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FDA Recalls

January 8, 2003 - June 25, 2003

Attention all mdi Clients:

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 25, 2003:

CLASS II

MANUFACTURER: Stryker Medical, Kalamazoo, MI, by on site visits, beginning on May 1, 2002. Firm initiated recall is complete.

PRODUCT: Stryker Secure II hospital bed; model 3002.
Recall # Z-0868-03.

REASON: A wire may break at the crimp and present a potential electric shock hazard.

MANUFACTURER: Implant Innovations, Inc., Palm Beach Gardens, FL, by fax and e-mail on May 9, 2003, and by letters on May 12, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Product is a drill used in dental surgery labeled in part:
OFDR8 OsseoFix Drill 8mm Length 3i. Non Sterile Contents must be sterilized prior to use. RX only. Recall # Z-0923-03;
b) Products are surgical drills packaged separately or included in a surgical kit so two products will be listed. The second product is the 8mm drill included in a kit and It is labeled as OFKIT2 OsseoFix System Complete (Kit)3i. Non Sterile Contents must be sterilized prior to use. RX only. Recall # Z0924-03.

REASON: Some 8mm OsseoFix drills included in the kit may be incorrectly laser marked as 4mm OsseoFix drills.

MANUFACTURER: Venetec Intl, Inc., San Diego, CA, by telephone on or about May 12, 2003, and by letter on or about May 14, 2003. Firm initiated recall is ongoing.

PRODUCT: StatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6" LL. Model Number 2N9205K. Recall # Z-0925-03.

REASON: Set tubing disconnected from the male luer lock during use on patients. Misassembled.

MANUFACTURER: Misys Healthcare Systems, Tucson, AZ, by Product Safety Notice issued on May 13, 2003. Firm initiated recall is ongoing.

PRODUCT: Misys Laboratory System. Recall # Z-0926-03.

REASON: Two clients reported Quality Assurance dates could not be entered after 5/19/03.

MANUFACTURER: System O2, Inc., Roswell, GA, by telephone and letter on May 1, 2002. Firm initiated recall is ongoing

PRODUCT: a) System O2, Portable Humidified Oxygen Delivery System
Over 99% pure humidified oxygen. Box Includes Delivery system with Clear Base. 4 White Powder refills. 4 Black Powder refills. Water bottle. Nasal cannula. Medium concentration mask. Carry Case. Unit is intended to provide oxygen for emergency use. Recall # Z-0929-03;
b) Rejuv O2 Home Oxygen Spa - 98% + Pure, Non-pressurized Oxygen for Breathing. Reusable system. Box Includes Reusable reaction chamber with dome assembly. 4 White Powder refills. 4 Black Powder refills. Reusable water bottle. Nasal cannula. Medium concentration mask. Canvas
Carry Bag. This system is designed expressly for cosmetic and nutraceutical applications. Manufactured by Oxygen Delivery Systems, LLC, 490 Mathis Airport Road, Suwanee, GA. Recall # Z-0930-03.

REASON: System O2, Inc., Roswell, GA, by telephone and letter on May 1, 2002. Firm initiated recall is ongoing.

MANUFACTURER: Rehabilicare, New Brighton, MN, by letters dated May 21, 2003. Firm initiated recall is ongoing,

PRODUCT: Line Powered RePaks, Model Number 1785S.
Recall # Z-0931-03.

REASON: If there is a short, excessive heat could be generated in the transformer due to the use of the wrong fuse.

MANUFACTURER: Fujifilm Medical System USA, Inc., Stamford, CT, by letter during the week of May 12, 2003. Firm initiated recall is ongoing.

PRODUCT: Synapse. Recall # Z-0932-03.

REASON: Synapse Version 2.2.1 and 2.3.1.

MANUFACTURER: Braun, B Medical, Inc., Allentown, PA, by letters dated April 14, 2003. Firm initiated recall is ongoing.

PRODUCT: Gravity and Infusion Pump Intravenous (IV) Sets using the Y-site Ultrasite Valve including: Horizon Pump IV Sets; Vista Pump IV Sets; Primary IV Sets; Blood Sets; Burette Sets; Filtered Administration Sets; Extension Sets; Anesthesia Sets; Rate Flow Extension Sets; and Rate Flow IV Administration Sets. Recall # Z-0933-03.

REASON: Possible leakage.

MANUFACTURER: Abbott Laboratories HPD/ADD, Abbott Park, IL, by letter dated May 12, 2003. Firm initiated recall is ongoing.

PRODUCT: T-U-R-Y-Set Non-Vented Set for Transurethral Resection Procedures For Use with Flexible Irrigation Container System, 84 inch (213 cm) Nominal Length, No. 15252-02. Recall # Z-0934-03.

REASON: The irrigation set was mislabeled with the wrong delivery rate of 8 drops/ml when it actually has a delivery rate of ll drops/mL

MANUFACTURER: Sanarus Medical Inc., Pleasanton, CA, by letters on May 13, 2003. Firm initiated recall is ongoing.

PRODUCT: Sanarus brand Centrica( Rotational Core Biopsy medical device, Model/Product Code: CD-0500 (single Device); CD-1000 (5 pack). Recall # Z-0935-03.

REASON: Recent 'pre-tests' show that Argon gas has the potential to escape from the device during a biopsy procedure.

MANUFACTURER: Costa Rica, Abbott Laboratories, North Chicago, IL. Firm initiated recall is ongoing. Recalling Firm: Abbott Laboratories HPD/ADD, Abbott Park, IL, by letter dated May 12, 2003.

PRODUCT: Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Secure Lock, No. 19020.
Recall # Z-0936-03.

REASON: The I.V. administration set incorrectly lists the priming volume from the cassette inlet to distal male adapter as 13.5 mL instead of 11.3 mL.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on May 23, 2003. Firm initiated recall is ongoing.

PRODUCT: a) CryoValve Pulmonary Valve & Conduit.
Recall # Z-0938-03; b) CryoValve Pulmonary Valve & Conduit.
Recall # Z0939-03.

REASON: Microorganisms detected in associated allografts.

MANUFACTURER: Medtronic Physio Control Corp., Redmond, WA, by letter on May 23, 2003. Firm initiated recall is ongoing.

PRODUCT: LIFEPAK CR Plus defibrillator. Recall # Z-0940-03.

REASON: Defibrillation therapy may be delayed or not delivered for persons needing defibrillation therapy

MANUFACTURER: Cordis Corp., Miami Lakes, FL, by on site visit and letter dated May 5, 2003 and letter on May 30, 2003. Firm initiated recall is ongoing.

PRODUCT: Cordis Brite Tip Catheter Sheath Introducer (4, 7, 8, 8, 10 and 11 French sizes only). Recall # Z-0941-03.

REASON: Reports of broken or separated tips of the catheter sheath introducers.

MANUFACTURER: Cardinal Health, McGaw Park, IL, by telephone and letter on June 2, 2003. Firm initiated recall is ongoing.

PRODUCT: Temno Chiba Fine Needle Aspiration, Soft Tissue Biopsy Needle, 18 GA x 15 cm., product CH11815, Allegiance, Made in Dominican Republic. Recall # Z-0942-03.

REASON: The product was shipped prior to being sterilized.

CLASS III

MANUFACTURER: Cytyc Corp., Boxborough, MA, by letter on January 29, 2003. Firm initiated recall is ongoing.

PRODUCT: ThinPrep Microscope Slides for Non-Gynecologic Use Size 1" x 3" Reorder Number: 70214-001. Recall # Z-0922-03.

REASON: Microscope Slides contaminated with fungal material.

MANUFACTURER: Ventana Medical Systems, Inc., Tucson, AZ, by telephone and letter on May 6 and 7, 2003. Firm initiated recall is ongoing.

PRODUCT: IVIEW DAB Detection Kit. Catalog Number 760-091.
Recall # Z-0928-03.

REASON: Kit does not stain tissues properly.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 11, 2003:

CLASS II

MANUFACTURER: Guidant Corp-Cpi Division, St Paul, MN, by letter dated May 6, 2003. Firm initiated field correction is ongoing. A May 6, 2003 letter to physicians gave recommendations for avoiding the problem and indicated that software to prevent the problem would be introduced.

PRODUCT: a) Pulsar Multiprogrammable Pacemaker, DDD Model 970.
Recall # Z-0875-03;
b) Pulsar Multiprogrammable Pacemaker, DDD Model 972.
Recall # Z-0876-03;
c) Pulsar Multiprogrammable Pacemaker, DDD Model 976.
Recall # Z-0877-03;
d) Pulsar Multiprogrammable Pacemaker, DDDR Model 1270. Recall # Z-0878-03;
e) Pulsar Multiprogrammable Pacemaker, DDDDR Model 1272. Recall # Z-0879-03;
f) Pulsar Max Multiprogrammable Pacemaker.
Recall # Z-0880-03;
g) Pulsar Max II Multiprogrammable Pacemaker, DDDR
Model 1284. Recall # Z-0881-03;
h) Pulsar Max II Multiprogrammable Pacemaker, DDDR
Model 1286. Recall # Z-0882-03;
i) Discovery Multiprogrammable Pacemaker, DDDR
Model 1273. Recall # Z-0883-03;
j) Discovery Multiprogrammable Pacemaker, DDDR
Model 1274. Recall # Z-0884-03;
k) Discovery II Multiprogrammable Pacemaker, DDD
Model 981. Recall # Z-0885-03;
l) Discovery II Multiprogrammable Pacemaker, DDDR
Model 1280. Recall # Z-0886-03;
m) Discovery II Multiprogrammable Pacemaker, DDDR
Model 1283. Recall # Z-0887-03;
n) Meridian Multiprogrammable Pacemaker, DDDR
Model 1275. Recall # Z-0888-03;
o) Meridian Multiprogrammable Pacemaker, DDDR
Model 1286. Recall # Z-0889-03;
p) Insignia Plus Multiprogrammable Pacemaker, DDD
Model 985. Recall # Z-0890-03;
q) Insignia Plus Multiprogrammable Pacemaker, DDD
Model 986. Recall # Z-0891-03;
r) Insignia Plus Multiprogrammable Pacemaker, DDDR
Model 1294. Recall # Z-0892-03;
s) Insignia Plus Multiprogrammable Pacemaker, DDDR
Model 1295. Recall # Z-0893-03;
t) Insignia Extra Multiprogrammable Pacemaker, DDDR
Model 1296. Recall # Z-0894-03;
u) Insignia Extra Multiprogrammable Pacemaker, DDDR
Model 1297. Recall # Z-0895-03;
v) Insignia Extra Multiprogrammable Pacemaker, DDDR
Model 1298. Recall # Z-0896-03;
w) Contak TR Multiprogrammable Pacemaker, DDDR
Model 1241. Recall # Z-0897-03;

REASON: In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.

MANUFACTURER: PerkinElmer Life Sciences Inc., Norton, OH, by letter on January 8, 2003. Firm initiated recall is ongoing.

PRODUCT: Neonatal GALT Test Kit, 960 tests per box, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-1100. Recall # Z-0898-03.

REASON: The Control Cards are incorrectly labeled such that the normal 'N' and abnormal 'A' values are reversed.

MANUFACTURER: Diagnostica Stago, Inc., Parsippany, NY, by letters on March 5, 2003. Firm initiated recall is ongoing.

PRODUCT: STA-Compact Hemostasis System with Cap piercing capability. Recall # Z-0899-03.

REASON: With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury.

MANUFACTURER: Misys Healthcare Systems, Tucson, AZ, by fax on June 26, 2002. Firm initiated recall is complete.

PRODUCT: Misys Laboratory versions 5.2, 5.23 and 5.3 using Cache Database with linked CPUs. Recall # Z-0900-03.

REASON: Customer reports that the processor failed to make patient report updates with two processors running in the LABB area.

MANUFACTURER: Stryker Howmedica Osteonics, Mahwah, NJ, by letters and acknowledgement forms on April 29, 2003. Firm initiated recall is ongoing.

PRODUCT: Trident Insert Impactor. Recall # Z-0901-03.

REASON: The ball-retaining sleeve on the Trident Insert Impactor can possibly disassemble.

MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letters dated April 24, 2003. Firm initiated recall is ongoing

PRODUCT: a) Hill-Rom brand Affinity three birthing bed. Recall # Z-0902-03; b) Hill-Rom brand Century+ series bed. Recall # Z-0903-03.

REASON: Possible electrical shock hazard, as the power cord-grounding pin may break off or become detached.

MANUFACTURER: Smith and Nephew Wound Management (La Jolla), San Diego, CA, by telephone on or about May 2, 2003, and by letter on May 7, 2003. Firm initiated recall is ongoing.

PRODUCT: Dermagraft, Human Fibroblast-Derived Dermal Substitute, 2 in. by 3 in. Recall # Z-0904-03.

REASON: Did not meet finished device specifications for DNA criteria.

MANUFACTURER: Electric Mobility Corp., Sewell, NJ, by letter on February 7, 2003, and posted on the firms website on February 14, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Rascal Powered Scooters. Recall # Z-0909-03; b) Chauffeur Powered Scooters. Recall # Z-0910-03.

REASON: The plastic tires may shatter if the tire is over-inflated and could cause serious injury.

MANUFACTURER: Merit Medical Systems, Inc., South Jordan, UT, by letter on May 16, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Inject 10 Coronary Control Syringe (CCS), 10ml. Recall # Z-0912-03; b) Custom Kit. Recall # Z-0913-03.

REASON: Cracks in the syringe barrels could allow for air aspiration into the syringe barrel.

MANUFACTURER: Datascope Corp., Fairfield, NJ, by letters on March 28, 2003, and March 31, 2003. Firm initiated recall is ongoing.

PRODUCT: 10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits, which contain a Datascope 11.5 Fr. 11" introducer sheaths. These introducer sheaths include a hemostasis valve and a hub, which work in conjunction with an introducer dilator. The introducer sheath, after it is dilated by the introducer dilator, is intended to assist the percutaneous insertion of the 10.5 Fr. Intra-Aortic Balloon catheter into the vasculature. Recall # Z-0916-03.

REASON: 10.5 Fr. Percor STAT-DL Intra-Aortic Balloon Insertion Kit, Introducer Sheath failed water leak test during final inspection.

MANUFACTURER: Roche Molecular Systems, Inc., Belleville, NJ, by telephone, and letter on March 6, 2003. Firm initiated recall is ongoing.

PRODUCT: COBAS TaqMan analyzer, Series 96; catalog number 8080216.
Recall # Z-0917-03.

REASON: A false positive result may be reported.

MANUFACTURER: Surgical Specialties Puerto Rico, Inc., Rincon, PR, by fax on May 7, 2003. Firm initiated recall is ongoing.

PRODUCT: 2.75 mm Slit Knife, Angled, Bevel Up. Labeled "Stylus 2.75 mm Slit Knife Angled, Bevel, Up One Unit STERILE R Disposable Surgical Specialties Corporation Reading, PA 19606". Recall # Z-0918-03.

REASON: Incorrect handle was used in the manufacture of product 52-2761.

MANUFACTURER: Misys Healthcare Systems, Tucson, AZ, by facsimile on April 1, 2003. Firm initiated recall is ongoing.

PRODUCT: Misys Commercial Laboratory version 2.x thru 3.4.1.
Recall # Z-0920-03.

REASON: Urgent care STAT reports are not printing in a timely fashion.

CLASS III

MANUFACTURER: Abbott Laboratories HPD/ADD, Abbott Park, IL, by letter dated May 12, 2003. Firm initiated recall is ongoing.

