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FDA Recalls

January 1, 2005 - June 30, 2005

• Recalls as of June 22, 2005

• Recalls as of June 15, 2005

• Recalls as of June 8, 2005

• Recalls as of June 1, 2005

• Recalls as of May 25, 2005

• Recalls as of May 18, 2005

• Recalls as of May 11, 2005

• Recalls as of May 4, 2005

• Recalls as of April 27, 2005

• Recalls as of April 20, 2005

• Recalls as of April 13, 2005

• Recalls as of April 6, 2005

• Recalls as of March 30, 2005

• Recalls as of March 23, 2005

• Recalls as of March 16, 2005

• Recalls as of March 9, 2005

• Recalls as of March 2, 2005

• Recalls as of February 23, 2005

• Recalls as of February 16, 2005

• Recalls as of February 9, 2005

• Recalls as of February 2, 2005

• Recalls as of January 19, 2005

• Recalls as of January 12, 2005

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 22, 2005:

CLASS I ****CORRECTION**** The Enforcement Report 05-20 dated May 18, 2005, Recall # Z-0805-05, the recall product is the CM 100-Headstart Adapter Cable, Cat. No. 920650 (not Laerdal Medical Corp, CM 100-HeadStart® Automatic External Defibrillator Adapter Cables). The recalled Adapter Cables are for use with the Laerdal Heartstart 4000 and various Philips models listed. The Laerdal Heartstart 3000 is not involved or affected by this recall. It should not be included. The subject Adapter Cable cannot be attached to a Heartstart 3000. Customers are instructed to discontinue use of the Adapter Cables, and to order alternative cabled electrodes that do not require adapters (not alternative cables) from Philips Medical Systems. The recalling firm is Laerdal Medical, not Volex Inc., and Laerdal’s firm initiated recall is ongoing.

CLASS II

MANUFACTURER: Recalling Firm: Spinal Specialties, Inc., San Antonio, TX, by letter on April 15, 2005. Manufacturer: Becton Dickinson & Co, Franklin Lakes, NJ. Firm initiated recall is ongoing.

PRODUCT: a) Clinical Technologies, Inc., 25 G Spinal Painpak, Reorder No.: 4043. Recall # Z-0885-05; b) 22G Nerve Block PainPak, Reorder No.: 3269. Recall # Z-0886-05.

REASON: Becton Dickinson recalled the needles due to reports of leakage associated with an undersized Luer taper in the spinal needle hub.

MANUFACTURER: LifeScan, Inc., Milpitas, CA, by letters on November 17, 2003. Firm initiated recall is complete.

PRODUCT: LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number 020-244-07; Recall # Z-0887-05.

REASON: A Control Solution range for the OneTouch Ultra Test Strip of 111-150 mg/dL was incorrectly labeled as 97-131 mg/dL.

MANUFACTURER: Hitachi Medical Systems America Inc., Twinsburg, OH, by letters on April 21, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Hitachi Altaire Magnetic Resonance Imaging Device. Recall # Z-0888-05; b) Hitachi AIRIS II Magnetic Resonance Imaging Device. Recall # Z-0889-05; c) Hitachi AIRIS Elite Magnetic Resonance Imaging Device. Recall # Z-0890-05.

REASON: Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.

MANUFACTURER: Synovis Surgical Innovations A Division of Synovis Life Technologies, Inc., St. Paul, MN, by telephone and recall notice, dated May 31, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V), 4506 ETS-V. PSD-V is an implantable surgical mesh comprised of non-crosslinked bovine pericardium in a dehydrated form. Do not reuse. Consult Instructions for Use. Sterilized. Product treated with sodium hydroxide. Produt derived from USDA-inspected cattle. Made in the U.S.A. Rx Only. Recall # Z-0891-05; b) Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V), 4506 E-V. PSD-V is an implantable surgical mesh comprised of non-crosslinked bovine pericardium in a dehydrated form. Do not reuse. Consult Instructions for Use. Sterilized. Product treated with sodium hydroxide. Product derived from USDA-inspected cattle. Made in the U.S.A. Rx Only. Recall # Z-0892-05.

REASON: Device is contained in 2 pouches. The outer pouch’s seal may be compromised; this may render the exterior of the interior pouch non-sterile.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 15, 2005:

CLASS II

MANUFACTURER: Nichols Institute Diagnostics, San Clement, CA, by letter on May 2, 2005. Firm initiated recall is ongoing.

PRODUCT: Nichols Advantage Sample hGH Diluent Set, Catalog No. 62-7756. Recall # Z-0873-05.

REASON: Under recovery of diluted samples by as much as 20%.

MANUFACTURER: Nichols Institute Diagnostics, San Clement, CA, by letter on April 28, 2005. Firm initiated recall is ongoing.

PRODUCT: Nichols Advantage TSH -- Third Generation. Recall # Z-0874-05.

REASON: Does not meet performance claims in the labeling for analytical and functional sensitivity.

MANUFACTURER: Recalling Firm: Liko, Inc, Franklin, MA, by letter dated September 29, 2004. Manufacturer: Liko Ab, Lulea, Sweden. Firm Initiated recall is ongoing.

PRODUCT: a) UNO 102 EM/EE/ES Patient Lift. Recall # Z-0875-05; b) UNO 100 EM/EE Patient Lift. Recall # Z-0876-05; c) Sabina I and II EM/EE Patient Lift. Recall # Z-0877-05.

REASON: Incorrect length support screws may cause patient lift failure.

MANUFACTURER: Recalling Firm: Maquet Inc, Bridgewater, NJ, by letter on March 31, 2005. Manufacturer: Maquet Critical Care AB, Solna, Sweden. Firm initiated recall is ongoing.

PRODUCT: Servo-I Ventilator. Recall # Z-0878-05.

REASON: Complaints about batteries indicating a satisfying remaining time but after a short time suddenly shut off without giving alarms to indicate short remaining battery back-up time. (Power off alarm will be given).

MANUFACTURER: Recalling Firm: Perkin Elmer Life and Analytical, North Billerica, MA, by letter on March 11, 2005 and May 5, 2005. Manufacturer: Perkin Elmer Life Sciences, Turku, Finland. Firm initiated recall is ongoing.

PRODUCT: Perkin ELmer Life and Analytical Sciences - NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit. Recall # Z-0879-05.

REASON: Pump failure may affect data integrity.

MANUFACTURER: Spinal Concepts, Inc, An Abbott Laboratories Company, Austin, TX, by telephone around August 2002. Firm initiated recall is complete.

PRODUCT: SC-AcuFix Thinline Low-Profile Anterior Cervical Plate System. Recall # Z-0880-05.

REASON: Complaints were received where swivels came out of plate and where the screw went through the plate.

MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated April 18, 2005. Manufacturer: Roche Diagnostics GmbH, Mannheim, Germany. Firm initiated recall is ongoing.

PRODUCT: a) Roche brand AccuData GTS Plus System; Catalog number 3000249, material number 03000249001. Recall # Z-0881-05; b) Roche brand AccuData GTS System; Catalog number 404, material number 03136833001. Recall # Z-0882-05; c) Roche brand AccuData GTS/GTS Plus System Replacement Base/Module; Catalog number 3426050, material number 03426050001. Recall # Z-0883-5.

REASON: If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using 'C' cell batteries to power their base and could render the system inoperable (system won't turn on) for customers using the A/C adaptor without batteries.

CLASS III

MANUFACTURER: International Remote Imaging Systems Inc, Chatsworth, CA, by telephone on April 29, 2005. Firm initiated recall is ongoing.

PRODUCT: IRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074. Recall # Z-0884-05.

REASON: Nonconformance to performance specifications. The instrument failed to report a positive result for nitrite which was expected for a conforming part B control.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 8, 2005:

CLASS II

MANUFACTURER: Arrow International Inc., Reading, PA, by letter on/about February 17, 2005. Firm initiated recall is ongoing.

PRODUCT: Arrow Continuous Nerve Block Needle, Latex-Free, Rx only, Sterile. Recall # Z-0852-05.

REASON: Possible difficulty in passing the catheter through the needle due to a reduced ID of the needle caused by over crimping of the needle during the manufacturing process.

MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated March 3, 2005. Manufacturer: Baxter Healthcare Corporation of Puerto Rico, Aibonito, PR. Firm initiated recall is ongoing.

PRODUCT: a) Baxter PosiFlow Access Device for IV Access; PRODUCT code 2N9050; a single use, sterile device with PosiFlow Positive Displacement Feature and Male Luer Lock Adapter, 0.06 mL. Recall # Z-0853-05; b) Baxter Extension Sets with PosiFlow Access Device for IV Access; Product codes 2N9051, 2N9052, 2N9053, 2N9054, 2N9055, 2N9057; a single use, sterile fluid pathway devices with PosiFlow Positive Displacement Feature. Recall # Z-0854-05.

REASON: Inadequate directions for use resulting in fluid leaks, valves sticking in the open position, and flow output restriction.

MANUFACTURER: Arizant Inc., Eden Prairie, MN, by letters beginning March 11, 2005. Firm initiated recall is ongoing.

PRODUCT: Bair Hugger Temperature Management Blanket, Model 555 Pediatric Full Access Blanket. Use only with a Bair Hugger temperature management unit. Not sterile. Do not use I f primary packaging has been previously opened or is damaged. Recall # Z-0855-05.

REASON: Air channel seals on a limited number of Bair Hugger Model 555 Pediatric underbody blankets could separate when inflated with air from Bair Hugger warming unit. This separation would create a bulging area in the blanket's air channels, which could have a potential to shift the patient's position on the blanket.

MANUFACTURER: Recalling Firm: Wahl Clipper Corp, Sterling, IL, by a Stop Sales notice on/or about December 10, 2004. Manufacturer: Wahl Clipper Ningbo Ltd, Zhejiang, China. Firm initiated recall is ongoing.

PRODUCT: Discovery Channel brand 8-Way Massager with Heat; therapeutic massager; Model Number 4196-1. The model number and date code are molded into the side of the handle of the massager near the on/off switch. Recall # Z-0856-05.

REASON: The housing of the massager's heating applicator attachment may crack during use. If the plastic housing cracks and breaks it could expose the user to live electrical connections and pose a shock hazard.

MANUFACTURER: Cryolife, Inc, Kennesaw, GA, by telephone on May 17, 2005. Firm initiated recall is complete.

PRODUCT: a) Aortic Valve & Conduit, Donor #77647, Model #AV00. Recall # Z-0859-05; b) Pulmonary Valve & Conduit. Donor #77647, Model #PV00. Recall # Z-0860-05.

REASON: Subsequent to tissue release, CryoLife received new information related to the donor time of death, which caused the donor to no longer meet CryoLife's acceptance criteria for warm ischemic time.

MANUFACTURER: Zimmer Inc., Warsaw, IN, by email on February 9, 2005. Firm initiated recall is ongoing.

PRODUCT: Zimmer brand fracture blade plate instrument Chisel, 95 degree, small; assembly part 4705-03-10, catalog number 00-4705-003-10. Recall # Z-0864-05.

REASON: The engraved calibration lines are incorrectly specified, which will result in the user obtaining a reading that the chiseling removed material to a depth 10mm deeper than what was actually removed, thus guiding the user to select a blade plate that is longer than will fit.

MANUFACTURER: Philips Ultrasound, Inc., Bothell, WA, by letter on May 6, 2005. Firm initiated recall is ongoing.

PRODUCT: Philips HDI 4000 Ultrasound System Part numbers 9896 053 15031 (8500-0066-01), 9896 053 18811 (8500-0080-01), 9896 053 22011 (8500-0087-01). Recall # Z-0865-05.

REASON: The acoustic display of Mechanical Index and Thermal Index is inaccurate - two transducers may exceed limits for acoustic intensity and MI.

MANUFACTURER: Ortho-Clinical Diagnostics, Rochester, NY, by letters dated April 18, 2005. Firm initiated recall is complete.

PRODUCT: VITROS VALP Reagent, REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Recall # Z-0866-05.

REASON: Negatively biased results may be observed when the reagent is stored on the VITROS 5,1FS Chemistry System for less than seven days.

