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

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.