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FDA Recalls

August 7, 2002 - December 25, 2002

Attention all mdi Clients:

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 25, 2002:

CLASS II

MANUFACTURER: Digene Corp., Gaithersburg, MD, by telephone and fax beginning October 8, 2002. Firm initiated recall is ongoing.

PRODUCT: Detection Reagent 1 of Digene's Hybrid Capture(TM) System Human Papilloma Virus DNA Assay test kit, catalog #4401-1030. Recall # Z-0330-3.

REASON: IVD test kit reagent may give false negative results.

MANUFACTURER: Stryker Corp., Kalamazoo, MI, by letter on October 23, 2002. Firm initiated recall is ongoing.

PRODUCT: Stryker Wedge turning frame stretcher, model 965.

Recall # B-0331-3.

REASON: Weld failure-anterior and posterior frame may dislodge from stretcher litter.

MANUFACTURER: Joy House, China. Firm initiated recall is ongoing. Recalling Firm: Avon Products, Inc., New York, NY, by voice message on July 25, 2002 and by letter on July 29, 2002.

PRODUCT: Little Soothers Cold pack. Each boxed set (unit) contains 3 patches. The Little Soother is a 3-inch by 2-inch sealed plastic liquid-filled patch. It was manufactured in three shapes: a yellow fish, a pink butterfly, and a blue penguin. Recall # Z-0332-3.

REASON: Microbial contamination.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on/about October 4, 2002. Firm initiated recall is ongoing.

PRODUCT: Cryolife Valve Allograft. Recall # Z-0333-3.

REASON: Donor tissue had possible sepsis secondary to pyogenic brain abscess.

MANUFACTURER: Baxter Healthcare Corporation, Largo, FL. Firm initiated recall is ongoing. Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated September 19 and 20, 2002.

PRODUCT: HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems; Made in U.S.A.; Recall # Z-0334-3/Z-0339-3. The following models are affected:

a) Baxter HomeChoice Automated PD System, catalog 5C4471,

115 volt; b) Baxter HomeChoice Automated PD System, catalog 5C4474, 220 volt; c) Yume Automated PD System, catalog T5C4441, 100 volt; d) Baxter HomeChoice PRO Automated PD System, catalog 5C8310, 115 volt; e) Baxter HomeChoice PRO Automated PD System, catalog 5C8320, 220 volt; f) Yume Plus Automated PD System, catalog T5C8300, 100 volt.

REASON: Possible overfill.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 18, 2002:

CLASS II

MANUFACTURER: Stryker Howmedica Osteonics Corp. Co., Cork, Ireland. Firm initiated recall is ongoing. Recalling Firm: Howmedica Osteonics Corp., Rutherford, NJ, by letters on June 26, 2002.

PRODUCT: Alumina V40 Head Femoral Bearing Head Hip Joint, Metal/Ceramic/Polymer, Semi-Constrained Cemented or Nonporous Uncemented prosthesis. Recall # Z-0327-3.

REASON: V40 Alumina Heads may not assemble properly onto V40 hip stems.

MANUFACTURER: Arrow Intl., Inc., Reading, PA, by letters dated October 14, 2002. Firm initiated recall is ongoing.

PRODUCT: Epidural Catheterization Kit, model number AK-05503L. The kit is labeled as containing a 19 gauge catheter. The catheter permits access to the epidural space.

Recall # Z-0328-3.

REASON: Mislabeled - package may contain incorrect gauge catheter.

CLASS III

MANUFACTURER: Abbott Laboratories, Inc., Irving, TX. Firm initiated recall is ongoing. Recalling Firm: Abbott Laboratories, Inc., Abbott Park, IL, by telephone on October 10, 2002 and by letters sent on October 11, 2002.

PRODUCT: Qwikwash Tubing (Air, Waste, Water), list 6208-23; an accessory for use with the Abbott Commander Parallel Processing Center (PPC) and Qwikwash Instruments; each package contains 3 pieces of tubing. Recall # Z-0326-3.

REASON: Visual discoloration of water tubing assembly.

MANUFACTURER: Aesculap Ag & Co., Kg. Tuttlingen, Donau. Firm initiated recall is complete. Recalling Firm: Aesculap, Inc., Center Valley, PA, by letters dated September 11, 2002.

PRODUCT: Trade Name: ABC Fixation Pin.

System Name: ABC Cervical Plating System.

Common Name: Plate Fixation Pin. The device product number is FJ833R and sold 2 per box. Recall # Z-0329-3.

REASON: Pin manufactured with sharp tip and not hardened, pin may be susceptible to bending.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 11, 2002:

CLASS II

MANUFACTURER: Medtronic Puerto Rico, Inc., Villalba, RQ. Firm initiated recall is ongoing. Recalling Firm: Medtronic, Inc., Minneapolis, MN, by letter dated October 29, 2002.

PRODUCT: Medtronic RF Enhancr SC Single-Curve Steerable Ablation Catheters,Model numbers 11744523, 11745523, 11745533, 19745533, 19746534. Recall # Z-0320-3;

Medtronic RF Enhancr NTC (Non-Thermocouple) Steerable

Mapping/Ablation Catheters, Model numbers 21744523, 21745523, 29745533, 29746534. Recall # Z-0231-3.

REASON: In some of the catheters, the catheter manipulator wire detached from the catheter insulating tip anchor during operation of the catheter deflection mechanism and after detachment penetrated the catheter wall and protruded from the shaft.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 4, 2002:

CLASS II

MANUFACTURER: Alto Development Corp., Farmingdale, NJ, by letter on August 27, 2002. Firm initiated recall is complete.

PRODUCT: MYO/WIRE™ Temporary Cardiac Pacing Wire.

Recall # Z-0305-3.

The wire has a piece for connecting to a generator on one end and the opposite end has a hook shaped needle designed for contact with the heart. Outer carton labeled in part, **MYO/WIRE***Temporary Cardiac Pacing Wire***Soft multi-stranded surgical steel wire***Extruded PTFE insulation*** ***Contents: 24 individual sterile wires***Instructions for use and warnings inside box.***Single use. Do not resterilize.”

The INCORRECT Insert is labeled in part: "MYO/WIRE II Sternotomy Sutures.

The CORRECT insert is labeled in part: “MYO/WIRE Temporary Cardiac Pacing Wires.

REASON: Insert mix-up.

MANUFACTURER: Allied Healthcare Products, Inc., St. Louis, MO, by letter on October 7, 2002. Firm initiated recall is ongoing.

PRODUCT: AC/DC portable aspirators manufactured under the following brand names: Gomco OptiVac Aspirator, Model G178; w/carrying case, Model GC178Life Support Products OptiVac Aspirator, Model L178; w/carrying case, Model LC178 Schuco OptiVac Aspirator, Model S178; w/carrying case Model SC178 RX device. Recall # Z-306-3.

REASON: Power supply could overheat.

MANUFACTURER: Boehringer Laboratories, Norristown, PA, by telephone June 7, 2002. Firm initiated recall is ongoing.

PRODUCT: Boehringer Suction Regulator, Suction Regulator.

Recall # Z-0309-3.

REASON: Units provided three positions instead of the described two.

MANUFACTURER: Spacelabs Burdick, Inc., Deerfield, WI, by letters dated November 5, 2002. Firm initiated recall is ongoing.

PRODUCT: Spacelabs Burdick Cassette Holter Recorders, Models 90205 (2 channel) and 90208 (3 channel).

Recall # Z-0311-3.

REASON: The tape head slide spring may cause the tape speed to change.

MANUFACTURER: Hill-Rom Air-Shields, Hatboro, PA, by letter dated May 20, 2002. FDA initiated recall is ongoing.

PRODUCT: a) Micro-Lite Phototherapy System, Model PTS68-1, Recall # Z-1324-2;

b) Infant Intensive Care System 7850 Photherapy, Model PTM78-3. Recall # Z-1325-2.

REASON: The power supply malfunctions, causing the unit to become inoperable.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 27, 2002

CLASS I

MANUFACTURER: Tri-State Hospital Supply Corp., Howell, MI, by letters on October 11, 2002. Firm initiated recall is ongoing.

PRODUCT: Recall # Z-0183-3/Z-0239-3.

The following products under the Centurion Healthcare Products brand:

Oral Swabs, Sodium Bicarb Treated, 2/Pkg., 800/case.

Latex-free. Reorder 3599SB2.

10/Pkg. Sodium Bicarb Oral Swabs, 100 per case. Reorder MC110SB. 20/Pkg. Sodium Bicarb Oral Swabs, Rorder MC120SB. Admission Kits. Reorder H895. Large Oral Swabs, 4000/case. Reorder 3599XT. Plain Oral Swab, 1/package, 800/case, latex-free. Reorder 3599XT1. Oral Swabs, 2/Package, 800/case. Latex-free. Reorder 3599XT2. Mouth Care Kit, latex-free [contents 5 oral swabs], 100 per case. Reorder MC105. Mouth Care Kit 5/pkg., latex-free [contents 5 plain oral swabs], 100 per case. Reorder MC105MG. 10/Pkg. plain Oral Swabs, 4 dispenser packs of 25 bags. Reorder MC110. 20/Pkg. Plain Oral Swabs; 50 pkgs per case. Reorder MC120. Mouth Care Kit, latex-free [contents lip balm, mouth rinse, oral swabs]. Reorder: MC200.

Mouth Care Kit, latex-free [contents lip moisturizer, mouth rinse, plain oral swabs]. Reorder MC320. Mouth Care Kit, latex-free [contents mouth rinse, medicine cup, mouth moisturizer, sodium bicarb oral swabs]. Reorder MC325.

The Medical Center Mouthcare Kit, latex-free [contents mouth moisturizer, mouth rinse, oral swabs]. Reorder: MC335.

Mouth Care Kit, latex-free [contents medicine cup, toothpaste, mouthwash, mouth moisturizer, oral swabs]. Reorder: MC340.

Large Mouth Care Kit, latex-free [contents oral swabs, mouth rinse, mouth moisturizer]. Reorder MC350.

Small Mouth Care Kit, latex-free [contents mouth rinse, oral swabs]. Reorder: MC355.

Mouth Care Kit, latex-free [contents mouth rinse - mint flavored, mouth moisturizer, mouthwash and oral swabs]. Reorder: MC370.

Mouth Care Kit, latex-free [contents mouth moisturizer, toothpaste, mouth rinse, plain oral swabs]. Reorder: MC390.

Mouth Care Kit, latex-free [contents mouth moisturizer, mouth rinse, oral swabs. Reorder MC405.

Mouth Care Kit, latex-free [contents toothpaste, toothbrush, mouth moisturizer, mouthwash, oral swabs]. Reorder: MC410.

Mouth Care Kits, latex-free [contents mouth moisturizer, mouth rinse, medicine cup, oral swabs]. Reorder: MC420.

Mouth Care Kits, latex-free [contents mouth moisturizer,

toothpaste, mouthwash, oral swabs]. Reorder MC440.

Mouth Care Kits, latex-free [contents mouth moisturizer, mouth rinse, toothpaste, oral swabs]. Reorder: MC445.

Mouth Care Kit [contents 5 oral swabs], 50 per case. Reorder MC465.

Short Term Mouth Care Kit, latex-free [mouthwash and plain oral swabs]. Reorder: MC505.