PRODUCT: a) LifeShield Latex-Free 150 mL Burette Set, Nonvented,
117 Inch with Prepierced Injection Site, Backcheck Valve, 2 CLAVE Ports and Removable 4-Way High Flow Stopcock Microdrip Soluset. Recall # Z-0914-3; b) LifeShield Latex-Free Microdrip Soluset100 mL BurettePlumset Convertible Pin, 121-1/2 Inch with CLAVE and OPTION-LOK Dual Channel Secondary Port.
Recall # Z-0915-3.

REASON: IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced.

MANUFACTURER: Ortho-Clinical Diagnostics, Rochester, NY, via letter dated March 26, 2003. Firm initiated recall is ongoing.

PRODUCT: Vitros TP Slides, for in vitro diagnostic use to quantitatively measure total protein concentration in serum and plasma. Packed 5 x 50 slides per box. Box identified with CAT 839 2292. Firm on label: Ortho-Clinical Diagnostics, a Johnson & Johnson Company.
Recall # Z-0919-03.

REASON: Slides may exhibit random, elevated imprecision of results.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 4, 2003:

CLASS I

MANUFACTURER: Sims Portex, Inc., Keene, NH, by telephone on November 15, 2002, and November 18, 2002, and by letter dated November 19, 2002. Firm initiated recall is ongoing.

PRODUCT: a) Portex 1st Response Adult Manual Resuscitators REF 8506P, expandable tube reservoir, peep valve.  Recall # Z-0808-03; b) Portex 1st Response Adult Manual Resuscitators REF 8500P, Bag Reservoir, peep valve. Recall # Z-0809-03; c) Portex 1st Response Adult Manual Resuscitators REF 8503P, 40" tube reservoir. Recall # Z-0810-03.

REASON: Peep valve set at the highest level and could result in patient injury.

CLASS II

MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letter on October 2, 2001. Firm initiated recall is ongoing.

PRODUCT: Aeroset Analyzer, item 9D05-01. Recall # Z-0843-03.

REASON: Extensive use of cuvettes causes inaccurate results. Preventative maintenance did not specify replacement schedule.

MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by Technical Service Bulletins dated August 15, 2002, and by letter on August 20, 2002. Firm initiated recall is ongoing.

PRODUCT: Aeroset Analyzer. Recall # Z-0844-03.

REASON: Design of high concentration waste line causes formation of a precipitate in the waste line-causing overflow of waste.

MANUFACTURER: Instrumentation Laboratory, Co., Lexington, MA, by telephone on March 7, 2003. Firm initiated recall is complete.

PRODUCT: a) GEM Premier 3000 Pak pH, pC02, p02, Hct Sensor and Reagent Cartridge Part No. 24330004 (300 Sample Size) For In-Vitro Diagnostic Use. Recall # Z-0845-03;
b) GEM Premier 3000 Pak Sensor pH, pC02, p02, Hct and Reagent Cartridge Part No. 24345004 (450 Sample Size) For In-Vitro Diagnostic Use. Recall # Z-0846-03;

REASON: Incorrect bar code applied to cartridges could result in inaccurate p02 value.

MANUFACTURER: Gimelli No: 7625.006; Emerson #: HK70W;
Gimelli No: 7625.005; Emerson #: NC70.

PRODUCT: a) "Hello Kitty", Plaque Removing Powered Toothbrush, Model HK70W. Recall # Z-0847-03;
b) "NASCAR", Electric Powered Toothbrush, Model NC70.
Recall # Z-0848-03.

REASON: Powered toothbrushes are exploding due to gas build-up.

MANUFACTURER: Vygon Corporation, East Rutherford, NJ, by letters, via e-mails and telephone on April 9, 2003. Firm initiated recall is complete.

PRODUCT: a) Nutriline with Peelable Sheath 2 Fr. Peripherally inserted Catheter (PIC). Included with this catheter is a 2 Fr. Insertion sheath. Product is packaged in tyvek sealed plastic tray. Recall # Z-0849-03.  b) Neonatal Catheter & Insertion Tray is a catheter kit that is comprised of the Nutriline Peelable Sheath 2 Fr. Catheter and a separately packaged catheter tray. Recall # Z-0850-03.

REASON: Nutriline with Peelable Sheath 2 Fr. And Neonatal Catheter & Insertion Tray were packaged with a 3 Fr. Insertion sheath.

MANUFACTURER: Medegen Medical Products, LLC, Northglenn, CO, by letter on April 30, 2003. Firm initiated recall is ongoing.

PRODUCT: Gent-L-Kare Sterile Mid-Stream Urine Collector.
Recall # Z-0859-03. Gent-L-Kare Sterile 3OZ. Ear/Ulcer Bulb Syringe Single Use. Recall # Z-0860-03.

REASON: Finished products were not sterilized.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on May 5, 2003. FDA initiated recall is ongoing.

PRODUCT: Cryo Valve Allograft, Pulmonary Heart valve & Conduit. Recall # Z-0861-03.

REASON: Microorganisms were detected in associated allografts after initial release of donor.

MANUFACTURER: Guidant Corporation ACS, Temecula, CA, by letter dated May 6, 2003. Firm initiated recall is ongoing.

PRODUCT: Multi-Link Pixel Coronary Stent System Size: 2.0 x 13 mm OTW Part Number: 1007830-13. Recall # Z-0862-03.

REASON: Sterility compromised.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on April 30, 3003. FDA initiated recall is ongoing.

PRODUCT: Cryo Valve Allograft, Heart valve. Recall # Z-0866-03.

REASON: Microorganisms were detected in associated allografts.

MANUFACTURER: Misys Healthcare Systems, Tucson, AZ, by fax on April 14, 2003. Firm initiated recall is ongoing.

PRODUCT: Misys Laboratory System. Recall # Z-0867-03.

REASON: Incorrect results could be filed.

MANUFACTURER: Tecan U.S. Inc., Durham, NC, by letter, and via e-mail on/about March 13, 2003. Firm initiated recall is ongoing.

PRODUCT: Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or lower.
Recall # Z-0869-03.

REASON: Firmware defect. Under certain conditions a strip rack is no longer in the initial position after a motor overload of the barcode scanner PosID2.

MANUFACTURER: Roche Diagnostics, Corp., Indianapolis, IN, by letter on April 21, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Elecsys Troponin T; catalog number 2017644.
Recall # Z-0870-03; b) Elecsys Troponin T STAT; catalog number 2017423.
Recall # Z-0871-03.

REASON: Hemoglobin interference limitation revised downward; hemolyzed samples may result in false negative results.

MANUFACTURER: Dade Behring, Inc., Newark, DE, by telephone on April 24, 2003, and by letter dated April 25, 2003. Firm initiated recall is ongoing.

PRODUCT: Dimension TSPA (Total Prostate Specific Antigen) Flex Reagent Cartridge. The product is shipped 4 cartridges per carton. Recall # Z-0873-03.

REASON: Test results may be inaccurate by 0.2 to 0.5 ng/mL.

CLASS III

MANUFACTURER: Philips Medical Systems (Cleveland), Inc., Highlands Heights, OH, by a "Product Safety Notification", dated April 2, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Philips MX8000 IDT CT Scanner, utilizing V2.1 software.
Recall # Z-0835-03; b) Philips MX8000 Dual v, Exp CT Scanner, utilizing V2.0 software. Recall # Z-0836-03;

REASON: Patient images may be incorrectly stored in the archive directory of a different patient.

MANUFACTURER: Ev3, Inc., St. Paul, MN, by letter dated April 15, 2003. Firm initiated recall is ongoing.

PRODUCT: Protege Self-Expanding Nitinol Stent 6 mm x 40 mm, model number SER6-40-135. Recall # Z-0863-03.

REASON: The label has an expiration date of August 2005, but the correct expiration date is February 2005.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Mountain View, CA, by letters on March 24, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Acuson Diagnostic Ultrasound System Transducer; Model Number(s): L582 Linear Array Transducer for use on the 128XP Ultrasound System; Catalog Numbers: 23656 (New), 45441 (Refurb). Recall # Z-0864-03; b) Acuson Diagnostic Ultrasound System Transducer; Model Number(s): L582 Linear Array Transducer for use on the 128XP Ultrasound System; Catalog Numbers: 23656 (New), 45441 (Refurb). Recall # Z-0865-03;

REASON: The product has a software condition in that the surface temperature of the transducer may reach above the thermal limit.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter dated May 8, 2003. Firm initiated recall is ongoing.

PRODUCT: ACCESS Estradiol Reagent Test System. Recall # Z-0872-03.

REASON: Short volume, resulting possibility of falsely elevated results.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 28, 2003:

CLASS II

MANUFACTURER: Misys Healthcare Systems, Tucson, AZ, by fax on March 26, 2003. Firm initiated recall is ongoing.

PRODUCT: Misys Laboratory System. Recall # Z-0791-03.

REASON: With SMART enabled, for an accession number with multiple tests, credits and additions, the system may delete and reorder resulted tests.

MANUFACTURER: Abbott Laboratories, Morgan Hill, CA, by letters on April 1, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) Gemstar_ 7 Therapy I.V. Infusion Pump, List#: 13000-04; 2.9 Software Version. Recall # Z-0792-03;
b) Gemstar_ 6 Therapy I.V. Infusion Pump, List#: 13100-04; 2.9 Software Version. Recall # Z-0793-03;
c) Gemstar_ Therapy Pain Management I.V. Infusion Pump, List#: 13150-04; 2.9 Software Version. Recall # Z-0794-03;

REASON: Products contain software deficiencies, which could allow over infusion thereby administering excess medication.

MANUFACTURER: Greiner VACUETTE North America, Monroe, NC, by letter on/about March 6, 2003. Firm initiated recall is ongoing.

PRODUCT: Vacuette Safety Blood Collection Set with Luer Adapter. Recall # Z-0797-03.

REASON: The needle portion of the Safety Blood Collection Sets, may become separated from the body of the Luer Adapter.

MANUFACTURER: Deltec, Inc., St Paul, MN, by letters on March 14, 2003. Firm initiated recall is ongoing.

PRODUCT: Deltec Cozmo Insulin Pump, Model 1700, Product Catalog Numbers 21-1711-01, 21-1712-01 and 21-1713-01. The 3 versions vary only in the color of the exterior. Recall # Z-0798-03.

REASON: A software error can result in the delivery of a larger bolus of insulin than anticipated when the pump is programmed in a particular manner.

MANUFACTURER: Abbott Laboratories HPD/ADD, Abbott Park, IL, by letter on April 7, 2003. Firm initiated recall is ongoing.

PRODUCT: Anti-HBs Reagent Kit, 100 tests. Recall # Z-0801-03.

REASON: Particulate matter in the microparticle component.

MANUFACTURER: Hu-Friedy Mfg., Co., Inc, Chicago, IL, by letters dated April 10, 2003. Firm initiated recall is ongoing.

PRODUCT: Non-Sterile Suture Needles, Reverse Cutting, 1/2 Circle, Stainless Steel; 12 suture needles per glass vial; part code: SN4. Recall # Z-0802-03.

REASON: The suture needles were mislabeled with the wrong size.

MANUFACTURER: Misys Healthcare Systems, Tucson, AZ, by fax on March 27, 2003. Firm initiated recall is ongoing.

PRODUCT: Misys Laboratory System. Recall # Z-0804-03.

REASON: Software anomaly may result in incorrect values and interpretations.

MANUFACTURER: Action Products Incorporated, Hagerstown, MD, by letter on February 25, 2003. Firm initiated recall is ongoing.

PRODUCT: Twister (tm) Cube Back-Cane Short, a wheelchair back seat support strap, part number WPHS. Recall # Z-0812-03.

REASON: Stitching in wheelchair seat back is not effective and may not support user.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by letters dated March 12, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) CoaguChek Pro DM meter; catalog # 1894048, and 1893211. Recall # Z-0813-03;
b) CoaguChek Plus meter; catalog # 4757298, and 12816001. Recall # Z-0814-03.

REASON: High frequency signals from other medical or communications equipment will result in a

MANUFACTURER: Ossur North America, Inc., Aliso Viejo, CA, by telephone and letters on March 17, 2003. Firm initiated recall is ongoing.

PRODUCT: Mauch XG, Caron Knee Frame. Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750.

Recall # Z-0815-03.

REASON: Knee frame defect led to breakage and injury. Knee bolt end came loose.

MANUFACTURER: Aspen Surgical Products, Inc., Bryon Center, MI, by telephone on April 30, 2003. Firm initiated recall is ongoing.

PRODUCT: Dr. Fog Endoscopic Fog Prevention Kit; model DF-3120. Each box contains 40 packages. Each package contains one Dr. Fog treated sponge. Recall # Z-0828-03.

REASON: Sterility compromised - incomplete sterile package seal.

MANUFACTURER: Steris Corp., Mentor, OH, by telephone and letter on April 23, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) C1141 Flexible Endoscope Processing Container, Designed to fit the Steris System I Processor. The unit may be sold individually or with the processing tray assembly (C1140). Recall # Z-0829-03.
b) C1140 Flexible Endoscope Processing Container and Tray assembly. Recall # Z-0830-03.

REASON: The container flow port is inverted, which restricts the flow of sterilant to the endoscope and affects the sterilization process.

MANUFACTURER: Boston Scientific Corporation, Natick, MA, by letter on April 29, 2003. Firm initiated recall is ongoing.

PRODUCT: MaxForce TTS High Performance Esophageal Balloon Dilatation Catheter 8mm/24 Fr. Recall # Z-0831-03.

REASON: Catheter is mislabeled as 8 mm/24 Fr instead of a 6 mm/18 Fr.

MANUFACTURER: Baxter Healthcare Corp., Round Lake, IL, by letters on March 20, 2003. Firm initiated recall is ongoing.

PRODUCT: Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora. Recall # Z-0833-03.

REASON: The dialysis treatment may be run without the bicarbonate due to an undetected bicarbonate pump stall following a sodium change.

MANUFACTURER: Permobile, Inc., Lebanon, TN, by letter, on March 7, 2003. Firm initiated recall is ongoing.

PRODUCT: Permobil Chairman 2K powered wheelchair. Recall # Z-0834-03.

REASON: One of the wheelchair motors needed a grounding strap to ensure that the motors are at the same voltage potential as the chassis of the wheelchair.

MANUFACTURER: Specialized Health Products, Inc, Bountiful, UT, by letter on April 14, 2003. Firm initiated recall is ongoing.

PRODUCT: SHPI LiftLoc Safety Infusion Sets. Recall # Z-0837-03.

REASON: Pouch seals on Safety Infusion Sets may be defective, possibly compromising sterility.

MANUFACTURER: 3m Health Care, Saint Paul, MN, by letter dated April 7, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) 3M Ioban 2 Antimicrobial Incise Drapes. Recall # Z-0838-03;
b) 3M Ioban 2 Antimicrobial Incise Drapes. Recall # Z-0839-03.

REASON: The product does not meet its specifications for iodine content, and has the possibility of causing moderate short-term skin irritation if used.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Malvern, PA. Update instructions on the new software were sent on August 2, 2002 by mail. Firm initiated recall is complete.

PRODUCT:
a) Leonardo MM-WS systems. System, Image Processing. Recall # Z-0841-03;
b) Smatom Sensation 16, Computed Tomography System, Diagnostic Imaging. Recall # Z-0842-03.

REASON: Perfusion CT is displaying a higher gray and color values than normal. A software problem.

CLASS III

MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letter on January 27, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) ARCHITECT I System External Waste Pump. Recall Z-0795-03;
b) AEROSET System External Waste Pump. Recall # Z-0796-03.

REASON: External waste pump has metal edge around perimeter sharp enough to cause scratch or cut.

