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Recall Archive 8

FDA Recalls

January 2001 - June 2001

Attention all mdi Clients:

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.

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

CLASS II

MANUFACTURER: Pharmacia & Upjohn Company, Kalamazoo, MI.

PRODUCT: CeeOn foldable Intraocular Lens, Model 920. Recall #Z-482-1.

REASON: The lenses from a batch with serial nos. beginning with 081E may have the diopter mislabeled. (Lenses labeled as 18.0 diopter may actually be 23.5 diopter lenses and vice versa.)

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

PRODUCT: Trans Lift Resident Sling Lift (Non-Ac powered patient lift ). Trans Lift Resident Sling Lift, Model No. P433A. Recall #Z-484-1

REASON: The devices can induce a weld failure due to metal fatigue.

MANUFACTURER: IMPRA, Inc., Tempe, Arizona.

PRODUCT: Bard Albumin Coated DeBakey Vascular II Vascular Prostheses. Recall #Z-486-1.

REASON: Three released lots did not meet the specifications for water permeability and could lead to excessive bleeding at the time of implantation.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN.

PRODUCT: Advantage II Glucose Test Strip, Catalog No. 2030659. Recall #Z-488-1; Catalog No. 2030667. Recall #Z-489-1.

REASON: The device will no longer provide an audible beep to let the user know that a second drop of blood can be added to the glucose test strip if the first drop is insufficient.

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

PRODUCT: Premier VZV IgG ELISA, a diagnostic test kit for the detection of IgG Antibody to Varicella-Zoster Virus in Human Serum. Recall #Z-0490-1.

REASON: Test instructions are labeled incorrectly and may result in invalid test results.

MANUFACTURER: Agilent Technolgies Deutschland GMBH, Boeblingen, Baden-WTTBG, Germany.

PRODUCT: Agilent M1347A SafeConnect DECG Adapter Used to connect the M1362B SafeConnect DECG Leg Plate Adapter Cable to: (A)DECG transducer M1357A (Agilent/HP Series 50 Fetal Monitors, models M1350A,B,C, M1351A, and M1353A) (B)DECG transducer 15240A (for Agilent/HP Fetal Monitor 8040A). Recall #Z-0491-1.

REASON: Incomplete connection of adapter and transducer may prevent reliable ECG.

MANUFACTURER: Datex Ohmeda Division Instrumentarium Corp. Helsinki, Finland.

PRODUCT: Datex-Ohmeda Nellcor Compatible Saturation Module: "M-NSAT". Recall #Z-0492-1.

REASON: SpO2 Value may freeze on the Monitor display under certain conditions.

MANUFACTURER: Philips Medical Systems Nederlands B.V.

PRODUCT: One-Monitor Ceiling Suspension, Used with the Integris or MultiDiagnost Systems. Models 9896-000-33421 and 9898-000-33422. Recall #Z-0493-1.

REASON: Ceiling Suspension May Loosen and Cause Monitor to Fall.

MANUFACTURER: Philips Medizin Systeme GMBH, Hamburg, Germany

PRODUCT: Optimus CP (OMCP) X-ray generator models with Release 7.x, 8.1, 8.2 and 8.3 firmware. Delivered in Vascular Integris Systems in combination with an MRM 04/10 x-ray tube and Bolus Chase R3 option. Recall #Z-0494-1.

REASON: If a bolus run is started, the injector may inject contrast medium without exposure.

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

PRODUCT: EasyVision CT/MR Workstation with software release 1.x AND 2.x. Recall #Z-0495-1.

REASON: If Ct scans made on different dates, the Image sets are merged into one exam.

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

PRODUCT: Premier Giardia, an EIA diagnostic test kit for the detection of Giardia lamblia antigens in patient stool samples. Recall #Z-0497-1.

REASON: The stability data does not support the labeled expiration date.

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

PRODUCT: Premier VZV IgG ELISA, a diagnostic test kit for the detection of IgG Antibody to Varicella-Zoster Virus in Human Serum. Recall #Z-0499-1.

REASON: The positive control is incorrectly labeled and may lead to invalid test results.

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

PRODUCT: Gyroscan T5 Magnetic Resonance Diagnostic Device NT. Recall #Z-0500-1.

REASON: If computer shuts down the system patient nurse call alarm is not activated.

MANUFACTURER: Zoll Medical Corp., Burlington, MA.

PRODUCT: ZOLL "M Series" Defibrillator/Pacemaker. Recall #Z-0501-1.

REASON: Device may fail to deliver correct energy with low transthoracic impedance.

MANUFACTURER: Diagnostica-Stago, Inc., Parsippancy, NJ.

PRODUCT: ST4 600 Disposable Cuvettes Coagulation instrument. Recall #Z-502-1.

REASON: The opaque cuvettes gave a much lower APCR Ratio than the clear cuvettes.

MANUFACTURER: Adven Medical, Lubbock, TX.

PRODUCT: Reprocessed Bone Shaver. Recall #Z-503-1.

REASON: Metal shavings may come off the device into a patient during surgery.

MANUFACTURER: Howmedica Osteonics Corp., Allendale, NJ.

PRODUCT: Osteonics Cuttingh Edge Broach C5PF7: a) Cutting Edge Broach C5PF7, Catalog No. 1126-0507. Recall # Z-504-1. b) Cutting Edge Broach C6PF8, Catalog No. 1126-0608. Recall #Z-505-1.

REASON: Devices may be susceptible to breakage intra-operatively due to its small cross sectional area that is confined to the two smallest sized Cutting Edge Broaches.

MANUFACTURER: Commed Corporation, Utica, NY.

PRODUCT: ECG Electrodes: a) - Model No. 1410, Catalog No. 1410-001; Model No. 1410, Catalog No. 1410-003; Model No. 1410, Catalog No. 1410-030. Recall #Z-506-1; b) - Model No. 1501, Catalog No. 1501-001; Model No. 1501, Catalog No. 1501-003;

Model No. 1501, Catalog No. 1501-0125. Recall #Z-507-1; c) - Model No. 1520, Catalog No. 1520-003. Recall #Z-508-1; d) - Model No. 1580, Catalog No. 15380-005. Recall #Z-509-1.

REASON: The sensing element is separating from the body of the electrode when the leadwire is removed.

CLASS III

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN.

PRODUCT: Sample Cups on COBAS Integra(r), Catalog No. 1045318. Recall #Z-487-1.

REASON: Sample cups in this lot labeled for use on the Integra analyzers are actually designed for use on the Mira analyzers.

MANUFACTURER: BIOSTAR, Inc., Boulder, CO.

PRODUCT: Strep A OIA Max kit. Recall #Z-0496-1.

REASON: Strep A MAX kits contain Chlamydia devices.