MANUFACTURER: Smiths Medical ASD, Inc., Keene, NH, by letter on/about May 16, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Portex Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 7.0mm Product Number: 535070. Recall # Z-0867-05; b) Portex Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 8.0mm Product Number: 535080. Recall # Z-0868-05; c) Portex Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 9.0mm Product Number: 535090. Recall # Z-0869-05; d) Portex Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 7.0mm Product Number: 538070E. Recall # Z-0870-05; e) Portex Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 8.0mm Product Number: 538080E. Recall # Z-0871-05; f) Portex Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 9.0mm Product Number: 538090E. Recall # Z-0872-05.

REASON: Guiding catheter may have thinner and weaker sidewalls than designed, and may break. CLASS III MANUFACTURER: Recalling Firm: Mick Radio Nuclear Instruments, Inc., Mount Vernon, NY, by letters on March 30, 2005, and telephone on April 22, 2005. Manufacturer: Manan Medical Products, Inc., Wheeling, IL. Firm initiated recall is ongoing. PRODUCT: Mick TP Prostate Seeding Needles, 18 Gauge, Catalog/Model Number MTP-1820-C. --- Brand Name: Mick TP Disposable Needle 18 Gauge. Common/Usual Name: TP Needle 18 Gauge. Classification Name: System, Applicator, Radionuclide, Manual. The needle is an accessory to the Mick 200-TPV Applicator and Kit. This one time use needle is used for brachytherapy. The product is sold in cartons with each carton containing a total of 25 needles. Each carton contains 4 packages of 5 needles, and 5 packages containing one needle each. Recall # Z-0857-05. REASON: Some of the Mick TP Prostate Seeding Needles do not fit properly into the Mick 200-TPV Applicator.

MANUFACTURER: Smiths Medical ASD, Inc., Keene, NH, by telephone on May 5, 2005, May 12, 2005 and by letter on May 17, 2005. Firm initiated recall is ongoing.

PRODUCT: Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G x 1", Catalog Number: 4238. Recall # Z-0858-05.

REASON: Mislabeled: Product may contain an incorrect needle size. Product labeled as a 25G x 1" may contain a 25G x 5/8".

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of June 1, 2005:

CLASS II

MANUFACTURER: Darex Container Products, Division of W.R. Grace & Co., Chicago, IL, by letters dated March 30, 2005. Firm initiated recall is ongoing.

PRODUCT: 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; Manufactured by: W.R. Grace & Co. - Conn., 6050 West 51st St., Chicago, IL 60638; the product is packaged in pre-paks(pre-filled 2.5 lb. canisters, 12 per carton) and 5-gallon pails. Recall # Z-0850-05.

REASON: Both lots were found to be out of specification due to an elevated level of small particles (fines).

MANUFACTURER: Recalling Firm: Inamed Corp, Goleta, CA, by letter on May 5, 2005 and follow-up telephone calls. Manufacturer: McGhan Medico, SA, Barreal de Heredia, Costa Rica. Firm initiated recall is ongoing.

PRODUCT: Style 363 Saline-Filled BIOCELL textured Breast Implants. Recall # Z-0851-05.

REASON: Wrong size Implant was mislabeled with the wrong size.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 25, 2005:

CLASS I

MANUFACTURER: Lifescan Inc, Milpitas, CA, by letters on April 11, 2005. Firm initiated recall is ongoing.

PRODUCT: a) LifeScan brand OneTouch Ultra Blood Glucose Meter. Recall # Z-0821-05; b) LifeScan brand OneTouch FastTake Blood Glucose Meter. Recall # Z-0822-05; c) LifeScan brand InDuo Blood Glucose Meter. Recall # Z-0823-05;

REASON: User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.

MANUFACTURER: Biomerieux, Inc, Durham, NC, by letter on/about March 7, 2005. Firm initiated recall is ongoing.

PRODUCT: Simplastin HTFÆ Reagents, 20ml H2O, (and 6 ml H2O). Product numbers 259846, 259847. Recall # Z-0843-05.

REASON: The ISI labeling for SimplastinÆ HTF on the Coag-a-MateÆ MAX and Thrombolyzer instrument platforms is not correct. The Simplastin HTF ISI assignment was mis-assigned and the published values are higher than expected for the listed instrument platforms.

CLASS II

MANUFACTURER: AMF Support Surfaces, Inc., Corona, CA, by letters dated January 28, 2005. Firm initiated recall is ongoing.

PRODUCT: Cool/Heat Versatility Main Controller Unit with 7-pin port only (for use with Thermal Resistive Type mattress). Recall # Z-0844-05.

REASON: Operator misconnected device power cords causing failure of the device.

MANUFACTURER: Recalling Firm: Baxter Healthcare, Corp, Round Lake, IL, by letters dated February 28, 2005. Manufacturer: Baxter Healthcare, Corp. of Puerto Rico, Aibonito, PR. Firm initiated recall is ongoing.

PRODUCT: Baxter ClearLink Intravenous (IV) Solution Sets and Extension Sets that have a ClearLink luer activated valve for IV access, which allows the administration of medications/solutions with a needleless luer syringe; Recall # Z-0845-05.

REASON: Possible occlusion of the Clearlink injection site valve due to inadequate silicone lubrication of the slit in the upper seal of the valve.

MANUFACTURER: Hitachi Medical Systems America, Inc., Twinsburg, OH, by site inspections beginning on November 19, 2004. Firm initiated recall is ongoing.

PRODUCT: Altaire, Magnetic Resonance Imaging Device. Recall # Z-0846-05.

REASON: The absorber unit in the helium compressor which is located in equipment rooms, and is not accessed by patients or system operators, may fail under pressure, causing an explosion that damages the compressor.

MANUFACTURER: Recalling Firm: Ciba Vision Corp., Duluth, GA, by letters on April 21, 2005. Manufacturer: Ciba Vision Corp., Des Plaines, IL. Firm initiated recall is ongoing.

PRODUCT: Fresh Look * Radianceô * Moonlight, (phemfilcon) Contact Lenses * -2.75 median, Median Dia:14.5 * Rx only * The product has been distributed in twin packs containing six pairs of lenses. Recall # Z-0847-05.

REASON: The actual power of the lenses may be different from what is indicated on the package labeling.

MANUFACTURER: Philips Medical Systems, Andover, MA, by letter on May 2, 2005. Firm initiated recall is ongoing.

PRODUCT: Philips Medical HeartStart MRx Monitor/Defibrillator, Model: M3535A, M3536A. Recall # Z-0848-05.

REASON: The device may disarm and not deliver shock when performing a Synchronized Cardioversion.

MANUFACTURER: Edwards Lifesciences Llc, Irvine, CA, by voice mail and letters on April 28, 2005 and May 2, 2005. Firm initiated recall is ongoing.

PRODUCT: Edwards LifeStent NT Self-Expanding Stent and Delivery System; Models: NT186901(D); NT187901(D); NT186902(D); NT187902(D); NT356901(D); NT357901(D);NT356902; NT357902(D). Recall # Z-0849-05.

REASON: Potential for deployment difficulties.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 18, 2005:

CLASS I

MANUFACTURER: Recalling Firm: Laerdal Medical Corporation, Wappingers Falls, NY, by press release on April 28, 2005, and by letters on April 29, 2005.

Manufacturer: Volex Inc., North Dartmouth, MA. Firm initiated recall is ongoing.

PRODUCT: LAERDAL ADAPTER CABLE, Cat. No. 920650. The cables allow the use of the Laerdal HeartStart multifunction defibrillator pads to be used with the HeartStart 3000 and 4000 series defibrillators and Philips Medical Systems CodeMaster 100 and XL series defibrillators. The Adapter Cable is supplied to customers as an independent accessory and is sold in a clear poly bag with a white stick on label that reads "PART # 920650 ADAPTER CM100/LMC ELECTRODE". There is no other labeling and no directions for use that accompany the product. The Adapter Cable is also included as a component of the CodeMaster 100 Accessory Pack. Recall # Z-0805-05.

REASON: Incidents of wire breakage in adapter cable resulting in inability to operate the defibrillator.

MANUFACTURER: MRL, Inc., A Welch Allyn Company, Buffalo Grove, IL, by letters dated April 28, 2005. Firm initiated recall is ongoing.

PRODUCT: Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Model AED20, part number 972200E. Recall # Z-0806-05.

REASON: The Welch Allyn AED 20 product may display a "Defib Comm" error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropiate therapy.

CLASS II

MANUFACTURER: Recalling Firm: Medtronic Perfusion Systems, Brooklyn Park, MN, by letters beginning March 25, 2005.

Manufacturer: Medtronic Mexico, S. De R.L. De C.V., Tijuana, Baja California, Mexico. Firm initiated recall is ongoing. PRODUCT: Medtronic Custom Packs and Total System Packs. Pack can contain a number of different components specified by the customer and individualized for their bypass circuit set up requirements. Intersept Custom Tubing Pack, Sterile and nonpyrogenic Fluid Path: Do not use if package is opened or damaged. For Single Use Only. Label reads: Manufacturer: Medtronic, Inc. Minneapolis, MN. Recall # Z-0808-05.

REASON: Some warehouse inventory of Custom Pack product bags were found with ruptured seals. The seals were partially opened in the center of the bag's Tyvek edge. Since this bag is used to enclose and seal the custom pack assembly and had been sterilized, the ruptured seal breaches the sterility barrier for the package.

MANUFACTURER: Nichols Institute Diagnostics, San Clemente, CA, by letters on March 9 and ll, 2005. Firm initiated recall is ongoing.

PRODUCT: Nichols IRMA Intact PTH Assay, catalog No. 40-2171. Recall # Z-0809-05.

REASON: Firm noted a change in performance and therefore changed the labeled performance specifications in the Directional Insert portion of the labeling.

MANUFACTURER: Nichols Institute Diagnostics, San Clemente, CA, by letters dated March 25, 2005. Firm initiated recall is ongoing.

PRODUCT: Bio-Intact PTH (1-84) Assay, Catalog No. 62-7040. Recall # Z-0810-05.

REASON: Values do not agree with Directional Instructions (DI). Lot 62-402598's results were outside the DI claim for functional sensitivity, reproducibility, parallelism and two interfering substances. Lot 62-402622's results were outside the DI claim for functional sensitivity, reproducibility, recovery, parallelism and two interfering substances.

MANUFACTURER: Recalling Firm: Heartport, Inc., Somerville, NJ, by telephone on April 8, 2005. Manufacturer: MedSource Technologies-Laconia, Laconia, NH. Firm initiated recall is ongoing.

PRODUCT: The Heartport EndoClamp aortic catheter is a 10.5 Fr. wirewound, three-lumen catheter with an elastomeric balloon near its tip. This device is used with a 200 cm j-hook guide wire accessory device. Product Code EC1001. Recall # Z-0811-05.

REASON: Guidewire is protruding through the film portion of the packages which compromises the sterility of the device.

MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on July 12, 2004. Firm initiated recall is ongoing.

PRODUCT: a) ENTrak Navigation and Visualization System. Recall # Z-0812-05; b) ENTrak Plus Navigation and Visualization System. Recall # Z-0813-05; c) InstaTrak 3500 Navigation and Visualization System. Recall # Z-0814-05; d) InstaTrak 3500 Plus Navigation and Visualization System. Recall # Z-0815-05;

REASON: Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.

MANUFACTURER: Del Medical Systems Group, Franklin Park, IL, by letters dated March 10, 2005. Firm initiated recall is ongoing.

PRODUCT: Tube Stand for the Dynarad Phantom Mobile X-Ray System. Catalog #501031. Recall # Z-0816-05.

REASON: The Phantom Portable X-Ray System Stand may have a suspect weld supporting the bracket holding the locking cylinder assembly. If the weld fails, the tubehead arm assembly could fall and contact the patient or operator.

MANUFACTURER: Eastman Kodak Co., Rochester, NY, by letters on April 8, 2005. Firm initiated recall is ongoing.

PRODUCT: KODAK GP FLEXIBLE PHOSPHOR SCREENS, for use with Kodak Direct View CR 500 systems. Screens are sold in the following sizes and Cat. No's: (1) Cat. #812-7334 - 15 x 30 cm; (2) Cat #825-9269 - 18 x 24 cm; (3) Cat #167-8663 - 24 x 30 cm; (4) Cat #810-7823 - 35 x 35 cm; (5) Cat #160-5906 - 35 x 43 cm. Recall # Z-0817-05.