MANUFACTURER: Medtronic, Inc, Danvers, MA, by e-mail on March 17, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) Z2 Guiding Catheter 6 F JL3.5 SH Item No.: Z26JL35SH. Recall # Z-0799-03;
b) Z2 Guiding Catheter 6 F JR3.5 SH Item No.: Z26JR35SH. Recall # Z-0800-03.

REASON: The PTCA catheter is mislabeled: the curve style (Judkin Left vs. Judkin Right) of the catheter may not correctly match the box label.

MANUFACTURER: Abbott Laboratories Diagnostic Div., South Pasadena, CA, by letters on March 28, 2003. Firm initiated recall is ongoing.

PRODUCT: Aeroset Direct HDL Reagent, LN 7D67-01. Recall # Z-0803-03.

REASON: Degradation prior to expiry date.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on March 28, 2003. Firm initiated recall is ongoing.

PRODUCT: COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use. Recall # Z-0805-03.

REASON: Software problem may cause the instrument to skip the probe-wash step before processing different reagents.

MANUFACTURER: Misys Healthcare System, Plano, TX, by letter on March 13, 2003. Firm initiated recall is complete.

PRODUCT: Misys Commercial Laboratory, Laboratory Information System. Recall # Z-806-03.

REASON: Software logic error. Dates were printing incorrectly on cumulative reports.

MANUFACTURER: Ciba Vision Corporation, Duluth, GA, by letter on May 6, 2003. Firm initiated recall is ongoing.

PRODUCT: Focus DAILIES Toric (nelfilcon), One-Day Contact Lenses, Daily Disposable (hydrophilic) soft contact lens, Rx only, Sterile, -1.50, -1.75 x 090, BC 8.6, DIA 14.2. The product is packaged and distributed as 15 and 30 packs. Recall # Z-0827-03.

REASON: Lenses may be labeled with the incorrect axis.

MANUFACTURER: Becton Dickinson Infusion Therapy, Sandy, UT, by telephone and fax on April 4, 2003. Firm initiated recall is ongoing.

PRODUCT: BD First PICC 3F 65 cm Single Lumen Procedure Kit. Recall # Z--0832-03.

REASON: A 4 Fr catheter was packaged in PICC convenience kits labeled as 3 Fr.

MANUFACTURER: Philips Medical Systems (Cleveland) Inc, Highland Heights, OH, by a "Product Safety Notification", dated April 2, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) Philips MX8000 IDT CT Scanner, utilizing V2.1 software. Recall # Z-0835-03.
b) Philips MX8000 Dual v. EXP CT Scanner, utilizing V2.0 software. Recall # Z-0836-03.

REASON: Patient images may be stored in the archive directory of a different patient.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on July 3, 2002. Firm initiated recall is complete.

PRODUCT: MagicView 1000 and Magic View Mondo. Digital Image Communication. Recall # Z-0840-03.

REASON: Potential error can occur with the 3D post processing options MPR, MIP, and VRT. If a very large series are loaded into the 3D application, the scan range is not displayed entirely in the reconstruction.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 21, 2003:

CLASS II

MANUFACTURER: DentalEZ (StarDental), Lancaster, PA, by service representative starting in May 2003. Firm initiated recall is ongoing.

PRODUCT: Portable HDX Dental X-Ray System. Recall # Z-1272-02.

REASON: The Portable HDX Intraoral Dental X-Ray Systems contained a noncompliant date format on the labels and the serial number and date on the labels of were not legible.

MANUFACTURER: SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN. FDA initiated recall is ongoing. Recalling Firm: Sedecal USA, Inc., Arlington Heights, IL, by letters dated September 26, 2002.

PRODUCT: Sedecal X-Ray High Voltage Generators and Controls. Recall # Z-0649-03.

REASON: Incorrect identification labels and their certification testing program failed in noncompliance with the U.S. Federal performance standard.

MANUFACTURER: SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN. FDA initiated recall is ongoing. Recalling Firm: Sedecal USA, Inc., Arlington Heights, IL, by letters dated September 26, 2002.

PRODUCT: Easy Moving Motor Driven Mobile X-Ray Unit,

a) Model SM-20HF. Recall # -650-03;
b) Model SM-30HF. Recall # Z-651-03.

REASON: Incorrect identification labels and failure of the certification testing resulting in noncompliance with the U.S. Federal performance standard.

MANUFACTURER: SEDECAL, C/Pelya 9 Pol. Ind. Rio De Janeiro, 28110 Algete (Madrid) SPAIN. FDA initiated recall is ongoing. Recalling Firm: Sedecal USA. Inc., Arlington Heights, IL, by letters dated September 24, 2002.

PRODUCT: Optima URS X-Ray System. Recall # Z-0652-03.

REASON: Incorrect identification labels and their dertification testing program failed in noncompliance with the U.S. Federal performance standard.

MANUFACTURER: Ohio Medical Instrument Co, Inc., Cincinnati, OH, by email and telephone on February 26, 2003. Firm initiated recall is ongoing.

PRODUCT: Halo Support Bracket Assembly (Part # 438-B1010). The bracket is sold as a component of the BUDDE Halo Neurosurgical Retractor System, or sold as a separate component. The defective sub-assembly part is the Clamp Assembly (Part #438A1071), which is part of the Halo Bracket Assembly. Recall # Z-0781-03.

REASON: The component was manufactured with an insufficient weld that could break during use.

MANUFACTURER: Abbott Laboratories, Abbott Park, IL, by telephone and letters on March 31, 2003. Firm initiated recall is ongoing

PRODUCT: Architect Progesterone Reagent Kit:

a) List 6C26-27 (100 tests);
b) List 6C26-22 (400 tests). Recall # Z-0782-03.

REASON: Lot gives lower specimen results compared to results generated with other lots.

MANUFACTURER: General Electric Medical Systems Information Technology, Milwaukee, WI, by letter on April 14, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) MAC-LAB 1000EX systems. Recall # Z-0783-03.
b) MAC-LAB 3000EX systems. Recall # Z-0784-03.
c) MAC-LAB 5000EX systems. Recall # Z-0785-03;
d) MAC-LAB (Classic) systems. Recall # Z-0786-03;

REASON: There is an incorrect jumper set-up on a motherboard of the devices that could eventually cause a polyfuse to overheat resulting in smoke.

MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letter on February 24, 2003. Firm initiated recall is ongoing.

PRODUCT: AEROSET ICT Module, Reagent module for sodium, potassium, and chloride. List number 9D05-01.

Recall #Z-0788-03.

REASON: Software failure to detect error in reference solution set-up can cause inaccurate results for Sodium, Potassium, and Chloride.

MANUFACTURER: KAZ, Inc, Hudson, NY, by letters dated April 16, 2003. Firm initiated recall is ongoing.

PRODUCT: Vicks brand Warm Mist Humidifier, Model V610, "Pure warm moisturizer for soothing relief of cold and flu symptoms" sold over the counter. Recall #Z-0790-03.

REASON: Humidifiers may overheat.

MANUFACTURER: Phillips ADAC Milpitas, CA, by letters on July 24, 2002. Firm initiated recall is complete.

PRODUCT: Phillips ADAC brand C-PET and Allegro Imaging Systems. Recall # Z-0811-03.

REASON: Resulting images may be labeled incorrectly on PETView and receiving system.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 7, 2003:

CLASS II

MANUFACTURER: Kinetic Concepts, Inc., San Antonio, TX, by service representative, from November 1997 through March 1998. Firm initiated recall is complete.

PRODUCT: TransportAir, Accessory to an Air Bed, Auxiliary Blower Unit. Recall # Z-0718-03.

REASON: Battery out-gassing due to battery over charging and/or secondary failure mode of deep-discharge.

MANUFACTURER: Boston Scientific Corporation, Natick, MA, by letter on March 17, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) Boston Scientific/Microvasive Open End Ureteral Catheter (4 Fr x 70 cm) Product Number: 400-200. Recall # Z-0734-03;
b) Boston Scientific/Microvasive Open End Ureteral Catheter (5 Fr x 70 cm) Product Number: 400-201. Recall # Z-0735-03;
c) Boston Scientific/Microvasive Open End Ureteral Catheter (7 Fr x 70 cm) Product Number: 400-2003. Recall # Z-0736-03;
d) Boston Scientific/Microvasive Cone Tip Ureteral Catheter (5 Fr x70 cm) Product Number: 400-211. Recall # Z-0737-03;
e) Boston Scientific/Microvasive Cone Tip Ureteral Catheter (6 Fr x70 cm) Product Number: 400-212. Recall # Z-0738-03;
f) Boston Scientific/Microvasive Open End Ureteral Catheter (7 Fr x 70 cm) Product Number: 400-213. Recall # Z-0739-03;
g) Boston Scientific/Microvasive Open End Ureteral Catheter (6 Fr x 70 cm) Product Number: 400-202. Recall # Z-0740-03.

REASON: Warning flag may be detached from the tip protector on the catheter and result in the tip protector advancing through the catheter during use.

MANUFACTURER: I-Flow Corporation, Lake Forest, CA, by email on March 18, 2003. Firm initiated recall is ongoing.

PRODUCT: Easypump LT 6024 Easypump InfusionPump (60 ml x 22 ml/hr). Recall # Z-0741-03.

REASON: Overinfusion due to misassembly.

MANUFACTURER: Tyco Healthcare/Kendall, Mansfield, MA, by letter on March 20, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 19 cm Arterial Cuff/22cm Venous Cuff Code #: 8888-219226. Recall # Z-0742-03;
b) Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 23 cm Arterial Cuff/26cm Venous Cuff Code #: 8888-223266. Recall # Z-0743-03;
c) Tandem-Cath Hemodialysis Cuffed Catheter with side holes 10 Fr 28 cm Arterial Cuff/31cm Venous Cuff Code #: 8888-228316. Recall # Z-0744-03;
d) Tandem-Cath Hemodialysis Cuffed Catheter with no side holes 10 Fr 19 cm Arterial Cuff/22cm Venous Cuff Code #: 8888-219220. Recall # Z-0745-03;
e) Tandem-Cath Hemodialysis Cuffed Catheter with no side holes 10 Fr 23 cm Arterial Cuff/26 cm Venous Cuff Code #: 8888-223260. Recall # Z-0746-03;
f) Tandem-Cath Hemodialysis Cuffed Catheter with no side holes 10 Fr 28 cm Arterial Cuff/31cm Venous Cuff Code #: 8888-228310 Recall # Z-0747-03.

REASON: Tandem Hemodialysis Catheter may have splits in the catheter shaft below the extension adapter.

MANUFACTURER: Kinetic Concepts, Inc., San Antonio, TX, by Technical Bulletin on April 11, and September 11, 2000, and by letter in October, 2002. Firm initiated recall is ongoing.

PRODUCT:
a) TriaDyne I and TriaDyne II Powered Adjustable Hospital Beds. Recall # Z-0748-03;
b) KinAir IV TheraPaulse II AC-Powered Adjustable Hospital Beds. Recall # Z-0749-03;
c) BariAir AC-Powered Adjustable Hospital Beds. Recall # Z-0750-03. d) PediDyne AC-Powered Adjustable Hospital Beds. Recall # Z-751-03; e) TransportAir Auxiliary Blower Unit. Recall # Z-0752-03.

REASON: Battery Failure/Outgassing.

MANUFACTURER: Windstone Medical Inc., Billings, MT, by telephone and letter on March 25, 2003. Firm initiated recall is ongoing.

PRODUCT: Custom surgical packs for a variety of surgical applications. Each pack is custom assembled and contains a variety of components including blades, gowns, needles, sponges, towels, syringes, gloves, etc. All products could have the WINDSTONE MEDICAL INC. label or the CARDIO-PAK label.
a) Major Pack. Recall # Z-0753-03;
b) RJT&A Pack. Recall #Z-0754-03;
c) T & A Pack. Recall # Z-0755-03;
d) Back Pack. Recall # Z-0756-03;
e) Arthroscopy Pack. Recall # Z-0757-03;
f) Cloward Pack. Recall # Z-0758-03;
g) Dr Desai's Pack. Recall # Z-0759-03;
h) Abdominal Gyn Pack. Recall # Z-0760-03;
i) Shoulder Pack. Recall # Z-0761-03;
j) Knee Pack. Recall # Z-0762-03;
k) Craniotomy Pack. Recall # Z-0763-03;
l) Laminectomy Pack. Recall # Z-0764-03;
m) Knee Arthroscopy Pack. Recall # Z-0765-03;
n) Shoulder Arthroscopy. Recall # Z-0766-03;
o) Lami Lap Pack. Recall # Z-0767-03;
p) Band Bag W/Fastener. Recall # Z-0768-03;
q) Band Bag. Recall # Z-0769-03;
r) Pick Up Pack. Recall # Z-0770-03;
s) Penrose Ace Bandage. Recall # Z-0771-03;
t) Subclavian Procedure Tray. Recall # Z-0772-03;
u) Isolation Gown Pack. Recall # Z-0773-03;
v) Valve Accessory Pack. Recall # Z-0774-03;

REASON: Product has latex free symbol on package, yet contains latex components.

MANUFACTURER: Guidant Corporation ACS, Temecula, CA, by facsimile on April 1, 2003. FDA initiated recall is ongoing.

PRODUCT: Guidant Multi-Link Vision Coronary Stent System. Catalog Numbers: 30 different catalog numbers have been listed. Recall # Z-0775-03.

REASON: Complaints that the stents are being dislodged from the delivery system.

MANUFACTURER: Boston Scientific Scimed, Maple Grove, MN, by letter dated March 17, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) Boston Scientific Scimed Radius Monorail 4.0 mm Stent Systems, Catalog Number H74917485400. Recall # Z-0776-03;
b) Boston Scientific Scimed Radius 3.0 mm x 31 mm Self- Expanding Coronary Stent with Over-the-Wire Delivery System, Catalog Number H74917500301. Recall # Z-0777-03;
c) Boston Scientific Scimed Radius 4.0 mm x 31 mm Self- Expanding Coronary Stent with Over-the-Wire Delivery System, Catalog Number H74917500401. Recall # Z-0778-03.

REASON: A component within the manifold of the stent delivery systems was found to have pyrogen levels above specification.

MANUFACTURER: Gish Biomedical, Inc., Rancho Santa Margarita, CA, by fax on March 31, 2003. Firm initiated recall is ongoing.

PRODUCT: Vision Hollow Fiber Oxygenator. Recall # Z-0780-03.

REASON: Two reports of leakage.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 30, 2003:

CLASS II

MANUFACTURER: Terumo Cardiovascular Systems, Corporation, Ashland, MA, by telephone, fax and letter on November 8, 2002. Firm initiated recall is ongoing.

PRODUCT: Heat Exchanger Coil used in the "Custom Cardiovascular Procedure Kits". Recall # Z-0298-3.

REASON: Heat exchanger may contain loose particulate matter.

MANUFACTURER: Biosound Esaote, Inc., Indianapolis, IN, by service upgrade notices, on or about January 22, 2003. Firm initiated recall is ongoing.

PRODUCT: Biosound Caris Plus Ultrasound System with phased array probes, model 7230; Biosound Megas Ultrasound System with phased array probes, model 7250. Recall # Z-0299-03.

REASON: Excessive power output due to a faulty voltage controller.

MANUFACTURER: Sedecal SA, Madrid, Spain. Firm initiated recall is ongoing. Recalling Firm: Sedecal US, Inc, Arlington Heights, IL, by telephone, and letter on April 9, 2003.

PRODUCT: Sedecal High Voltage Generators and Sedecal Controls. Recall # Z-0649-03.

REASON: An incorrect identification label and the failure of the certification testing program resulted in Generators and High Voltage Controls not complying with the U.S. Federal performance standard.