Mouth Care Kit, latex-free [contents lip moisturizer, mouthwash, oral swabs]. Reorder MC520.

Mouth Care Kit, latex-free [contents mouth moisturizer, mouth rinse, oral swabs]. Reorder: MC540.

Oral Care Kit, latex-free [contents mouth moisturizer, mouthwash, oral swabs]. Reorder: MC550.

Mouth Care Kit with Suction-Swabstick, latex-free [contents mouth moisturizer, oral swabs, mouth care kits]. Reorder: MC585.

Mouth Care Protocol Kit, latex-free [contents large oral swabs, mouth moisturizer, mouth care kit]. Reorder: MC590.

Mouth Care Kit, latex-free [contents toothbrush, toothpaste, mouth moisturizer, peroxide, oral swabs]. Reorder: MC600.

Mini Mouth Care Kits, latex-free [contents peroxide and sodium bicarb swabs], 50 per case. Reorder MC605.

Mouth Care Kit, latex-free [contents mouth moisturizer, mouth rinses, toothpaste, oral swabs]. Reorder: MC620.

Mouth Care Kit, latex-free [contents mouth rinse, mouth

moisturizer, plain oral swabs]. Reorder: MC625.

Mouth Care Kit, latex-free [contents mouth rinse, mouth

moisturizer, medicine cup, plain oral swabs]. Reorder: MC655.

Mouth Care Kit, latex-free [contents mouth moisturizer, medicine cups, mouthwash, sodium bicarb swabs]. Reorder: MC660.

Mouth Care Kit with Plain Swabs, latex-free [contents mouth

moisturizer, mouth rinse, toothpaste plain oral swabs]. Reorder: MC665.

Mouth Care Kit, latex-free [contents mouth moisturizer, mouthwash, sodium bicarb oral swabs]. Reorder: MC670.

Mouth Care Kit with SofTouch Suctioning Swab [contents toothpaste, mouth moisturizer, mint flavored 1.5% hydrogen peroxide mouth rinse, disposable suction device, plain oral swabs]. Reorder: MC675.

Mouth Care Kit, latex-free [contents large oral swabs, mouth rinse, toothpaste]. Reorder: MC690.

Mouth Care Kit, latex-free. [contents 8 plain oral swabs]. Reorder MC730.

Mouth Care Kit, latex-free [contents mouth rinse and plain oral swabs]. Reorder: MC745.

Mouth Care Kit, latex-free [contents mouth moisturizer, mouthwash, plain oral swabs]. Reorder: MC755.

Mouth Care Kit, latex-free [contents mouth moisturizer, mouth rinse, oral swabs]. Reorder: MC785.

Mouth Care Kit with SofTouch Suctioning Swab [contents mouth moisturizer, lip moisturizer, mouth rinse, disposable suction device, plain oral swabs]. Reorder: MC795.

Mouth Care Kit with SofTouch Suctioning Swab [contents mouth moisturizer, mint flavored 1.5% hydrogen peroxide mouth rinse, disposable suction devices, plain oral swab]. Reorder: MC800.

Mouth Care Kit, latex-free [contents mouth moisturizer, mouth rinse, oral swabs]. Reorder: MC820.

Mouth Care Kit, latex-free [contents medicine cup, lip moisturizer, mouth rinse, plain oral swabs]. Reorder: O80.

REASON: The sponge may become dislodged from the oral swab and present a choking hazard.

CLASS II

MANUFACTURER: Division IMPRA Medica Munich, Germany. Firm initiated recall is complete. Bard Peripheral, Vascular Tempe, AZ, by letter dated October 18, 2002.

PRODUCT: Bard LUMINEXX 7F Biliary Stent and Delivery System (length 60 cm). Recall # Z-0270-3;

Bard LUMINEXX 7F Vascular Stent and Delivery System (length 60 and 120 cm). Recall # Z-0271-3;

Bard LUMINEXX 7F Biliary Stent and Delivery System (length 80 and 120 cm). Recall # Z-0272-3;

memotherm-FLEXX Biliary Stent and Delivery System (length 60 cm). Recall # Z-0273-3;

memotherm-FLEXX Biliary Stent and Delivery System (length 80 and 120 cm). Recall # Z-0274-3;

memotherm-FLEXX Vascular Stent and Delivery System (length 60 and 120 cm). Recall # Z-0275-3.

REASON: Sterile barrier compromised.

MANUFACTURER: Boston Scientific Corp., Glens Falls, NY. Firm initiated recall ongoing. Recalling Firm: Boston Scientific Corp./

Microvasive Urology, Div. Natick, MA, by letter on October 30, 2002.

PRODUCT: UroMax Ultra High Pressure Balloon Dilatation Catheters with HydroPlus Coating (kits) as follows:

a) UroMax Ultra Balloon Dilatation Catheters U2q/4-4/6/75, 10CC LWIG Kit, Catalog Number: 622512.

Recall # Z-0276-3;

b) UroMax Ultra Balloon Dilatation Catheters U2q/8-8/6/75,10CC LWIG Kit, Catalog Number: 622513.

Recall # Z-0277-2.

REASON: Mislabeled: The unit carton for the UroMax Ultra 8mm-8cm kit contained a 4mm-4cm Balloon Catheter, and the UroMax Ultra 4mm-4cm kit contained a 8mm-8cm Balloon Catheter.

MANUFACTURER: Nicolet Biomedical, Madison, WI, by letter on September 23, 2002. Firm initiated recall is outgoing.

PRODUCT: a) Endeavor 16-channel Neuromonitoring System;

b) VikingSelect 2, 4 or 8-channel Neuromonitoring System. Recall # Z-0279-3.

REASON: Amplifiers used in the Endeavor and 8-channel VikingSelect Neuromonitoring Systems have a slow recovery from electrocautery so that physiologic signal monitoring can be delayed by up to several minutes.

MANUFACTURER: LXN Corporation, San Diego, CA, by letters beginning October 21, 2002. Firm initiated recall is ongoing.

PRODUCT: a) ExpressView Glucose 50 Test Strips, part Number 20025

is packaged 50 strips per vial and the vial is shrink wrapped. There is no outer carton/package. Recall # Z-0280-3;

b) In Charge Glucose Value pack, Part Number 30008 contains two vials of 25 glucose test strips (for a total of 50

glucose test strips) and one vial of 4 GlucoProtien test

strips in one outer package/carton. (note: the

GlucoProtein Test Strips contained in the In Charge

Value Pack were previously recalled under recall numbers

Z-103-3 and Z-104-3.)Recall # Z-0281-3;

c) In Charge Glucose 50 Test Strips, Part Number 20005

contains two vials of 25 glucose test strips (for a total of 50 glucose test strips) in one outer package/carton.

Recall # Z-0282-3.

REASON: Stability failure.

MANUFACTURER: Bayer Diagnostics, East Walpole, MA. Firm initiated recall is ongoing. Recalled by Bayer Corporation, Business Group Diagnostics, Tarrytown, NY, by e-mail on October 4, 2002.

PRODUCT: Brand Name: ACS:180(R) Automated Chemiluminescence System Valproic Acid. Common Name: ACS:180(R) Valproic Acid:

a) Catalog/Part Number 129216, 50 tests total:

Contents: 1 vial of ACS:180 Valproic Acid Lite Reagent,

1 vial of ACS:180 Valproic Acid Solid Phase, ACS:180

Valproic Acid Master Curve Card. Recall # Z-0283-3;

b) Catalog/Part Number 129217, 300 tests total:

Contents: 6 vials of ACS:180(R) Valproic Acid Lite

Reagent, 6 vials of ACS:180 Valproic Acid Solid Phase,

ACS:180 Valproic Acid Master Curve Card.

Recall # Z-0284-3.

REASON: Photo-oxidation of the ACS:180 Valproic Acid reagent has occurred due to inadequate instructions for storage.

MANUFACTURER: Interpore Cross Intl., Irvine, CA, by letter on September 19, 2002. Firm initiated recall is complete.

PRODUCT: Geo-Inserter for spinal implants, Catalog No. 1000-9015. Recall # Z-0285-3.

REASON: Tips break while surgeon is seating implant.

MANUFACTURER: Stryker Trauma GmbH Kiel, Germany. Firm initiated recall is ongoing. Recalling Firm: Howmedica Osteonics Corp., Rutherford, NJ, by letter on August 16, 2002.

PRODUCT: T2 Screwdriver 3.5, extra short. Recall # Z-0286-3;

T2 Screwdriver Bit, short. Recall # Z-0287-3;

T2 Screwdriver bit, long. Recall # Z-0288-3;

T2 Screwdriver, long. Recall # Z-0289-3;

T2 Screwdriver, short. Recall # Z-0290-3;

T2 Compression Screwdriver Bit. Recall # Z-0291-3;

T2 Screwdriver Shaft. Recall # Z-0292-3;

Orthopedic Manual Surgical Instrument.

REASON: The screwdrivers might be susceptible to intra-operative breakage at tip.

MANUFACTURER: Quest Medical, Inc., Allen, TX, by letter on September 19, 2002. Firm initiated recall is ongoing.

PRODUCT: Quest Myocardial Protection System Back-up Set (MPSBUS), packaged within two molded-foam halves with the handle in a shipping box. Instructions are place directly on the unit. Two disposable individually wrapped, sterile, pressure-monitor parts are included in a secondary box.

Recall # Z-0300-3.

REASON: Wrong size Roll pin (part), could cause the belt tensioner to disengage and result in stop of fluid flow during surgery.

MANUFACTURER: Won Yong, South Korea. Firm initiated recall is ongoing. Recalling Firm: Avon Products, Inc., New York, NY, by voice message on May 30, 2002.

PRODUCT: Little Soothers.

Classification Name: Cold Pack, The Little Soother is a 3 inch by 2 inch sealed plastic patch containing several ingredients including propylene glycol. The propylene glycol in the Little Soother acts to keep the device cool when the device is chilled. It was manufactured in three shapes: a yellow fish, a pink butterfly, and a blue penguin. There are 3 patches per unit container labeled in part, "xxx LITTLE SOOTHERS SET OF THREE xxx AVON wellness xxx". Recall # Z-0301-3.

REASON: The product contains ethylene glycol instead of propylene glycol.

MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated October 17, 2002. Firm initiated recall is ongoing.

PRODUCT: Hill-Rom brand Affinity Three birthing bed.

Recall # Z-0302-3.

REASON: Calf support may become unstable.

MANUFACTURER: AGA Medical Corporation, Golden Valley, MN, by letters dated November 1, 2002. Firm initiated recall is ongoing.

PRODUCT: AMPLATZER Delivery Systems. Recall # Z-0303-3.

7 French, Order Number 9-DEL-7F-45/80;

8 French, Order Number 9-DEL-8F-45/80;

9 French, Order Number 9-DEL-9F-45/80;

9 French, Order Number 9-DEL-9F-45/100;

10 French, Order Number 9-DEL-10F-45/80;

10 French, Order Number 9-DEL-10F-45/100;

12 French, Order Number 9-DEL-12F-45/80;

12 French, Order Number 9-DEL-12F-45/100.

b) AMPLATZER Exchange Systems:

12 French, Order Number 9-EXCH-12F-45/80.

REASON: Smaller than specified delivery cable screw diameter can lead to separation of device from delivery cable.