MANUFACTURER: Abbott Laboratories, Abbott Park, IL.

PRODUCT: Abbott AxSYM System Solution 4 Line Diluent; 10 L bag in box; item no. 8A46-01; for in vitro diagnostic use; 0.1 M Phosphate Buffer with sodium azide preservative and antimicrobial agent. Recall #Z-0498-1.

REASON: Diluent contaminated with trace levels of ethanol.

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

CLASS II

MANUFACTURER: Wuestec Medical, Inc., Mobile, AL.

PRODUCT: Dr. Sweat's Atlas Orthogonal Chiropractic Adjustment Table (aka Atlas Table). Recall #Z-347-1.

REASON: A patient could be pinned to the stylus by the headrest.

MANUFACTURER: Alcon Laboratories, Houston, Texas.

PRODUCT: Alcon Custom Paks containing Becton-Dickinson 3 ml syringe with 21G x 1.5" Needle. Recall #Z-460-1.

REASON: The 3 ml syringe(s) with 21 gauge needle contained in the Custom pak may have a loose or missing protector cap.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA.

PRODUCT: Cryovalve Allograft; Model No. AV00. Recall #Z-469-1.

REASON: The firm received additional donor information from the procurement agency, confirming that a duplicate set of serologies possessed discordant HbsAg results. The tissue was released in error.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA.

PRODUCT: Cryovalve Allograft; a)Model No. AV05. Recall #Z-470-1; b)Model No. PV05. Recall #Z-471-1.

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

MANUFACTURER: Ohmeda Medical, Laurel, MD.

PRODUCT: Ohmeda Medical Giraffe(tm) Omnibed(tm), Various Serial Numbers. Recall #Z-472-1.

REASON: Oxygen concentration variations (resulting in too much or too little oxygen) may occur inside the infant incubator compartment when the device is operated in the "incubator" mode.

MANUFACTURER: Ethicon, Inc., San Angelo, TX.

PRODUCT: Coated VICRYL (polyglactin 910) suture, MONOCRYL (poliglecaprone 25) suture, PDS II (Polydioxanone) suture, E-Pack Procedure Kits. Recall #Z-0475/0478-1.

REASON: Possibly non-sterile sutures.

MANUFACTURER: Max Hauser GmbH, D-78507 Tuttlinger, Germany.

PRODUCT: OctoBase Retractor Rack (product number 28701). Recall #Z-0479-1.

REASON: The retractor may lock-up during use.

MANUFACTURER: Medtronic, Inc., Neurological Division, Minneapolis, MN.

PRODUCT: Medtronic DBS Lead Kits, Models 3387 and 3389, For deep brain stimulation. Recall #Z-0480-1.

REASON: Some electrodes in the leads are not connected to the proper connector sleeve.

MANUFACTURER: Boston Scientific Scimed, Inc., Maple Grove, MN.

PRODUCT: Boston Scientific Scimed Maverick Monorail PTCA Dilatation Catheters, Several Models numbers. Recall #Z-0481-1.

REASON: Possibility of a hole between the wire and the inflation lumens.

CORRECTION: The Enforcement Report for April 11, 2001 (Recall #Z-347-1) has been reassigned to a new product (Dr. Sweat's Atlas Orthogonal Chiropractic Adjustment Table (aka Atlas Table). The New Recall Nos. for (Femoral Hip Stems) follows: ________ PRODUCT: Femoral Hip Stems; a) Lat. Answer Cemented Femoral 9 x 125 mm Lateralized Stem. Recall #Z-461-1; b) Lat. Answer Cemented Femoral 11.0 x 135 mm Lateralized Stem. Recall #Z-462-1; c) CB Answer Cemented Femoral 9.0 x 125 mm Stem. Recall # Z-463-1. d) Mallory/Head Cemented Femoral Interlok/Minus 5 mm Neck, 5 mm x 7 mm. Recall #Z-464-1. e) Mallory/Head Cemented Femoral Interlok/with Collar 7.0 x 140 mm Stem. Recall #Z-465-1. f) Mallory/Head Collared Femoeral 7.0 x 140 mm Stem. Recall #Z-466-1. g) Mallory/Head C Femoral Reduced 5P/7D x 105 mm Minus 5 mm Neck. Recall #Z-467-1. h) Modified Mallory/Head C Femoral 5 mm x 7 mm x 115 mm Stem Minus 5 mm Neck. Recall #Z-468-1. MANUFACTURER: Biomet Orthopedics, Inc., Warsaw, IN, RECALLED BY: Manufacturer, by facsimile letter on January 18, 2001. Firm-initiated recall ongoing. DISTRIBUTION: United States, Canada, France and Korea. QUANTITY: 159. REASON: The cobalt-chrome alloy may have a streak of pure cobalt.

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

CLASS II

MANUFACTURER: Edwards Lifesciences LLC, Irvine, CA.

PRODUCT: Obturator for Mitral Valves Model No. 1162, sizes 25mm-35mm. Recall #Z-277-1.

REASON: Sizers do not match the heart valves and the directions for use are inadequate.

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

PRODUCT: Ash Split Cathether Repair Kit. Recall #Z-0281-1.

REASON: No 510k clearance & potentially not sterile.

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

PRODUCT: Hemo-Flow Long Term High Flow Access Catheters. Recall #Z-0282-1 to Z-0289-1.

REASON: Marketed without 510k clearance.

MANUFACTURER: Nellcor Puritan Bennett Ireland, LTD., Galway, Ireland.

PRODUCT: Puritan-Bennett 740 and Puritan-Bennett 760 Ventilator. Recall #Z-0290-1 to Z-0291-1.

REASON: Remote probability for the ventilator to remain in Safety Valve Open condition.

MANUFACTURER: Possis Medical, Inc., Minneapolis, MN.

PRODUCT: AngioJet Rheolytic Thrombectomy System Pump Set. Recall #Z-0293-1.

REASON: Holes in outer sterile packages.

MANUFACTURER: SMV International, Cedex, France.

PRODUCT: Nuclear Medicine Scanner, DS Series. Recall #Z-0294-1.

REASON: Improper latching mechanism may allow collimator to disengage during camera use.

MANUFACTURER: ZEVEX, Inc., Salt Lake City, UT.

PRODUCT: Zevex Inc., EnteralEZ Enteral Feeding Pump. Recall #Z-0295-1.

REASON: Enteral feeding pump delivers feeding solution at rates lower than specified.

MANUFACTURER: Smith & Nephew, Inc., Mansfield, MA.

PRODUCT: Smith & Nephew RotorC Drill. Recall #Z-0297-1.

REASON: Potential for drill to puncture sterile package.

MANUFACTURER: AvidCare Corporation, Milwaukee, WI.

PRODUCT: Home Health Monitoring System. Recall #Z-0298-1.