MANUFACTURER: Sedecal SA, Madrid, Spain. Firm initiated recall is ongoing. Recalling Firm: Sedecal US, Inc, Arlington Heights, IL, by telephone, and letter on April 9, 2003.

PRODUCT: Sedecal Mobile X-Ray System. Recall # Z-0650-03/Z-0651-03.

REASON: An incorrect identification label and the failure of the certification testing program resulted in the Mobile Systems not complying with the U.S. Federal performance standard.

MANUFACTURER: Sedecal SA, Madrid, Spain. Firm initiated recall is ongoing. Recalling Firm: Sedecal US, Inc, Arlington Heights, IL, by telephone, and letter on April 9, 2003.

PRODUCT: Sedecal URS X-Ray System. Recall # Z-0652-03.

REASON: An incorrect identification label and the failure of the certification testing program resulted in the Sedecal URS X-Ray Systems not complying with the U.S. Federal performance standard.

MANUFACTURER: Deroyal Surgical-Rose Hill, Rose Hill, VA, by certified mail on February 25, 2003. Firm initiated recall is ongoing.

PRODUCT: Biosound Caris Plus Ultrasound System with phased array probes, model 7230. Biosound Megas Ultrasound System with phased array probes, model 7250. Recall # Z-0708-03.

REASON: Non-sterile surgical medical device is labeled as sterile product.

MANUFACTURER: I-Flow Corporation, Lake Forest, CA, by fax on March 5, 2003, and email on March 6, 2003. Firm initiated recall is ongoing.

PRODUCT: Paragon Administration Set (100 ml x 0.5 ml/hr) Part Number 5000936. Recall # Z-0709-03.

REASON: Wrong component may result in over infusion of medications.

MANUFACTURER: Boston Scientific Scimed, Maple Grove, MN, by letter dated March 20, 2003. Firm initiated recall is ongoing.

PRODUCT: Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250. Recall # Z-0711-03.

REASON: The product units in the recalled lot are in pouches, which may have incomplete seals that could lead to compromised sterility

MANUFACTURER: Datex-Ohmeda, Madison, WI, by letters dated February 12, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Multi Absorbers, reference number 8003138. Recall # Z-0713-03; b) Multi Absorbers, reference number 8003138, in S/5 Aespire Start-up Kits (each containing 2 Multi Absorbers). Recall # Z-0714-03.

REASON: Multi Absorbers for anesthesia delivery equipment may have missing or damaged filters, exposing the patient to dust from soda lime in the absorbers.

MANUFACTURER: Roche Diagnostics, Corp., Indianapolis, IN, by letters dated February 12, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Accu-Chek Comfort Curve glucose test strips; part numbers 2030420, 2030365, 2030373, 2030381, 3000133 and 3000141. Recall # Z-0715-03; b) Accu-Chek Advantage glucose test strips; part numbers 336, 556, 787 and 966. Recall # Z-0716-03.

REASON: Crack in the bottom of the test strip vial will cause erroneously low or high blood glucose readings.

MANUFACTURER: Linvatec Corp., DBA Linvatec/Hal, Largo, FL., by telephone and letter beginning on January 24, 2003. Firm initiated recall is ongoing.

PRODUCT: Product is packed in a pouch, which is labeled as MicroChoice FOOTSWITCH Linvatec. Recall # Z-0717-03.

REASON: The Footswitch functions of the left and right foot pedals may be reversed in some units.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by telephone on February 24, 2003, and by letter on March 6, 2003. Firm initiated recall is ongoing.

PRODUCT: CryoValve Allograft, Heart Valve. Recall # Z-0719-03.

REASON: Pre-processing cultures detected certain microorganisms in donor tissue.

MANUFACTURER: Roche Diagnostics, Corp., Indianapolis, IN, by letter in February, 2003. Firm initiated recall is ongoing.

PRODUCT: CoaguChek PT test strips, sold in 12 pack. Recall # Z-0720-03.

REASON: Discrepancy between INR and the % Quick displayed on the meter.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on March 19, 2003. Firm initiated recall is ongoing.

PRODUCT: a) CryoValve Heart-valve, allograft. Recall # Z-0722-03; b) CryoValve Heart-valve, allograft. Recall # Z-0723-03. REASON: The recipient of one of the kidneys from the donor has developed renal cell carcinoma. MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letter on February 24, 2003. Firm initiated recall is ongoing.

PRODUCT: Aeroset Software versions 1.00ER005, catalog number 2-89996-01; and software version 1,00ER005.2, catalog number 2-89996-02. Recall # Z-0725-03.

REASON: Under certain operating conditions, smart wash feature disables with multiple samples.

MANUFACTURER: Abbott Laboratories HPD/ADD, Abbott Park, IL, by letter dated March 4, 2003. Firm initiated recall is ongoing.

PRODUCT: Abbott IMx AFP Calibrators, list 2271-01; a box of 6 bottles (4 mL each) with AFP (human), nonreactive for anti-HIV-1/HIV-2 and HCV and nonreactive for HBsAg, inbuffered calf serum at the following concentrations: A - 0, B - 15, C - 50, D - 100, E - 200 and F - 350. Recall # Z-0726-03.

REASON: The Imx AFP Calibrators may cause depressed values for the Imx AFP Low Control, and cause patient results to be 20% lower than actual values.

MANUFACTURER: W.R. Grace & Company, Chicago, IL. Firm initiated recall is ongoing. Recalling Firm: Darex Container Products, Div of W. R. Grace & Co, Chicago, IL, by letter dated February 11, 2003.

PRODUCT: a) High Performance Sodasorb Carbon Dioxide Absorbent, Diving Grade(18%) Soda Lime USP-NF with an ethyl violet indicator, which turns from white to violet as absorber, is depleted; the product is packaged in 5-gallon pails under the W.R. Grace label. Recall # Z-0730-03; b) Sodasorb Carbon Dioxide Absorbent, Medical Grade (16%) Soda Lime USP-NF with an ethyl violet indicator which turns from white to violet as absorber is depleted; the product is packaged in pre-packs(pre-filled 2.5 lb. canisters, 12 per carton), canister packs (pre-measured 2.5 lb. bags, 12 per carton), 5-gallon pails and 55-gallon drums under the W.R. Grace label and the Portex label. Recall # Z-0731-03.

REASON: Contaminated with epoxy chips.

MANUFACTURER: C. R. Bard, Inc., Urological Division, Covington, GA, by letter on March 25, 2003. Firm initiated recall is ongoing.

PRODUCT: Bard Dispoz-A-Bag, Disposable Urinary Leg Bags, with Flip-Flo Drainage Valve, 19 oz or 32 oz with a Fabric Leg Strap, Contents Sterile. Recall # Z-0732-03.

REASON: There is a potential for package seals to b open after sterilization.

CLASS III

MANUFACTURER: Avanta Orthopaedics, Inc., San Diego, CA, by telephone on January 24, 2003. Firm initiated recall is complete.

PRODUCT: Finger Joint Implants, Silicone Models a) TRL-10 and b) TRL-20. Recall # Z-0710-03.

REASON: Wrong silicone elastomer used in construction.

MANUFACTURER: Sybron Dental Specialties, Orange, CA, by notice on March 7, 2003. Firm initiated recall is ongoing.

PRODUCT: Gluteraldehyde Concentration Indicators. a) MetriTest 1.5%; b) MetriTest 1.8%; c) OmniChek 1.5%; d) OmniCheck 1.8. Recall # Z-0712-03.

REASON: Moisture ingress into packaging of test strips may cause premature failure.

MANUFACTURER: Siemens Medical Solutions, USA, Inc., Hoffman Estates, IL, by letters dated February 10, 2003. Firm initiated recall is ongoing.

PRODUCT: ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems. Recall # Z-0727-03.

REASON: ICON 9.5 software does not apply flood corrections during whole body SPECT studies with multiple bed positions.

MANUFACTURER: 3m Health Care, Saint Paul, MN, by letter on January 8, 2002. Firm initiated recall is complete.

PRODUCT: 3 M Attest Steam Pack 1276F (biological indicator of steam sterilization for use at hospitals). Recall # Z-0779-03.

REASON: Some 3M Attest Steam Packs 1276F (biological indicator challenge for steam sterilization) were labeled as 3M Attest Rapid Readout Steam Pack 1296F.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 23, 2003:

CLASS II

***CORRECTION***

The Enforcement Report of April 9, 2003 for Class III, Recall # Z-0668-03 stated Toshiba American Med Systems, Inc. recalled by letters of February 12 & February 13, 2002. The letters were issued on February 12 & February 13, 2003.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 16, 2003:

CLASS I

MANUFACTURER: Disetronic Medical Systems AG Burgdorf, Switzerland. Firm initiated recall is ongoing. Recalling Firm: Disetronic Medical Systems, Inc. St. Paul, MN, by letter dated June 17, 2002.

PRODUCT: Disetronic D-TRON Insulin Infusion Pump, Models 8100001 D-TRON (blue) and 8100005 D-TRON (anthracite). Recall # Z-1350-02. This correction was previously classified as a Class II. The health risk was reevaluated after receipt of new information.

REASON: Some pumps started programming a bolus that was not initiated by the pump user, and the delivery of an unintended bolus was made unless interrupted by the device user.

CLASS I1

MANUFACTURER: I-Flow Corporation, Lake Forest, CA., by fax on March 4, 2003, and telephone on March 5, 2003. Firm initiated recall is ongoing.

PRODUCT: Homepump Eclipse Infusion Pump, Disposable Elastomeric Infusion System (100 ml x 50 ml/hr) Model E100500, Part No. 5001065. Recall # Z-0687-03.

REASON: Product infuses too fast at rate of 30 minutes instead of 2 hours. Component mix-up.

MANUFACTURER: Thoratec Corp., Pleasanton, CA., by Safety Bulletin and Safety Instructions on February 7, 2003. Firm initiated recall is ongoing.

PRODUCT: HeartMate Stroke Volume Limiter (SVL) Catalog # 1295. Recall # Z-0688-03.

REASON: Driveline tubing connections on the SVL if under STRESS condition may snap off, VAD support is compromised, a serious injury or death can occur.

MANUFACTURER: Abbott Health Products, Inc., Barceloneta, PR, by letter on December 11, 2002. Firm initiated recall is ongoing.

PRODUCT: a) AxSYM Tricyclic Antidepressants Reagent. Recall # Z-0689-03; b) Adx Tricyclic Antidepressants Reagent. Recall # Z-0690-03; c) TDx/TDxFlx Tricyclic Antidepressant Reagent. Recall # Z-0691-03.

REASON: Unexpected false positive TCA results.

MANUFACTURER: Biotronik, Inc., Lake Oswego, OR, by letter dated February 21, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Tachos DR-Implantable Cardioverter Defibrillator. Recall # Z-0700-03; b) Deikos A+ Implantable Cardioverter Defibrillator. Recall # Z-0701-03; c) Tachos DR - Atrial TX Implantable Cardioverter Defibrillator. Recall # Z-0702-03.

REASON: Potential for battery to delivery less than full amount of energy.

MANUFACTURER: Ciba Vision Corporation, Duluth, GA, via traceable mail on/about March 17, 2003. Firm initiated recall is ongoing.

PRODUCT: Glitter Eyes (tefilcon), daily wear soft (hydrophilic) contact lenses packed as single units or kits in multiple glass vials. Recall # Z-0703-03.

REASON: The lens may partially 'delaminate' in the area of one of the encapsulated cosmetic prints.

MANUFACTURER: Beckman Coulter, Brea, CA, by letter dated February 20, 2003. Firm initiated recall is ongoing.

PRODUCT: ICON DS hCG, an in-vitro diagnostic. Part number 44025. Recall # Z-0706-03.

REASON: Failure to meet sensitivity claims at end of shelf life. Potential for false negative reports.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 9, 2003:

CLASS II

MANUFACTURER: Simmler, Inc., St Louis, MO, by letters dated December 12, 2002 and mailed on December 18, 2002. FDA initiated recall is ongoing.

PRODUCT: Fetal Cell Stain Kit No. S0412-00, contents include 3 x 120ml Fetal Cell Fixing Solution (80% Reagent Alcohol), 3 x 120ml Fetal Cell Citrate Buffer Solution (Citrate Buffer, 0.081M), and 3 x 120ml Fetal Cell Stain (Erythrosin-B, Fast Green). Recall # Z-0653-03.

REASON: Fixing solution bottles are labeled as buffering solution.

MANUFACTURER: Digene Corp., Gaithersburg, MD, by telephone and fax on February 7, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Digene's Hybrid Capture 2 HPV DNA Test, Catalog # 5101-1096. Recall # Z-0654-03; b) Digene's Hybrid Capture 2 HPV DNA Test, Catalog # 5196-1230, labeled for export only. Recall # Z-0655-03; c) Hybrid Capture 2 high-Risk HPV DNA Test, Catalog # 5101-1296. Recall # Z-0656-03; d) Hybrid Capture II CT-ID Twst, Catalog # 5135-10501VT, (labeled for export only). Recall # Z-0657-03;

REASON: In Vitro diagnostic test kit may produce false positive patient results.

MANUFACTURER: DeRoyal Industries, San Luis Obispo, CA, by letter dated February 19, 2003. Firm initiated recall is ongoing.

PRODUCT: Flexgard, off-the-shelf knee brace, product number 14761106. Recall # Z-0658-03.

REASON: Manufacturing defect possibly causing screws to come loose causing the brace to collapse during use.

MANUFACTURER: Interpore Cross International, Inc., Irvine, CA, by telephone on February 7, 2003. Firm initiated recall is ongoing.

PRODUCT: TPS-TL Straight Drill Guide Applicator, Catalog Number 1300-9016. Recall # Z-0659-03.

REASON: Instrument fell apart during cleaning prior to surgery.

MANUFACTURER: Baxter Healthcare Corp., Deerfield, IL. Firm initiated recall is ongoing. Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated February 20, 2003.

PRODUCT: a) Baxter SPS 550 Single Patient System Hemodialysis Machine. Recall # Z-0660-03; b) Baxter 1550 Single Patient System Hemodialysis Machines. Recall # Z-0661-03.

REASON: Excess or insufficient ultrafiltration may occur during manual control of ultrafiltration via adjustment of transmembrane pressure (TMP).

MANUFACTURER: Medtronic Xomed, Inc., Jacksonville, FL, by letter on January 25, 2003. Firm initiated recall is ongoing.

PRODUCT: Product is labeled as "Oto-Flex Bur", Medtronic-Xomed brand, packed into a sterile pouch. Product is further packaged into a shelf box with similar labeling as follows: Part Number 31-55631 Oto-Flex carbide 1.0mm Bur; Part Number 31-55632 Oto-Flex carbide 2.3mm Bur; Part Number 31-55642 Oto-Flex diamond 2.3mm Bur; Part Number 31-55647 Oto-Flex diamone 0.7 mm Bur. Part Number and Lot Number is listed on pouch and box label. Recall # Z-0662-03.

REASON: Product packaging pouches may be open thereby compromising the sterile barrier.

MANUFACTURER: Curon Medical, Inc., Sunnyvale, CA., by letters on February 21, 2003. Firm initiated recall is ongoing.

PRODUCT: Stretta brand Catheter and Accessory Kit, Part # 175-2575. Model 4301K. Recall # Z-0663-03.

REASON: Catheter shaft has potential to crack during use.

MANUFACTURER: Terumo Cardiovascular Systems Corp.

PRODUCT: Sarns MP4 Cardioplegia Sets; catalog number 15501.

Recall # Z-0664-03.

REASON: There is a potential for delivery of a lower than intended amount of cardioplegia solution to the heart during surgery.