MANUFACTURER: MeSys GmbH (Medizinische Systeme) Hanover.

Firm initiated recall is ongoing. Recalling Firm: Baxter Healthcare Corp., Deerfield, IL, by e-mail on October 24, 2002.

PRODUCT: Accura Hemo Filtration Device, catalog #5M5660. Recall # Z-0304-3.

REASON: Blood leaks from the blood pump segment of the tubing set.

CLASS III

MANUFACTURER: Jari Electrodes, Gilroy, CA. FDA initiated recall is ongoing. Recalling Firm: Cadwell Laboratories, Inc., Kennewick, WA, by letter dated September 27, 2002.

PRODUCT: Monopolar needle electrode: disposable, sterile monopolar needle electrode used in electromyography (EMG) studies. Electromography is the measurement of skeletal muscle nerve activity. Recall # Z-0293-3/Z-0297-3.

Product is packaged and labeled in part "CADWELL Monopolar EMG Needle Electrodes Disposable/Pre-Sterilized ** 10 needles/package.

REASON: Inconsistent electrical performance of monopolar emg needles.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 20, 2002:

CLASS II

MANUFACTURER: Steris Corp., Mentor, OH, by telephone on October 3,2002 and by fax on October 4, 2002.

PRODUCT: Steris Quick Connect Kits, catalog nos. #QCL1629 and #QLC1646. Recall # Z-0246-3/Z-0247-3.

#QCL1629 is for Olympus 40/140/240 Series Non-Therapeutic GI Endoscopes in the STERIS SYSTEM 1 Sterile Processing System with the C1160 Universal Flexible Processing Tray; and #QLC1646 is for Olympus 40/140/240 Series Duodenoscopes and Therapeutic GI Endoscopes in the STERIS SYSTEM 1 Sterile Processing System with the C1160 Universal Flexible Processing C1160 Tray.

REASON: Incorrect adapter component may affect the sterilization process of scopes.

MANUFACTURER: Invacare Corp., Elyria, OH, by letters on October 3, 2002. Firm initiated recall is complete.

PRODUCT: Invacare Venture HomeFill I Home Oxygen System.

Recall # Z-0257-3/Z-0258-3.

REASON: The high-pressure hose may separate from unit and cause injury to operator.

MANUFACTURER: Bunnell, Inc., Salt Lake City, UT, by letter on August 5, 2002.

Firm initiated recall is complete.

PRODUCT: HFJV Patient Circuit Kit (Includes 2 ea. Circuits with 2 ea. 2.5mm and 2 ea. 3.5mm LifePort Endotracheal Tube Adapters) CAT: #937 Disposable - Single Patient Use Only. (Lots 2D0087, 2D0102, 2E0116, 2E0132, 2F0151, or 2G0155). Recall # Z-0259-3.

Contained in these kits are Individual Life Pulse HFV Humidifier Cartridge Patient Breathing Circuits (Lots 2C0074, 2D0093, 2D0105, 2E0115, or 2E0118). 

REASON: Reported failures of pinch tubing in Patient Circuit Kit.

MANUFACTURER: Gyrus ENT, LLC., Bartlett, TN, by letter on July 25, 2002.

Firm initiated recall is ongoing.

PRODUCT: McGee Piston, Ossicular Replacement Prosthesis, Catalogue No.: 140332. Recall # Z-0260-3.

REASON: Lack of sterility assurance.

MANUFACTURER: Axya Medical Inc., Beverly, MA, by letter on October 24, 2002. Firm initiated recall is ongoing.

PRODUCT: 5 mm Preloaded AxyaLoop Titanium Bone Anchor in the following single or 3 driver kit configuration:

a) 5 mm Preloaded AxyaLoop Titanium Bone Anchor Polypropylene Suture, CAT#1221. Recall # Z-0261-3;

b) 5 mm Preloaded AxyaLoop Titanium Bone Anchor Nylon Suture, CAT#1227. Recall # Z-0262-3;

c) Mini-Open Rotator Cuff Procedural Kit,CAT#1501-3. Recall # Z-0263-3;

d) Arthroscopic Rotator Cuff Procedural Kit,CAT#1502-3. Recall # Z-0264-3;

e) Arthrocopic Rotator Cuff Procedural Kit, CAT#1506-3. Recall # Z-0265-3.

REASON: Driver Shaft May Break and Not Engage with Head of Anchor.

MANUFACTURER: Rozinn Electronics, Inc., Glendale, NY, by letters and fax dated January 23, 1998. Firm initiated recall is complete.

PRODUCT: RZ152 Digital Holter Recorder with Removable Flashcard. Recall # Z-0266-3.

NOTE: the affected part was the 7-Lead cable, Part Number CBL-113.

RZ152 Digital Holter Recorder applications include 3-channel Holter recording for up to 48 hours. RZ152 can perform all three recording applications simultaneously.

REASON: RZ 152 Digital Holter Recorders were distributed with defective lead cables.

MANUFACTURER: Davol Inc., Subsidiary of C. R. Bard Inc., Cranston, RI, by letter on October 29, 2002. Firm initiated recall is complete.

PRODUCT: Davol EndoAvitene Microfibrillar Collagen Hemostat.

Recall # Z-0267-3.

REASON: Device not manufactured in conformance with the Device Master Record.

MANUFACTURER: Draeger Medical Inc., Telford, PA, by letters on/about November 1, 2002. Firm initiated recall is ongoing.

PRODUCT: Narkomed 6000 (NM6000), Anesthesia Machines, Catalog Numbers 4114586-001 and 4116660.

Recall # Z-0268-3/Z-0269-3.

REASON: Malfunction - sparks and smoke.

CLASS III

MANUFACTURER: Helix Medical, Inc., Carpinteria, CA, by letters sent on June 19, 2002. Firm initiated recall is complete.

PRODUCT: In-Health Blom-Singer Humidifier Holder, Cat. No. BE1060. Recall # Z-0256-3.

REASON: Mispackaging. Caps were labeled as holders.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 13, 2002:

CLASS II

MANUFACTURER: Alcon Laboratories, Inc., Orlando, FL. Firm initiated recall is complete.

PRODUCT: Summit Autonomous Inc. LADAR Vision Excimer Lasers Systems, Ophthalmic Excimer Laser System. Recall # Z-0145-3.

REASON: Patient had unsatisfactory vision correction due to error in ablation mask function during Lasix treatment.

MANUFACTURER: Stryker Trauma, GmbH Kiel, Germany. Firm initiated recall is ongoing. Recalling Firm: Howmedica Osteonics Corp., Rutherford, NJ, by letters on August 26, 2002.

PRODUCT: 2.8mm Drill Radiolucent Target. Recall # Z-0161-3;

3.2mm Drill Radiolucent Target. Recall # Z-0162-3;

3.7mm Drill Radiolucent Target. Recall # Z-0163-3;

4.0mm Drill Radiolucent Target. Recall # Z-0164-3'

4.3mm Drill Radiolucent Target. Recall # Z-0165-3;

5.0mm Drill Radiolucent Target. Recall # Z-0166-3;

5.5mm Drill Radiolucent Target. Recall # Z-0167-3.

REASON: Drill can penetrate blister package causing loss of sterility.

MANUFACTURER: Cryolife, Inc., Marietta, GA, by letter August 15, 2002.

Firm initiated recall is ongoing.

PRODUCT: Allograft Heart Valve. Recall # Z-0168-3.

REASON: Donor post-mortem blood culture were positive for Clostridium septicum.

MANUFACTURER: Philips Medical Systems, Netherlands. Firm initiated recall is complete. Recalling Firm: Philips Medical Systems North America, Inc., Bothell, WA, by letter dated September 20, 2002.

PRODUCT: Multidiagnost 3 and Multidiagnost 4 X-Ray Systems: multi functional/universal system used for general R/F. Fluorscopy, radiography and angiography can be performed with other specialized interventional applications. Units involved have joysticks. Recall # Z-0169-3/Z-0170-3.

REASON: Potential for x-ray stand or table to move.

MANUFACTURER: Philips Medical Systems, Highland Heights, OH, by letter dated September 23,2002. Firm initiated recall is ongoing.

PRODUCT: AXIS/IRIX Gamma Camera Systems. Recall # Z-0171-3/Z-0172-3.

REASON: The collimator latches may not fully engage when performing collimator exchanges.

MANUFACTURER: Depuy Orthopaedics, Inc., Warsaw, IN, by letter on August 26, 2002. Firm initiated recall is ongoing.

PRODUCT: Depuy Ace brand Ace Trochanteric Nail, as follows:

Product 9032-11-225; 125 degree, 200mm X 11 mm.

Recall # Z-0240-3;

Product 9032-11-230; 130 degree, 200mm X 11 mm.

Recall # Z-0241-3;

Product 9032-11-240; 140 degree, 200mm X 11 mm.

Recall # Z-0242-3;

Product 9032-13-225; 125 degree, 200mm X 13 mm.

Recall # Z-0243-3;

Product 9032-13-230; 130 degree, 200mm X 13 mm.

Recall # Z-0244-3;

Product 9032-13-240; 140 degree, 200mm X 13 mm.

Recall # Z-0245-3.

REASON: May be packaged/etched with an incorrect neck angle.

MANUFACTURER: Steris Corp., Mentor, OH, by telephone on October 3, 2002 and by fax on October 4, 2002. Firm initiated recall is complete.

PRODUCT: Steris Quick Connect Kits, catalog nos. #QCL1629 and #QLC1646. #QCL1629 is for Olympus 40/140/240 Series Non-Therapeutic GI Endoscopes in the STERIS SYSTEM 1 Sterile Processing System with the C1160 Universal Flexible Processing Tray. Recall # Z-0246-3;

#QLC1646 is for Olympus 40/140/240 Series

Duodenoscopes and Therapeutic GI Endoscopes in the

STERIS SYSTEM 1 Sterile Processing System with the C1160

Universal Flexible Processing C1160 Tray. Recall # Z-0247-3.

REASON: Incorrect adapter component may affect the sterilization process of scopes.

MANUFACTURER: Access Cardiosystems Inc., concord, MA. Firm initiated recall is ongoing. Recalling Firm: Access Cardiosystems, Concord , MA, by e-mail on October 14, 2002.

PRODUCT: Portable Automated External Difibrillators [AED]

Model No. 9100-0100:

a) AccessAED; b) AccessALS

Recall # Z-0248-3.

REASON: Portable External Defibrilator May Fail Self Test and Fail to Function.

MANUFACTURER: Alcon laboratories Houston, TX, by letter dated March 14, 2002. Firm initiated recall is ongoing.

PRODUCT: Viscous Fluid Injector Pak (aka the VFI Pak), 10cc, an accessory to the Accurus Ophthalmic Surgical System.

Recall # Z-0249-3.

REASON: Malfunction may result in the operator's inability to stop the flow of fluid already present in the needle portion of the device

MANUFACTURER: Boston Scientific Corp., Glens Falls, NY, by telephone on March 11, 2002 and by letter on/about March 12, 2002.

Firm initiated recall is complete.

PRODUCT: a) NAMIC High Pressure Contrast Injection Line - 10"

(25 cm). Recall # Z-0250-3;

b) NAMIC Low Pressure Contrast Injection Line - 10" (25 cm).

Recall # Z-0251-3.

Product description: The device is an extension between an angiographic catheter and an injector.