REASON: Screens may be affected with image artifacts.

MANUFACTURER: Siemens Medical Solutions USA, Inc., Malvern, PA, by visit beginning on April 1, 2005. Firm initiated recall is ongoing.

PRODUCT: Axiom Artis MP X-Ray System. Recall # Z-0818-05.

REASON: Potential problem with the fluoroscopy switch on the power grip.

MANUFACTURER: CTI PET Systems Inc., Knoxville, TN, by letters beginning April 5, 2005. Firm initiated recall is ongoing.

PRODUCT: ECAT PET Scanners (mobile systems), Reveal XL (mobile systems), and Sceptre and Sceptre XL (mobile systems). Recall # Z-0819-05.

REASON: Failure to properly secure the Mobile Bed Supports during transit could cause the support screws on the Patient Handling System to become loose and possibly break due to increased vibration during transit.

MANUFACTURER: Kingswood Laboratories, Inc., Indianapolis, IN, by press release and letter dated April 22, 2005. Firm initiated recall is ongoing.

PRODUCT: Moi-Stir oral swabsticks, an aid to mouth care and oral hygiene, Contents: 3 fibre-tipped swabsticks premoistened with Moi-Stir mouth moistening solution and saliva supplement; Product No's. 55299-703-03 and 55299-703-25. Swabs are sold only in case quantities of 25 foil packs to the carton and 100 fail packs to the case. Recall # Z-0820-05

REASON: Contaminated with Aspergillus and Penicillum molds.

MANUFACTURER: Dunlee, Aurora, IL, by letters dated April 4, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Dunlee DA 200 & MX 200 CT X-Ray Tube Housing Assembly (989600087501); replacement x-ray tube housing assemblies; Model DA 200 and MX200, Part number 875-01; Recall # Z-0838-05; b) Dunlee DA 200 PRO & MX 200 PRO CT X-Ray Tube Housing Assembly (989600088401); replacement x-ray tube housing assemblies; Model DA 200 PRO and MX200 PRO, part number 875-01. Recall # Z-0839-05; c) Dunlee DA 200 Ultra & MX 200 Ultra CT X-Ray Tube Housing Assembly (989600088701); replacement x-ray tube housing assemblies; Model DA 200 Ultra and MX200 Ultra, Part number 875-01. Recall # Z-0840-05.

REASON: The X-ray tube housing assembly may have been mounted with the incorrect sized bolts.

MANUFACTURER: Medrad, Inc., Indianola, PA, by letter dated March 9, 2005. Firm initiated recall is ongoing

PRODUCT: Continuum MR Compatible Infusion Pump. Pump Model #3009135. Recall # Z-0841-05.

REASON: Customer complaint that a continuum infusion pump was attracted to an MR scanner due to customer not completely engaging the pump into the bracket

MANUFACTURER: Arrow International, Inc., Reading, PA, by letter beginning on March 23, 2005. Firm initiated recall is ongoing.

PRODUCT: The Arrow Trerotola Percutaneous Thrombolytic Device (Product Codes: PT-65709-WC, PT-65709-W, PT-65709-HFWC, and PT-12709-WC) consists of a catheter with an expandable fragmentation basket attached to a through lumen torque cable and an outer catheter sheath. The catheter is used in conjunction with a low-speed, battery operated rotator unit to treat thrombosed hemodialysis grafts and AV fistulas. The macerating mechanism is done by 9 mm basket (made up of four stranded stainless steel wires) that rotates at 3000 rpm when rotator is activated. The current device is 7 Fr in size and comes in two lengths -- 65 cm and 120 cm. This device is used by inserting the catheter into the occluded graft or fistula via introducer sheath and then activating the rotator unit. Recall # Z-0842-05. REASON: The orange Pebax lumen located within the catheter basket may separate from the catheter basket sleeve permitting the lumen to become dislodged during use. CLASS III MANUFACTURER: Recalling Firm: Diasorin Inc., Stillwater, MN, by letter, on September 24, 2004. Manufacturer: Polymedco, Inc., Cortlandt Manor, NY. Firm initiated recall is ongoing. PRODUCT: Programming software (all versions) for Polymedco PolyTiter Immunofluorescent Titration System and used with DiaSorin Anafluor Indirect Fluorescent Antibody Test. Recall # Z-0807-05.

REASON: A problem with software for the PolyTiter Immunofluorescent Titration System in that no flags or warnings appear when PolyTiter Calibrator Values are re-entered or changed (including values changed to unacceptable values) after the initial curve has been generated, if the "refresh button" has not been pressed. The graph may appear valid; however erroneous results may occur.

MANUFACTURER: Smiths Medical PM, Inc, Waukesha, WI, by e-mail on March 16, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654225. Recall # Z-0824-05; b) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 920654335. Recall # Z-0825-05; c) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925474325. Recall # Z-0826-05; d) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925554325. Recall # Z-0827-05; e) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925574325. Recall # Z-0828-05; f) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925654220. Recall # Z-0829-05; g) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925654325. Recall # Z-0830-05; h) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925674320. Recall # Z-0831-05; i) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925674335. Recall # Z-0832-05; j) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925754335. Recall # Z-0833-05; k) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 925774325. Recall # Z-0834-05; l) Advisor Vital Signs Monitor (model 9200) with Capnography options installed (model 9212S or model 9212A), catalog no. 92E654325. Recall # Z-0835-05.

REASON: Altitude testing of the Advisor with Capnography module found the CO2 (End Tidal and Inspired) values are incorrect when the Advisor is configured to display in the relative units of percent (%) at elevations above 4,100 feet (at standard temperature pressure). The % CO values displayed will be lower than the actual CO2 value.

MANUFACTURER: Tri-State Hospital Supply Corp, Howell, MI, by letter dated April 12, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Centurion brand CirClamp with 1.3 cm bell, sterile, single use: product 330. Recall # Z-0836-05; b) Centurion brand CirClamp with1.1 cm bell, sterile, single use; product 310. Recall # Z-0837-05.

REASON: Lot 11224 of product 330 may contain a 1.1 cm clamp and bell and neither lot is labeled as reprocessed, when they have been reprocessed.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 11, 2005:

CLASS II

MANUFACTURER: Sunrise Medical, Inc., Longmont, CO, by telephone and letters, dated February 3, 2005. Firm initiated recall is ongoing.

PRODUCT: Sunrise Hoyer Advance Hydraulic and battery powered Patient lifts. a) Model: Hoy-Advance-E; b) Model: Hoy-Advance-H. Recall # Z-0785-05.

REASON: The leg actuation mechanism on certain Hoyer Advance Patient Lifts may not operate properly, which could cause the lift to become unstable.

MANUFACTURER: Fisher Imaging Corporation, Denver, CO, by letters on September 30, 2004. Firm initiated recall is ongoing.

PRODUCT: VersaRad Generator. Recall # Z-0787-05.

REASON: Some VersaRad Systems have a faulty weld that may result in oil leakage.

MANUFACTURER: Asahi Medical Co. Ltd, Chiyoda Ku, Japan, by letters dated March 30 and 31, 2005, April 8, April 13, and 14, 2005 and April 21, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Asahi AM-BIO Series Hollow Fiber Dialyzers; a wet model multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; 12 units per case; Schein product code 629-6426, Model AM-BIO-65 ‚ 1.3 m2 surface area, Schein product code 629-3146, Model AM-BIO-75 ‚ 1.5 m2 surface area, Schein product code 629-0041, Model AM-BIO-100 ‚ 2.0 m2 surface area. Recall # Z-0788-05; b) Asahi AM-BIO-HX Extended Range Series Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; 12 units per case; Schein product code 629-6404,Model AM-BIO-HX-75 ‚ 1.5 m2 surface area and Schein product code 629-8540, Model AM-BIO-HX-100 ‚ 2.0 m2 surface area. Recall # Z-0789-05; c) Asahi APS Series Hollow Fiber Dialyzers; a wet model mutiple use dialyzer consisting of hollow fiber membranes of polysulfone housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; 12 units per case; Schein product CODE 629-4923, Model APS-21R - 2.1 m2 surface area. Recall # Z-0790-05; d) Terumo Clirans Series E Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (23 microns thick) of vitamin E coated copolymer cellulose housed within a polyurethane casing, filled at the factory with fluid to facilitate priming by the user, and sterilized by autoclaving before shipment; 24 units per case; Schein product code 629-9041, Model CL*E12NLA - 1.2 m2 surface area, Schein product code 629-5978, Model CL*E15NLA ‚ 1.5 m2 surface area, Schein product code 629-1824, Model CL*E18NLA - 1.8 m2 surface area and Schein product code 629-7278, Model CL*E20NLA ‚ 2.0 m2 surface area. Recall # Z-0791-05; e) Terumo Clirans Series EE Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (28 microns thick) of vitamin E coated copolymer cellulose housed within a polyurethane casing, filled at the factory with fluid to facilitate priming by the user, and sterilized by autoclaving before shipment; 24 units per case; Schein product code 629-3169, Model CL*EE12NLA - 1.2 m2 surface area, Schein product code 629-8232, Model CL*EE15NLA ‚ 1.5 m2 surface area and Schein product code 629-5106, Model CL*EE20NLA - 2.0 m2 surface area. Recall # Z-0792-05.

REASON: Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis.

MANUFACTURER: Stryker Medical, Kalamazoo, MI, by letter dated March 31, 2005. Firm initiated recall is complete.

PRODUCT: Stryker brand Birthing Bed; Model 4701. Recall # Z-0793-05.

REASON: Trendelenburg and reverse trendelenburg features may not function.

MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated March 24, 2005. Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.

PRODUCT: Axiom Artis X-Ray System using software version VB11D or VB20B. Recall # Z-0796-05.

REASON: Live display in exam room may sporadically stop working although the display in the control room remains fully operational.

MANUFACTURER: Hitachi Medical Systems America, Inc., Twinsburg, OH, by letter, dated April 11, 2005. Firm initiated recall is ongoing.

PRODUCT: Altaire, Magnetic Resonance Imaging Device. Recall # Z-0797-05.

REASON: The electrical cables that supply gradient power to the magnet can become loose over time and create a potential fire hazard.

MANUFACTURER: Recalling Firm: Selectivemed Components, Inc., Mount Vernon, OH, by letter, dated March 15, 2005. Manufacturer: MRP, Inc., Monticello, IN. Firm initiated recall is ongoing.

PRODUCT: Iontophoresis active electrode, small, 1.5cc capacity, sold as Model # NC89250B. Product is packaged in 12 treatment kit box labeled as Buffered Iontophoretic Delivery Electrode System Treatment Kit, 12 treatments. Recall # Z-0799-05.

REASON: The conductor portion of the electrode is installed backwards, with the plastic and silver portions of the electrode reversed.

MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters, dated March 28, 2005. Manufacturer: Baxter Healthcare Corp., Cleveland, MI. Firm initiated recall is ongoing.

PRODUCT: Baxter Spinal Anesthesia Trays; sterile, single use only procedure trays that contain BD 25 G x 8.9 cm (3-1/2î) Whitacre Spinal Needles. Recall # Z-0800-05.

REASON: The anesthesia trays contain BD 25G Spinal Needles which have leakage at the plastic hub of the needle.

MANUFACTURER: Ela Medical Llc, Plymouth MN, by letter, on January 25, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Sentinel Implantable Cardioverter-DefibrilIator (ICD) model 2010 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and bradycardia pacing support. Recall # Z-0801-05; b) Sentinel Implantable Cardioverter-DefibrilIator (ICD) model 2012 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and bradycardia pacing support. Recall # Z-0802-05.

REASON: A change in the automatic capacitor reform schedule during the later portion of the deviceIs useful life can result in excessive 750V charge times and disable the deviceIs ability to report an End of Life (EOL) indicator due to excessive charge times unless the patient is receiving periodic 750V therapy shocks.

MANUFACTURER: Recalling Firm: Frank Mobility Systems, Inc., Oakdale, PA, by letter on September 1, 2004. Manufacturer: Ulrich-Alber Gmbh, Albstadt Tailfingen, Germany. Firm initiated recall is ongoing.

PRODUCT: a) e-fix E19 power drive. The product is a wheelchair component/accessory. Recall # Z-0803-05; b) e-fix E20 power drive. The product is a wheelchair component/accessory. Recall # Z-0804-05.