MANUFACTURER: Misys Healthcare Systems, Tucson, AZ, by fax on February 19, 2003. Firm initiated recall is ongoing.

PRODUCT: Misys Laboratory System Version 5.3. Recall # Z-0670-03.

REASON: Software anomaly. The HIDE command used to suppress suspected individual microbiology observations does not work in GUI inquiry.

MANUFACTURER: Permobile, Inc., Lebanon, TN, by letter with repair kit on March 10, 2003. Firm initiated recall is ongoing.

PRODUCT: Permobil Chairman 2K powered wheelchair, Model 1280.

REASON: Incidents were reported where a drive wheel has come off its motor axle, due either to loosening of the wheel bolt or a broken wheel bolt.

MANUFACTURER: Cryolife, Inc.,Kennesaw, GA, by telephone on February 4, 2003 and February 24, 2003, and by letter on February 25, 2003. Firm initiated recall is ongoing.

PRODUCT: CryoValve Allograph, Heart valve. Recall # Z-0672-03.

REASON: Microorganisms were detected in distributed allografts.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on/about February 20, 2003. Firm initiated recall is ongoing.

PRODUCT: CryoValve Allograft, heart valve. Recall # Z-0673-03.

REASON: Microorganisms were detected in distributed donor tissue.

MANUFACTURER: Cti Pet Systems, Inc., Knoxville, TN, by letter beginning on March 4, 2003. Firm initiated recall is ongoing.

PRODUCT: ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission Tomography) systems: Siemens Models: ECAT EXACT, ECAT EXACT HR, ECAT EXACT HR+, ECAT ART, ECAT EMERGE and ECAT ACCEL CTI Models: ECAT EXACT, ECAT EXACT HR+, ECAT ART, ECAT EMERGE, ECAT ACCEL, REVEAL QS and REVEAL XL Marconi Models: Magellan Hitachi Models: Sceptre and Sceptre XL. Recall # Z-0674-03.

REASON: Incorrect patient information is displayed in the reconstructed images of a whole body patient scan.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by telephone on/about January 23, 2003, and on site visit on January 30, 2003. Firm initiated recall is complete.

PRODUCT: CryoValve Allograft heart valve. Recall # Z-0675-03.

REASON: An allograft associated with this donor has been linked to an alleged infection.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by telephone on/about January 23, 2003, and on site visit on January 30, 2003. Firm initiated recall is complete.

PRODUCT: CryoValve Allograft heart valve. Recall # Z-0676-03.

REASON: An allograft associated with this donor has been linked to an alleged infection.

MANUFACTURER: DCI Donor Services Tissue Services Division, Nashville, TN, by memorandum on August 20, 2002. Firm initiated recall is complete.

PRODUCT: One heart and pericardium. Recall # Z-0677-03.

REASON: Human tissue was procured from donor using non-sterile instruments.

MANUFACTURER: Misys Healthcare Systems, Tucson, AZ., by fax on January 17, 2003. Firm initiated recall is ongoing.

PRODUCT: Misys Laboratory, Calculator Data processing Module for Clinical Use. Recall # Z-0678-03.

REASON: Software anomally. Graphical display omits results containing a less than (<), greater than (>) or percent (%) symbol.

MANUFACTURER: Abbott Laboratories HPD/ADD, Abbott Park, IL., by letter dated March 4, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Abbott AxSYM CA 15-3 Master Calibrator Pack, list 3B42-30; the pack contains two 4-mL bottles, with Master Calibrator 1 having 0 U/mL and Master Calibrator 2 having 60 U/mL. Recall # Z-0679-03; b) CA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of 115D8:DF3 reactive determinants prediluted in TRIS buffer with protein stabilizers to yield the following assay values: A - 0 u/mL, B - 15 U/mL, C - 60 U/mL, D - 120 U/mL, E - 180 U/mL and F - 250 U/mL. Recall # Z-0680-03; c) IMx CA 15-3 Reagent Pack, list 6A75-22; this reagent pack contains two 4-mL bottle of Mode 1 Calibrator along with other reagents. Recall # Z-0681-03;

REASON: The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.

MANUFACTURER: Invacare Corp.,Elyria, OH, by letters on March 10, 2003. Firm initiated recall is ongoing.

PRODUCT: Tarsys 1st Generation Seating System - an optional accessory for the Powered Wheelchairs. Recall # Z-0682-03.

REASON: A short circuit within the charger harness may cause heat damage to the units with potential for fire.

CLASS III

MANUFACTURER: Implant Innovations, Inc., Palm Beach Gardens, FL, by fax on January 28, 2003. Firm initiated recall is ongoing.

PRODUCT: LTX Endosseous Implant 6.0 mm x 11.5 mm and also

LTX Endosseous Implant 5.0 mm X 15 mm, Sterile. Recall # Z-0665-03.

REASON: Sterile Endosseous implants may be packaged in mislabeled packaging with the incorrect size.

MANUFACTURER: Symbiosis, Corp., Miami, FL, by letter on November 27, 2002. Firm initiated recall is ongoing.

PRODUCT: Medi-Tech Magic Torque Glidex hydrophilic coated guidewire, .035 inch/180 cm and .035 inch/260 cm lengths. Packaged in a sterile pouch and a three pack shelf box. Recall # Z-0666-03.

REASON: The 180 cm guidewire is mislabeled as 260 cm. The 260 cm guidewire is mislabeled as 180 cm.

MANUFACTURER: Toshiba American Med Systems, Inc., Tustin, CA, by letters on February 12, and February 13, 2002. Firm initiated recall is ongoing.

PRODUCT: X-ray, computed Tomography, Model TSX101A. Recall # Z-0668-03.

REASON: Misassembly can cause fire.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by telephone and letters from January 27, 2003 to February 3, 2003. Firm initiated recall is ongoing.

PRODUCT: LH 700 Series Hematology Analyzers. Part numbers 66056032, 6605633, 6605645. Recall # Z-0669-03.

REASON: Incorrect Hemoglobin result can be reported at software version 2A and higher.

MANUFACTURER: EMD Chemicals, Inc., Gibbstown, NJ, by telephone and letter on December 17, 2002, January 24, 2003, January 28, 2003, and February 4, 2003. FDA initiated recall is ongoing.

PRODUCT: a) Ethanol Standard, 1.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case. Recall # Z-0683-03; b) Ethanol Standard, 0.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case. Recall # Z-0684-03; c) Papanicolaou Stain EA-50. Product size configurations: 1L, 4L, and 10L. Recall # Z-0685-03.

REASON: a) The Ethanol Standard is OOS on the high end. The results were 1.58 mg/mL while the specification is 1.477-1.538 mg/mL; b) The Ethanol Standard is OOS on the low end. The results were 0.44 mg/mL while the specification is 0.48-0.52 mg/mL; c) Difficulty in reading slides due to the stain is much greener than normal.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letters dated January 30, 2003, and February 5, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Access 2 Immunoassay System. Recall # Z-0692-03; b) Access 2 Immunoassay side of Lxi 725. Recall # Z-0693-03.

REASON: False results from secondary pour off tubes.

MANUFACTURER: Advanced Sterilization Products, Irvine, CA, by emails and letters between February 14, 2003 and February 27, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Cidex Solution Test Strips Browne GA Indicators for Cidex Solution Test Strips. Recall # Z-0694-03; b) Cidex Plus Solution Test Strips. Recall # Z-0695-03.

REASON: Test strips which are used for QC of sterilant solution fail due to ingress of moisture.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 26, 2003:

CLASS II

MANUFACTURER: Alcon Laboratories, Inc., Fort Worth, TX, by letter on November 18, 2002. Firm initiated recall is ongoing.

PRODUCT: SKBM Microkeratome cutting tool. Recall # Z-0612-03.

REASON: Degradation of glue causes glass movement resulting in misalignment that can cause deeper cuts than anticipated.

MANUFACTURER: Misys Healthcare Systems, Tucson, AZ, by fax on January 31, 2003. Firm initiated recall is ongoing.

PRODUCT: Misys Laboratory System. Recall # Z-0614-03.

REASON: Software anomaly. Rejecting the selected Auto filing status may result in the change being accepted rather than rejected.

MANUFACTURER: Thermo Biostar, Inc., Louisville, CO, by telephone on February 6, 2003 and by letter on February 10, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Chlamydia OIA. For in vitro diagnostic use.

Recall # Z-0615-03;

b) Chlamydia OIA. For in vitro diagnostic use.

Recall # Z-0616-03.

REASON: Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Hoffman Estates, IL., by letters dated February 10, 2003. Firm initiated recall is ongoing.

PRODUCT: Integrated Orbiter Single Detector General Purpose Gamma Camera System. Recall # Z-0617-03.

REASON: Unintended yoke rotational motion.

MANUFACTURER: Medtronic, Inc., Rice Creek Facility, Fridley, MN, by 'Important Product Management Information' letter, dated November 25, 2002. Firm initiated recall is ongoing.

PRODUCT: Atakr II RF Power Generator, Models 4802 and 4803. Recall # Z-0618-03.

REASON: An RF pulse occurs each time the temperature set point increase button is activated while ablating and this can result in heart rhythm disturbances.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by a mandatory field modification was issued on December 19, 2002. Firm initiated recall is ongoing.

PRODUCT: Access and Access 2 Immunoassay Systems Discrete photometric chemistry analyzer for clinical use.

REASON: Spring failure, design defect in component.

MANUFACTURER: Merit Medical Systems, Inc., South Jordan, UT, by telephone and fax on February 12, 2003. Firm initiated recall is complete.

PRODUCT:

• a) Custom Angiographic Kit. Recall # Z-0620-03;
• b) Custom Angiographic Kit. Recall # Z-0621-03;
• c) Custom Angiographic Kit. Recall # Z-0622-03.

REASON: A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.

MANUFACTURER: Siemens Medical Solutions, USA, Inc., Hoffman Estates, IL, by letters dated February 10, 2003. Firm initiated recall is ongoing.

PRODUCT: e.cam Emission Imaging Computed Tomography Systems used for all common nuclear medicine procedures. Recall # Z-0623-03.

REASON: Unexpected release of the radial and rotate brakes in the case of multiple simultaneous fault conditions.

MANUFACTURER: E Med Future, Inc., Columbus, OH, by telephone on August 15, 2002. Firm initiated recall is ongoing.

PRODUCT: NEEDLEZAP, a battery operated needle destruction device. The product is labeled and marketed for use only in the law enforcement market or veterinary market. Recall # Z-0624-03.

REASON: Their NeedleZap devices were not manufactured in accordance with the Quality System Regulations, and were shipped without an approved PMA.

MANUFACTURER: Medtronic, Inc., Danvers, MA, by letter, on January 31, 2003. Firm initiated recall is ongoing.

PRODUCT: Medtronic AVE Everest PTCA Inflation Catheter 20 cc Item #AC2200. Recall # Z-0625-03.

REASON: PTCA balloon catheter contains a pressure gauge that does not accurately reflect the pressure of the balloon.

MANUFACTURER: Misys Healthcare Systems, Tucson, AZ, by fax on January 31, 2003. Firm initiated recall is ongoing.

PRODUCT: Misys Laboratory System. Recall # Z-0626-03.

REASON: Software anomaly. Patient results may be filed in the incorrect patient file.

MANUFACTURER: Abbott Health Products, Inc., Barceloneta, PR, by letters on December 11, 2002. Firm initiated recall is ongoing.

PRODUCT: AFP Control Kit distributed under the following label: AxSYM and Imx, Abbott Laboratories USA, North Chicago, IL. Recall # Z-0627-03.

REASON: Results lower than package insert ranges.

MANUFACTURER: Biomerieux, Inc., Durham, NC, by letter on December 23, 2002. Firm initiated recall is ongoing.

PRODUCT: BIOMERieux, Thromboplastin Reagent, Simplastin Excel S, 6 ml Diluent. Recall # Z-0628-03.

REASON: Vial to vial variability which can result in prolonged clot times.

MANUFACTURER: Biomerieux, Inc, Durham, NC, by letter on/about February 4, 2003. Firm initiated recall is ongoing.

PRODUCT: Simplasitin Excel, 10 x 6ml, 25200, For Prothrombin Time determinations. The product consists of two vials, a thromboplastin reagent and a diluent (the vials are mixed together before use). Recall # Z-0629-03.

REASON: Product is being recalled due to vial variability of clotting time results.

MANUFACTURER: Lifescan, Inc., Milpitas, CA, by letters on January 13, 2003. Firm initiated recall is ongoing.

PRODUCT: One Touch SureStep Glucose Test Strips; One Touch SureStep Pro Glucose Test Strips (hospital use). Recall # Z-0630-03.

REASON: The Test Strips have manufacturing errors, in that the "Confirmation Dot" is off-center or split in half, and defective bottle cap.

MANUFACTURER: Misys Healthcare Systems, Tucson, AZ, by fax on February 7,2003. Firm initiated recall is ongoing.

PRODUCT: Misys Laboratory System. Recall # Z-0631-03.

REASON: Missing patient data on Location Chart Copy Cumulative Reports.

MANUFACTURER: Varian Medical Systems, Inc., Palo Alto, CA, by letters on January 16, 2003 and February 4, 2003. Firm initiated recall is ongoing.

PRODUCT: VARiS 1.4G and Vision/Soma Vision Radiation Therapy Systems; VARiS versions 6.1.33 and 6.2.19 in conjunction with Eclipse 6.x/Soma Vision 6.x. Recall # Z-0633*03.

REASON: The product has a software problem. This could result in a treatment without a motorized wedge where one had been planned.

MANUFACTURER: BD Opthalmic Systems, Waltham, MA, by telephone and email on January 24, 2003. Firm initiated recall is ongoing.

PRODUCT: BD K-3000 Microkeratome Blade REF378607.

Recall # D-0634-03.

REASON: Microkeratome Blade may cause irregular corneal flap which may delay patients procedure.

MANUFACTURER: American Healthcare Products, Inc, Signal Hill, CA, by letter on July 23, 2002. Firm initiated recall is ongoing.

PRODUCT: Latex examination gloves, Uniseal drand.

REASON: Unfit for intended use due to stickiness.

MANUFACTURER: Abbott Laboratories, Inc., Bedford, MA, by letters dated January 21, 2003. Firm initiated recall ongoing.

PRODUCT:

• a) MediSense Precision PCx Blood Glucose Test Strips, List Number: 98757-12. Recall # Z-0636-03.
• b) MediSense Precision Plus Blood Glucose Test Strips List Number: 99565-01. Recall # Z-0637-03.
• c) MediSense QID Blood Glucose Test Strips. List Number: 97401-12. Recall # Z-0638-03.
• d) MediSense Precision Plus List Number: 97430-12 Internalional: Norway. Recall # Z-0639-03.
• e) MediSense Precision Plus Blood Glucose Test Strips. List Number: 97345-12 International: Australia. Recall # Z-0640-03.
• f) MediSense Precision QID Blood Glucose Test Strips List Number: 98433-12 Internalional: Greece, Ireland, Portugal, Spain, and UK. Recall # Z-0641-03.
• g) MediSense Precision Plus List Number: 98430-12 Internalional: Denmark, Norway, Finland, and Sweden. Recall # Z-0642-03.
• h) MediSense Precision Plus List Number: 98724-12 International: Germany. Recall # Z-0643-03.

REASON: Glucose test strips may give high falsely positive readings.

MANUFACTURER: Medline Industries, Inc., Mundelein, IL, by letter dated February 11, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Sterile 8 Fr Suction Catheter Kit - Latex Free; 50 kits per case. Recall # Z-0644-03.

b) Sterile Dressing Change Tray with CloraPrep - Latex Free, 28 trays per case. Recall # Z-0645-03.