REASON: Lack of 510(k) clearance for new device features.

MANUFACTURER: Medical Specialties, Inc., Tarpon Springs, FL.

PRODUCT: CliniCath IR Peripherally Inserted Central Catheter, 5 French, Reorder Number 21-2575. all #Z-0299-1.

REASON: Product packages contain the wrong size introducer.

MANUFACTURER: Intracel Corporation, Issaquah, WA.

PRODUCT: a) Bartels CMV EIA kit, catalog #B1029-91. Recall #Z-0300-1. b) CMV IEA Antibody & Conjugate Kit,catalog #B1029-91A. Recall #Z-0301-1.

REASON: Diminishing fluorescence.

MANUFACTURER: Olympic Medical Corp., Seattle, WA.

PRODUCT: Olympic Warm-Scale - infant scale equipped with a heater that provides warmth for an infant while being weighed. Recall #Z-0302-1.

REASON: Potential for tray and warming platform to overheat.

MANUFACTURER: MEDTRONIC, INC., Neurological Division, Minneapolis, MN.

PRODUCT: Supplemental Reference Manuals: a) IsoMed Constant-Flow Infusion System, Clinical Reference Guide for Pain Therapy. B) IsoMed Constant-Flow Infusion System, Catheter Access Port Procedure, Quick Reference Tool for Intrathecal Drug Delivery. c) IsoMed Constant-Flow Infusion System, Clinical Reference Guide for Hepatic Arterial Infusion Therapy. d) IsoMed Constant-Flow Infusion System, Catheter Access Port Procedure, Quick Reference Tool for Hepatic Arterial Infusion for Chemotherapy. Recall #Z-0304-1 to Z-0307-1.

REASON: Manuals contain incorrect table for calculating time for drug to traverse catheter.

MANUFACTURER: Data Critical Corp., Bothell, WA

PRODUCT: StatView Receiver used with the StatView System. Recall #Z-0308-1.

REASON: Random and/or missed pages for patient monitoring.

MANUFACTURER: Utah Medical Products, Inc., Midvale, UT.

PRODUCT: Utah Medical Products a) Umbilicup and b) Umbilicup II Umbilical Cord Blood Sampling System. Recall #Z-0309-1 to Z-0310-1.

REASON: Sterility of the units can not be guaranteed.

MANUFACTURER: Neurocontrol Corp. Valleyview, Ohio.

PRODUCT: FREEHAND Electrode Positioning Kits (EPK), Model 1111-1. Recall #Z-0311-1.

REASON: Device does not comply with the performance standard for electrode lead wires and patient cables, 21 CFR 898.

MANUFACTURER: Fluidsense Corp., Newburyport, MA.

PRODUCT: FluidSense FS-01 Infusion Pump. Recall #Z-0312-1.

REASON: If two microprocesors simultaneously reboot, an alarm would not sound.

MANUFACTURER: Bioteque America, Inc., Langhorne, PA.

PRODUCT: IUI Tomcat Catheters Kit. Recall #Z-0362-1.

REASON: No 510k clearance and lack of sterility assurance.

MANUFACTURER: Bioteque America, Inc., Langhorne, PA.

PRODUCT: WC400 Word/Bartholin Catheters. Recall #Z-0363-1.

REASON: No 510k clearance and lack of sterility assurance.

MANUFACTURER: Steris Corp., Mentor, OH.

PRODUCT: The STERIS Quick Connect Kit Booklets, for STERIS Quick Connect Kits #C1402, #C1403, and C1622 that are used to process Pentax 30/40/30K series gastroscopes in the STERIS SYSTEM I. Recall #Z-0364-1 to Z-0366-1.

REASON: Inadequate instructions may result in ineffective sterilization of water jet port.

MANUFACTURER: Possis Medical, Inc., Minneapolis, MN.

PRODUCT: AngioJet(r) Rheolytic(tm) Thrombectomy System Pump Set. Recall #Z-0367-1.

REASON: Holes in sterile packaging.

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

PRODUCT: Flexilab Laboratory Information System (not for use in blood banks). Recall #Z-0369-1.

REASON: Software anomaly allows misprint of patient information.

MANUFACTURER: Howmedica Osteonics Corporation, Rutherford, NJ

PRODUCT: Duracon Unicompartmental Knee System: Z-371-1 - Right Medial/Left Lateral Small Tibial Component Catalog No. 6634-9-108, 8 mm Catalog No. 6634-9-110, 10 mm Catalog No. 6634-9-112, 12 mm Catalog No. 6634-9-114, 14 mm Catalog No. 6634-9-116, 16 mm Z-372-1 - Left Medial/Right Lateral Small Tibial Component Catalog No. 6634-9-008, 8 mm Catalog No. 6634-9-010, 10 mm Catalog No. 6634-9-012, 12 mm Catalog No. 6634-9-014, 14 mm Catalog No. 6634-9-016, 16 mm Z-373-1 - Right Medial/Left Lateral Medium Tibial Component - 6 - Catalog No. 6634-9-308, 8 mm Catalog No. 6634-9-310, 10 mm Catalog No. 6634-9-312, 12 mm Catalog No. 6634-9-314, 14 mm Catalog No. 6634-9-316, 16 mm Z-374-1 - Left Medial/Right Lateral Medium Tibial Component Catalog No. 6634-9-208, 8 mm Catalog No. 6634-9-210, 10 mm Catalog No. 6634-9-212, 12 mm Catalog No. 6634-9-214, 14 mm Catalog No. 6634-9-216, 16 mm Z-375-1 - Right Medial/Left Lateral Medium/Large Tibial Component Catalog No. 6634-9-508, 8 mm Catalog No. 6634-9-510, 10 mm Catalog No. 6634-9-512, 12 mm Catalog No. 6634-9-514, 14 mm Catalog No. 6634-9-516, 16 mm Z-376-1 - Left Medial/Right Lateral Medium/Large Tibial Component Catalog No. 6634-9-408, 8 mm Catalog No. 6634-9-410, 10 mm Catalog No. 6634-9-412, 12 mm Catalog No. 6634-9-414, 14 mm Catalog No. 6634-9-416, 16 mm Z-377-1 - Right Medial/Left Lateral Large Tibial Component Catalog No. 6634-9-708, 8 mm Catalog No. 6634-9-710, 10 mm Catalog No. 6634-9-712, 12 mm Catalog No. 6634-9-714, 14 mm Catalog No. 6634-9-716, 16 mm Z-378-1 - Left Medial/Right Lateral Large Tibial Component Catalog No. 6634-9-608, 8 mm Catalog No. 6634-9-610, 10 mm Catalog No. 6634-9-612, 12 mm Catalog No. 6634-9-614, 14 mm Catalog No. 6634-9-616, 16 mm Z-379-1 - Right Medial/Left Lateral Extra Large Tibial Component Catalog No. 6634-9-908, 8 mm Catalog No. 6634-9-910, 10 mm Catalog No. 6634-9-912, 12 mm Catalog No. 6634-9-914, 14 mm Catalog No. 6634-9-916, 16 mm Z-380-1 - Left Medial/Right Lateral Extra Large Tibial Component Catalog No. 6634-9-808, 8 mm Catalog No. 6634-9-810, 10 mm Catalog No. 6634-9-812, 12 mm Catalog No. 6634-9-814, 14 mm Catalog No. 6634-9-816, 16 mm - 7 -

REASON: Polyethylene components may be oxidizing.