REASON: Product may short circuit within the interface due to long term exposure of liquid. CLASS III

MANUFACTURER: Stryker Endoscopy, San Jose, CA, by telephone and Urgent Product Recall Notice on February 8, 2005. Firm initiated recall is ongoing.

PRODUCT: Stryker Brand 5.5mm 6 Flute Barrel Bur, Model Number: 375-951-000. Recall # Z-0786-05.

REASON: The device has the potential to overheat and cause patient burns during use. MANUFACTURER: Recalling Firm: U.S. Filter/Ionpure, Inc., Lowell, MA, by letter between March 17, and March 28, 2005.

Manufacturer: U.S. Filter Water Process Inc, Colorado Springs, CO. Firm initiated recall is ongoing.

PRODUCT: MedRo Rx ‚ Reverse Osmosis System All Models All Voltages. Models: MRORXO1, MRORXO2, MRORXO3,MRORXO4, MRORXO5, MRORXO6, MRORXO8,MRORXO9, MRORX12. CMRORX01, CMRORX02, CMRORX03, CMRORX04, CMRORX05, CMRORX08. Recall # Z-0798-05.

REASON: Incorrect type of stainless steel firm used 303 vs 316.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of May 4, 2005:

CLASS II MANUFACTURER: Recalling Firm: Ethicon Endo-Surgery, Cincinnati, OH, by letters,dated December 14, 2004. Manufacturer: Ethicon Endo-Surgery, Inc. S.A. de C.V. Planta II, Ciudad Juarez, Chihuahua, Mexico. Firm initiated recall is ongoing.

PRODUCT: a) Endopath 5 mm Graspers with Ratchet Handles(product code5DSG). Recall # Z-0724-05; b) Endopath 5 mm Babcocks with Ratchet Handles (product code 5BB). Recall # Z-0725-05; c) Endopath 10 mm Anvil Graspers with Ratchet Handles (product code 10AG). Recall # Z-0726-05; d) Endopath 10 mm Babcocks with Ratchet Handles (product code 10BB). Recall # Z-0727-05; e) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit code FDC21. Recall # Z-0728-05; f) FlexTrayTM EndopathÆ Cholecsystectomy Tray, CK141. Recall # Z-0729-05; g) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit code FDC24. Recall # Z-0730-05; h) FlexTrayTM EndopathÆ Bariatric Tray, Kit code KBW22. Recall # Z-0731-05; i) FlexTrayTM EndopathÆ Bariatric Tray, Kit code KBW42. Recall # Z-0732-05; j) FlexTrayTM EndopathÆ Bariatric Tray, Kit code KBW46. Recall # Z-0733-05; k) FlexTrayTM EndopathÆ Bariatric Tray, Kit code KBW49; Recall # Z-0734-05; l) FlexTrayTM EndopathÆ Bariatric Tray, Kit code KBW71S. Recall # Z-0735-05; m) FlexTrayTM EndopathÆ GYN Tray, Kit code KD005. Recall # Z-0736-05; n) FlexTrayTM EndopathÆ Gastric Tray, Kit code KDG05. Recall # Z-0737-05; o) FlexTrayTM EndopathÆ Gastric Tray, Kit code KDG15. Recall # Z-0738-05; p) FlexTrayTM EndopathÆ Appendectomy Tray, Kit code KNB12. Recall # Z-0739-05; q) FlexTrayTM EndopathÆ Appendectomy Tray, Kit code KNB19. Recall # Z-0740-05; r) FlexTrayTM EndopathÆ Gastric Tray, Kit code KNG05. Recall # Z-0741-05; s) FlexTrayTM EndopathÆ Bariatric Tray, Kit code TBW70S. Recall # Z-0742-05; t) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit code FDC09. Recall # Z-0743-05; u) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit code FDC45. Recall # Z-0744-05; v) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit code TDC78S. Recall # Z-0745-05; w) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit code TDC86S. Recall # Z-0746-05; x) FlexTrayTM EndopathÆ Gastric Tray, Kit code TGB01S. Recall # Z-0747-05; y) FlexTrayTM EndopathÆ Gen. Laparoscopy Tray, Kit code TGL45. Recall # Z-0748-05; z) FlexTrayTM EndopathÆ Gen. Laparoscopy Tray, Kit code TGL62. Recall # Z-0749-05; aa) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit Code TNC06. Recall # Z-0750-05; bb) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit Code TNC12. Recall # Z-0751-05; cc) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit Code TNC15. Recall # Z-0752-05; dd) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit Code TNC20. Recall # Z-0753-05; ee) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit Code TNC61. Recall # Z-0754-05; ff) FlexTrayTM EndopathÆ Cholecsystectomy Tray, Kit Code TNC69. Recall # Z-0755-05; gg) FlexTrayTM EndopathÆ Gastric Tray, Kit Code TNG42. Recall # Z-0756-05; hh) FlexTrayTM EndopathÆ Gastric Tray, Kit Code TNG73. Recall # Z-0757-05; ii) FlexTrayTM EndopathÆ Gastric Tray, Kit Code TNG89. Recall # Z-0758-05; jj) FlexTrayTM EndopathÆ Bariatric Tray, Kit code KBW30. Recall # Z-0759-05.

REASON: Due to tolerance issues with the device, pins can work free from their respective holes. The result during use could be separation of the handles that could lead to compromised ratchet button functionality. Loss of ratchet button functionality may lead to the end effector being locked in the open or closed position.

MANUFACTURER: Recalling Firm: MMS Sales Corp, Pharr, TX, by letter on February 21, 2004.Manufacturer: CPM De Reynosa S.A. De C.V., Reynosa, Mexico. Firm initiated recall is ongoing.

PRODUCT: a) Meridian Nexus, single use. Part Numbers: C4N00D001,15867, 15880, 15880-30, 12000-1, 40000-1, 40200-1, 40301-1, 40301-1ML, 40301-1-13, 40301-1-13MM, 40301-1-24, 40301-1-30, 40302-1C24, 60000-1, 60201-1, 60300-M, 60301-1, 60301-1-24, 60302-1HM30-70, 60301- 13042M, 72300-1-4-30-70, 72301-1, 72000-50-7589, 60301-1304042, and 72000-75. Recall # Z-0760-05; b) Circuit-Unilimb, Pediatric, 1M (40"), Disposable, Clean Non-Sterile, Pediatric Anethesia Circuit, Part Number DYNJAPF4000. Recall # Z-0761-05; c) Unilimb Circuit 40'' Bulk, single use Part Number 225-4400-300. Recall # Z-0762-05; d) Meridian Nexus- Pediatric, single use Part Numbers 60211-1304042, 60111-1, 60111-1MN, 40111-13042, 15900, 40010-1, and 40111-1. Recall # Z-0763-05; e) Portex Adult Single Limb Anesthesia Breathing Circuit, single use, Part Numbers: 386000 and 384001. Recall # Z-0764-05; f) Circuit- Maching Kit, 40" Adult, 3L LPF, single use, Part Numbers RP640F0D0 and RP660F0D0. Recall # Z-0765-05; g) Circuit-Nexus, Adult, single use, Part Numbers: N7A110CG06, N4A100CE06, C4N0121000, 60010-1B, and 40301-1-2730. Recall # Z-0766-05; h) Coaxial Rebreathing Circuit 1.5 M and 2 M, single use, Part nubers T61500 (1.5 M) and T18116 (2 M). Recall # Z-0767-05; i) Circuit-Unilimb, Adult, 1M (40"), Disposable, Clean Non-sterile, Adult Anesthesia Circuit, Part Numbers DYNJAAF4000, DYNJAAF6225, and DYNJAAF6261. Recall # Z-0768-05.

REASON: Partial occlusion in the T-piece resulting in airway obstruction.

MANUFACTURER: Medline Industries, Inc, Waukegan, IL, by letters dated March 18, 2005 and March 23, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Medline Custom Open Heart CDS Kit (non-sterile), reorder number CDS840144A, which contains Meridian Nexus Unilimb Rebreathing Circuit, part 40301-1-30, among other components needed for open heart surgery; Recall # Z-0769-05; b) Medline Custom Anesthesia Super Circuit Adult 60 Unilimb Kit (non-sterile), reorder number DYNJAAF6267; the kit contains the Nexus Adult Unilimb Circuit -- 60", part 60010-1B, along with a 3 liter latex breathing bag, anesthesia tubing clip, suction catheter, adult anesthesia mask, suction canister, drawstring poly bag and poly bag. Recall # Z-0770-05; c) Medline Custom Anesthesia Set Up Kit - Latex Free (non-sterile), reorder number DYNJAA0078C; the kit contains the Nexus Adult Unilimb Circuit -- 40", part C4N000D001, along with a 3 liter latex free breathing bag, suction catheter, adult medium anesthesia mask, suction tubing, humid vent hme filter and poly bag. Recall # Z-0771-05; d) Medline Custom Anesthesia Circuit Adult 40in Mask 3L Kit (non-sterile), reorder number DYNJAA4749; the kit contains the Nexus Adult Unilimb Circuit - 40", part C4N000D001, along with a 3 liter latex free breathing bag, adult medium anesthesia mask and poly bag. Recall # Z-0772-05; e) Medline Custom Anesthesia Circuit 40in Adult Unilimb Kit (non-sterile), reorder number DYNJAAF4304B; the kit contains the Nexus Adult Unilimb Circuit -- 40", part C4N012100, along with a 3 liter latex free breathing bag, gas sampling coestrud and poly bag. Recall # Z-0773-05; f) Medline Custom Anesthesia Circuit 40in Adult Unilimb Kit (non-sterile), reorder number DYNJAA4315; the kit contains the Nexus Adult Unilimb Circuit - 40", part C4N012100, along with a 3 liter latex breathing bag, adult large anesthesia mask, gas line and poly bag. Recall # Z-0774-05.

REASON: The procedure packs contain anesthesia/breathing circuits being recalled due to partial occlusion of the T-piece resulting in airway obstruction.

MANUFACTURER: Staar Surgical Co, Inc, Monrovia, CA, by telephone and letter on April 7,2004. Firm initiated recall is ongoing.

PRODUCT: Staar Phaco Tubing Kit. Recall # Z-0775-05.

REASON: Complaints of leaking with question of sterility and risk of infection in eye.

MANUFACTURER: Varian Medical Systems, Inc., Palo Alto, CA, by letters on February 4, 2005. Firm initiated recall is ongoing.

PRODUCT: Varian brand Clinac 600C (CD, EX) and Portal Vison with Dynamic MLC or RPM system capability. Recall # Z-0777-05.

REASON: Treatment beam may not completely pause while device changes field shape; Potential for mistreatment could occur.

MANUFACTURER: Recalling Firm: Advanced Sterilization Products, Irvine, CA, by letter dated March 16, 2005. Manufacturer: Johnson & Johnson Medical, Ltd, Skipton, North Yorkshire, UK. Firm initiated recall is ongoing.

PRODUCT: Cidexplus Solution Test Strips. Product Code: 2924, and Product Code2926. Recall # Z-0779-05.

REASON: CIDEX test strips were found to pass solution below MEC.

MANUFACTURER: Recalling Firm: Boston Scientific Corp., Natick, MA, by letters on March 11, 2005. Manufacturer: Boston Scientific Corp., Glens Falls, NY. Firm initiated recall is ongoing.

PRODUCT: a) Vaxcel Low Profile Port with PASV Valve and 6F Polyurethane Catheter. CATALOG NO. 45-233. Ref. # M001452330. Recall # Z-0780-05; b) Vaxcel Low Profile Port with PASV valve and 8F Silicone Catheter. Catalog No. 45-236, Ref. # M001452360. Recall # Z-0781-05; c) Vaxcel Low Profile Port with PASV valve and 8F Polyurethane Catheter. CATALOG NO. 45-238, Ref. # M001452380. Recall # Z-0782-05.

REASON: Potential separation of the port base from the port cover after implantation.

MANUFACTURER: Abbott Laboratories MPG, Abbott Park, IL, by e-mail on March 11, 2005. Firm initiated recall is ongoing.

PRODUCT: Architect Folate Reagent Kit, list 6C12-20 (4 x 100 tests), 6C12-25 (1 x 100 tests) and 6C12-30 (4 x 500 tests). Recall # Z-0783-05.