REASON: Some of the kits labeled as latex free contain latex gloves, which are properly labeled.

MANUFACTURER: Misys Healthcare Systems, Tucson, AZ, by fax on February 6, 2003. Firm initiated recall ongoing.

PRODUCT: Misys Laboratory System. Recall # Z-0646-03.

REASON: Two customers report that the organism identified on the patient's lab file do not match the reported susceptibility battery.

MANUFACTURER: Sunquest Information Systems, Tucson, AZ, by facsimile on October 18, 2002. Firm initiated recall is complete.

PRODUCT: Misys Laboratory System. Recall # Z-0647-03.

REASON: Software anomaly, incorrect coding. Some comments were not transferred when coming from the Reference Laboratory Interface.

MANUFACTURER: Abbott Laboratories, Santa Clara, CA, by letters on October 16, 2002. Firm initiated recall ongoing.

PRODUCT: Abbott brand Diluent/Sheath, Cell-Dyn 4000 System Cell-Dyn Reagent Model/List Number 01H73-01. Recall # Z-0648-03.

REASON: Product elicits fluorescent signal interference due to contamination.

CLASS III

MANUFACTURER: Remel, Inc., Lenexa, KS, by letters dated December 5, 2002. Firm initiated recall is complete.

PRODUCT: REMEL CXM 30 Cefuroxime 30 mcg, Antimicrobial Susceptibility Test Disk, 50 disks to a cartridge, 5 cartridges to a kit, catalog Number 33999. Recall # Z-0613-03.

REASON: Packages of Cefuroxime susceptibility disks erroneously contained Cefaclor susceptibility disks.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 12, 2003:

CLASS II

MANUFACTURER: X-Cel X-Ray Corp., Crystal Lake, IL, by telephone on November 19, 2002 and letters dated February 27, 2003. Firm initiated recall is complete.

PRODUCT: X-Cel MB-700 A/C Podiatry X-Ray System.

Recall #Z-0424-03.

REASON: The X-Ray system contained a defective X-Ray tube shield.

MANUFACTURER: Cook, Inc., Bloomington, IN, by letters on November 26, 2002. Firm initiated recall is ongoing.

PRODUCT:

• a) COOK Stiffened Micropuncture(r) Introducer Set, 4 FR. Product Reorder Number: MPIS-401-10.0-SC. Recall # Z-0425-03;
• b) COOK Stiffened Micropuncture(r) Introducer Set, 4 FR. Product Reorder Number: MPIS-401-10.0-SC-NT. Recall # Z-0426-03;
• c) COOK Stiffened Micropuncture(r) Introducer Set, 4 FR. Product Reorder Number: MPIS-401-10.0-SC-NT-U. Recall # Z-0427-03;
• d) COOK Stiffened Micropuncture(r) Introducer Set, 4 FR. Product Reorder Number: MPIS-401-15.0-SC-NT. Recall # Z-0428-03.
• e) COOK Stiffened Micropuncture(r) Introducer Set, 4 FR. Product Reorder Number: MPIS-401-20.0-SC-NT-UA-082900. Recall # Z-0429-03;
• f) COOK Stiffened Micropuncture(r) Introducer Set, 5 FR. Product Reorder Number: MPIS-501-10.0-SC. Recall # Z-0430-03;
• g) COOK Stiffened Micropuncture(r) Introducer Set, 5 FR. Product Reorder Number: MPIS-501-10.0-SC-LONDON-062593. Recall # Z-0431-03;
• h) COOK Stiffened Micropuncture(r) Introducer Set, 5 FR. Product Reorder Number: MPIS-501-10.0-SC-NT. Recall # Z-0432-03;
• i) COOK Stiffened Micropuncture(r) Introducer Set, 5 FR. Product Reorder Number: MPIS-501-10.0-SC-NT-U. Recall # Z-0433-03;
• j) COOK Stiffened Micropuncture(r) Introducer Set, 5 FR. Product Reorder Number: MPIS-501-10.0-SC-U. Recall # Z-0434-03;
• k) COOK Stiffened Micropuncture(r) Introducer Set, 5 FR. Product Reorder Number: MPIS-501-15.0-SC. Recall # Z-0435-03;
• l) COOK Stiffened Micropuncture(r) Introducer Set, 5 FR. Product Reorder Number: MPIS-501-15.0-SC-NT. Recall # Z-0436-03;
• m) COOK Stiffened Micropuncture(r) Introducer Set, 5 FR. Product Reorder Number: MPIS-501-15.0-SC-T-MKDT-090600. Recall # Z-0437-03;

REASON: The tip of the stiffened cannula might break during use and remain in the patient.

MANUFACTURER: Megadyne Medical Products, Inc., Draper, UT, by letter on December 20, 2002. Firm initiated recall ongoing.

PRODUCT:

• a) Megadyne Mega Tip, E-Z Clean Non Stick Cautery Tip, Single Use Only, STERILE. Recall # Z-0468-3;
• b) Megadyne Mega Tip, Modified E-Z Clean Non Stick Cautery Tip, Single Use Only, STERILE. Recall # Z-0469-3.

REASON: The metal substrate cautery tip may break during use.

MANUFACTURER: Thermage, Hayward, CA, by faxed recall notification on December 8, 2002 with a follow-up letter on December 9, 2002. Firm initiated recall is ongoing.

PRODUCT: ThermaCool TC 1.0 cm2 Treatment Tip, Single Patient Use Only. Recall # Z-0556-03.

REASON: The product tip has potential to liquid leakage into the internal circuitry causing malfunction and may result in epidermal injury.

MANUFACTURER: Philips Medical Systems, Bothell, WA, by letter dated January 10, 2003. Firm initiated recall is ongoing.

PRODUCT: MultiDiagnost 4 - x-ray system, multi functional/universal system for general use. Recall # Z-0586-03.

REASON: Internal short circuit - May allow for stand and table to move spontaneously in upward or downward movement.

MANUFACTURER: Stryker Howmedica Osteonics, Mahwah, NJ, by letters on January 7, 2003 and February 12, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Modular femoral and proximal tibial replacement system

consisting of femoral head/neck, body, stem and condyle components. Also proximal tibial body rotating hinge-type knee and stem components. Recall # Z-0587-03;

b) Modular Replacement System with Extra-Cortical Porous

Coating, Femoral Module Stem and Tibial Module Stem.

Recall # Z-0588-03.

REASON: Some components have disassociated post-operatively resulting in additional surgery to the patient.

MANUFACTURER: Jomed Catheters, Inc., Queensbury, NY, via e-mail on November 21, 2002. Firm initiated recall is complete.

PRODUCT: JOGRAPHY Cardiovascular Angiographic Catheter, 5F *** pigtail *** tapered with perfusion ports *** Single use, sterile, disposable intravascular catheters with an traumatic tip. Recall # Z-0593-03.

REASON: 6 Fr. Catheters packaged and labeled as 5 Fr.

MANUFACTURER: Philips Medical Systems, Inc. Cardiac & Monitoring Systems, Andover, MA, by letter on/about February 19, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Viridia/Agilent Information Center Model: M3150A#C01.

Recall # Z-0594-03;

b) Viridia/Agilent Information Center Model: M3151A#C01.

Recall # Z-0595-03;

c) Intellivue Information Center Model: M3150B#C01.

Recall # Z-0596-03;

d) Intellivue Information Center Model: M3150BU#C01.

Recall # Z-0597-03;

REASON: Central Station Monitoring Information Centers may experience screen freeze, i.e. loss of display, keyboard or mouse lock up.

MANUFACTURER: C. R. Bard, Inc. Electrophysiology Division, Billerica, MA, by letter on January 8, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Bard Stinger Ablation Catheter: Several Item Numbers. Recall # Z-0598-03;

b) Bard Stinger M Ablation Catheters: Several Item Numbers. Recall # Z-0599-03;

c) Bard Stinger S Ablation Catheter: Several Item Numbers. Recall # Z-0600-03;

d) Bard Stinger SM Ablation Catheter: Several Item Numbers. Recall # Z-0601-03;

e) Bard Orbiter ST Artrial Mapping Steerable Catheter: Several Item Numbers. Recall # Z-0602-03;

f) Bard Orbiter PV Steerable Catheter Item #: 320100

(Marketed in Europe Only). Recall # Z-0603-03.

REASON: Sterile barrier maybe perforated compromising sterility of the device.

MANUFACTURER: Integra LifeSciences Corp., Plainsboro, NJ, by letter and reply form on December 16, 2002. Firm initiated recall ongoing.

PRODUCT: External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implants, S.A. Recall # Z-0606-03.

REASON: The check valve in the patient line may stick in the closed position.

MANUFACTURER: Novartis Nutrition Corp., St Louis Park, MN, by letter dated January 31, 2003. Firm initiated recall ongoing.

PRODUCT: a) Compat Enteral Delivery Pump Set with Piercing Spike.

Recall # Z-0607-03;

b) Compat 500 mL Baggle Top Fill Enteral Feeding Container with Preattached Enteral Delivery Pump Set.

Recall # Z-0608-03.

c) Compat DualFlo Enteral Delivery Pump Set with 1000-mL

Twist Cap Formula Vinyl Bag and 1000-mL Twist Cap Water

Bag. Recall # Z-0609-03.

REASON: Some of the sets may leak or disconnect near the pump adapter during use. The patient could ingest air and vomit causing a safety concern.

MANUFACTURER: Datex-Ohmeda, Madison, WI, by letters dated September 16, 2002. Firm initiated recall ongoing.

PRODUCT: a) Datex-Ohmeda S/5 Oxygen Saturation Module (M-OSAT). Recall # Z-0610-03;

b) Datex-Ohmeda Cardiocap/5 Anesthesia Monitor with N-XOSAT SpO2 measurement option. Recall # Z-0611-03.

REASON: Falsely high blood oxygen saturation readings in some circumstances, which could result in no alarm in a critical life-threatening situation.

CLASS III

MANUFACTURER: Symbiosis Corp., Miami, FL, by letter on July 16, 2002. Firm initiated recall is complete.

PRODUCT: Scimed ChoICE PT "J" Tip 182 cm Guide Wire, a single use, sterile (EO), device packaged in a carrier tube, which is held in a coil by plastic clips. The carrier tube assembly of the guide wire is sealed into a pouch. The pouch assemblies are packaged in a five-pack product box.

Recall # Z-0589-03.

REASON: Labeled as J tip but may be straight tip.

MANUFACTURER: Symbiosis, Corp., Miami, FL, by letters on August 22, 2002. Firm initiated recall is ongoing.

PRODUCT: a) Scimed ChoICE PT Extra Support PTCA Guide Wire with ICE

Hydrophilic Coating, 300 cm length. Recall Z-0590-03.

b) Scimed PT Graphix Intermediate PTCA Guide Wire with ICE

Hydrophilic Coating, 300 cm length. Recall Z-0591-03.

REASON: Product labeled as Scimed Choice PT Extra Support PTCA Guide Wire 300 cm were actually Scimed PT Graphix Intermediate PTCA Guide Wire 300 cm.

MANUFACTURER: Baxter Healthcare, Corp., Round Lake, IL, by letter dated November 15, 2002. Firm initiated recall ongoing.

PRODUCT: Baxter Meridian Hemodialysis Instrument. The instrument is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultra filtration controller to prevent excessive loss of water from the patient's blood, an extra corporeal blood set, and a high permeability dialyzer. The standard features of the Meridian instrument include a high blood flow rate capacity (for shortened hemodialysis treatment time), automatic ultra filtration control, standard and variable bicarbonate and sodium capabilities and automated chemical disinfection. The Meridian will operate in either the bicarbonate or acetate mode for concentrates. Recall # Z-0605-03.

REASON: Meridian hemodialysis instrument may reset when in shutdown mode causing the system to reset with potential for patient increased bioburden exposure.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 5, 2003:

CLASS II

MANUFACTURER: Steris Corp., Mentor, OH, by letter and fax on February 21, 2003. Firm initiated recall ongoing.

PRODUCT: Steris Quick Connect (tethered) C1406, QLC1406, C1473, and QLC1473 Quick Connect for Olympus 30/40/160/200/240 Series Bronchoscopes in the C1140 Universal Processing Trays. Catalog numbers: C11473 and QLC1473. Recall # Z-0547-03.

REASON: The Steris device may not attach properly to retrofitted Olympus bronchoscopes, and become loose during the sterile processing cycle.

MANUFACTURER: Sulzer Spine-Tech, Minneapolis, MN, by letter dated January 17, 2003. Firm initiated recall ongoing.

PRODUCT: Spine-Tech Ancillary Discectomy Instrument (Box Curette), Catalog Number 07.00254.001, in Spine-Tech Ancillary Discectomy Instrument Set, Catalog Number 07.00316.001. Recall # Z-0559-03.

REASON: The product may have a twisted or broken tip.

MANUFACTURER: Ventana Medical Systems, Inc., Tucson, AZ, by letter on September 27, 2002. Firm initiated recall is complete.

PRODUCT: ChemMate (brand) Keratin Primary Antibody, Clones AE1, AE3, CAM 5.2 and 35 betaH11. Catalog number PAB111. Recall # Z-0560-3.

REASON: Inappropriate staining of tissue specimen caused by decreased sensitivity with certain component of antibody cocktail.

MANUFACTURER: Boston Medical Products, Inc., Westborough, MA, by letter on January 22, 2003. Firm initiated recall is ongoing.

PRODUCT: Boston Medical Products Otocell Ear Wick 15 mm, sterile Ref: EW-0915. Recall # Z-0561-03.  2 -

REASON: Product sterility may be compromised.

MANUFACTURER: Philips Medical Systems, Inc., Cleveland, OH, by a "Customer Advisory Notice" on January 23, 2003. Firm initiated recall ongoing.

PRODUCT: Prism 3000S and 3000XP Gamma Camera Systems.

Recall # Z-0563-03.

REASON: The radius motion may exceed the hardware limits, resulting in the detector head to drop towards the patient.

MANUFACTURER: Ortho Development Corporation, Draper, UT, by telephone and e-mail on December 26,2002. Firm initiated recall is ongoing.

PRODUCT: a) Hip Prosthesis as a component of Primaloc

Cementless/Collared Hip System. Recall # Z-0566-03;

b) Hip Prosthesis as a component of Primaloc

Cementless/Collarless Hip System. Recall # Z-0567-03;

c) Hip Prosthesis as a component of Primaloc

Cemented Hip System. Recall # Z-0568-03;

d) Hip Prosthesis as a component of TriFix J Cemented Hip. (Manufactured for distribution in Japan only.)

Recall # Z-0569-03;

REASON: Cleaning agent residue from packaging material was adhering to implantable hip stems.

MANUFACTURER: Dynarex Corporation, Orangeburg, NY, by letter on December 31, 2002. FDA initiated recall ongoing.

PRODUCT: a) Ear Loop Procedure Masks, for one time use only,

Glass-Free, Reorder No. 2201, packed in a cardboard

Box (unit box). Made in China. Product is labeled with a Latex-free symbol that states, "This product does not contain any natural rubber latex".

Recall # Z-0572-03;

b) Ear Loop Procedure Masks with plastic shield, for one time use only, Glass-Free, Reorder No. 2202, packed in a cardboard box (unit box). Made in China. Product is labeled with a Latex-free symbol that states, "This product does not contain any natural rubber latex".

Recall # Z-0573-03.

REASON: Product labeled as "latex free" but recent tests indicate that it contains minute amounts of latex.

MANUFACTURER: Nobel Biocare USA, Inc., CA, by recall letter and web. Firm initiated recall is ongoing.

PRODUCT: Nobel Biocare Replace Select Radiographic Template, part number 30159. Recall # Z-0575-03.