REASON: Product mix up. Low pressure line labeled High Pressure.

MANUFACTURER: Payless Wholesale Inc., Glendale, NY, by letters on August 15, 2002. FDA initiated recall is ongoing.

PRODUCT: Blood Glucose Test Strips - two (2) brands are involved:

a) Genuine ONE TOUCH(TM), 50 Test Strips per unit carton. Unit carton labeled in part, "*** Genuine ONE TOUCH(TM) *** 50 TEST STRIPS *** For the quantitative measurement of glucose in whole blood *** For use with all ONE TOUCH(TM) Brand Glucose Meters *** LIFESCAN a Johnson & Johnson company Milpitas, California 95035 ***

LOT *** 53885 10631 (UPC #)***. Recall # Z-0252-3;

b) Uni-Check (TM) BLOOD GLUCOSE TEST STRIPS, 50 strips per unit carton. Unit carton labeled in part,"*** Uni-Check(TM) *** BLOOD GLUCOSE TEST STRIPS *** 50 Test Strips for Use with ONE TOUCH METERS *** 53885 10631 (UPC #)*** For Quantitative Measurement of Glucose in Whole Blood *** Produced for Diagnostic Solutions, Inc. Irvine, CA U.S.A. One Touch is a registered trademark of LifeScan Inc. a Johnson & Johnson company *** LOT ***. Recall # Z-0253-3.

Outer carton containing 24 unit packages is labeled in part, *** UNI-CHECK TEST STRIPS *** CATALOG NO. 1702720 *** QTY: 24 PACKAGES of 50 STRIPS/PACKAGES *** LOT No.: *** EXPIRES: ***".

REASON: Products not approved for sale in USA & Canada, and may give inaccurate readings when used with readers from US & Canada.

MANUFACTURER: Meridian Bioscience, Inc., Cincinnati, OH, by letter dated May 23, 2002. Firm initiated recall is ongoing.

PRODUCT: Premier HSV, an EIA diagnostic test kit, packaged under the

Meridian Premier brand label. Recall # Z-1339-2.

REASON: The OPD Substrate Tablets have deteriorated due to moisture, and may result in inaccurate test results.

CLASS III

MANUFACTURER: Stryker Trauma SA Geneva, Switzerland. Firm initiated recall is ongoing. Recalling Firm: Howmedica Osteonics Corp., Rutherford, NJ, by letter on May 2, 2001.

PRODUCT: Hoffmann II Hybrid Ring Clamp

Catalog No: 4936-2-010 Lot code: all manufacturing lot codes. Recall # Z-0144-3.

REASON: The ring clamps may not tighten around post.

MANUFACTURER: Xomed, Inc., Jacksonville, FL, by letter on July 22, 2002.

Firm initiated recall is ongoing.

PRODUCT: Medtronic Xomed "Cottle Mallet", a reuseable manual surgical instrument indicated for use in ENT (Nasal) surgical procedures.

Product is Catalog Number 37-14353 and some are contained in Kit Catalog Number 37-17008RF which is a nasal ENT surgical kit containing this mallet as a component and it is labeled as "Toriumi Set" Recall # Z-0151-3.

REASON: Nylon Mallet head may deform when sterilized at insert parameters.

MANUFACTURER: Metrex Research Corp., Romulus, MI on/before May 28, 2002. Firm initiated recall is ongoing. Recalling Firm: Sybron Dental Specialties, Inc., Orange, CA, by letters.

PRODUCT: a) MetriCide 14 Day, cold sterilant solution, 1 gallon.

Recall # Z-254-3;

b) Gluteraldehyde NS, cold sterilant solution, 1 gallon.

Recall # Z-0255-3.

REASON: Cross-contamination with dissimilar steriliant.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 6, 2002:

CLASS II

MANUFACTURER: Sulzer IntraTherapeutics Inc., St. Paul, MN, by letter

on October 9, 2002. Firm initiated recall is ongoing.

PRODUCT: a) IntraStent DoubleStrut ParaMount, Premounted Biliary Stent System; b) Protégé Self Expanding Nitinol Stent, Biliary System. c) IntraStent DoubleStrut ParaMount XS Premounted Biliary Stent System. Recall # Z-0153-3.

REASON: Some of the pouches for maintaining device sterility were unsealed.

CLASS III

MANUFACTURER: Zeus Scientific, Inc., Branchburg, NJ. Firm initiated recall is ongoing. Meridian Bioscience, Inc., Cincinnati, OH, by letters dated December 31, 2001 and July 2, 2002.

PRODUCT: EBV-VCA IgG ELISA and EBV-VCA IgM ELISA, diagnostic test kits, packaged under the Meridian Bioscience label. These kits are:

a) Epstein-Barr Virus (EBV) IgM. Recall # Z-0141-3;

b) IgG Viral-Capsid-Antigen (VCA) Test Systems.

Recall # Z-0142-3.

REASON: Inaccurate test results (false positive or false negative) due to label error.

MANUFACTURER: Hand Innovations, Inc. Miami, FL, by letter dated August 23, 2002. Firm initiated recall is ongoing.

PRODUCT: Hand Innovations, Inc. brand of Distal Volar Radius Locking Plate System, Catalog Number is DVR-ST, the common name for the device is the Distal Volar Radius Locking Plate with pegs and screws. Recall # B-0143-3.

REASON: Instructions for use contain an incorrect sterilization procedure.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letter in February 2002. Firm initiated recall is ongoing.

PRODUCT: Synchron LX 20, Part # 466101;

Synchron LX 20 Pro, Part # 466200. Recall # Z-0150-3.

REASON: Low results on the cartridge chemistry assays, syringe valve seat issue.

MANUFACTURER: Exactech, Inc., Gainesville, FL, by "Important Product Recall Notice" on October 2, 2002. Firm initiated recall is ongoing.

PRODUCT: a) Exactech brand Optetrak CR Tibial Insert( catalog no. 200-22-09). Recall # Z-0154-3;

b) Optetrak PS Tibial (catalog # 204-22-09) inserts.

Recall # Z-0155-3.

These are used as implants during a knee replacement surgery.

REASON: The PS tibial insert was labeled as a CR tibial insert.

MANUFACTURER: Benz Research and Development Corp., Sarasota, FL, by letters on or about July 8, 2002. Firm initiated recall is complete.

PRODUCT: Benz Research and Development brand Extreme H20 Contact Lens, diopter - 3.25, Base curve MED, Diameter 14.20. Recall # Z-0156-3.

REASON: Lenses may be labeled with an incorrect diopter power.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 30, 2002:

CLASS II

MANUFACTURER: Aesculap Ag & Co. Kg. Tuttlingen, Donau, Germany. Firm initiated recall is complete. Recalling Firm: Aesculap, Inc., Center Valley, PA, by letters dated June 14, 2002.

PRODUCT: Aesculap Ti Bone Screws, 4x56 mm. Recall # Z-0116-3.

REASON: Smaller than specified core diameter may lead to screw breakage during and post-implantation.

MANUFACTURER: Meridian Medical Systems, Inc., Indianapolis, IN, by letter dated September 18, 2002. Firm initiated recall is complete.

PRODUCT: a) Meridian Medical Systems (MMS) brand Wye-Swivel, Plain; Part/Model Number 020104347. Recall # Z-0121-3;

b) Meridian Medical Systems (MMS) brand Wye-Swivel, GSP; Part/Model Number 020104348. Recall # Z-0122-3.

REASON: Swivel leg may crack and leak at connection with the body.

MANUFACTURER: Drager Medical, Telford, PA, by letter on August 14, 2002.

Firm initiated recall is ongoing.

PRODUCT: Fabius GS Anesthesia Gas Machine. Recall # Z-0123-3.

REASON: Intermittent leaks associated with APL valve.

MANUFACTURER: Boin Medica Co. Inc., Kumi City, Kyungbuk, Korea. Firm initiated recall is ongoing. Recalling Firm: Becton Dickinson & Co., Franklin Lakes, NJ, by letter on September 6, 2002 and October 3, 2002.

PRODUCT: 0.5cc 30G x 5/16 Walgreens brand syringes (cases of 5 boxes of 100 or boxes of 100 each)and .5cc 29GA x 1/2" (12.7mm) insulin syringe. Recall # Z-0125-3/Z-0126-3.

REASON: Product has a recessed cannula which makes it difficult to remove the bubbles.

MANUFACTURER: Medtronic, Inc., Neurological Division, Minneapolis, MN, by letter dated September 2002. Firm initiated recall is ongoing.

PRODUCT: SynchroMed EL Implantable Infusion Pumps, Models 8626-10, 8626L-10, 8627-10, 8627L-10, 8626-18, 8626L-18, 8627-18, and 8627L-18. Recall # Z-0127-3/Z-0134-3.

REASON: Inadequate directions for use.

MANUFACTURER: Prosurg Inc., San Jose, CA. Firm initiated recall is ongoing. Recalling Firm: Mentor Minnesota Inc., Minneapolis, MN., by telephone on September 27 and 28, 2002 and by letter on September 27, 2002.

PRODUCT: SABRE Bioabsorbable Polymer Sling With Introducer, catalog numbers 93-1030 (1.0 cm x 3.0 cm sling) and 93-1575 (1.5 cm x 7.5 cm sling) and SABRE Introducer, catalog number 93-1000. Recall # Z-0135-3.

REASON: Holes observed in the sterile packaging.

MANUFACTURER: Walter Lorenz Surgical, Inc., Jacksonville, FL, by telephone on May 23, 2002 and by letter June 4 -7, 2002. Firm initiated recall is complete.

PRODUCT: Lorenz brand 99-7215-01 Low Profile Center Drive 1.5X15mm Titanium Screw. Sold one per package and 5 per package. Recall # Z-0136-3/Z-137-3.

REASON: Screws were not fully cleaned per current SOP's before distribution.

MANUFACTURER: Perry Baromedical Corporation, Riviera Beach, FL, by letter on June 11, 2001. FDA initiated recall is ongoing.

PRODUCT: Perry Baromedical Hyperbaric Chambers- SIGMA MP Multiplace Hyperbaric Oxygen Treatment Chambers. These prescription devices are used in hospitals and clinics to treat multiple patients at a time for conditions such as air or gas embolism, gas gangrene, necrotizing soft tissue infections and thermal burns. Recall # Z-0139-3.

REASON: Change testing of Fire Suppression System to monthly.

MANUFACTURER: IntraLase Corporation, Irvine, CA, by letter dated October 2, 2002. FDA initiated recall is ongoing.

PRODUCT: INTRALASE FS 600 C Laser System (Model 1), Laser Keratome. Recall # Z-0147-3.

REASON: Design defect, wire breakage, causes laser failure, interrupting surgery.

****CORRECTION****

The Enforcement report 02-42, for 10/23/02, Recall # Z-0110-03, Vistacon, one of the lot numbers was listed incorrectly. The Lot listed as "B000WJK(XXX )" should be listed as "Lot B000WJP (XXX )(-5.00D, 8.7 B.C.)".

CLASS III

MANUFACTURER: Palco Laboratories, Inc., Santa Cruz, CA, by letters on August 27, 2002. Firm initiated recall is ongoing.

PRODUCT: Palco Laboratories brand Pulse Oximeter; Models: 100, 130, and Aero (non-medical pulse oximeter)

a) For Model 100 Product Number is: 1001010.

