           The unit indicates an improper end of service message and enters into backup mode disabling defibrillation therapy.  

MANUFACTURER:      Howmedica Osteonics Corporation, Allendale, N.J.

PRODUCT:          a) Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left #9 35mm, Catalog No. 6088-0935-300L.

                  Recall#Z-520-1.

                  b) Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left #11 40mm, Catalog No. 6088-1140-300L.

REASON:           The Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left #9 35mm was labeled as the Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left # 11 40mm, and the Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left # 11 40mm was labeled as The Osteonics Omnifit Cemented Long Stem Femoral Hip Component - Left #9 35mm.
 

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