REASON: Misprinted radiographic template plates. Misprinted labeling.

MANUFACTURER: Allegiance Healthcare, Corp., El Paso, TX. Firm initiated recall is ongoing. Recalling Firm: Allegiance Healthcare, Corp., McGaw Park, IL, by letter dated January 22, 2003.

PRODUCT: Convertors three quarter sheet (Drape Sheet), catalog #29350. Individually packaged drapes, 20 packages per case. Recall # Z-0576-03.

REASON: The product labeled as sterile had not been through its sterilization cycle.

MANUFACTURER: Cook Biotech, Inc., West Lafayette, IN, by visit on December 13 and 17, 2002. Firm initiated recall is complete.

PRODUCT: Surgisis peripheral vascular patch; catalog number C-VSLH-$S-lx10. Recall # Z-0577-03.

REASON: Adverse events-suspected pseudoaneurysm.

MANUFACTURER: Lifecor, Inc., Pittsburgh, PA, by telephone on January 10, 2003 and letters on January 17, 2003. Firm initiated recall ongoing.

PRODUCT: Life Vest (WCD 3000) Electrode Belt. Wearable Cardioverter Defibrillator. Product label 20A0051-FI. Recall #Z-0578-03.

REASON: Wires may break or pull out, causing device to malfunction.

MANUFACTURER: Stryker Howmedica Osteonics, Mahwah, NJ, by letters on January 20, 2003. Firm initiated recall is ongoing.

PRODUCT: a) Gamma Drill 5.5x300mm. Recall # Z-0579-03;

b) Gamma AO Drill 5.5x300mm. Recall # Z-0580-03;

c) Gamma Drill Dia. 4.2x300mm. Recall # Z-0581-03;

d) T2 3.5x130mm AO Drill Bit. Recall # Z-0582-03;

e) T2 3.5x130mm Tri Flat Drill Bit. Recall # Z-0583-03;

f) T2 4.2mmx130mm AO Drill Bit. Recall # Z-0584-03;

g) T2 4.2mmx130mm Tri Flat Bit. Recall # Z-0585-03;

REASON: Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.

CLASS III

MANUFACTURER: Ortho-Clinical Diagnostics, Rochester, NY, by letters dated December 18, 2002. Firm initiated recall is ongoing.

PRODUCT: Carton Label: "TDM Performance Verifier I"; 6x2 mL vials****Catalog Number 896 2540. Recall # Z-0557-03

REASON: Cartons labeled "TDM Performance Verifier I" may contain TDM Performance Verified II.

MANUFACTURER: Ortho-Clinical Diagnostics, Rochester, NY, by letters dated January 10, 2003. Firm initiated recall is ongoing.

PRODUCT: Vitros Immunodiagnostic Products***Universal Wash Reagent***for in vitro diagnostic use only. The product is sold in cartons containing 2 bottles (5 liters each). CAT 838 9793. Recall # Z-0558-03.

REASON: Label printing irregularities on cartons and/or bottles.

MANUFACTURER: Symbiosis, Corporation, Miami, FL, by letters on September 3, 2002. Firm initiated recall is ongoing.

PRODUCT: Boston Scientific Microvasive Radial Jaw 3 Single-Use Maximum Capacity Biopsy Forceps Needle, 240 cm length, 3.3 mm Jaw Outside Diameter. Each device is packaged in a Tyvek laminate pouch. The pouch assemblies are packaged in a five-pack product box. Recall # Z-0562-03.

REASON: Product does not have the needle component as part of the jaw assembly.

MANUFACTURER: Baxter Healthcare, Corp., Largo, FL. Firm initiated recall is ongoing. Recalling Firm: Baxter Healthcare, Corp., Round Lake, IL, by letters dated December 23, 2002.

PRODUCT: a) HomeChoice Automated Peritoneal Dialysis Systems; Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, C4474R, T5C4441, T5C4441R. Recall # Z-0564-03;

b) HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R. Recall # Z-0565-03.

REASON: Potential for low ultrafiltrate volumes when using the Low Fill Mode during continuous cycling peritoneal dialysis (CCPD) therapy.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter dated January 20, 2003. Firm initiated recall is ongoing.

PRODUCT: Act 5 diff Cap Pierce Hematology Analyzer 864.5220 Automated differential cell counter. Recall #Z-0570-03.

REASON: Failure to cycle properly among samples.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by visit starting December 10, 2002. Firm initiated recall is ongoing.

PRODUCT: Coulter LH 700 series and GEN S Hematology Analyzers 864.5220 Automated differential cell counter.

Recall # Z-0571-03.

REASON: Device design allows for cross contamination to occur, possibly affecting assays and results reports.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 26, 2003:

CLASS I

***CORRECTION***

Enforcement Report for February 19, 2003, (03-08), the recall listing for Baxter, Recall # Z-0504-3/0523-3, list Baxter Healthcare, Corp., Deerfield, IL., as the manufacturer, the correct manufacturer is Baxter Healthcare, Corp., Cleveland, MS., and Baxter Healthcare, Corp., Albonito, PR.

MANUFACTURER: General Electric Med Systems, Waukesha, WI, by field modification instructions on November 21, 2002. Firm initiated recall is ongoing.

PRODUCT: Revolution XR/d Wall Stand, Model Number 2291655, for Revolution XR/d Digital Radiographic Imaging Systems .

Recall # Z-0157-03.

REASON: The devices do not meet requirements in 21 CFR 1010.2 in that they lack certification labels.

MANUFACTURER: Allegiance Healthcare, Corp., Mannford, OK. Firm initiated recall is ongoing. Recalling Firm: Allegiance Healthcare, Corp., McGaw Park, IL, by letters dated November 15,2002.

PRODUCT: Pharmaseal Thoracentesis Tray with Catheter, catalog number 4341B; a sterile, single use, Rx, latex free procedure tray containing a 7" long Thoracentesis Catheter with a 14 gauge x 2" needle, catheter guard, 60 ml syringe, needles, 5 ml syringe, drainage tube with needle, fluid collection bag, three prelabeled specimen vials with caps, 2 swab sticks, three gauze pads, fenestrated drape with adhesive strips, towel, 5 ml -1% lidocaine hydrochloride, hospital wrap and bandage. Recall # Z-0420-03.

REASON: Raw material used in the manufacture of catheters may contain a contaminant predisposing the catheter to become brittle, possibly breaking during use.

MANUFACTURER: Baxter Healthcare Corp., Cleveland, MS. Firm initiated recall is ongoing. Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letter dated December 18, 2002.

PRODUCT:
a) Y-Type Blood/Solution Set, catalog #1C8029; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, Injection Site, Male Luer Lock Adapter, 111'' long, 10 drops per mL. Recall # Z-0448-03;
b) Y-Type Blood/Solution Set, catalog #1C8117; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, Injection Site, Male Luer Lock Adapter, 88'' long, 10 drops per mL. Recall # Z-0449-3.
c) Y-Type Blood/Solution Set, catalog #1C8372; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, 2 Injection Sites, Male Luer Lock Adapter, 111'' long, 10 drops per mL. Recall # Z-0450-3;
d) Y-Type Blood/Solution Set, catalog #1C8459; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, 3 Injection Sites, Male Luer Lock Adapter, 111" long, 10 drops per mL. Recall # Z-0451-3;
e) Y-Type Blood/Solution Set with Pressure Pump, catalog #1C8658; Standard Blood Filter (170 to 260 micron), Drip Chamber Pump, Injection Site, Male Luer Lock Adapter, 109" long, 10 drops per mL. Recall # Z-0452-3.

REASON: Leakage may occur at the inlet port.

MANUFACTURER: Stryker Instruments, Instruments Div., Kalamazoo, MI, by telephone, beginning on December 3, 2002, and by letter dated December 6, 2002. Firm initiated recall is complete.

PRODUCT: Stryker brand Neptune waste management system, model 711-27-1. Recall # Z-0524-03.

REASON: Cap may be cracked and fail, exposing O.R. staff to patient blood, and cause an unexpected loud noise in the O.R.

MANUFACTURER: Cook Urological, Inc., Spencer, IN, by telephone and letter beginning on January 22, 2003. Firm initiated recall is ongoing.

PRODUCT:
a) Pursuit ureteral dilation balloon catheters, 6 mm x 4 cm. Order # PAB-050080-6-4.0. Recall # Z0554-3;
b) Pursuit ureteral dilation balloon catheters, 6 mm x 8 cm. Order # PAB-050080-6-8.0. Recall # Z-0555-03.

REASON: Product is labeled sterile, but was not sterilized.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 19, 2003:

CLASS I

MANUFACTURER: Baxter Healthcare Corp., Deerfield, IL. Firm initiated recall ongoing. Recalling Firm: Baxter Healthcare Corp., Round Lake, IL., by letter dated October 17, 2002.

PRODUCT: a) Baxter Vented Buretrol Volumetric Pump Solution Set, 10 drops/mL; catalog 1C8384; 10 units per case. ecall # Z-0504-03;
b) Baxter Interlink System Minivolume Extension Set; catalog 1C8412. Recall # Z-0505-03;
c) Baxter Y-Type Minivolume Extension Set; catalog C8499. Recall # Z-0506-03;
d) Baxter Interlink System Extension Set with 0.22 Micron Filter, catalog 1C8546. Recall # Z-0507-03;
e) Baxter Interlink System Vented Buretrol Solution Set,10 drops/mL; catalog 1C8560. Recall # Z-0508-03;
f) Baxter Interlink System Minivolume Extension Set with 0.22 Micron Filter, catalog 1C8577. Recall # Z-0509-03;
g) Baxter Interlink System Buretrol Solution Set, 10 drops/mL; catalog 1C8633. Recall # Z-0510-03;
h) Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8516 and 1M8516Y. Recall # Z-0511-03;
i) Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8522 and 1M8522Y. Recall # Z-0512-03;
j) Baxter Auto Syringe Micro-Volume Extension Set with 0.22 Micron Filter, catalog 1M8527 and 1M85827Y. Recall # Z-0513-03;
k) Baxter Auto Syringe Extension Set with 0.22 Micron Filter, catalog 1M8529. Recall # Z-0514-03;
l) Baxter Minivolume T-Connector Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2C5683, 48 units per case. Recall # Z-0515-03;
m) Baxter Minivolume Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2C5693, 48 units per case. Recall # Z-0516-03;
n) Baxter Interlink System Microbore T-Connector Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2N3332, 200 units per case. Recall # Z-0517-03;
o) Baxter Interlink System Microbore T-Connector Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2N3333, 200 units per case. Recall # Z-0518-03;
p) Baxter Microbore 3-Lead Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2N3342, 50 units per case. Recall # Z-0519-03;
q) Baxter 36" Micro-Volume Extension Set, catalog 2N3347. Recall # Z-0520-03;
r) Baxter 60" Micro-Volume Extension Set, catalog 2N3350. Recall # Z-0521-03;
s) Baxter Interlink System Minivolume Extension Set, catalog 1C8483. Recall # Z-0522-03;
t) Baxter Interlink System Buretrol Solution Set,60 drops/mL; catalog 1C8600. Recall # Z-0523-03.

REASON: The I.V. filter sets contain a 1.2 micron filter instead of the labeled 0.22 micron filter.

CLASS II

***CORRECTION***

Enforcement Report for February 12,2003, (03-07), the recall listing for Spinal 26 Gauge Quincke with Bupivacaine, Epinephrine, and Lidocaine, Recall # Z-0527-03 has Abbott Laboratories, Abbott Park, IL listed as the Recalling Firm/Manufacturer, the correct Recalling Firm/Manufacturer is Abbott Laboratories, Laurinburg, NC

MANUFACTURER: X-Cel X-Ray Corporation, Crystal Lake, IL, by technician visit beginning February 13, 2003. Firm initiated recall ongoing.

PRODUCT: X-Cel MB-700 A/C Podiatry X-Ray System. Recall # Z-0424-03.

REASON: The X-Ray system contained a defective X-Ray tube shield.

MANUFACTURER: Gulden Ophthalmics, Elkins Park, PA., by letters on November 29, 2002. Firm initiated recall ongoing.

PRODUCT:
a) Venus Eye Sphere 12 mm (Sterile). Recall # Z-0528-03;
b) Venus Eye Sphere 14 mm (sterile). Recall # Z-0529-03;
c) Venus Eye Sphere 16 mm (sterile). Recall # Z-0530-03;
d) Venus Eye Sphere 18 mm (sterile). Recall # Z-0531-03;
e) Venus Eye Sphere 20 mm (sterile). Recall # Z-0532-03;
f) Venus Eye Sphere 22 mm (sterile). Recall # Z-0533-03;
g) Conformer Small (sterile). Recall # Z-0534-03;
h) Conformer Medium (sterile. Recall # Z-0535-03;
i) Conformer Large (sterile). Recall # Z-0536-03;
j) Conformer Small with holes (sterile). Recall # Z-0537-03;
k) Conformer Medium with holes (sterile). Recall # Z-0538-03;
l) Conformer Large with holes (sterile). Recall # Z- 0539-03;
m) Venus Eye sphere 10 mm (Sterile). Recall # Z-0540-03.

REASON: Lack of sterility assurance.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA., by letters on January 10, 2003. Firm initiated recall is ongoing.

PRODUCT: Coulter LH 700 Series Hematology Analyzers. Recall # Z-0541-03.

REASON: Biohazard situation exists for users.

MANUFACTURER: Medtronic Physio Control Corp., Redmond, WA, by letter, on January 27, 2003. Firm initiated recall is ongoing.

PRODUCT: Lifepak 12 defibrillator/monitor is a portable battery operated, complete acute cardiac care response system with both manual and semi-automatic defibrillation operation. Recall # Z-0542-03.

REASON: Impact and damage to the high voltage connectors results in poor or no electrical contact from the cable to the LIFEPAk 12 unit.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA., by letter on December 16, 2002. Firm initiated recall is ongoing.

PRODUCT: Synchron LX20 and LX20 Pro. Recall # Z-0545-03.

REASON: The disk that controls the home position of the sample wheel comes loose preventing a proper home sequence.

MANUFACTURER: Biomet, Inc., Warsaw, IN., by letter on January 21, 2003. Firm initiated recall is ongoing.

PRODUCT: Radiopaque bone cement, 40 gram. Product number 424800. Recall # Z-0546-03.

REASON: There may be cracks in the blister pack overwrap for the glass ampoule containing the liquid monomer.

MANUFACTURER: Zoll Medical Corp., Burlington, MA., by letter on December 17, 2002. Firm initiated recall is ongoing.

PRODUCT: Zoll AED Plus Defibrillator (Automatic External Defibrillator). Recall # Z-0548-03.

REASON: Defibrillator may fail to function due to false detection of safety fault condition.

MANUFACTURER: Boston Scientific Corp., Natick, MA., by letter dated January 27, 2003, and mailed January 29,2003. Firm initiated recall is ongoing.

PRODUCT: a) Boston Scientific/Microvasive Rapid Exchange retrieval Balloon/8.5 mm balloon, Catalog #4544. Recall # Z-0551-03; b) Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/11.5 mm balloon, Catalog #4545. Recall # Z-0552-03. c) Boston Scientific/Microvasive Rapid Exchange Retrieval Balloon/15.5 mm balloon, Catalog #4546. Recall # Z-0553-03.

REASON: Breach in sterile barrier may compromise sterility.

CLASS III

MANUFACTURER: Surgical Specialties Corp., Reading, PA., via fax on November 8, 2002 and December 10, 2002 and via email on November 5, and November 12, 2002. Firm initiated recall is complete.

PRODUCT: 25 Gauge Hydrodissection Cannula 1" (25 mm) with U-Shaped Flattened End. Recall # Z-0543/Z-0544-03.