Recall # Z-0118-3;

b) For Model 130, Product Number is: 1001013.

Recall # Z-0119-3;

c) For AERO Model, Product Number is: 1001012.

Recall # Z-0120-3.

REASON: A capacitor was loaded backwards into the Pulse Oximeter.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letters on June 12, 2002. Firm initiated recall is ongoing.

PRODUCT: Access 2 Immunoassay Systems -- Systems Software

Versions 1.0; 1.1; 1.2; and 1.3.1. Recall # Z-0124-3.

REASON: Erroneous result flags can result on printed reports and screen displays in rare circumstances.

MANUFACTURER: Norfolk Medical Products, Inc., Skokie, IL. Firm initiated recall is ongoing. Recalling Firm: Horizon Medical Products, Inc., Manchester, GA, by visit in January 2001.

PRODUCT: Vortex Port-LP Access System with Attachable Catheter. Recall # Z-0138-3.

REASON: Vortex Port-LP Access System with Attachable Catheter. Recall # Z-0138-3.

MANUFACTURER: IntraLase Corp., Irvine, CA, by letters dated October 2, 2002. Firm initiated recall is ongoing.

PRODUCT: INTERLASE FS 600 C Laser System (Model 1), Laser Keratome. Recall # Z-0140-3.

REASON: Cooling system problem causes machine to become inoperable.

MANUFACTURER: Xomed, Inc., Jacksonville, FL, by letter dated September 4, 2002. Firm initiated recall is ongoing.

PRODUCT: "FrameLock" device, Product Number 960-808, intended for intra-operative use with the LandmarX Image Guided Surgery System as a device to regidly mount a reference arc to a patient's skull. The product has an open cannula nut which is missing for the referenced lot number. The kit is packaged in a metal sterilization tray which is wrapped in plastic. Recall # Z-0146-3.

REASON: Framelock assemblies packed with Open Cannula Nuts.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 23, 2002:

CLASS II

****CORRECTION****

On the Enforcement Report 02-40 for October 9, 2002, Recall # Z-1451-1, Architect CA 19-9 Reagent Kit was list incorrectly. It should be Z-1451-2.

MANUFACTURER: Pulmonetic Systems, Inc., Colton, CA. Firm initiated recall is ongoing. Recalling Firm: Pulmonetic Systems, Inc., Minneapolis, MN, by letter dated September 30, 2002.

PRODUCT: Pulmonetic Systems Ventilators:

Models:

a) LTV-1000,Recall # Z-0010-3;

b) LTV-950, Recall # Z-0011-3;

c) LTV-900, Recall # Z-0012-3;

d) LTV-800. Recall # Z-0013-3.

REASON: Printed circuit board malfunction may result in the ventilator becoming non-functional (no ventilation provided), with a possibility of no audible alarm sounding to alert the caregiver to the situation.

MANUFACTURER: MIDAS REX, L.P. FORT WORTH, TX, by telephone, letter and sales rep follow up from August 9, 2002 through August 16, 2002. Firm initiated recall is complete.

PRODUCT: Medtronic Midas Rex Legend Attachments. Recall # Z-0037-3.

REASON: The o ring can fall out or migrate, causing difficulty of the attachment engaging the motor.

MANUFACTURER: Abbott Laboratories, Inc., Abbott Park, IL, by letter dated September 26, 2002. Firm initiated recall is ongoing.

PRODUCT: AxSYM Troponin-I Reagent Pack list:

a) 3C29-20 (100 test pack);

b) 3C29-15 (50 test pack). Recall # Z-0039-3.

REASON: VOLUME OF PRODUCT IN COMMERCE a) 15,589 - 100 test kits; b) 8,795 - 50 test kits.

MANUFACTURER: Medtronic Xomed France Sas Bourbon l'archambault. Firm initiated recall is ongoing. Recalling Firm: Xomed, Inc., Jacksonville, FL, by fax or letter on August 28, 2002.

PRODUCT: MicroFrance Instruments brand of Monopolar, non-Laparoscopic Electrosurgical (ESU) Instruments, Intended to remove tissue and control bleeding. Recall # Z-0040-3/Z-0096-3.

REASON: Dielectric withstand voltages tested below acceptable limits.

MANUFACTURER: Baxter Healthcare Corporation, Mountain Home, AR. Firm initiated recall is ongoing. Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated September 9, 2002.

PRODUCT: Baxter Syntra 120 & 160 Single Use Dialyzers; 24 dialyzers per case; a) catalog R5M6243: Syntra*120 - 1.2 square meters surface

area. Recall # Z-0097-3; b) catalog R5M6246: Syntra*160 - 1.6 square meters surface area. Recall # Z-0098-3.

REASON: Saline and blood leaks from the header.

MANUFACTURER: Novoste Corp., Norcross, GA, by letters on or about August 19, 2002. Firm initiated recall is complete.

PRODUCT: Novoste B-Rail 3.5F Delivery Catheters. Recall # Z-0099-3

REASON: Catheter tip damage and detachment.

MANUFACTURER: Respiratory Support Products, Inc., San Diego, CA. Firm initiated recall is ongoing. Recalling Firm: Deltec, Inc., St. Paul, MN, by fax on July 31, 2002.

PRODUCT: CADD-Prizm High Volume Administration Set, Reorder No. 21-7057-01, (for use with the CADD-Prizm Pump).

Recall # Z-0100-3.

REASON: Some shelf cartons of High Volume Administration Sets, Reorder 21-7057-01, were incorrectly labeled as High Volume Administration Sets with 0.2 micron filter and injection site, product 21-7055-01.

MANUFACTURER: St. Jude Medical, Daig Division, Inc., Minnetonka, MN, by visit beginning February 25, 2002. Firm initiated recall is complete.

PRODUCT: Livewire TC Bi-Directional Steerable Electrophysiology Catheter, Large Sweep, Reorder Number 402272. Recall # Z-0102-3.

REASON: The push-pull wire of the device can sometimes improperly protrude through the catheter side-wall.

MANUFACTURER: Lxn Corp., San Diego, CA., by letter on August 16 or 19, 2002. Firm initiated recall is ongoing.

PRODUCT: a) Duet II Glucose Control Monitoring System, In Charge tm.

Recall # Z-0103-3;

b) Duet Glucose Control Monitoring System, Duet and ProPak tm. Recall # Z-0104-3. All Non-expired lots.

REASON: Stability.

MANUFACTURER: Johnson & Johnson Vision Products, Inc., Jacksonville, FL, by telephone on September 27, 2002. Firm initiated recall is ongoing.

PRODUCT: The contact lens is covered with a sealed plastic envelope labeled in part: "ACUVUE 2 (etafilcon A) CONTACT LENS STERILE**BC**DIA**D**" ALSO THE EXPIRATION DATE AND LOT NUMBER IS ON THE LENS (MASTER AND TRAIL).The lens shelf box is labeled in Part: "***ACUVUE 2 BRAND CONTACT LENSES Johnson & Johnson VISTAKON, Jacksonville, Florida**Contents 6 lenses (58% H20) in buffered saline** LOT**PRODUCT CODE ***"

Recall # Z-0110-3.

REASON: Firm cannot adequately document if product lot went through sterilization.

MANUFACTURER: Becton Dickinson & Co., Columbus, NE. Recalling Firm: Becton Dickinson & Co., Franklin lakes, NJ, by letter on February 25, 2002.

PRODUCT: BD Interlink Lever Lock Cannula, reorder number 303370.

Blunt plastic cannula, Used for Aspiration/Injection of fluids. Recall # Z-0112-3.

REASON: Leakage.

MANUFACTURER: Siemens Medical Solutions Erlangen, Germany.

Firm initiated recall is complete. Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ, by letter on June 13, 2002.

PRODUCT: Siemens Fluorospot compact, Digital image storage and processing. Recall # Z-0113-3.

REASON: Incorrect labeling of images in DICOM composed format.

MANUFACTURER: Stryker Corp., Kalamazoo, MI, by letter on September 19, 2002. Firm initiated recall is ongoing.

PRODUCT: a) Stryker Adel Advanced Delivery System Maternity Bed,

Model 4700;

b) Stryker Adel Advanced Delivery System Maternity Bed,

Model 5012;

Recall # Z-0114-3.

REASON: Foot section may fall off when the bed is moved.

MANUFACTURER: Aesculap Ag & Co. Kg. Tuttlingen, Donau.

Firm initiated recall is complete. Recalling Firm: Aesculap, Inc., Center Valley, PA, by letters on June 14, 2002.

PRODUCT: Aesculap Ti Bone Screws, 4x56 mm. Recall # Z-0116-3.

REASON: Smaller than specified core diameter may lead to screw breakage during and post-implantation.

MANUFACTURER: Bayer Corp., Elkhart, IN, by visit in September 2002.

Firm initiated recall is complete.

PRODUCT: Bayer Glucometer Esprit 2 Blood Glucose Meter; product code 3960. Recall # Z-0117-3.

REASON: Inappropriate measurement system for South African market

MANUFACTURER: LG Electronics Inc. Gyeong, Nam, Korea. Recalling Firm: Maytag Appliances, Amana Commercial Products Amana, IA, by letters dated May 17, 2002.

PRODUCT: Amana Model LD10 and LD10D Commercial Microwave Oven. Recall # Z-1227-2.

REASON: Amana Model LD10 and LD10D Commercial Microwave Oven. Recall # Z-1227-2.

CLASS III

MANUFACTURER: Portex, Inc., Keene, NH, by letter on September 25, 2002. Firm initiated recall is ongoing.

PRODUCT: Portex Spinal Tray 25G Whitacre Needle. Recall # Z-0038-3.

REASON: Spinal tray incorrectly packaged with a Quincke spinal needle instead of a Whitacre spinal needle.

MANUFACTURER: Acuson Corp., Mountain View, CA, by letters dated August 6, 2002. Firm initiated recall is ongoing.

PRODUCT: Acuson brand Aspen® Diagnostic Ultrasound System

Catalog Numbers: 82-47888, 82-61531, 82-47887, 82-53683. Recall # Z-0105-3/Z-0108-3.

REASON: Product labeling did not include ALARA (As Low As Reasonably Achievable) safety instructions.

MANUFACTURER: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing. Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ, by letter in July 2002.

PRODUCT: Somatom Sensation 16 systems. Software upgrade from Somaris/5 VA50A to VA50B. Recall # Z-0109-3.

REASON: Scans may be aborted if scans are started manually.

MANUFACTURER: Medtronic A/S 2740 Skovlunde. Firm initiated recall is ongoing. Recalling Firm: Medtronic Gastroenterology & Urology Shoreview, MN, by letter dated September 13, 2002.

PRODUCT: Disposable Sensory Needle Electrodes, Model Numbers:

a) 9013R0222 (0.70mm X 30mm);

b) 9013R0252 (0.35mm X 30mm);

c) 9013R0271 (0.35mm X 20mm).

Recall # Z-0111-3.

REASON: Some needles were not the length specified on labeling.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 16, 2002:

CLASS II

MANUFACTURER: Hitachi Ltd., Instrument Division, Ibaraki-ken, Japan. Firm initiated recall ongoing. Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by telephone on August 8, 2002.

PRODUCT: Roche brand Elecsys 2010 clinical chemistry analyzers. Recall # Z-0005-3.