MANUFACTURER: Sterile Recoveries, Inc., Clearwater, FL.

PRODUCT: Surgical Procedure Packs. Recall #Z-382-1

REASON: The sterilization process did not meet one temperature parameter.

CLASS III

MANUFACTURER: C. R. Bardm Inc., Covington, GA.

PRODUCT: Fischer Needle Guide: a) Catalog No. GF1200 (12 Gauge Needle Guide). Recall #Z-278-1; b) Catalog No. GF1416 (14/16 Gauge Needle Guide). Recall #Z-279-1

REASON: Contains 12 gauge needle guide but labeled as containing 14/16 gauge needles.

MANUFACTURER: Medtronic, Inc., Parker, CO.

PRODUCT: Medtronic PT Cartridge, Prothrombin Time Cartridge. Recall #Z-0292-1.

REASON: Inactive thromboplastin causes invalid clotting times.

MANUFACTURER: R & D Systems, Inc., Minneapolis, MN.

PRODUCT: SEDRite Plus Hematology Erythrocyte Sedimentation Rate Control. Recall #Z-0368-1.

REASON: Microbiological contamination in the control caused the red blood cells to lyse.

MANUFACTURER: Lifecore Biomedical, Inc., Chaska, MN.

PRODUCT: Lifecore SuperCAT Self-Tap Implant, NP Mnt 3.3x10 mm (SD), Titanium, Catalog number TC3310. Recall #Z-0370-1.

REASON: Dental implant mislabeled as to length. - 8 - MANUFACTURER: Olympus America, Inc., Melville, NY.

PRODUCT: Integrated Endosurgery EndoALPHA Software Version 3.01. Recall #Z-381-1.

REASON: The device software version 3.01 prevented the control unit from retaining the user-programmer coagulation setting.

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

CLASS II

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN.

PRODUCT: Roche Chemstrip 9 Urine Test Strips, Catalog No. 417109. Recall #Z-328-1.

REASON: One of the component pads for the leukocyte test area was missing, which will result in a false negative result for leukocytes.

MANUFACTURER: DePuy Orthopaedics, Inc., Warsaw, IN.

PRODUCT: DePuy PS Reusable Tourniquet Cuffs, Bier's Block: a) PS Reusable Tourniquet Cuff, 18 inch, Single Hose, Bier's Block, Catalog No. 6671-50-000. Recall #Z-332-1. b) PS Reusable Tourniquet Cuff, 26 inch, Single Hose, Bier's Block, Catalog No. 6671-52-000. Recall #Z-333-1; c) PS Reusable Tourniquet Cuff, 26 inch, Single Hose, Bier's Block, Catalog No. 6671-52-000. Recall #Z-334-1; d) PS Reusable Tourniquet Cuff, 18 inch, Double Hose, Bier's Block, Catalog No. 6672-50-000. Recall #Z-335-1.

REASON: Deflation of the tourniquet cuff as a result of the hose disconnecting from the port of the cuff.

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

PRODUCT: Dash Patient Monitors, Models 2000 and 3000 a) Dash Patient Monitor, Model No. 2000. Recall #Z-337-1; b) Dash Patient Monitor, Model No. 3000. Recall #Z-338-1.

REASON: The monitor alarms fail to sound after 414 days of usage.

MANUFACTURER: Micro Therapeutics, Inc., Irvine, CA.

PRODUCT: Flowrider Micro Catheter: a) Model No. 105-5060(1.8F). Recall #Z-339-1; b) Model No. 105-5062 (FlowRider II). Recall #Z-340-1; c) Model No. 105-5063(1.5F). Recall #Z-341-1.

REASON: The device fails to perform as designed. The device may leak therapeutic agents and contrast media into the peripheral and neuro vasculature due to failure of the catheter wall.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN.

PRODUCT: Accu-Chek(r) Advantage(r) meters and Accu-Chek(r) Voicemate(r). a) Accu-Chek Advantage I meter. Recall #Z-342-1; b) Accu-Chek Advantage II meter. Recall #Z-343-1; c) Voicemate System. Recall #Z-344-1.

REASON: A software problem causes the memory to store erroneous values under specific circumstances. If the user performs a test when the meter's internal clock registers 12:00 (midnight) - 12:10 am on the day the meter believes is Day 1 of a 7 day cycle, the test result can be incorrect. The same software problem also causes the Voicemate meters for the visually impaired to orally report erroneous values taken from the meter memory.

MANUFACTURER: Abbott Laboratories, Inc., San Diego, CA.

PRODUCT: Abbott Provider 5500 Infusion Pump. Recall # Z-383-1; Abbott Provider 6000 Infusion Pump. Recall # Z-384-1.

REASON: The product can overinfuse in the "bolus only" mode which does not result in a failure alarm.

MANUFACTURER: COBE Cardiovascular, INC., Arvada, CO.

PRODUCT: a) Customized Heart Lung Perfusion Packs, 44 catalog numbers: Recall # Z-0409-1 to Recall #Z-0452-1; b) Sterile Sample Customized Heart Lung Perfusion Packs Recall #Z-0453-1 to Recall #Z-0458-1; c) Bulk Sterile Purge Line #029177100. Recall #Z-0459-1;

REASON: Plastic one-way valve located in the arterial filter purge line may break.

CLASS III

MANUFACTURER: Medtronic Xomed, Inc., Jacksonville, FL.

PRODUCT: Total Ossicular Reconstruction Prostheses - Wiet Flex H/A Offset Head H/A, and Causse Flex H/A Notched H/A Offset: a) Weit Flex H/A Offset Head H/A, Catalog No. 0515. Recall #Z-316-1; b) Causse Flex H/A Notched H/A Offset, Catalog No. 0518. Recall #Z-317-1.

REASON: The product labeling was switched.

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

PRODUCT: ALCYON Clinical Chemistry Analyzer. Recall #Z-325-1. ALCYON Direct HDL. Recall #Z-326-1.

REASON: There is possible to obtain depressed or lower HDL Cholesterol results in some lipemic specimns when using the ALCYON Direct HDL method.