REASON: The wrong product in the box.

MANUFACTURER: Ascension Orthopedics, Inc., Austin, TX., by e-mail and telephone on October 31, 2002 and November 1, 2002. Firm initiated recall is ongoing.

PRODUCT: a) Ascension PIP, Prosthesis, finger, semi-constrained, pyrolytic carbon, uncemented. The Ascension PIP received Humanitarian Device Exemption approval on March 22, 2002, under HDE number H010005. Recall # Z-0549-03; b) Ascension MCP, Prosthesis, Finger Joint, Metacarpophalangeal. Recall # Z-0550-03.

REASON: Brochures approved for international distribution only were distributed domestically.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 12, 2003:

CLASS II

***CORRECTION***

Enforcement Report for February 5, 2003, (03-06), the recall listing for Baxter's Sodium Chloride Flush and Heparin Lock Flush Syringes, Recall # Z-456/458-3 has Baxter, Deerfield, IL listed as the manufacturer, the correct manufacturer is Baxter, Nashville, TN.

MANUFACTURER: LifeNet, Virginia Beach, VA, by telephone and letter on December 19, 2002. Firm initiated recall complete.

PRODUCT: Pulmonary heart valve allograft, human tissue for transplantation. Recall # Z-0525-03.

REASON: A heart valve from donor whose sera was found potentially positive for Hepatitis C, was distributed.

MANUFACTURER: Philips Medical Systems, Bothell, WA., by letter dated September 27, 2002. Firm initiated recall ongoing.

PRODUCT: Philips BV 300 Mobile X-Ray System. Recall # Z-0526-03.

REASON: The C-bow support can bend and break allowing C-arm to fall from support.

MANUFACTURER: Abbott Laboratories, Abbott Park, IL., by letters on September 12, 2002. Firm initiated recall ongoing.

PRODUCT: Spinal 26 Gauge Quincke with Bupivacaine, Epinephrine, and Lidocaine. Recall # Z-0527-03.

REASON: Mis-stenciling on tray. Tray stenciled Saddle Block instead of Spinal.

CLASS III

MANUFACTURER: Stryker Howmedica Osteonics, Mahwah, NJ., by letter on December 2, 2002. Firm initiated recall ongoing.

PRODUCT: a) Restoration #8 HA Hip Stem, Catalog No. 6013-1216; b) Restoration #8 HA Hip Stem, Catalog No. 6013-1218.  Recall # Z-467-3.

REASON: Product mix-up. 16mm stem in a 18mm package.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 5, 2003:

CLASS II

MANUFACTURER: Sulzer Dental Inc. Carlsbad, by telephone on July 31, 2001. Firm initiated recall complete.

PRODUCT: Hex-Lock Abutment, 2.5 mm Diameter. This medical device is designed for use in the firm's Sulzer Dental Implant Systems for use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The abutment is screwed onto an endosseous dental implant, protrudes through the gingiva and is attached to the prostheses or fabricated tooth. The catalog numbers affected are HLA3/4. The devices are labeled sterile. Recall # Z-1034-02.

REASON: Sterility

MANUFACTURER: Baxter Healthcare Corporation, Deerfield, IL. Firm initiated recall ongoing. Recalling Firm: Baxter Healthcare, Corp., Round Lake, IL. by letter dated December 12, 2002.

PRODUCT:
a) 0.9% Sodium Chloride Flush Syringe, 30 syringes per case. Recall # Z-0456-03;
b) 10 U/mL Heparin Lock Flush Solution USP, 5mL in 12 mL Syringe, 30 syringes per case. Recall # Z0457-3;
c) 100 U/mL Heparin Lock Flush Solution USP; 30 syringes per case. Recall # Z-0458-03.

REASON: Sterility questioned.

MANUFACTURER: Zimmer Inc., Warsaw, IN, by letter dated January 6, 2002. Firm initiated recall is ongoing.

PRODUCT:
a) Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a 0 neck length on Co-Cr 12/14 tapers. Cat. No. 6418-26-02. Recall # Z-0459-3;
b) Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a +3.0 neck length on Co-Cr 12/14 tapers. Cat. No. 6418-26-03. Recall # Z-0460-3;
c) Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a +3.5 neck length on Co-Cr tapers. Cat. No. 6418-28-03. Recall # Z-0461-3.

REASON: Compression test results are not in accordance with device approval submission.

MANUFACTURER: Meridian Bioscience Inc., Cincinnati, OH, by letter on December 26, 2002. Firm initiated recall is ongoing.

PRODUCT:
a) Premier brand C. difficile Toxin A, diagnostic test kits, one kit per pouch, one pouch per shipping box. Recall # Z-0463-3.
b) Premier brand Toxins A. & B, diagnostic test kits, one kit per pouch, one pouch per shipping box. Recall # Z-0464-3.
c) Premier Platinum brand HpSA, diagnostic test kits, one kit per pouch, one pouch per shipping box. Recall # Z-0465-3.

REASON: Due to defective packaging, the firm cannot assure product stability through the labeled expiration date.

MANUFACTURER: Kendall, a division of Tyco Healthcare Group LP Argyle, NY. Firm initiated recall is ongoing. Recalling Firm: Tyco Healthcare Group Lp/Kendall Mansfield, MA, by letter on October 2, 2001.

PRODUCT: Kendall Argyle 3.7 Fr Polyurethane Umbilical Vessel Catheter. Recall # Z-0471-3.

REASON: Lumen of Catheter may not accomodate the designated blood gas sensor.

MANUFACTURER: Zimmer, Inc., Warsaw, IN., by letter and via e-mail on January 7, 2003. Firm initiated recall ongoing.

PRODUCT:
a) Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size ll, standard body. Cat. No. 7841-11-10. Recall # Z-0472-30;
b) Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size l2, standard body. Cat. No. 7841-12-10. Recall # Z-0473-30;
c) Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size l3, standard body. Cat. No. 7841-13-10. Recall # Z-0474-30;
d) Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size l4, standard body. Cat. No. 7841-14-10. Recall # Z-0475-30;
e) Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size l5, standard body. Cat. No. 7841-15-10. Recall # Z-0476-30;
f) Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size l6, standard body. Cat. No. 7841-16-10. Recall # Z-0477-30;

REASON: The femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper.

CLASS III

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN., by letter dated December 16, 2002. Firm initiated recall is ongoing.

PRODUCT: PO2 electrode for Roche AVL OMNI Analyzers. Catalog number BP1734. Recall # Z-0438-3.

REASON: Air bubbles trapped in the PO2 electrode will cause falsely elevated patient test results.

MANUFACTURER: Hitachi Ltd., Ibaraki-ken 312-8504, Japan. Firm initiated recall is ongoing. Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated October 18, 2002.

PRODUCT: a) Roche/Hitachi Modular Analytics E 170 Module. Recall # Z-0454-3; b) Roche/Hitachi Integrated MODULAR ANALYTICS E 170 Module. Recall # Z-0455-3.

REASON: Fluid leak may cause smoke/damage analyzer.

MANUFACTURER: Sandhill Scientific, Inc., Highlands Ranch, CO, by letter on January 8, 2003. Firm initiated recall is ongoing.

PRODUCT: ComforTEC II Single Use pH Probe Latex Free. Packaged individually. Recall # Z-0466-3.

REASON: Failure of the dry silver chloride reference, resulting in malfunction and a 'Lead Off' indication.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 29, 2003:

CLASS II

MANUFACTURER: Abbott laboratories, Inc., Abbott Park, IL, by letters dated July 2, 2002. Firm initiated recall is ongoing.

PRODUCT: IMx Glycated Hemoglobin Reagent Sets, list 1A86-88;

the set is composed of the IMx Gylcated Hemoglobin 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. Recall # Z-0445-3.

REASON: Low Control reads high, out of insert range.

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The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 22, 2003:

CLASS II

MANUFACTURER: Action Products Incorporated, Hagerstown, MD, by letter on May 14, 2002. Firm initiated recall is complete.

PRODUCT: Drop Hooks for Xact (tm) Lo-Pro with Removeable Drop Seat, Xact Integrated, and Xact Individual with Integrated Drop Seat wheelchairs, model/item numbers 05D, 1D, and 15D. Packaged as set of four in a poly bag.

Recall # Z-316/318-3.

REASON: Wheelchair seat component is defective.

MANUFACTURER: Becton Dickinson & Co., Sparks, MD, by fax on November 18, 2002. Firm initiated recall is ongoing.

PRODUCT: Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitalex), microbiological media plates. Catalog # 221267. Recall # Z-0345-3.

REASON: Microbiological media may exhibit No Growth or reduced colony size of Haemophilus species.

CLASS III

MANUFACTURER: Ciba Vision Corporation, Duluth, GA, by letter on December 16, 2002. Firm initiated recall is ongoing.

PRODUCT: FreshLook, TORIC, for Astigmatism (phemfilcon A) Contact Lenses, BC Median, DIA 14.5, Lot 041599, 2007-01.

Recall # Z-405-3.

REASON: Mislabeling.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 15, 2003:

CLASS II

MANUFACTURER: Ciba Vision Corporation, Duluth, GA, by letter on November 12, 2002 with attached Business Reply Card form. Firm initiated recall is ongoing.

PRODUCT: Blue-Vis, CIBASOFT VISITINT, daily wear contact lens. Recall # Z-0342-3;

REASON: Lenses were labeled with the wrong prescription.

MANUFACTURER: SSL Americas Inc., Norcross, GA, by telephone and letter November 25, 2002. Firm initiated recall is ongoing.

PRODUCT: Biogel Skinsense N, Non-Latex, Powder-free Surgical Gloves with Biogel coating, Neoprene, Made from a synthetic Elastomer, Sterile/R, REGENT, One Pair sterile gloves packaged 50 pair per box/ 4 boxes per case/ total 200 pair per case. Recall # Z-0346-3.

REASON: Sulfur particles on the surface of gloves.

MANUFACTURER: River City Drug, Marietta, GA by letters on/about October 8, 2002. Firm initiated recall is ongoing.

PRODUCT: a) SureStep 50 Test Strips, For the measurement of glucose

in whole blood, Two bottles of 25 Test Srips, LIFESCAN.

Recall # Z-0398-3;

b) Genuine One Touch Glucose 50 Test Strips, For the

quantitative measure of glucose in whole blood, For Sale

Outside of the USA and Canada. Product is packed two

vials of 25 strips per vial. Recall # Z-0399-3;

REASON: Products labeled 'For Sale Outside The USA and Canada,' were being offered for sale in the U.S.

MANUFACTURER: Ohmeda Medical, Laurel, MD, by letter on October 21, 2002. Firm initiated recall is ongoing.

PRODUCT: Ohmeda Medical Giraffe(tm) Omnibeds; and Ohmeda Medical Giraffe(tm) Incubators. Recall # Z-409-3.

REASON: Electrical defects in neonatal incubators may lead to unintended movement.

MANUFACTURER: Laser Peripherals, LLC., Golden Valley, MN, by telephone on October 15, 2002. Firm initiated recall is ongoing.

PRODUCT: Side Fire Laser Fibers, Models;

a) DBLF-60SF;

b) HBLF-60SF.

Recall # Z-0411-3.

REASON: The laser fibers were manufactured with an expired epoxy sealant, which could result in degradation and misdirection of the laser beam.

CLASS III

MANUFACTURER: C.R. Bard, Inc., Urological Division, Covington, GA, by letters on November 4, 2002. Firm initiated recall is ongoing.

PRODUCT: Contigen Bard Collagen Implant. The product is one syringe filled with Contigen. Description: Contigen Bard collagen implant is a sterile, nonpyrogenic device composed of highly purified bovine dermal collagen. Recall # Z-0344-3.

REASON: Contigen Bard Collagen Syringe cartons have incorrect expiration dates.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter on May 20, 2002. Firm initiated recall is ongoing.

PRODUCT: EXPO 32 Software. Recall # Z-0407-3.

REASON: Software contains errors that might affect Cytometry instruments.

MANUFACTURER: Circon Acmi, Norwalk, OH. Firm initiated recall is ongoing.

Recalling Firm: ACMI Corporation, Racine, WI, by telephone on June 19, 2002

PRODUCT: Cryo-Tip T-1910 Exo-Endocervical, Part Number 90501 (as labeled) for use with the Circon Cryomedics MT-700 Cryosurgical System. Recall # Z-412-3.

REASON: Derm Bevel Cryo-Tips, Part Number 90512, were mislabeled as Exo-Endocervical Cryo-Tips, Part Number 90501.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 8, 2003:

CLASS II

MANUFACTURER: Philips Medical Systems, Highland Heights, OH, by letter dated October 8,2001. Firm initiated recall is ongoing.

PRODUCT: AXIS/IRIX Gamma Camera System, controlled with Odyssey computers, operating with version 8.5 software. Recall # Z-0353-3/Z-0364-3.

The systems are controlled with Odyssey computers that are connected to a Prism gantry. Some Odyssey computers operate as stand alone workstations. A Prism XPVT System, Tomography, Computed, Emission, 90KPS System.

REASON: A broken gantry wire may prevent the contact sensors from stopping motion of the unit.

MANUFACTURER: GE Medical Systems Europe, 78533 Buc Cedex, France. Firm initiated recall is ongoing.

PRODUCT: LC+, LCV+, and LCA Angiographic X-ray Systems.

Recall # Z-0365-3/Z-0381-3.

REASON: The motor gearshaft for the image intensifier may break allowing the image intensifier to slide down to its end stop.

MANUFACTURER: Becton Dickinson Critical Care Systems Pte Ltd., Singapore. Firm initiated recall is complete.

PRODUCT: BD DTX Plus Pressure Monitoring Kits and Extension Sets. Packaged as a single unit or assembled in pressure monitoring kits prior to sterilization. Recall # Z-0383-3/Z-0393-3.

REASON: Bond between the tubing and female or male luer fitting may fail.

MANUFACTURER: Arrow International, Reading, PA, by letters dated November 11, 2002. Firm initiated recall is ongoing.

PRODUCT: 9 Fr. Percutaneous Sheath Introducer KitZs, catheter introducer. Recall # Z-0394-3.

REASON: Possibility of leakage.

MANUFACTURER: Digene Corp., Gaithersburg, MD, by letters dated November 11, 2002. Firm initiated recall is ongoing.

PRODUCT: Digene's Rapid Capture System (RCS) robotic microplate processor, Catalog #6000-3111. Recall # Z-0395-3.

REASON: IVD instrument may measure incorrect sample volume for clinical testing.

MANUFACTURER: Greiner Vacuette North America, Inc., Monroe, NC, by letter dated September 11, 2002. Firm initiated recall is ongoing.

PRODUCT: Holdex tube holder. Recall # Z-0396-3.

REASON: Holdex tube holder malfunction: the inner metal tube of device dislodged.

MANUFACTURER: Medex, Inc., Hilliard, OH. Firm initiated recall is ongoing. Recalling Firm: Medex, Inc., Dublin, OH, by telephone and fax beginning October 17, 2002.

PRODUCT: Medex Vented Flow Clip Nitroglycerin Set, Pv22ml, sterile, packaged 20 units per case. Recall Z-0397-3.

REASON: Product contains latex, however the label incorrectly states 'Latex Free'.

CLASS III

MANUFACTURER: Deroyal Surgical, Rose Hill, VA, by letter on September 17, 2002. Firm initiated recall is ongoing.

PRODUCT: Myocardial Temperature Probe, YSI 400 Series, 15mm, packaged in sterile and non-sterile pouches, 20 or 40 pouches per carton. Catalog #81-030415 and #81-031415. Recall # Z-0406-3.

REASON: Surgical device is mislabeled with incorrect size.
 

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