REASON: Possible incorrect breast cancer marker results.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by telephone or letter on or about July 31, 2002. Firm initiated recall is ongoing.

PRODUCT: Access 2 Immunoassay System--Beta Human Chorionic Gonadotropin Reagent. Recall # Z-0006-3.

REASON: Stability.

MANUFACTURER: Medline Industries, Inc., Waukegan, IL, by visit on September 6, 2002. Firm initiated recall is complete.

PRODUCT: Medline Total Hip Pack Custom Sterile Kit. Recall # Z-0009-2.

REASON: Questionable sterility.

MANUFACTURER: Mobility Inc., San Diego, CA, by letter dated February 5, 2002. Firm initiated recall is complete.

PRODUCT: Toilet Seats, part number 50, used with several different models that do and do not lift patients to standing position. Recall # Z-0014-3.

REASON: Patient assist toilet seat locks up and won't lift patient to standing again.

MANUFACTURER: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing. Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ, by letter in June 2002.

PRODUCT: Somatom Model # 7005502 --Sensation 4; 4806118 --Volume Zoom; 7114023 --Volume Access; 3810152 –Balance; 3810160 –Emotion; 3810160 --Emotion Duo; 3810079 –Esprit;3810137 --Esprit + Recall # Z-0016-3.

REASON: A false patient name will appear when MPPS function is used.

MANUFACTURER: Siemens Medical Solutions Erlangen, Germany. Firm initiated recall is ongoing. Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ, by letter July 26, 2002.

PRODUCT: ICONOS R200 tilting X-Ray table. Recall # Z-0017-3.

REASON: Due to metal washers, the tilt drive is reduced.

MANUFACTURER: Cordis Corp., Miami Lakes, FL, by visit on or about January 31, 2002. Firm initiated recall is complete.

PRODUCT: Cordis DUCOR Angiographic Catheter, TS 6F .038 100CM JR4 MOD, Diagnostic Catheter. Recall # Z-0018-3.

REASON: Packages units seals may be opened compromising Sterility Barrier.

MANUFACTURER: Surgical Express, Plant City, FL. Firm initiated recall is complete.

Recalling Firm: Sterile Recoveries, Inc./Surgical Express Inc., Plant City, FL, by letters on December 20, 2001

PRODUCT: The firm is Field correcting with a warning sticker their SRI Disposable Procedure Packs containing Kimberly Clark Corp. ORTHOARTS Lower Extremity Drapes, Non-Sterile, stock code 79278-10, ORTHOCARTS Lower Extremity Drapes, Stock Code 89278-10, ORTHOCARTS Hip Drape, Non-Sterile, Stock Code 79346-10 and ORTHOCARTS Hip Drape, Stock Code 89346-10, ORTHOARTS drapes Stock number 79267-10 and also ORTHOARTS drapes Stock Number 89267-10, various lot

numbers. Kimberly Clark notified them initially on 12/19/01 and again on 1-31-02 (additional products and codes) of the recall

(ATL monitored recall classified under Z-784/796-2) and the component was repacked into one of their Surgical Kits that had to be field corrected in the field with a warning sticker.The surgical kits under correction are labeled as: (1) "SADDLEBACK MEMORIAL ARTHROSCOPY PACK, REORDER # ORO433A LOT # 20077 EXP DATE 10/01/04; (2) GARDEN CITY HOSPITAL ORTHO KNEE PACK RECORDER # ORO665B, LOT # 20490, EXP. DATE 4/01/03; (3) GARDEN CITY HOSPITAL KNEE ARTHROSCOPY PACK, RECORDER # ORO667, LOT # 20491, EXP. DATE 04/01/06; (4) E OKLAHOMA OUTPATIENT STERILE EXTREMITY REORDER # ORO375 LOT # 10174, EXP. DATE 03/01/04 SRI/STERILE RECOVERIES. Recall # Z-0020-3.

REASON: Supplier is recalling because the product may compromise the sterile field.

MANUFACTURER: Organogenesis Inc., Canton, MA, by telephone and fax on September 6, 2002. Firm initiated recall is complete.

PRODUCT: Apligraf (Graftskin). Recall # Z-0021-3

REASON: Product may be contaminated with mycoplasma.

MANUFACTURER: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is complete. Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ, by Customer Service Representative visit starting July 26, 2002.

PRODUCT: Bicor Hi-P and Neuorostar Hi-P Angiographic systems.

Recall # Z-0022-3.

REASON: Broken mounting bolts.

MANUFACTURER: Edwards Lifesciences Corporation of Puerto Rico, Anasco, Puerto Rico. Firm initiated recall is ongoing.

PRODUCT: AVA3X Advanced Venous Access Device (introducer valve)

Model numbers: IAVA3XI; M3L85FHS; M3L85FHSI; M3L85FHK; M3L85FHKI; M3L85FHK12; M3L85FHKIN;

M3L85FKI.

Recall # Z-0023-3.

REASON: Leakage betweem the anti-bleed back septum.

MANUFACTURER: Thales Microsonics, Sophia Antipolis Cedex, France. Firm initiated recall is ongoing. Recalling Firm: Thales Components Corporation, Totowa, NJ, by fax and letter dated June 7, 2002.

PRODUCT: Encore Brand, linear array, phased array, curved array, and microconvex probes: Model No. LK5.38EX, Encore L5, 5.5 MHz Linear probe; Model No. LK7.38EX, Encore L7, 7.0 MHz linear probe; Model NO. PK4.28EX, Encore V4, 3.5 MHz phased array probe; Model No. CK4.60EX, Encore C3, 3.5 MHz curved probe; Model No. CK6.10IX, Encore EC7, 6.5 MHz microconvex probe.

Each probe is serialized. Individual probes are packaged in a cardboard carrying case with inner foam padding. Each shipper would contain 3 case units. There is no physical labeling on the product that identifies the product brand names as indicated above. Each probe unit is tagged with only the following information: a serial number and the model number or partial brand name such as "C3" or "V4". Recall # Z-0024-3.

REASON: Excessive heat generated from probes.

MANUFACTURER: Utah Medical Products, Inc., Midvale, UT, by letter on September 13, 2002. Firm initiated recall is ongoing.

PRODUCT: CMI Velvet Touch Vacuum Extractor Cup Reusable Soft Silicone Cup for Vacuum Assisted Childbirth, Ref 202VT. Individually packaged. Non-Sterile. Latex free. Metal handle is stamped with the number 120301.

Recall # Z-0025-3.

REASON: Chrome plating reported flaking from the device handle.

MANUFACTURER: Baxter Healthcare Corp., Cartago, Costa Rica.

Firm initiated recall is ongoing. Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letter dated September 5, 2002.

PRODUCT: Baxter Swivel Wye Anesthesia Breathing Circuits:

a) Baxter Isoflex Adult Anesthesia Breathing Circuit with Swivel Wye, Gas Sampling Elbow with Luer Lock Port, and 2 Liter Roughcoat Bag. Recall # Z-0026-3;

b) Baxter Isoflex Adult Anesthesia Breathing Circuit with Swivel Wye, Gas Sampling Elbow with Luer Lock Port, and 3 Liter Bag. Recall # Z-0027-3;

c) Baxter Isoflex Adult Anesthesia Breathing Circuit with Swivel Wye, Gas Sampling Elbow with Luer Lock Port, Two-Way Filter (Bacterial/Viral Retentive) and 3 Liter Bag. Recall # Z-0028-3;

d) Baxter Isoflex Adult Anesthesia Breathing Circuit with Swivel Wye with Luer Lock Gas Sampling Port, Two-Way Filter (Bacterial/Viral Retentive) and 3 Liter Roughcoat Bag. Recall # Z-0029-3;

e) Baxter Adult Anesthesia Breathing Circuit with Swivel Wye, Gas Sampling Elbow with Luer Lock Port, Two-Way Filter (Bacterial/Viral Retentive) and 3 Liter Bag. Recall # Z-0030-3;

f) Baxter Adult Anesthesia Breathing Circuit with Swivel Wye, Gas Sampling Elbow with Luer Lock Port, and 3 Liter Bag. Recall # Z-0031-3;

g) Baxter Thick-Cuff Adult Anesthesia Breathing Circuit with Swivel Wye, Gas Sampling Elbow with Luer Lock Port,and 3 Liter Bag. Recall # Z-0032-3;

h) Baxter Thick-Cuff Adult Anesthesia Breathing Circuit with Swivel Wye, Gas Sampling Elbow with Luer Lock Port, Two-Way Filter (Bacterial/Viral Retentive) and 3 Liter Bag. Recall # Z-0033-3;

i) Baxter Adult Anesthesia Breathing Circuit with Swivel Wye with Luer Lock Gas Sampling Port, Two-Way Filter (Bacterial/Viral Retentive) and 3 Liter Roughcoat Bag. Recall # Z-0034-3;

j) Baxter Adult Anesthesia Breathing Circuit with Swivel Wye with Luer Lock Gas Sampling Port, and 3 Liter Roughcoat Bag. Recall # Z-0035-3;

k) Baxter Adult Anesthesia Breathing Circuit with Swivel Wye with Luer Lock Gas Sampling Port, Gas Sampling Elbow ith Luer Lock Port, and Two-Way Filters (Bacterial/Viral Retentive). Recall # Z-0036-3.

REASON: Cracks in anesthesia breathing circuits may cause inadequate ventilation.

CLASS III

MANUFACTURER: CIBA Vision Corp., DesPlaines, IL. Firm initiated recall is ongoing. Recalling Firm: Ciba Vision Corp., Duluth, GA, by letter on September 20, 2002.

PRODUCT: Contact Lenses. Recall # Z-0007-3.

REASON: Mislabeling on packages of multipak lenses.

MANUFACTURER: Remel Inc., Lenexa, KS, by telephone and letter on August 29, 2002. Firm initiated recall is ongoing.

PRODUCT: Remel Chocolate Agar, Product #01301, for use in the culturing of pathogenic Neisseria and Haemophilus, packaged 15 plates/pkg. Recall # Z-0008-3.

REASON: Doesn't exhibit growth of Haemophilus influenza ATCC10211.

MANUFACTURER: Medtronic A/S 2740 Skovlunde. Firm initiated recall ongoing. Recalling Firm: Medtronic Gastroenterology and Urology Shoreview, MN, by letter on August 15, 2002.

PRODUCT: Medtronic Bo-ject DHF 37 Disposable Hypodermic Needle Electrode, 37 mm x 0.41 mm, Product Catalog Number 9013S0441. Recall # Z-0015-3.

REASON: Some of the recalled hypodermic needle electrodes have blocked or partially blocked needle cannulas, leading to no or insufficient flow.

MANUFACTURER: Escalon Trek Medical, New Berlin, WI. Recalling Firm: Bausch & Lomb Surgical, Inc., St. Louis, MO, by letter on August 7, 2002.

PRODUCT: Bausch & Lomb CX5710 Viscous Fluid Injector Accessory Pack. Recall # Z-0019-3.

REASON: The flange of the syringe included within the CX5710 Viscous Fluid Injection Accessory Pack is too large to properly fit into the syringe coupler.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 9, 2002:

CLASS II

MANUFACTURER: Pacific Device, Inc. (avail medical), San Diego, CA. Firm initiated recall is ongoing. Recalling Firm: Ethicon, Inc., Somerville, NJ, by letter on August 7, 2002 for domestic consignees and on August 5, 2002 for international consignees.