MANUFACTURER: i-Stat Corp. East Windsor, NJ.

PRODUCT: i-STAT Creatinine Cartridge: i-STAT Catalog No. 320100; Recall #Z-329-1; Abbott laboratory List Nos. 06F10-01, 06F10-02. Recall #Z-330-1.

REASON: A change in the manufacturing process causes these cartridges to be incompatible with the analyzers (i-STAT Portable Clinical analyzer and the Hewlett Packard Blood Analysis Module).

MANUFACTURER: Weck Closure Systems, Research Triangle Park, NC.

PRODUCT: Hemoclip S15 Ligating Clip Appliers, Catalog No. 23701. Recall #Z-331-1.

REASON: A pinhole in the sterile blister pack.

MANUFACTURER: Cook Urological, Inc., Spencer, IN.

PRODUCT: Nitinol Laser Grasper Set, Catalog No. NLGS-030115-UDH. Recall #Z-336-1.

REASON: The cannula may separate from the PINT shaft at the proximal end inside the handle causing the handle to malfunction.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN.

PRODUCT: Sample Cups for use on Roche/Hitachi and Elecsys analyzers, Catalog 40904100. Recall #Z-345-1.

REASON: Some sample cups in this lot are manufactured incorrectly in that the liquid reservoir space is decreased. The decrease space could result in probe crash, compromised dead volumes and the possibility of samples being read incorrectly without a warning being sent to the system.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 28, 2001:

CLASS II

MANUFACTURER: Stryker Medical, Kalamazoo, MI.

PRODUCT: Rugged EZ-Pro 2, Model No. 6091 Ambulance Cots. Recall Number Z-187-1.

REASON: The device lock pin may not properly engage and therefore the cot may drop to the next lower level while transporting patients.

NOTE: This is an extension of the firm's original field correction of August 21, 2000. This action has been extended to include additional serial numbers and provides an additional correction for the problem.

MANUFACTURER: Hardy Diagnostics, Santa Maria, CA.

PRODUCT: Saline, 0.45%, 1.8 ml., Product No. D12, intended for use in preparation of standardized suspensions of microorganisms for use in Vitek automated identification and susceptibility test system. Recall No. Z-321-1.

REASON: Use of this product on certain Vitek susceptibility panels will result in insufficient growth of gram negative microbes.

CLASS III

MANUFACTURER: Diagnostica Stago, Inc., Parsippancy, NJ.

PRODUCT: STA LiaTest D-DI Kit, Model No. 0515. Recall #Z-280-1.

REASON: The product non-conformity is that the recovery of abnormal control is too low, in the order of 15 to 20% compared to the acceptable value.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN

PRODUCT: Cobas Mira Creatinine Reagent: a) Catalog No. 3033414. Recall #Z-313-1; b) Catalog No. 3034712. Recall #Z-314-1.

REASON: The device may produce falsely elevated creatinine results due to increased triglycerides in serum samples.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN.

PRODUCT: ROCHE c.f.a.s. Calibrator for Automated Systems, Catalog No. 759350. Recall #Z-315-1.

REASON: A slight positive bias of the product setpoints causes serum calcium results too high.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN.

PRODUCT: Roche Elecsys 2010 assay tips, Catalog No. 1706799. Recall #Z-318-1.

REASON: Some tips used to pipette samples and reagents may have plugged openings that may result in incorrect results.

MANUFACTURER: Beckman Coulter Inc., Brea, CA.

PRODUCT: Access Immunoassay System; Troponin I Reagent Pack. Recall #Z-319-1.

REASON: Some Troponin Reagent packs may not contain sufficient reagent to complete the 50 tests indicated in the labeling.

MANUFACTURER: Diagnostica Stago, Inc., Parsippancy, NJ.

PRODUCT: STA LiaTest von Williebrand vWF Factor Antigen Kits, Catalog No. 00518. Recall #Z-320-1.

REASON: We are assigning the contamination of the product was due to the Lab Technician inappropriately handling the product during the quality control analysis.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 21, 2001:

CLASS I

MANUFACTURER: Puritan Bennett Corp., Carlsbad, CA.

PRODUCT: Puritan-Bennett(r) 840 Series(tm) Ventilator System. Recall # Z-272-1.

REASON: A malfunction may result in overpressure and barotrauma that could lead to serious injury or death in patients whose body weight is less than 20 kg.

CLASS II

MANUFACTURER: Royal Enterprises, Helmet, CA.

PRODUCT: a) Model No. XGS dual gas spring portable mobile stand. Recall #Z-397-1. b) Model No. XGS Mark II dual gas spring portable mobile stand. Recall #Z-398-1.

REASON: Failure of the device's mounting stud may allow the trunnion of the xray unit to unintentionally separate from the tube arm and allow the xray unit to fall.

MANUFACTURER: Sulzer Orthopedics, Inc., Austin, TX.

PRODUCT: InterOp Acetabular Shell: a) Hemispherical, Catalog No. 4360-00-039/065. Recall #Z-404-1; b) Revision, Catalog No. 4361-00043/081. Recall #Z-405-1; c) Rim Flare, Catalog No. 4361-00-039/071, Recall #Z-406-1; d) Protrusion, Catalog No. 4363-00-053/081. Recall #Z-407-1

REASON: The device contains a manufacturing residue, machining oil.

MANUFACTURER: Midas Rex, L.P., Fort Worth, TX.

PRODUCT: Safety Seals, Catalog No. SS. Recall #Z-408-1.

REASON: The safety seals may swell during autoclaving which can cause the migration of the seals to an incorrect position within the motor-attachment assembly resulting in an increased chance of oil leaks and seal disintegration during surgery.

CLASS III

MANUFACTURER: Diagnostic Products Corp, Los Angeles, CA.

PRODUCT: Immolate brand of Valproic Acid Test Kit. Recall ##Z-385-1.

REASON: The barcode used to label the adjustor kit component had an error that caused the system to reject it. The printing error prevents the barcode from being read and the instruments will not process the assay and patient results will not be obtained.

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

PRODUCT: a) Vitros 250 and Vitros 250 AT Chemistry Systems Software version below 7.0.; Recall #Z-386-1. b) Vitros 950 and Vitros 950AT Chemistry Systems with software version below 3.07. Recall #Z-387-1.

REASON: The Bilirubin (Unconjugated Bilirubin) results may be reported as 0.0 mg/dL or Bc (Conjugated Bilirubin) result may not be flagged with a potential interferent code when a spectral interferent is present in a patient sample.

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

PRODUCT: Vitros Clinical Chemistry - Performance Verifier I. Kodatrol I and II Control and Diluent Set, Model and Catalog Numbers Performance Verifier I, Catalog No. 806 7324. Recall #Z-388-1.