REASON: Concentrations for normal samples generated with current reagent lots of the Architect Folate assay are lower than data generated for the package insert.

CLASS III

MANUFACTURER: Recalling Firm: Diasorin Inc., Stillwater, MN, by letter, fax or email beginning April 8, 2005.

Manufacturer: DiaSorin S.p.A. Saluggia, Italy. Firm initiated recall is ongoing.

PRODUCT: DiaSorin ETI-HA-IGMK PLUS Enzyme Immunoassay for the Detection of IgM Antibody to Hepatitis A Virus (IgM anti-HAV) in Human Serum or Plasma Catalog No. P001925. Recall # Z-0776-05.

REASON: The package insert for Hepatitis A Virus IgM antibody kit (ETI-IgMK Plus, catalog P001925), may inadvertently contain pages 5 through 12 from the instructions for Hepatitus A virus Total antibody test (ETI-AB-HAVK Plus, catalog P001926).

MANUFACTURER: Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated March 2, 2005. Manufacturer: Valcom, Inc, Las Vegas, NV. Firm initiated recall is ongoing.

PRODUCT: Configuration Transfer Cable; an accessory for the Colleague Infusion pump, Product code 2M8155. Recall # Z-0778-05.

REASON: The Configuration Transfer Cable for the Colleague Infusion Pumps has incorrect thumb screws on it, not allowing firm connections of the cable to the pump to transfer data to the biomedical engineer's diagnostic device.

MANUFACTURER: Recalling Firm: Diasorin, Inc., Stillwater, MN, by telephone and e-mail on March 16, 2005. Firm initiated recall is ongoing. Manufacturer: Phoenix Bio-Tech Corp., Mississauga, Ontario, Canada. Firm initiated recall is ongoing.

PRODUCT: Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960. Recall # Z-0784-05.

REASON: Package insert incorrectly states that specimen diluent is ready to use, however specimen diluent bottle in kit states that the diluent must be diluted to one liter.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 27, 2005:

CLASS II

MANUFACTURER: Fischer Imaging Corporation, Denver , CO , by letter on January 13, 2005. Firm initiated recall is ongoing.

PRODUCT: Bloom DTU-215-B Programmable Stimulator. Recall # Z-0713-05.

REASON: Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients.

MANUFACTURER: Bard Access Systems, Inc., Salt Lake City, UT , by letter on October 4, 2004 and October 15, 2004. Firm initiated recall is complete.

PRODUCT: a) Site-Rite Sterile Needle Guide Kit – 18 gauge. Product Code 9001C0212. Recall # Z-0714-05; b) Site-Rite Sterile Needle Guide Kit – 20 gauge. Product Code 9001C0214. Recall # Z-0715-05; c) Site-Rite Sterile Needle Guide Kit – 21 gauge. Product Code 90013B01. Recall # Z-0716-05; d) Site-Rite Sterile Ultrasound Probe Cover with Gel. Product Code 9001C0197. Recall # Z-0717-05; e) Intraoperative Ultrasound Cover Kit. Product Code 900023B01. Recall # Z-0718-05; f) Ultra/Phonic Conductivity Gel, 20 ml, each unit is an oil to foil pouch. Product is packaged 25 pouches per box. Product Code 9001C0200. Recall # Z-0719-05. g) Site Rite II, Site Rite 3, and Site Rite IV Systems with 2 Sterile Kits each. Recall # Z-0720-05.

REASON: Conductivity gel pouches, labeled as sterile, and packaged in various needle guide kits may not be sterile.

MANUFACTURER: Recalling Firm: Nellcor Puritan Bennett, Pleasanton , CA , by letters on December 3, 2004 . Manufacturer: MMJ S.A. De C.V., Cuidad Juarez, Mexico. Firm initiated recall is complete.

PRODUCT: Shiley FlexTra brand Flexible Dual- Cannula Tracheostomy Tube, Models: 358060, Size 6, FlexTra Cuffed; 358070, Size 7, FlexTra Cuffed; 358080, Size 8, FlexTra Cuffed; 358090, Size 9, FlexTra Cuffed; 358100, Size 10, FlexTra Cuffed; 359060, Size 6, FlexTra Uncuffed; 359070, Size 7, FlexTra Uncuffed; 359080, Size 8, FlexTra Uncuffed; 359090, Size 9, FlexTra Uncuffed; 359100, Size 10, FlexTra Uncuffed. Recall # Z-0721-05.

REASON: Outer cannula has the potential to separate from the head/flange assembly, leading to ineffective ventilation, which could result in serious injury.

MANUFACTURER: Allen Medical Systems, Acton, MA, by letter dated March 4, 2005. Firm initiated recall is ongoing.

PRODUCT: Allen A-91000 Shoulder Positioner. Recall # Z-0722-05.

REASON: Shoulder positioner may break near the rail that attaches to the operating table.

MANUFACTURER: Intuitive Surgical, Inc, Sunnyvale , CA , by letters on March 9, 2005 . Firm initiated recall is ongoing.

PRODUCT: Intuitive Surgical da Vinci 8 mm Endo Wrist Curved Scissors, in box. FDA Device Listing # R100529, Model # 400178-01. 510(k) number K021036. Recall # Z-0723-05.

REASON: Blades on the scissor may break and separate from the main unit as a result of corrosion damage.

CLASS III

MANUFACTURER: Tri-State Hospital Supply Corp., Howell, MI, by letter dated March 8, 2005. Firm initiated recall is ongoing.

PRODUCT: Centurion brand sterile Huber needle infusion set, 20 GA x 1 inch; product EXHNO10S. Recall # Z-0696-05.

REASON: Some of the needles in these sets are ¾ inches in length instead of the labeled 1 inch.

MANUFACTURER: Diasorin , Inc., Stillwater , MN , by letters on December 1, 2004 . Firm initiated recall is ongoing.

PRODUCT: Version 12 software program written for the Bio-Tek ELx800 automated microtiter plate reader with use of PRO- Trac Tacrolimus ELISA kit. Recall # Z-0702-05.

REASON: The software program written for use in the automated microtiter plate reader (Bio- Tek ELx800) for use with the Pro- Trac II Tacrolimus ELISA kit was found to be faulty. Assay software program did not include the Calibrator Zero OD specification (STDO>=1.500) as specified in the product insert.

MANUFACTURER: Diasorin , Inc., Stillwater , MN , by telephone on May 20, 2004 . Firm initiated recall is ongoing.

PRODUCT: Version 7 software for wash program on Bio Tek Automated Microplate Washer Model Elx50 which performs the washing steps for various programmed mictotiter plate assays. Recall # Z-0703-05.

REASON: When software was updated for the Washer program of the Bio Tek Automated Microplate Washer Model Elx50, the software did not automatically clear old versions of the wash program when new ones were added.

MANUFACTURER: Diagnostic Systems Laboratories, Inc., Webster, TX. Firm initiated recall is ongoing. Recalling Firm: Diasorin, Inc., Stillwater , MN , by letters on May 25, 2004 .

PRODUCT: DiaSorin GammaCoat Androstenedione - 125 I, RIA Kit for the quantitative determination of androstenedione levels in serum. Catalog No. CA-1725. Recall # Z-0704-05.

REASON: Standards contained in the GammaCoat Androstenedione RIA Kit appeared yellowish in color and were gelatinous upon reconstitution. The assay validation criteria failed when the gelatinous standards were used.

MANUFACTURER: Diasorin , Inc., Stillwater , MN , by letter on June 30, 2004 . Firm initiated recall is ongoing.

PRODUCT: DiaSorin 25-HydroxyvitaminD [125I] RIA Kit. For the quantitative determination of 25-OH-D and other hydroxylated metabolites in serum or plasma. REF: 68100E. Recall # Z-0705-05.

REASON: An incorrect expiration date of 2005/08/18 was placed on the kit box label for 25-hydroxyvitamin D [125I] RIA kits, Catalog 68100E, Lot 113300B. Correct label expiration date is 2004/08/18.

MANUFACTURER: Diasorin , Inc., Stillwater , MN , by letter on June 30, 2004 . Firm initiated recall is ongoing.

PRODUCT: DiaSorin Analyte Specific Reagent. Recall # Z-0706-05.

REASON: Expiration date of 2005/1/6 stamped on vial label of Anti-Human igG, Fluorescein Conjugate is incorrect. Correct expiration date is 2006/1/6.

MANUFACTURER: Trek Diagnostic Systems, Inc., Sun Prairie, WI. Firm initiated recall is ongoing.

PRODUCT: Versa TREK REDOX 2 80 ml Anaerobic blood culture bottles, Product Code: 7103-44. The product was distributed in cases containing 50 bottles per case. Recall # Z-0708-05.

REASON: Blood culture bottles with an error in the bar code on the labels, were shipped.

MANUFACTURER: Porex Surgical, Inc., Newnan , GA , by email, telephone and letter on March 7, 2005 and March 8, 2005 . Firm initiated recall is ongoing.

PRODUCT: MEDPOR® Surgical Implant * POREX Surgical Products Group * Sterile/EO * Implant, Non-Pyrogenic, For Single Use Only, CAT #6317 DIM 20mm Diameter * Lot xxxxxx * QTY: 1 *. Recall # Z-0712-05.

REASON : The product, which is a 20mm MEDPOR Sphere, was mislabeled in that the package contained 18mm MEDPOR Spheres.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 20, 2005:

CLASS II

MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on December 13, 2004. Firm initiated recall is ongoing

PRODUCT: a) ENTrak Navigation and Visualization System. The particular accessories (“Sensors”) involved are: Short Range Transmitter; Snap Receiver Cable; Extended Range Transmitter; and T-Handle Spine Tool Receiver. Recall # Z-0687-05; b) ENTrak Plus Navigation and Visualization System. The particular accessories (“Sensors”) involved are: Short Range Transmitter; Snap Receiver Cable; Extended Range Transmitter; and T-Handle Spine Tool Receiver. Recall # Z-0688-05; c) Insta Trak 3000 Navigation and Visualization System. The particular accessories (“Sensors”) involved are: Short Range Transmitter; Snap Receiver Cable; Extended Range Transmitter; and T-Handle Spine Tool Receiver. Recall # Z-0689-05; d) Insta Trak 3500 Navigation and Visualization System. The particular accessories (“Sensors”) involved are: 1) Short Range Transmitter; Snap Receiver Cable; Extended Range Transmitter; and T-Handle Spine Tool Receiver. Recall # Z-0690-05; e) Insta Trak 3500 Plus Navigation and Visualization System. The particular accessories (“Sensors”) involved are: 1) Short Range Transmitter; Snap Receiver Cable; Extended Range Transmitter; and T-Handle Spine Tool Receiver. Recall # Z-0691-05; - 2 - f) Fluro Trak 9800 Plus Navigation and Visualization System. The particular accessories (“Sensors”) involved are: 1) Short Range Transmitter; Snap Receiver Cable; Extended Range Transmitter; and T-Handle Spine Tool Receiver. Recall # Z-0690-05;

REASON: Enhanced sterility testing revealed the sterilization efficacy of accessories (“Sensors”) used with certain Navigation and Visualization systems may be compromised.

MANUFACTURER: Manufacturer: Baxter Healthcare Corp, Aibonito, PR. Firm initiated recall is ongoing. Recalling Firm: Baxter Healthcare Corp, Round Lake, IL, by letters dated January 20, 2005

PRODUCT: a) Baxter Posiflow Access Device for IV Access; a single use, sterile device with Posiflow Positive Displacement Feature and Male Luer Lock Adapter, 0.06 mL. Recall # Z-0693-05; b) Baxter Extension Sets with Posiflow Access Device for IV Access; a single use, sterile fluid pathway devices with Posiflow Positive Displacement Feature. Recall # Z-0694-05.

REASON: Product older than three years may not operate as intended

MANUFACTURER: Philips Medical Systems, Netherlands. Firm initiated recall is ongoing. Recalling Firm: Philips Medical Systems Sales & Service Region No. America, Bothell, WA, by letter on January 31, 2005.

PRODUCT: Easy Access Image Management System with CL. Net. Recall # Z-0695-05.

REASON: Failure to update correctly when re-transmitting an image from the modality.