PRODUCT: Ethicon J-VAC Reservoir is a single-use, disposable device that provides suction and fluid collection for wound drains. Recall # Z-0001-3.

REASON: Y Body of the Suction Port could separate from the reservoir.

MANUFACTURER: Misys Healthcare Systems, Inc., Tucson, AZ, by fax July 5, 2002. Firm initiated recall is complete.

PRODUCT: Misys Laboratory. Recall # Z-0002-3.

REASON: Software anomaly. Quality assurance flags were not appearing, as they should on cumulative reports.

MANUFACTURER: Princeton Biomeditech Corp., Monmouth Junction, NJ, by telephone and e-mail on July 23, 2002. Firm initiated recall is ongoing.

PRODUCT: Mono-plus Immunometric Assay In Vitro Diagnostic Kit. For

Qualitative Detection (used in the diagnosis) of Infectious Mononucleosis Heterophile Antibodies in Serum, Plasma or Whole Blood. Outer carton labeled in part, "PRODUCT NO. 84M4 30 TESTS For In Vitro Diagnostic Use MONO-plus***P-4204*** Immunometric Assay for Qualitative Detection of Infectious Mononucleosis Heterophile Antibodies in Serum, Plasma or Whole Blood***An aid in the diagnosis of Infectious Mononucleosis***For Professional Use Only***THIS PRODUCT CONTAINS DRY NATURAL RUBBER*** ***KIT CONTENTS: 30 EACH MONO-plus

TEST DEVICES: Contain a membrane strip coated with bovine erythrocyte extracts and a pad impregnated with antibody-dye conjugate in a protein matrix containing 0.1% sodium azide. ***DEVELOPER SOLUTION (D):***MONO-plus POSITIVE CONTROL:***MONO-plus NEGATIVE CONTROL:***CAPILLARY

TUBES***PACKAGE INSERT"Wampole Pouch labeled in part, "1 TEST DEVICE***MONO-plus***For In Vitro Diagnostic Use***Store at 2ú -30úC *** ***P-3201***FL-084M2-01***WB LOT 222B21 EXP MAR03***US. PATENT NO. 5,559,041" BioSign Pouch labeled in part, "BioSign Mono***One Step IM — IgM Test One Test Device*** For In Vitro Diagnostic Use.***Store at 4ú -30úC (40ú -86ú* F) sealed.***PBM***

Insert labeled in part, "P-5207-B***MONO-plus***Immunometric Assay for Qualitative Detection of Infectious Mononucleosis Heterophile Antibodies in Serum, Plasma or Whole Blood*** An aid in the diagnosis of Infectious Mononucleosis.***For In Vitro Diagnostic Use***CLIA COMPLEXITY: MODERATE***CDC ANALYTE IDENTIFIER CODE: 2809***CDC TEST SYSTEM IDENTIFIER CODE: 70084*** ***PRINTED IN USA 1997, 2000 CARTER-WALLACE, INC. IN-084M4-02 ISSUED: SEPTEMBER, 2000". Recall # Z-0003-3.

REASON: False positive results when whole blood used as test specimen.

MANUFACTURER: M-Pact Corp., Eudora, KS. Firm initiated recall is ongoing. Recalling Firm: Rhein Medical Tampa, FL, by fax and letter beginning on May 20, 2002.

PRODUCT: Product is an Ophthalmic Sponge under the brand name "Rhein PVAc Eye Spears" Product Code 09-70012. This product is for all anterior segment surgery of the eye and helps prevent line and other fibers from affecting the surgical site. The soft distal sponge tip conforms to the cornea and us used to absorb fluids during surgery. Recall # Z-0004-3.

REASON: Field complaints of device causing keratitis of the stoma.

MANUFACTURER: NKUS Lab (Nihon Koden), Irvine, CA, by telephone and in-person visit on June 28, 2002. Firm initiated recall is complete.

PRODUCT: CNS-9303A Series Central Monitor Station.

Recall # Z-1386-2.

REASON: Capacitor failure causes screen to blank.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter dated August 8, 2002. Firm initiated recall is ongoing.

PRODUCT: CryoValve Allograft, Human Heart Valve. Recall # Z-1388-2.

REASON: Failure to meet serodilution of plasma guidelines.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter dated August 8, 2002. Firm initiated recall is complete.

PRODUCT: CryoValve Allograft, Human Heart Valve. Recall # Z-1389-2.

REASON: Failure to meet serodilution of plasma guidelines.

MANUFACTURER: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing. Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ, by hardware modification on May 23, 2002.

PRODUCT: Nuclear Resonance Magnetic Imaging System, Diagnostic Imaging. Recall Z-1390-2/Z-1393-2.

Magnetom Harmony

Magnetom Symphony

Magnetom Harmony Upgrade Syngo MR

Magnetom Symphony Upgrade Syngo MR

REASON: Smoke generating from gradient cabinet.

MANUFACTURER: USA Instruments, Inc., Aurora, OH, by letter on August 30, 2002. Firm initiated recall is complete.

PRODUCT: Insight-Plus 9000 Phased Array Torso & Pelvis Coil, 1.5T field strength. The device is sold under the GE label. Recall # Z-1394-2.

REASON: The coil may overheat and cause skin burns during an MRI scan.

MANUFACTURER: Spacelabs Medical, Inc., Redmond, WA, by letter on October 22, 2001. Firm initiated recall is ongoing.

PRODUCT: Recall # Z-1395-2/Z-1401-2.

a) Telemetry Digital Processors Models 90342, 90344,

90346, 90348. Recall # Z-1395-2/Z-1398-2;

b) Integrated Multiparameter Module Model 90470.

Recall # Z-1399-2;

c) Telemetry Receiver Module Model 90478.

Recall # Z-1400-2;

d) Ultarview Command Module Model 90496.

Recall # Z-1401-2.

REASON: ECG software fails to detect low heart rates in range of 12 to 15 bpm.

MANUFACTURER: Thermo Trace Noble Park, Victoria, Australia.

Firm initiated recall is complete. Abbott Laboratories, Inc., South Pasadena, CA, by letter during the week of July 15, 2002.

PRODUCT: AEROSET Magnesium Reagent, List Number 7D70-01.

Recall # Z-1401-2.

REASON: Elevated results.

MANUFACTURER: DPC Cirrus Inc., Flanders, NJ, by fax on June 21, 2002.

Firm initiated recall is ongoing.

PRODUCT: DPC Immulite 2000 System. Recall # Z-1404-2.

This product uses the Longwell LS-7C gray two prong power cord sold with Hewlett Packard DeskJet Printers 800 and 900 Series. The power cords were recalled by Hewlett Packard.

REASON: Power cord may crack posing electrical hazard.

MANUFACTURER: Misys Healthcare Systems, Inc., Tucson, AZ, by fax on June 13, 2002. Firm initiated recall is ongoing.

PRODUCT: Misys laboratory version 5.3 with custom Result Interface 11. Recall # Z-1405-2.

REASON: Software anomaly causing mixing of patient data.

MANUFACTURER: Deroyal Surgical, Rose Hill, VA, by fax and letter on August 15, 2002. Firm initiated recall is ongoing.

PRODUCT: Custom Latex Tubing, sterile, packaged in sterile paper wrapper and labeled as "Custom Latex Tubing" and additionally labeled as "Latex Safe", for use in cardiovascular surgery, 5/16" x1/2 x12 ft, 25 tubes per case. Catalog #32-1526. Recall # Z-1406-2.

REASON: Latex surgical tubing is labeled as latex-safe.

MANUFACTURER: Maximm Medical, Inc., Athens, TX, by letter dated May 15, 2002.

Firm initiated recall is ongoing.

PRODUCT: Custom Angiography Procedure Kits which contain Heparin Sodium Injection that has been recalled. There are 43 different configurations of the kits involved. Recall # Z-1407-2/Z-1449-2.

REASON: Kits contain recalled heparin sodium injection.

MANUFACTURER: Lifescan, Inc., Milpitas, CA, by letters on August 26, 2002. Firm initiated recall is ongoing.

PRODUCT: LifeScan brand OneTouch® SureStep® Test Strip and SureStep® Pro Test Strip used in OneTouch® SureStep® Blood Glucose Meter. Recall # Z-1450-2.

REASON: Use of Test Strips may give inaccurate very low glucose results.

MANUFACTURER: Abbott Laboratories, Inc., Abbott Park, IL, by letter dated September 6, 2002. Firm initiated recall is complete.

PRODUCT: Architect CA 19-9 Reagent Kit; Recall # Z-1451-1.

a) list 6C04-20: 4 x 100 tests;

b) list 6C04-25: 1 x 100 tests.

REASON: MCC1 control out of range low.

MANUFACTURER: Sims Portex, Inc., Keene, NH. Firm initiated recall is ongoing. Recalling Firm: Portex, Inc., Keene, NH, by telephone on September 12, 2002.

PRODUCT: Portex Continuous Epidural Tray- 18 Gauge Hustead

Catalog No. 15536-22. Recall # Z-1458-2.

REASON: Trays may contain ampules of Bupivacaine HCl Inj. 0.50% instead of 0.25%.

MANUFACTURER: Wesley Jessen Corp., Des Plaines, IL, by letters dated March 5, 2002. Firm initiated recall is complete.

PRODUCT: Freshlook Toric (Phemfilcon A) Soft Contact Lenses for Astigmatism with Handling Tint, the soft contact lenses are individually packaged in sterile foil-sealed plastic packages, 3 packs per box. Recall # Z-1459-2.

REASON: Mislabeled for corrective power, cylinder & axis.

MANUFACTURER: Stryker Corp., Kalamazoo, MI, by letters on August 22, 2002. Firm initiated recall is ongoing.

PRODUCT: Stryker M-1 roll-in system rugged ambulance cot, model 6100-003-000. Recall # Z-1460-2.

REASON: Legs supports may become loose and the cot may tip.

MANUFACTURER: Thermo Trace Noble Park, Victoria Australia. Recalling Firm: Abbott Laboratories, Inc., South Pasadena, CA, by letter during the week of July 15, 2002.

PRODUCT: AEROSET Magnesium Reagent, List Number 7D70-01.

Recall # Z-1464-2.

REASON: Elevated results.

CLASS III

MANUFACTURER: Beckman Coulter Inc., Brea, CA, by letters dated May 15, 2002. Firm initiated recall is ongoing.

PRODUCT: Cytomics RXP software. Recall # Z-1387-2.

REASON: When analyzing multiple listmode files using a multi-file analysis protocol, incorrect percentage results may occur if "% in Regions" is selected.

MANUFACTURER: Spectrum Designs, Inc., Carpineteria, CA, by telephone and letter on July 2, 2002.

PRODUCT: Nasal Dorsum Style 7

a) Size 2; P/N: 400-724S L/N: 8221. Recall # Z-1402-2;

b) Size 3; P/N: 400-734S L/N: 8228. Recall # Z-1403-2.

REASON: Wrong sizes in packages.

MANUFACTURER: Roche Diagnostics GmbH Mannheim, Germany. Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by notice dated September 6, 2002.

PRODUCT: Roche COBAS Integra ferritin, catalog # 753556.

Recall # Z-1457-2.