REASON: Sodium QC results may run above the published Range-of-Means (ROM) on some analyzers with this lot of Performance Verifier control fluid.

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

PRODUCT: VITROS Immunodiagnostic Product: a) Ferritin Reagent Pack, Catalog No. 835 6636. Recall #Z-389-1; b) Total B-hCG Reagent Pack. Recall # Z-390-1.

REASON: Incorrect placement of reagent bottles in the reagent pack. The incorrect configuration will cause very low light signal, which will result in either failure to calibrate, an error code, or signal results of 0 ng/mL.

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

PRODUCT: Vitros Immunodiagnostic Products CA 15-3(tm) Reagent Packs, Catalog No. 6800039. Recall #Z-391-1.

REASON: Reagent bottles are incorrectly positioned in these products and using them would produce CA 15-3 results of less than 1U/ml.

MANUFACTURER: Community Products LLC/Community Playthings, Rifton, NY

PRODUCT: Rifton Chairs: a) Small, low back, Recall #Z-392-1. b) Medium, low back. Recall #Z-393-1 c) Medium, high back. Recall #Z-394-1 d) Medium, low back. Recall #Z-395-1 e) Large, high back. Recall #Z-396-1

REASON: The plastic housing, into which the brackets that hold the seat is inserted have broken.

"Correction: The Enforcement Report for February 14, 2001, (Recall Number Z-200-1) and January 31, 2001 (Recall Number Z-180-1) listed the recalls as ongoing. The recalls are complete".

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 14, 2001:

CLASS II

MANUFACTURER: Edwards Lifesciences LLC, Irvine, CA.

PRODUCT: Obturator for Mitral Valves Model No. 1162, sizes 25mm-35mm. Recall #Z-277-1.

REASON: Sizers do not match the heart valves and the directions for use are inadequate.

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

PRODUCT: Ash Split Cathether Repair Kit. Recall #Z-0281-1.

REASON: No 510k clearance & potentially not sterile.

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

PRODUCT: Hemo-Flow Long Term High Flow Access Catheters. Recall #Z-0282-1 to Z-0289-1.

REASON: Marketed without 510k clearance.

MANUFACTURER: Nellcor Puritan Bennett Ireland, LTD., Galway, Ireland.

PRODUCT: Puritan-Bennett 740 and Puritan-Bennett 760 Ventilator. Recall #Z-0290-1 to Z-0291-1.

REASON: Remote probability for the ventilator to remain in Safety Valve Open condition.

MANUFACTURER: Possis Medical, Inc., Minneapolis, MN.

PRODUCT: AngioJet Rheolytic Thrombectomy System Pump Set. Recall #Z-0293-1.

REASON: Holes in outer sterile packages.

MANUFACTURER: SMV International, Cedex, France

PRODUCT: Nuclear Medicine Scanner, DS Series. Recall #Z-0294-1.

REASON: Improper latching mechanism may allow collimator to disengage during camera use.

MANUFACTURER: ZEVEX, Inc., Salt Lake City, UT.

PRODUCT: Zevex Inc., EnteralEZ Enteral Feeding Pump. Recall #Z-0295-1.

REASON: Enteral feeding pump delivers feeding solution at rates lower than specified.

MANUFACTURER: Smith & Nephew, Inc., Mansfield, MA.

PRODUCT: Smith & Nephew RotorC Drill. Recall #Z-0297-1.

REASON: Potential for drill to puncture sterile package.

MANUFACTURER: AvidCare Corporation, Milwaukee, WI.

PRODUCT: Home Health Monitoring System. Recall #Z-0298-1.

REASON: Lack of 510(k) clearance for new device features.

MANUFACTURER: Medical Specialties, Inc., Tarpon Springs, FL.

PRODUCT: CliniCath IR Peripherally Inserted Central Catheter, 5 French, Reorder Number 21-2575. Recall #Z-0299-1.

REASON: Product packages contain the wrong size introducer.

MANUFACTURER: Intracel Corporation, Issaquah, WA.

PRODUCT: a) Bartels CMV EIA kit, catalog #B1029-91. Recall #Z-0300-1. b) CMV IEA Antibody & Conjugate Kit, catalog #B1029-91A. Recall #Z-0301-1.

REASON: Diminishing fluorescence.

MANUFACTURER: Olympic Medical Corp., Seattle, WA.

PRODUCT: Olympic Warm-Scale - infant scale equipped with a heater that provides warmth for an infant while being weighed. Recall #Z-0302-1.

REASON: Potential for tray and warming platform to overheat.

MANUFACTURER: MEDTRONIC, INC., Neurological Division, Minneapolis, MN.

REASON: Manuals contain incorrect table for calculating time for drug to traverse catheter.

MANUFACTURER: Data Critical Corp., Bothell, WA.

PRODUCT: StatView Receiver used with the StatView System. Recall #Z-0308-1.

REASON: Random and/or missed pages for patient monitoring.

MANUFACTURER: Utah Medical Products, Inc., Midvale, UT.

PRODUCT: Utah Medical Products a) Umbilicup and b) Umbilicup II Umbilical Cord Blood Sampling System. Recall #Z-0309-1 to Z-0310-1.

REASON: Sterility of the units can not be guaranteed.

MANUFACTURER: Neurocontrol Corp. Valleyview, Ohio.

PRODUCT: FREEHAND Electrode Positioning Kits (EPK), Model 1111-1. Recall #Z-0311-1.

REASON: Device does not comply with the performance standard for electrode lead wires and patient cables, 21 CFR 898.

MANUFACTURER: Fluidsense Corp., Newburyport, MA.

PRODUCT: FluidSense FS-01 Infusion Pump. Recall #Z-0312-1.

REASON: If two microprocesors simultaneously reboot, an alarm would not sound.

MANUFACTURER: Bioteque America, Inc., Langhorne, PA.

PRODUCT: IUI Tomcat Catheters Kit. Recall #Z-0362-1.

REASON: No 510k clearance and lack of sterility assurance.

MANUFACTURER: Bioteque America, Inc., Langhorne, PA.

PRODUCT: WC400 Word/Bartholin Catheters. Recall #Z-0363-1.

REASON: No 510k clearance and lack of sterility assurance.

MANUFACTURER: Steris Corp., Mentor, OH.

REASON: Inadequate instructions may result in ineffective sterilization of water jet port.

MANUFACTURER: Possis Medical, Inc., Minneapolis, MN.

PRODUCT: AngioJet(r) Rheolytic(tm) Thrombectomy System Pump Set. Recall #Z-0367-1.

REASON: Holes in sterile packaging.

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

PRODUCT: Flexilab Laboratory Information System (not for use in blood banks). Recall #Z-0369-1.

REASON: Software anomaly allows misprint of patient information.