MANUFACTURER: Remington Medical Inc., Alpharetta, GA, by letter on February 15, 2005. Firm initiated recall is ongoing.

PRODUCT: Automatic Cutting Needle Model: NAC-1820B, Size 18 GA x 20 CM, Single use: Ethylene Oxide sterilized. Recall # Z-0697-05.

REASON: The stylet hub detaches from the stylet needle.

MANUFACTURER: Wilson-Cook Medical, Inc., Winston Salem, NC, by letter on April 1, 2005. Firm initiated recall is ongoing.

PRODUCT: a) ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew - Right Device: Flexible TI - Knot Device: External Accessory Channel: 6mm./75 cm.; * Suture Quickload Units (2); TI - Knot Quickload Units (2) * Disposable - Single Use Only * Sterile/EO * Rx Only. Recall # Z-0698-05; b) BCP-7A, Quick Silver Bipolar Coagulation Probe, For use w/dual Plug Bipolar Generators * Catheter Diameter: 7 FR. Catheter Length: 35 CM. Disposable – Single Use Only * Sterile/EO * Rx Only * Recall # Z-0699-05.

REASON: The expiration date listed on the product label is greater than the vendor recommended expiration date.

MANUFACTURER: Neoprobe Corp, Dublin, OH, by telephone and e-mail beginning on December 2, 2004. Firm initiated recall is ongoing.

PRODUCT: a) CSN00210 8MHz blood flowmeter probe used with the Quantix/OR system. Recall # Z-0700-05; b) CSN00200 4MHz blood flowmeter probe used with the Quantix/OR system. Recall # Z-0701-05.

REASON: The probe’s faceplate seal can fail and allow penetration of cleaning fluids during the cleaning and soaking cycle between uses or ingress of biohazard fluids during surgical procedures.

MANUFACTURER: Guidant Corporation Advanced Cardiovascular System, Temecula, CA, by letter on January 27, 2005. Firm initiated recall is ongoing.

PRODUCT: Voyager RX Coronary Dilatation Catheter. Recall # Z-0707-05.

REASON: Leak at guide wire exit notch could introduce air into the artery.

MANUFACTURER: St. Jude Medical, Sylmar, CA, by visit beginning on March 10, 2005. Firm initiated recall is ongoing

PRODUCT: Implantable Cardioverter-Defibrillator Models affected include the following: Atlas+ Models V-193, V-193C and V-243 Epic+ Models V-196, V-236 and V-239 Epic Models V-197 and V-233 Atlas Model V-242 Epic HF Models V-337 and V-338 Epic+HF Models V-339 and V-350 Atlas+ HF Models V-340, V-341 and V-343. Recall # Z-0709-05.

REASON: Sensitivity of a magnetic switch was not being set correctly. This could result in delivery of an unneeded shock during surgery with use of electrocautery

MANUFACTURER: Maquet, Inc., Bridgewater, NJ, by internal task team, updates started on January 11, 2005. Firm initiated recall is ongoing.

PRODUCT: KION Anesthesia System. Recall # Z-0710-05.

REASON: Software update so US customers will be updated equally with worldwide customers. Ver. 5.0 will be upgraded to ver 7.0. Quality will improve and enhance functionality.

MANUFACTURER: Medtronic Surgical Navigation Technologies, Inc., Louisville, CO, by letters dated January 28, 2005 and February 2, 2005. Firm initiated recall is complete.

PRODUCT: Stealth Station Cranial Application v.4.5. Catalog Numbers: 960-201 and 9730888. Recall # Z-0711-05.

REASON: The Stealth Station Cranial Application Version 4.5 contains a software anomaly, which may present a hazard to the patient. The user has the option to create and make visible supplemental contours of specific anatomy viewable during a surgical procedure. Activation of a new tip extension feature will move the location of these contours in such a manner that they no longer correlate to the intended anatomy. Potential consequences may include improper resection of the brain tissue.

MANUFACTURER: Diasorin Inc., Stillwater, MN, by telephone on November 1, 2004. Firm initiated recall is ongoing.

PRODUCT: DiaSorin ETI-EA-G assay kit, Catalog No. 7570. Recall # Z-0658-05.

REASON: The kits contained the wrong microtiter plate. The plate provided in the kits was for a different product, the Pro Trac II Tacrolimus kit.

MANUFACTURER: Abbott Health Products, Inc., Barceloneta, PR, by letter on February 25, 2005. Firm initiated recall is ongoing.

PRODUCT: IMx HAVAB Controls in Vitro Test. Recall # Z-0660-05.

REASON: Abbott identified through investigational studies that IMxHAVAB Controls is generating Negative Control values outside the upper range specified in the IMxHAVAB Package Insert.

MANUFACTURER: Diasorin, Inc., Stillwater, MN, by letter on April 20, 2004. Firm initiated recall is ongoing.

PRODUCT: DiaSorin programming software written for a specific automated microtiter plate instrument, Bio-Tek Elx800 reader for use with the ENA 6 Screen ELISA kit assay. Recall # Z-0672-05.

REASON: An error in the Bio-Tek Elx800 microplate reader programming specifications for the ENA screen Assay exists in that an equivocal (borderline) zone is missing.

MANUFACTURER: Diasorin, Inc., Stillwater, MN, by letter on April 12, 2004. Firm initiated recall is ongoing.

PRODUCT: Data reduction program written specifically for Bio-Tek Elx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit. Recall # Z-0673-05.

REASON: The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek Elx800 reader) was found to be faulty. This program is used to calculate the cut off values for Diastat Anti-Mitochondrial Antibody Kit. Program should include a borderline specification to indicate repeat testing is needed.

MANUFACTURER: Diasorin, Inc., Stillwater, MN, by letter on October 26, 2004. Firm initiated recall is ongoing

PRODUCT: Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek Elx800 reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA assay kit. Recall # Z-0674-05.

REASON: The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek Elx800 reader) is faulty in that the positive result limit is to be greater than 15 U/ml, rather than greater than or equal to 15 U/ml.

MANUFACTURER: Diasorin, Inc., Stillwater, MN, by letter on April 12, 2004. Firm initiated recall is ongoing

PRODUCT: Data reduction program software written specifically for Bio-Tek Elx800 (DiaSorin part # 15713) automated microtiter plate reader with use of Diastat Anti-Thyroglobulin Assay (manufacturer part #7700). Recall # Z-0675-05.

REASON: The data reduction program written for a specific automated microtiter plate reader (Bio-Tek Elx800) was found to be faulty. This program is used to calculate the cut off values for the Diastat Anti-Thyroglobulin Kit assay. The negative Control Upper Limit should be less than 0.95, rather than less than 1.0.

MANUFACTURER: Diasorin, Inc., Stillwater, MN, by telephone and letter on June 30, 2004. Firm initiated recall is ongoing.

PRODUCT: PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titration System, DiaSorin part # PT100 which is programmed for DiaSorin ANAFLUOR Indirect fluorescent Antibody Test For the detection and titration of circulating antinuclear antibodies. REF: 1624, 1662, 1660, 6624, 1604. Recall # Z-0676-05.

REASON: The program is for a specific immunofluorescent titration system (Polymedco PolyTiter immunofluorescent Titration System) was found faulty in that the calibrator 2 value was incorrectly programmed as 1:120 instead of 1:160

MANUFACTURER: The Spineology Group, Stillwater, MN, by product update on January 28, 2005 and by telephone between January 28 and January 31, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Fill Tube, diverted, Catalog # 300-1002, is used for the delivery of granular autograft or allograft into Spineology’s OptiMesh implant. Fill tube is identified with Spineology, catalog number and lot number printed directly onto the metal. Recall # Z-0677-05; b) Fill Tube, straight, Catalog # 300-1001, is used for the delivery of granular autograft or allograft into Spineology's OptiMesh implant. Fill tube is identified with Spineology, catalog number and lot number printed directly onto the metal. Recall # Z-0678-05; c) Platen, Catalog # 301-124, is a mechanism used to lock or hold the fill tube in place as it is filled with graft material. Platen is identified with Spineology, catalog number and lot number printed directly onto the metal. Recall # Z-0679-05;

REASON: Three malfunctions, due to jamming of bone material in the fill tube occurred. Fill tubes are used in delivery of bone graft materials.

MANUFACTURER: CryoLife, Inc., Kennesaw, GA, by letter on December 2, 2004. Firm initiated recall is ongoing.

PRODUCT: CryoValve, Aortic Valve and Conduit. Donor #56844, Model #AV00. Recall # Z-0686-05.

REASON: An incorrect lot number was entered in the production record for the solution in which this allograft was packaged

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 13, 2005:

CLASS I

MANUFACTURER: Dade Behring Inc, West Sacramento, CA, by letters on January 27, 2005 and February 10, 2005. Firm initiated recall is ongoing.

PRODUCT: MicroScan Ô Rapid Pos Inoculum Broth, Catalog #: B1015-14. Recall # Z-0668-05.

REASON: There is a potential for reporting of false susceptible anti-microbic results that could result in inappropriate and/or less effective therapy.

CLASS II

MANUFACTURER: CTI PET Systems, Inc, Knoxville, TN, by letter on May 27, 2004. Firm initiated recall is ongoing.

PRODUCT: PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tomography (CT) systems: • Siemens Models: Biograph PET/CT • CTI Models: Reveal PET/CT. Recall # Z-0547-05.

REASON: Misalignment of CT and PET scans from performing additional CT scans may produce an incorrect fused data set. In performing additional CT scans, the original PET and CT scans may become misaligned and produce an incorrect fused data set.

MANUFACTURER: Cryolife Inc., Kennesaw, GA, by letter on January 12, 2005. Firm initiated recall is complete.

PRODUCT: CryoValve, Pulmonary Valve and Conduit. Donor Number: 70022, Model Number: PV00. Recall # Z-0669-05.

REASON: During a retrospective review CryoLife's Medical Director identified pre-processing and incoming bioburden cultures of the heart tissue, which detected Staphylococcus aureas.

MANUFACTURER: Cincinnati Sub-Zero Products, Cincinnati, OH, by letter dated January 18, 2005. Firm initiated recall is ongoing.

PRODUCT: Electri-Cool II. Recall # Z-0670-05.

REASON: There is the potential that the power switch assembly can dislodge from the cabinet during use.

MANUFACTURER: Cincinnati Sub-Zero Products, Cincinnati, OH, by letters dated January 18, 2005. Firm initiated recall is ongoing.

PRODUCT: Micro-temp II heat therapy unit, model #747. Recall # Z-0671-05.

REASON: There is the potential that the power switch assembly can dislodge from the cabinet during use.

MANUFACTURER: Hudson RCI Tecate S. de R.L. de C.V., Mexico. Firm initiated recall is ongoing. Recalling Firm: Teleflex Medical, Bannockburn, IL, by letter on February 23, 2005.

PRODUCT: a) Sheridan Sher-I-Bronch Left Endobronchial Tube; an Rx, sterile, sinlge use endobronchial tube with modified tip for left bronchial intubation, 37 Fr.; sold under the following catalog numbers: • catalog number (REF) V5-16037: Novaplus Sterile Sher-I- Bronch Endobronchial Tube for Left Bronchial Intubation, 37 Fr., Novation Corporation, • catalog number (REF) 5-16037: Hudson RCI Sheridan Sher-I-Bronch Endobronchial Tube for Left Bronchial Intubation, 37 Fr. Recall # Z-0680-05; b) Sheridan Sher-I-Bronch Endobronchial Tube for Right Bronchial Intubation; an Rx, sterile, sinlge use endobronchial tube with modified tip for right bronchial intubation, 37 Fr.; catalog number (REF) 5-16137. Recall # Z-0681-05.

REASON: The distal end of the tube may be printed incorrectly, with catalog numbers V5-16037 and 5-16037 stating "Bronchial - Right" instead of "Bronchial - Left", and catalog number 5-16137 stating "Bronchial - Left" instead of "Bronchial - Right".

MANUFACTURER: Hitachi Medical Systems, CT Product Division, Kashiwa, Japan. Firm initiated recall is ongoing. Recalling Firm: Philips Medical Systems Sales and Service, Region No. America, Bothell, WA, by on site visit, beginning on February 10, 2005.

PRODUCT: Tomoscan. Recall # Z-0682-05.

REASON: Potential for shift of reference lines.