REASON: Some sera may under-recover ferritin by up to 35%.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 2, 2002:

CLASS II

MANUFACTURER: Coulter Corp., Hialeah, FL. Firm initiated recall is ongoing.

Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letters on June 4, 2002.

PRODUCT: Automated differential cell counters:

a) Coulter LH 700 Series Hematology Analyzers.

Recall # Z-1322-2;

b) Coulter GEN S Hematology Analyzers. Recall # Z-1323-2.

REASON: Incorrectly gates Neutrophil population in patient samples.

MANUFACTURER: Hill-Rom Co. Inc., Batesville, IN, by letter dated August 16, 2002. Firm initiated recall is ongoing.

PRODUCT: a) P645 Specialite Patient Light. Recall # Z-1346-2;

b) P696IL Integris 1000 Patient Light. Recall # Z-1347-2;

c) P2003B Integris B Patient Lite Rail. Recall # Z-1348-2.

d) P780D Deep Impression Light for use with the Impression

Series Headwall. Recall # Z-1349-2.

REASON: Switch fails to function as intended due to incorrect amp size switch.

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-1350-2.

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.

MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by telephone on July 16, 2002. Firm initiated recall is complete.

PRODUCT: Aeroset Software Version 1.01ER000. Recall # Z-1352-2.

REASON: Sample results may be skewed by failure to properly 'blank' the sample.

MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated August 15, 2002.

Firm initiated recall is ongoing.

PRODUCT: a) Hill-Rom brand Advanta 1600 series hospital beds as follows: Model P1600B; full featured general hospital bed.

Recall # Z-1353-2;

b) Model P1603B; semi-de-featured general hospital bed.

Recall # Z-1354-2;

c) Model P1604B; de-featured general hospital bed.

Recall # Z-1355-2.

REASON: Unintentional movement of the bed.

MANUFACTURER: Medline Industries, Inc., Mundelein, IL, by letters dated August 16, 2002. Firm initiated recall is ongoing.

PRODUCT: Sterile 4" x 4", 16-ply gauze sponges packaged 10 sponges per formed plastic tray with tyvek lid,

The following gauze products are being recalled:

a) Medline Accu-Sorb X-Ray Detectable USP Type VII Gauze.

Recall # Z-1357-2;

b) Medline Gauze Sponge USP Type VII Gauze.

Recall # Z-1358-2.

REASON: Compromised packaging integrity - questionable sterility.

MANUFACTURER: Medical Research Laboratories, Arleta, CA. Firm initiated recall is ongoing. Recalling Firm: Medical Data Electronics, Inc., Arleta, CA, by letter on August 1, 2002

PRODUCT: Defibrillator/ Pacer.

Medical Research Laboratories external adult defibrillator paddle set- used with Medical Data Electronics Escort defibrillator pacer models 20201 and 20202.

Recall # Z-1360-2.

REASON: Intermittent operation of the paddles.

MANUFACTURER: Parallax Medical, Inc., Scotts Valley, CA, by letters, telephone and visits beginning on July 19, 2002. Firm initiated recall is ongoing.

PRODUCT: Parallax Medical brand EZFlow Cement Delivery System

Catalog #s:

a) CDS-110;

b) CDS-122;

c) CDS-132;

d) CDS-2210;

e) CDS-2212. Recall # Z-1361-2.

REASON: Firm has identified a number of units which may have breaches in the pouch seal.

MANUFACTURER: Medical Data Electronics, Inc., Arleta, CA, by letter beginning August 2002. Firm initiated recall is ongoing.

PRODUCT: MDE Escort Prisim SE

A portable patient monitor. Recall # Z-1362-2.

REASON: Printed circuit board flaw might allow cuff to over inflate.

MANUFACTURER: Sorenson Medical, Inc., West Jordan, UT, by letter on August 23, 2002. Firm initiated recall is ongoing.

PRODUCT: a) REF 220039, MicroJect 30 Pump, continuous low flow.

Recall # Z-1363-2;

b) REF 220041, MicroJect 200 Pump, intermittent or continuous

flow. Recall # Z-1364-2.

REASON: Reports of under-infusion and pump housing separation.

MANUFACTURER: Ortho Development Corp., Draper, UT, by telephone and letters on May 28, 2002. Firm initiated recall is complete.

PRODUCT: a) Balanced Knee System, PS Tibial Insert Size 6 16mm;

b) Balanced Knee System, PS Tibial Insert Size 4 20mm.

Each insert is a component of the Balanced Knee System, packaged individually. Recall # Z-1365-2.

REASON: Outer box product label showed incorrect size.

MANUFACTURER: Siemens Shanghai, Medical Equipment, Ltd., Shanghai, China 200090. Firm initiated recall is complete. Recalling Firm: Siemens Medical Systems, Inc., Iselin, NJ, by letter on or about May 2002.

PRODUCT: Computed tomography system, Diagnostic Imaging -- Model #7053502. Recall # Z-1366-2.

REASON: Errors can occur when performing gantry tilt examinations.

MANUFACTURER: bioMerieux, Inc., Hazelwood, MO, by telephone on August 5, 2002. Firm initiated recall is ongoing.

PRODUCT: Vitek GNS-204, product #V4526, gram negative susceptibility cards individually wrapped in a mylar pouch, 20 cards per box, for use in the antimicrobial susceptibility testing of rapidly growing aerobic and/or facultatively anaerobic, gram-negative bacilli. Recall # Z-1370-2.

REASON: Mislabeled. This results in an incorrect susceptible/resistant result for the AST's included in the GNS 204 card.

MANUFACTURER: General Electric Medical Systems, Waukesha, WI, by field engineer visits beginning January 2001. Firm initiated recall is ongoing.

PRODUCT: Proteus XR/a Stationary X-ray System, Model Numbers: 2244165, 2259976, 2212259, 2259973 and 2268970. Recall # Z-1371-2.

REASON: Screws that mount the collimator interface plate may loosen and fall out allowing the collimator to fall.

MANUFACTURER: Thoratec Corp., Pleasant, CA, by letter and fax on August 14, 2002. Firm initiated recall is ongoing.

PRODUCT: Thoratec TLC-II Portable VAD Driver System. Driver Model numbers: 20010-0000-081, 20010-0000-132. Recall # Z-1373-2.

REASON: Component defects that can cause TLC-II driver to abruptly stop functioning.

MANUFACTURER: Synthes (USA), Monument, CO. Firm initiated recall is ongoing.

Recalling Firm: Synthes (USA), Paoli, PA, by letters on August 2, 2002.

PRODUCT: Ti Cann Troch Fixation Nail. The generic name is Trochanteric Fixation Nail. Recall # 1374-2/Z-1376-2.

REASON: Manufactured outside design specifications The medial side of the oblique hole may be oval instead of round.

MANUFACTURER: Misys Healthcare Systems, Inc., Tucson, AZ, by fax on August 16, 2002. Firm initiated recall is ongoing.

PRODUCT: Misys Laboratory. Recall # Z-1377-2.

REASON: Software anomaly. Footnotes are incomplete and do not print on reports.

MANUFACTURER: Misys Healthcare Systems, Inc., Tucson, AZ, by fax July 5, 2002.

Firm initiated recall is ongoing.

PRODUCT: Misys Laboratory. Recall # Z-1378-2.

REASON: Software anomaly. When original results were modified or deleted in function MEH, original/unmodified results were saved.

MANUFACTURER: Farnes Enterprises dba MedSource Direct, Woods Cross, UT, by letter on August 17, 2002. FDA initiated recall is complete.

PRODUCT: Genuine ONE TOUCH *** Test Strips *** Lot No. *** Exp. Date ***

LIFESCAN INC a Johnson & Johnson company Milpitas, California. Recall # Z-1379-2;

UNI-CHECK Test Strips *** Catalog No.1702720 *** QTY: 24 Packages of 50 Strips/Package *** Lot No.: *** Expires: ***". Recall # Z-1380-2.

REASON: Blood glucose test strips were not approved for sale in the U.S. and Canada.

MANUFACTURER: Drager Medical, Telford, PA, by telephone on September 13, 2002. Firm initiated recall is complete.

PRODUCT: Caleo Infant Warming System. The product is an incubator.

Recall # Z-1381-2.

REASON: Temperature measurement error.

MANUFACTURER: Sorenson Medical, Inc., West Jordan, UT, by letter on September 5, 2002. Firm initiated recall is complete.

PRODUCT: Microject 30 Pump, Ref 220039. Packaged individually or in cases of 10. Recall # Z-1382-2.

REASON: Pumps were released after failing established AQL acceptance levels.

MANUFACTURER: Xomed, Inc., Jacksonville, FL, by letter on July 19, 2002.

Firm initiated recall is complete.

PRODUCT: Solan Trephine Blade, 9 mm and also the 10mm sizes (different products), packed one unit per box. Corneal Trephine, Recall # Z-1384-02.

REASON: Outer box mislabeled as 9mm when product is 10mm.

CLASS III

MANUFACTURER: Wesley Jessen Corp., Des Plaines, IL, by letters dated March 5, 2002. Firm initiated recall is complete.

PRODUCT: Freshlook Color Enhancers (phemfilcon A) Contact Lenses; the soft contact lenses are individually packaged in sterile foil-sealed plastic packages, 6 packs per box. Recall # Z-1351-2.

REASON: Mislabeled for corrective power.

MANUFACTURER: Meridian Bioscience, Inc., Cincinnati, OH, by letters dated August 27, 2002. Firm initiated recall is ongoing.

PRODUCT: MeriFluor CMV IgM IFA/IFT, packaged under the Gull label.

Recall # Z-1356-2.

REASON: The Negative Control does not meet labeled specifications.

MANUFACTURER: Becton Dickinson Vacutainer Systems, Broken Bow, NE. Firm initiated recall is ongoing. Recalling Firm: Becton Dickinson & Co., Franklin Lakes, NJ, by letters on July 17, 2002.

PRODUCT: BD 5 ml preservative Urine Culture and Sensitivity (C&S) Tube). Recall # Z-1359-2.

REASON: Label placement on urine tube is incorrect which could cause filling below specs.

MANUFACTURER: Becton Dickinson Caribe Ltd., San Lorenzo, Puerto Rico. Firm initiated recall is ongoing. Recalling Firm: Becton Dickinson & Co., Franklin Lakes, NJ, by letter on April 5, 2002.

PRODUCT: BD Unopette Brand Capillary Pipettes for use with Unopette Blood Diluting Pipette System. Recall # Z-1367-2.

REASON: Mispackaging of 20uL pipettes in 10uL containers.

MANUFACTURER: Digene Corp., Gaithersburg, MD, by telephone and fax on August 13, 2002. Firm initiated recall is ongoing.

PRODUCT: Digene Corporation's Hybrid Capture(tm)2 High Risk Human Papillomavirus (HPV) In-vitro diagnostic test kit, containing one vial of High Risk HPV Calibrator. Recall # Z-1368-2.

REASON: Human Papilloma Virus IVD Test kit contains incorrect calibrator.

MANUFACTURER: Ortho-Clinical Diagnostics, Inc., Cardiff, Wales. Firm initiated recall is ongoing. Recalling Firm: Ortho-Clinical Diagnostics, Inc., Rochester, NY, by letter on August 19, 2002.

PRODUCT: VITAMIN B12 CALIBRATORS; For in vitro diagnostic use only. Ca