MANUFACTURER: Howmedica Osteonics Corporation, Rutherford, NJ

PRODUCT: Duracon Unicompartmental Knee System: Z-371-1 - Right Medial/Left Lateral Small Tibial Component - several catalog numbers & sizes Z-372-1 - Left Medial/Right Lateral Small Tibial Component - several catalog numbers & sizes Z-373-1 - Right Medial/Left Lateral Medium Tibial Component - several catalog numbers & sizes Z-374-1 - Left Medial/Right Lateral Medium Tibial Component - several catalog numbers & sizes Z-375-1 - Right Medial/Left Lateral Medium/Large Tibial Component - several catalog numbers & sizes Z-376-1 - Left Medial/Right Lateral Medium/Large Tibial Component - several catalog numbers & sizes Z-377-1 - Right Medial/Left Lateral Large Tibial Component several catalog numbers & sizes Z-378-1 - Left Medial/Right Lateral Large Tibial Component - several catalog numbers & sizes Z-379-1 - Right Medial/Left Lateral Extra Large Tibial Component - several catalog numbers & sizes Z-380-1 - Left Medial/Right Lateral Extra Large Tibial Component - several catalog numbers & sizes

REASON: Polyethylene components may be oxidizing.

MANUFACTURER: Sterile Recoveries, Inc., Clearwater, FL.

PRODUCT: Surgical Procedure Packs. Recall #Z-382-1.

REASON: The Sterilization process did not meet one temperature parameter.

CLASS III

MANUFACTURER: C. R. Bardm Inc., Covington, GA

PRODUCT: Fischer Needle Guide: a) Catalog No. GF1200 (12 Gauge Needle Guide). Recall #Z-278-1; b) Catalog No. GF1416 (14/16 Gauge Needle Guide). Recall #Z-279-1

REASON: Contains 12 gauge needle guide but labeled as containing 14;/16 gauge needles.

MANUFACTURER: Medtronic, Inc., Parker, CO.

PRODUCT: Medtronic PT Cartridge, Prothrombin Time Cartridge. Recall #Z-0292-1.

REASON: Inactive thromboplastin causes invalid clotting times.

MANUFACTURER: R & D Systems, Inc., Minneapolis, MN.

PRODUCT: SEDRite Plus Hematology Erythrocyte Sedimentation Rate Control. Recall #Z-0378-1.

REASON: Microbiological contamination in the control caused the red blood cells to lyse.

MANUFACTURER: Lifecore Biomedical, Inc., Chaska, MN.

PRODUCT: Lifecore SuperCAT Self-Tap Implant, NP Mnt 3.3x10 mm (SD), Titanium, Catalog number TC 3310. Recall #Z-0370-1.

REASON: Dental implant mislabeled as to length.

MANUFACTURER: Olympus America, Inc., Melville, NY.

PRODUCT: Integrated Endosurgery EndoALPHA Software Version 3.01. Recall #Z-381-1

REASON: The device software version 3.01 prevented the control unit from retaining the user-programmer coagulation setting.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 7, 2001:

CLASS II

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

PRODUCT: Vitros ECi Immunodiagnostic System. Recall #Z-248-1.

REASON: Sample processing on the system may cause incorrect results.

MANUFACTURER: Angeion Corporation, St. Paul, MN.

PRODUCT: ELA/Angeion Lyra Implantable Cardioverter Defibrillators. Z-251-Model No. 2020; Z-252-Model No. 2021; Z-253-Model No. 2022.

REASON: The device may fail to provide pacing or defibrillation therapy.

MANUFACTURER: Z' Strong International, Inc., El Monte, CA.

PRODUCT: Bioelectrical Discharger: Recall #Z-273-1 - Model No. ZQ1; Recall #Z-274-1 - Model No. ZQ2.

REASON: Inappropriate medical claims.

CLASS III

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

PRODUCT: Vitros 250 Chemistry Systems with Software Versions 6.x (6.0,6.01, 6.02, etc). Recall #Z-249-1.

REASON: Test results may be mis-reported as 0.0 for any analyte including CK-MB, acetaminophen, iron, lithium, and salicylate.

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

PRODUCT: Carbamazepine (CRBM) slides; 5x18 slides. Recall #Z-250-1.

REASON: Carbamazepine (CRBM) slides; 5x18 slides. Recall #Z-250-1.

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

PRODUCT: Vitros ECi Immunodiagnostic Systems: Recall #Z-275-1.- Catalog No. 8633893; Recall #Z-276-1 - Catalog No. 6801059.

REASON: The DRD pump assembly is out of specification, and could result in deliver of excess fluid.

"Correction: The Enforcement Report for November 22, 2000 (Recall Number Z-030-1) incorrectly listed the address of Medical Data Electronics as Arleta, GA. The address is Arleta, California.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 28, 2000:

CLASS II

MANUFACTURER: Cytometrics, Inc., Philadelphia, PA.

PRODUCT: Cytodrape probe cover and drape. Recall #Z-0204-1.

REASON: May not have received adequate dose of radiation to sterilize product.

MANUFACTURER: EScreen Inc., Overland Park, KS.

PRODUCT: EScreen System, which collectively includes the eCUP, the eREADER optical imaging technology, and the eCUP data analysis software, for use in drug abuse testing. Recall #Z-205-1.

REASON: Distributed without 510(k) clearance.

MANUFACTURER: Alexon-Trend, Inc., Ramsey, MN.

PRODUCT: Giardia lamblia Antigen Detection Microwell ELISA. Cat.# GL-35M 96 Test. Recall #Z-0206-1

REASON: Product is not labeled as investigational use, has no 510(k) clearance.

MANUFACTURER: Becton Dickinson & Co., Franklin Lakes, NJ.

PRODUCT: BD Syringe 3 ml with 21G1.5íí PrecisionGlide Needle. Recall #Z-243-1.

REASON: The needle shields may disengage from the needle.

MANUFACTURER: Eclipse Surgical Technologies, Sunnyvale, CA.

PRODUCT: Model Eclipse TMR2000 Holmium Laser System. Recall #Z-245-1.

REASON: Lacked procedures for periodic recalibration of the laser system.

MANUFACTURER: EBI, L.P., Parsippany, NJ.