MANUFACTURER: CryoLife, Inc., Kennesaw, GA, by letters dated December 17, 2004, January 3, 2005, and January 19, 2005. Firm initiated recall is ongoing.

PRODUCT: a) CryoValve, Aortic Valve & Conduit SG. Donor #63601, Model #SGAV00. Recall # Z-0683-05; b) CryoValve, Pulmonary Valve & Conduit. Donor #65989, Model #PV00. Recall # Z-0684-05; c) CryoValve, Aortic Valve & Conduit. Donor #75651, Model #AV00. Recall # Z-0685-05.

REASON: During a retrospective review, CryoLife noted that the donor tissue exceeded the acceptable warm ischemic time when utilizing the “Last Seen Alive” time in their calculation.

CLASS III

MANUFACTURER: Rusch Inc, Duluth, GA. Firm initiated recall is ongoing. Recalling Firm: Teleflex Medical, Inc., Duluth, GA, by letter on May 13, 2004 and November 22, 2004.

PRODUCT: a) Latex-Free REF B1000, Belly Bag Urine Collection Bag with Hip Belt,**1000 ml Lot **Sterile EO. Recall # Z-0647-05; b) Latex-Free REF B1000P Belly Bag Urine Collection Bag with Sample Port **1000 ml Lot **Sterile EO*** Single use only. Recall # Z-0648-05.

REASON: Firm received complaints of leaking urine collection bags.

MANUFACTURER: Roche Diagnostics, Corp., Indianapolis, IN, letters dated February 15, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Roche COBAS INTEGRA HBA1c Kits for use with COBAS INTEGRA 400, 400+, 700 and 800 analyzers; catalog 20753521322. Recall # Z-0649-05; b) Roche ULTIMATE 3 HBA1C test kit for use with MIRA analyzers; catalog number 20755648322. Recall # Z-0650-05; c) Roche ULTIMATE 5 HBA1C test kit for use with MIRA analyzers; catalog number 20755656322. Recall # Z-0651-05.

REASON: The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of April 6, 2005:

CLASS II

MANUFACTURER: Compumedics USA, Ltd., El Paso, TX, by letter on February 24, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Compumedics E-Series Digital Amplifier System partnumber 8008-0001-01 and 8008-0001-02, manufactured by Compumedics Limited, Australia. Recall # Z-0652-05;b) Nonin Xpod Oximeter model numbers 3011 and 3012,distributed for use with the Compumedics E-Series Digital Amplifier. Recall # Z-0653-05.

REASON: Under specific conditions, the housing of the pulse oximeter connected to the amplifier can become excessively warm causing a burn upon contact with skin.

MANUFACTURER: Ethicon Endo-Surgery, Cincinnati, OH, by letter, dated February 28, 2005. Firm initiated recall is ongoing.

PRODUCT: a) ABSOLOK Extra Absorbable Ligating Clip cartridges,
small, code AP100. Ten cartridges are packaged per box. Recall # Z-0654-05;b) ABSOLOK Extra Absorbable Ligating Clip cartridges,medium, code AP200. Ten cartridges are packaged per box. Recall # Z-0655-05;c) ABSOLOK Extra Absorbable Ligating Clip cartridges, medium/large, code AP300. Ten cartridges are packaged per box. Recall # Z-0656-05.d) ABSOLOK Extra Absorbable Ligating Clip cartridges,large, code AP400. Ten cartridges are packaged per box. Recall # Z-0657-05.

REASON: The product is being recalled because the possibility exists that the sterility of the ligating clips may have been compromised by a tear in the ABSOLOK Extra packaging.

MANUFACTURER: Bio-Rad Laboratories, Inc, Redmond, WA, by letters on January 25-27, 2005 and January 31, 2005. Firm initiated recall is complete.

PRODUCT: Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATHFINDER RSV DIRECT ANTIGEN DETECTION SYSTEM 79674 IN VITRO TEST DIAGNOSTIC USE. Side of kit states Bio-Rad 3, boulevard Raymond Poincare France. Recall # Z-0659-05.

REASON: New instructions to recommend against using samples with visibly high level of blood.

MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated March 1, 2005. Firm initiated recall is ongoing

PRODUCT: Hill-Rom Total Care SpO2RT pulmonary therapy bed system, Model 1900. Recall # Z-0661-05.

REASON: Siderails may stay up without latching into place.

MANUFACTURER: Nellcor Puritan Bennett, Pleasanton, CA, by letters on October 18, 2004, and December 9, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Nellcor brand Pulse Oximeter, Model NPB290, MALLINCKRODT, Made in Ireland. Recall # Z-0662-05;b) Nellcor Puritan Bennett brand Pulse Oximeter, Model NPB295, Made in Ireland; Recall # Z-0663-05;c) Nellcor brand OxiMax Pulse Oximeter, model number N-595 Made in Ireland; Recall # Z-0664-05;d) Nellcor brand Pulse Oximeter, model N-395,Made in Ireland; Recall # Z-0665-05.

REASON: The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.

MANUFACTURER: Terumo Cardiovascular Systems Corp, Ann Arbor, MI, by letters dated March 17, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Terumo Advanced Perfusion System 1 (with 6 inch diameter roller pump), Catalog number 801041. Recall # Z-0666-05;b) Terumo Advanced Perfusion System 1 (with 4 inch diameter roller pump), Catalog number 801040. Recall # Z-0667-05.

REASON: The pumps will stop, show an overspeed error message, and will not restart using routine procedures if the user reduces the pump speed to zero RPM while the pump is operating in pulse mode.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 2, 2005:

CLASS II

MANUFACTURER: Zimmer Spine, Inc., Minneapolis, MN, by letters dated May 25, 2004. Firm initiated recall is ongoing.

PRODUCT: Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Zimmer Spine Trinica Anterior Cervical Plating Instrument sets (catalog numbers 07.00215.001 and 07.00546.001). Only the Trinica Bone Tap Instruments are being recalled from the sets. Recall # Z-1014-04.

REASON: The recalled bone taps could break inside the vertebral body during the tapping process.

MANUFACTURER: Nichols Institute Diagnostics, San Clemente, CA, by Customer Bulletin on June 30, 2004. Firm initiated recall is ongoing.

PRODUCT: Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033. Recall # Z-1118-04.

REASON: Lower than expected results are obtained.

MANUFACTURER: General Electric Med Systems LLC, Waukesha, WI, by Field Service Engineer visit, beginning on October24, 2004. Firm initiated recall is ongoing.

PRODUCT: he device generates whole body and head multislice X-ray computed tomography images that are used by the physician in the diagnosis of disease. Brand Name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FII; ProSpeed EII; CT HiSpeed Series. Recall # Z-0269-05.

REASON: Inadequate materials used to manufacture the upper shaft of patient tables that can result in uncontrolled table motion.

MANUFACTURER: Toshiba America Medical Systems, Tustin, CA, by Service Representative visit beginning on February 17, 2005. Firm initiated recall is ongoing.

PRODUCT: Model Number KXO-80G X-ray High Voltage Generator for Diagnostic Radiology use. Recall # Z-0494-05.

REASON: The units are defective under 21 CFR 1003.2 in that they fail to operate as required by 21 CFR 1020.31(a)(1) - Pre-exposure indication of the technique factors to be used during an exposure. Following an AEC exposure, the selected exposure time is indicated, but subsequent exposures are at the preset back-up time.

MANUFACTURER: E-Z-Em Co., Inc., Westbury, NY, by letters dated December 3, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886S. Ceiling Column Accessory: The CT and CTA Injector Systems employs an Articulating Arm that mounts to the Ceiling Column Accessory, which are designated as 9886S (11.25î), M (21.50î), and L (34.50î), i.e. 9886L. Recall # Z-0548-05; b) Brand Name: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886M. Ceiling Column Accessory: The CT and CTA Injector Systems employs an Articulating Arm that mounts to the Ceiling Column Accessory, which are designated as 9886S (11.25"), M (21.50"), and L (34.50"), i.e. 9886L. Recall # Z-0549-05; c) Brand Name of Device: EmpowerCT/EmpowerCTA Injector System Ceiling Column Accessory; Common/Usual Name: CT Injector System Ceiling Column Accessory, Catalog Number 9886L. Ceiling Column Accessory: The CT and CTA Injector Systems employs an Articulating Arm that mounts to the Ceiling Column Accessory, which are designated as 9886S (11.25"), M (21.50"), and L (34.50"), i.e. 9886L. Recall # Z-0550-05.

REASON: Out of specification welding could cause the ceiling mount accessory to detach from its mounting. The firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket and landed on the floor.

MANUFACTURER: Fisher and Paykel Healthcare, Inc., Laguna Hills, CA, by letter on December l7, 2004. Firm initiated recall is ongoing.

PRODUCT: RT130 and RT131 Neonatal/Infant Breathing Circuits, heated wire. For use with MR850 Respiratory Humidifier. Recall # Z-0553-05.

REASON: Pressure elbow may be partly occluded.

MANUFACTURER: Lemaitre Vascular, Inc., Burlington, MA, by letter on February 7, 2005. Firm initiated recall is ongoing.

PRODUCT: a) LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml, Length 60 cm. Latex Model: 1601-26. Recall # Z-0557-05; b) LeMaitre Embolectomy Catheter 3F Single Lumen, Balloon Volume 0.2 ml, Length 80 cm. Latex Model: 1601-38. Recall # Z-0558-05; c) LeMaitre Embolectomy Catheter 4F Single Lumen, Balloon Volume 0.75 ml, Length 80 cm. Latex Model: 1601-48. Recall # Z-0559-05; d) LeMaitre Embolectomy Catheter 5F Single Lumen, Balloon Volume 1.5 ml, Length 80 cm. Latex Model: 1601-58. Recall # Z-0560-05; e) LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml, Length 80 cm. Latex Model: 1601-28. Recall # Z-0561-05.

REASON: Product sterility maybe compromised due to defective packaging.

MANUFACTURER: TissueLink Medical, Inc., Dover, NH, by letter from February 7, 2005 to February 8, 2005. Firm initiated recall is ongoing.

PRODUCT: Tissuelink Dissecting Sealer DS3.5-C, Sterile Ref 13-121-1. Recall # Z-0563-05.

REASON: The tip may separate from the device and render it unusable.

MANUFACTURER: Zimmer Orthopaedic Surgical Products, Statesville, NC, by letter on February 11, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Zimmer? Orthopaedic Surgical Products, Disposable Cuff, Dual Port, Double Bladder Cuff. The cuff is a sterile, single use product equipped with an integral fill line and packed 10 cuffs per unit. Cat #60-7080-002-00, Cat #60-7080-003-00, and Cat #60-7080-002-00. Recall # Z-0564-05; b) Zimmer? Orthopaedic Surgical Products, Disposable Cuff, Single Port, Double Bladder Cuff. The cuff is a sterile, single use product equipped with an integral fill line and packed 10 cuffs per unit. Cat #60-7085-003-00, Cat #60-7085-002-00. Recall # Z-0565-05.

REASON: The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.

MANUFACTURER: Smiths Medical MD, Inc., Saint Paul, MN, by letter on October 15, 2004. Firm initiated recall is ongoing.

PRODUCT: Deltec Cozmo 3 ml Insulin Cartridge with 0.7 mm (22G) x 12.5mm (1/2 in.) needle and cap. Reorder #21-1750-24. Made in Mexico. Labeling states Cartridge is Sterile and nonpyrogenic unless package is opened or damaged, Rx Only Recall # Z-0566-05.

REASON: Complaints relating to two lots of Cozmo Cartridges describing leakage of insulin into the cartridge chamber.

CLASS III

MANUFACTURER: Cordis Corporation, Miami Lakes, FL, by letter in November 2004. Firm initiated recall is ongoing.

PRODUCT: Cypher BX Velocity Cardio Sirolimus Eluting Stents. All CWSXXXXX and CRSXXXXX.BX Velocity stent coated with the pharmaceutical agent, Sirolimus. Recall # Z-0555-05.

REASON: Inventory control stickers had incorrect expiration date. The stickers stated the expiration date was November 2004 instead of October 2004.

MANUFACTURER: Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letter on October 27, 2004. Firm initiated recall is ongoing. PRODUCT: The Triathlon Posteriorly Stabilized Femoral Component. Recall Z-0556-05.