PRODUCT: SpF Implantable Spinal Fusion Stimulator and OsteoGen Surgically Implanted Bone Growth Stimulator a) Z-254-1 - Model SpF XL 4/CW; b) Z-255-1 - Model SpF 2T/C; c) Z-256-1 - Model SpF 2TT/CW; d) Z-257-1 - Model SpF 2T/D; e) Z-258-1 - Model SpF 2T/DW; f) Z-259-1 - Model SpF 2T/F; g) Z-260-1 - Model SpF 2T/FW; h) Z-261-1 - Model SpF 2T/GW; i) Z-262-1 - Model SpF 2T/DLW; j) Z-263-1 - Model SpF 2T/GLW; k) Z-264-1 - Model SpF 4T/C; l) Z-265-1 - Model SpF 2/C; m) Z-266-1 - Model OSTEOGEN; n) Z-267-1 - Model OSTEOGEN-M; o) Z-268-1 - Model OSTEOGEN/F; p) Z-269-1 - Model SpF XL II, 2/DW; q) Z-270-1 - Model SpF XL, 2/DM; r) Z-271-1 - Model SpF-XL IIb, 2/DW.

REASON: The integrity of the sterile packaging may be compromised.

CLASS III

MANUFACTURER: Hardy Diagnostics, Santa Maria, CA.

PRODUCT: Screw Cap Centrifuge Tubes. Recall #Z-244-1.

REASON: Tubes break during centrifugation at speed within the limit.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 21, 2001:

CLASS II

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

PRODUCT: Vitros Immunodiagnostic Products AFP Reagent; Z-208-1 - Catalog No. 680 0784 AFP Reagent; Z-209-1 - Catalog No. 680 0038 CA 125 II Reagent Pack; Z-210-1 - Catalog No. 680 0039 CA 15-3; Z-211-1 - Catalog No. 189 6836 CK-MB Reagent Pack; Z-212-1 - Catalog No. 107 4053 Cortisol Reagent Pack; Z-213-1 - Catalog No. 835 6636 Ferritin Reagent Pack; Z-214-1 - Catalog No. 138 7000 Free T4 Reagent Pack; Z-215-1 - Catalog No. 193 1922 FSH Reagent Pack; Z-216-1 - Catalog No. 135 0198 LH Reagent Pack; Z-217-1 - Catalog No. 680 0030 NTx Reagent Pack; Z-218-1 - Catalog No. 184 9743 Prolactin Reagent Pack; Z-219-1 - Catalog No. 680 0269 Total B-hCG Reagent Pack.

REASON: Defective microtiter wells in the various reagent packs. Some wells were not coated with the binding agent (Streptavidin).

MANUFACTURER: Cryolife, Inc., Kennesaw, GA.

PRODUCT: Cryovalve Allograft; a) Z-236-1 - Model No. AV00, Serial No. 3874532; b) Z-237-1 - Model No. PV10, Serial No. 3874524.

REASON: 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: Cryovalve Allograft; a) Z-238-1 - Model No. AV00, Serial No. 3958221; b) Z-239-1 - Model No. PV00, Serial No. 3958248

REASON: 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: Cryovalve Allograft, Model Model No. PV05, Serial No. 3945944. Recall #Z-240-1.

REASON: 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: Cryovalve Allograft, Model No. AV05, Serial No. 3945936. Recall #Z-241-1.

REASON: 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: Cryovalve Allograft, Model No. PV00, Serial No. 3946096. Recall #Z-242-1.

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

CLASS III

MANUFACTURER: Den-Mat Corp., Santa Maria, CA.

PRODUCT: Florestore Flowable Composite with Fluoride Light Cure. Recall #Z-224-1.

REASON: Lot failed the bond strength test prior to the expiration date of the product.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 14, 2001:

CLASS II

MANUFACTURER: Neurosoft, Inc., El Paso, TX.

PRODUCT: Electromyography (EMG) Monitor, Nerve Locator/Stimulator, Model No. 302L A3000, Recall #Z-149-1; Model No. 302P A3000, Recall #Z-150-1.

REASON: The device violates the safety standard 601-1 identified in the premarket approval.

MANUFACTURER: Medtronic Xomed, Inc., Jacksonville, FL.

PRODUCT: Electromyography (EMG) Monitor, Nerve Locator/Stimulator Patient Interface for Model Nos. NIM2 and NIM2XL. Recall #Z-151-1

REASON: The device may fail to indicate the existence of a nerve and result in permanent nerve damage from surgery, which would have a serious impact on the patient. The device defect presents a moderate risk of severe adverse health consequences.

MANUFACTURER: Aeros Instruments, Inc., Gurnee, IL.

PRODUCT: Ohmeda Medical Two Mode Continuous Vacuum Regulators: Recall #Z-195-1, Model 67xx1225-9xx - 2 Mode Standard Clockwise Domestic; Recall #Z-196-1, Model 67xx1227-9xx - 2 Mode Low Clockwise Domestic; Recall #Z-197-1 Model 67xx-1330-9xx - 2 Mode High Clockwise Domestic; Recall #Z-198-1, Model 67xx-1230-9xx - 2 Mode High Counter-clockwise International; Recall #Z-199-1, Model 67xx-1233-9xx - 2 Mode Low Counter-clockwise International.

REASON: Continuous vacuum regulator is mislabeled.

MANUFACTURER: Theragenics Corporation, Norcross, GA.

PRODUCT: TheraSeed Palladium 103 (Pd-103) Seeds. Recall #Z-200-1

REASON: Substandard spacers may lead to difficulty during preparation and delivery of radiation therapy to the patient.

MANUFACTURER: DeRoyal Industries, Inc., Powell, TN

PRODUCT: Z-225-1 - Neoprene Knee Support with Ova Pad; Z-226-1 - Perforated Knee Splint; Z-227-1 - 3"Elastic Ankle Wrap; Z-228-1 - Universal Pelvic Traction Belt; Z-229-1 - Universal Abdominal Binder, 9"; Z-230-1 - Universal Rib Belt; Z-231-1 - 6" Rib Belt; Z-232-1 - Clavicle Strap II; Z-233-1 - Clavicle Strap - Self Adjusting; Z-234-1 - Tennis Elbow Strap; Z-235-1 - Universal Ambidextrous Wristlet;

REASON: Undeclared natural rubber in the products.

CLASS III

MANUFACTURER: Aaron Medical Industries, St. Petersburg, FL.

PRODUCT: High Temperature Power Handle. Catalog No. HIT1. Recall #Z-220-1

REASON: The descriptive labeling imprinted on the body of the device identifies it incorrectly as a "low temperature Power Handle." The labeling of the device on the outer box correctly identifies the device as a "High Temperature Power Handle."

MANUFACTURER: Sysmex Reagents America, Inc., Los Alamitos, CA

PRODUCT: Cellpack-GL, Catalog No. PGL-300A. RECALL #Z-221-1.

REASON: Reagent design deficiency provides too many false positive results.

MANUFACTURER: Den-Mat Corp., Santa Maria, CA.

PRODUCT: Tenure Dental Adhesive (DML-32). Recall #Z-222-1.

REASON: Dental adhesive lot failed the bond strength test prior to the expiration date of the product.

MANUFACTURER: Den-Mat Corp., Santa Maria, CA

PRODUCT: V