REASON: The fatigue testing of the Triathlon PS Femoral Component does not consistently meet the requirements of the finite element analysis predicted load as delineated in the 510(k) submittal. Please visit our websites at www.mdiconsultants.com for more information on mdi’s services, staff and items of interest.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 9, 2005:

CLASS I

MANUFACTURER: IV Flush LLC, Rowlett, TX, by letter on January 26, 2005 and February 16, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Heparin Lock Flush Solution. Recall # Z-0545-05; b) Sodium Chloride Injection USP. Recall # Z-0546-05.

REASON: Device marketed without 510(k) clearance and is suspected to be contaminated with P. Fluorescens.

CLASS II

MANUFACTURER: Greer Laboratories, Inc., Lenoir, NC, by telephone and letter on January 28, 2005. Firm initiated recall is ongoing.

PRODUCT: Sterile Empty Vials for Allergenic Extracts, 100ml size. Recall # Z-0567-05.

REASON: Product may not be sterile.

MANUFACTURER: Alaris Medical Systems Inc, San Diego, CA, by letter on November 15, 2004. Firm initiated recall is ongoing.

PRODUCT: Model 8100 Series Medley Medication Safety System Pump Module. Recall # Z-0568-05.

REASON: The device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module.

MANUFACTURER: Ross Products Division Abbott Laboratories, Columbus, OH, by telephone and letter on August 18, 2004. Firm initiated recall is ongoing.

PRODUCT: Flexiflo Quantum Enteral Pump. Recall # Z-0570-05.

REASON: Pumps were manufactured with an incorrect circuit board that may cause an increase in the feed rate and flush frequency of fluids.

MANUFACTURER: Maquet, Inc, Bridgewater, NJ, by letter on January 3, 2005. Firm initiated recall is ongoing.

PRODUCT: Servo-Ventilator, SV300/300A, Part numbers 6070391 and 6424704. Recall # Z-0571-05.

REASON: Failures of the air and oxygen gas modules occurred because of misuse/non-compliance of directions.

MANUFACTURER: Diasorin, Inc., Stillwater, MN, by telephone on September 10, 2003. Firm initiated recall is ongoing.

PRODUCT: Varcella Zoster ELISA kit for the detection of IgG antibodies to varicella zoster virus in human serum, Catalog No.: 4620. Recall # Z-0572-05.

REASON: Varicella Zoster ELISA kit assay was producing invalid runs on the ETI-Max 3000 automated microtiter plate instrument and/or false negative results.

MANUFACTURER: Roche Diagnostics Corp, Indianapolis, IN, by letters dated February 15, 2005. Firm initiated recall is ongoing. PRODUCT: a) BioTek brand Automated Microplate Reader; Model Elx800, Roche catalog number 21045059001. Recall # Z-0573-05; b) BioTek brand Automated Microplate Reader; Model Elx808, Roche catalog number 03145387001. Recall # Z-0574-05.

REASON: The parameters loaded in the analyzer for the hepatitis C virus do not match those in the package insert, and patient results may be reported out as false positives or false negatives.

MANUFACTURER: Deals Nothing Over A Dollar, Earth City, MO, by e-mail on February 16, 2005. Firm initiated recall is ongoing.

PRODUCT: Homedics PowerDent battery powered toothbrush, Model HD-30, individually packaged; Made in China; UPC 31262-00789, Deals Nothing Over A Dollar SKU #100608494. The individually packaged toothbrushes are packaged 49 per case labeled as Decent Trading Adult Battery Operated Toothbrush. Recall # Z-0575-05.

REASON: A defective seal allows water into the handle of the toothbrush via the bristles, and rusty water seeps back out of the toothbrush around the bristles.

MANUFACTURER: Beckman Coulter, Inc., Brea, CA, by letters on February 23, 2005. Firm initiated recall is ongoing.

PRODUCT: Access Immunoasay Systems Digoxin Reagent. Recall # Z-0576-05.

REASON: Variability in results on Patient and QC results of 20-25%, high and low.

CLASS III

In the March 2, 2005 (05-09) Enforcement Report, Recall # Z-0555-05 should read as follows:

MANUFACTURER: Cordis Corporation, Miami Lakes, FL, by letter on November 16, 2004. All Cypher product at U.S. hospitals was inspected between 11/17/2004 and 12/16/2004 for potential incorrect expiration date on Inventory Control Stickers applied at hospitals. None were found. Firm initiated Field Inspection is complete. All product involved in the inspection has expired. (CORRECTION)

PRODUCT: Cypher Sirolimus-eluting Coronary Stent on Raptor Over-the-Wire Delivery System (CWSxxxxx), and Cypher RX Sirolimus-eluting Coronary Stent on RaptorRail Rapid Exchange Delivery System (CXSxxxxx). (CORRECTION) Recall # Z-0555-05.

REASON: Inventory control stickers had incorrect expiration date. The stickers stated the expiration date was November 2004 instead of October 2004.

MANUFACTURER: Becton Dickinson & Company, Franklin Lakes, NJ, by letters on October 22, 2004. Firm initiated recall is ongoing.

PRODUCT: ReliOn Insulin Syringe 0.5cc 30 Gauge 5/16 inch (8mm) Needle (U-100 Insulin). NDC 81306-0515-23. Recall # Z-0569-05.

REASON: Syringes labeled as 5/16 inch product (30 ga) actually contained the 1/2 inch product (28 ga). Please visit our websites at www.mdiconsultants.com for more information on mdi’s services, staff and items of interest.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 16, 2005:

CLASS I

MANUFACTURER: Medtronic Emergency Response Systems, Inc., Redmond,WA, by letter on February 3, 2005 and by telephone and letter beginning on March 1, 2005. Firm initiated recall is ongoing.

PRODUCT: LIFEPAK 500 AED. Recall # Z-0562-05.

REASON: Potential to not detect patients at the low end of the patient impedance range.

CLASS II

MANUFACTURER: Medline Industries, Inc., Waukegan, IL, by letters dated March 4, 2005. Firm initiated recall is ongoing.

PRODUCT: Medline Custom Sterile Surgical Packs which contain a Tyvek Breather Pouch, part number 32901, the breather pouch measures 25.25 inches x 30.75 inches, 5 mil thick. Recall # Z-0554-05.

REASON: There is a potential for open side seals post-sterilization of the Tyvek breather pouches used in the custom sterile packs.

MANUFACTURER: DeRoyal Technologies, Inc., New Tazewell, TN, by letter on November 22, 2004. Firm initiated recall is ongoing.

PRODUCT: Cold Therapy Blanket. Recall # Z-0577-05.

REASON: There is a possibility of water leaking from the welded seam of the blanket.

MANUFACTURER: Sybaritic, Inc., Bloomington, MN, by telephone on January 5, 2005. Firm initiated recall is ongoing.

PRODUCT: Dermosonic Model 430300 and 440100 Non-Invasive Subdermal Therapy System. Recall # Z-0578-05.

REASON: Device is performing functions that are not cleared in the 510(k).

MANUFACTURER: Dentsply Friadent Ceramed, Lakewood, CO, by letters dated February 17, 2005. Firm initiated recall is ongoing.

PRODUCT: PepGen P-15 Putty(0.5cc). Article Number: 99U200-005. Recall # Z-0579-05.

REASON: PepGen P-15 Putty kit was labeled with the incorrect expiration date.

MANUFACTURER: Kinetic Concepts, Inc., San Antonio, TX, by telephone on June 6, 2003. Firm initiated recall is complete.

PRODUCT: KinAir MedSurg, flotation therapy, powered hospital bed. Recall # Z-0583-05.

REASON: Weld failure causes side rail welds to turn upside down or break off of the bed.

MANUFACTURER: Becton Dickinson Infusion Therapy, Sandy, UT, by telephone on February 3, 2005, and letters dated February 10, 2005. Firm initiated recall is ongoing.

PRODUCT: a) BD Nexiva Closed IV Catheter System, 18 gauge. Catalog Numbers: 383508, 383509. Recall # Z-0584-05; b) BD Nexiva Closed IV Catheter System, 20 gauge. Catalog Numbers: 383505, 383506, 383507. Recall # Z-0585-05; c) BD Nexiva Closed IV Catheter System, 22 gauge. Catalog Number: 383502. Recall # Z-0586-05; d) BD Nexiva Closed IV Catheter System, 24 gauge. Catalog Numbers: 383500, 383501. Recall # Z-0587-05; REASON: The Y-luer connection may crack during normal product use. MANUFACTURER: Proctor & Gamble CO., Cincinnati, OH, by letter dated February 23, 2005 and March 4, 2005. Firm initiated recall is ongoing. PRODUCT: a) The product is a battery operated toothbrush. Spinbrush Pro Whitening Ex Soft battery operated toothbrushes UPC 76687800191. Recall # Z-0589-05; b) The product is a battery operated toothbrush. Spinbrush Pro Whitening Medium battery operated toothbrushes UPC 76687800193. Recall # Z-0590-05; c) The product is refill heads for battery powered toothbrushes. Spinbrush Pro Whitening EX Soft Refill Heads, UPC776687800192.Recall # Z-0591-05; d) The product is refill heads for battery powered toothbrushes. Spinbrush Pro Whitening Medium Refill Heads, UPC776687800194.Recall # Z-0592-05; e) The product is a Spinbrush Pro EX Soft battery operated toothbrushes. UPC 76687800078. Recall # Z-0593-05; f) The product is a Spinbrush Pro Medium battery operated toothbrushes. UPC 76687800079. Recall # Z-0594-05; g) The product is a Spinbrush Pro EX Soft battery powered Refill heads for battery powered toothbrushes. UPC 776687800080. Recall # Z-0595-05; h) The product is refill heads for battery powered toothbrushes. Spinbrush Pro Medium Refill heads, UPC 776687800081. Recall # Z-0596-05.

REASON: The brushes may experience head breakage when insufficiently rinsed after use and when used in combination with toothpastes containing a combination baking soda, peroxide, and sodium lauroyl sarcosinate

MANUFACTURER: Medtronic Inc., Cardiac Rhythm Management, Fridley, MN, by letter starting on February 10, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Medtronic Marquis VR, model 7230 Single Chamber Implantable Cardioverter Defibrillator (ICD) devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user- selected therapies for the detected arrhythmia. Therapies are automatically delivered following detection or can be initiated via programming by the physician. These ICDs are multi-programmable and have the capability of transmitting via telemetry the programmed values, measured and collected data, and event markers. Recall # Z-0597-05; b) Medtronic Maximo VR, model 7232 Single Chamber Implantable Cardioverter Defibrillator (ICD). Recall # Z-0598-05; c) Medtronic Marquis DR, model 7274 Dual Chamber Implantable Cardioverter Defibrillator (ICD). Recall # Z-0599-05; d) Medtronic InSync Marquis, model 7277 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy. Recall # Z-0600-05; e) Medtronic Maximo DR, model 7278 Single Chamber Implantable Cardioverter Defibrillator (ICD). Recall # Z-0601-05; f) Medtronic InSync III Marquis, model 7279 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy. Recall # Z-0602-05; g) Medtronic InSync III Protect, model 7285 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy. Recall # Z-0603-05; h) Medtronic InSync II Marquis, model 7289 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy. Recall # Z-0604-05.

REASON: Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a few hours to a few days, after which there is a complete loss of device function.

MANUFACTURER: Roche Diagnostics, Corp., Indianapolis, IN, by letters dated December 21, 2004 and January 3, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Roche brand ISE SnapPak for use only in the AVL 9120/9130 Electrolyte Analyzer. Ref/No. 03112276180; Part number BP5016. Recall # Z-0605-05; b) Roche brand ISE SnapPak for use only in the AVL 9180/9181 Electrolyte Analyzer; Ref/No. 03112349180, Part number BP5186. Recall # Z-0606-05; c) Roche brand ISE SnapPak for use only in the AVL 9110/9140 Electrolyte Analyzer; Ref/No. 03112314018, Part number BP5032. Recall # Z-0607-05; d) Bayer brand Technicon RA/opeRA Systems ISE Fluid Pack for in vitro diagnostic use on the opera system only, Manufacturer part number T01-3606-01, Roche part number 03361322001. Recall # Z-0608-05; e) Alfa Wassermann brand REF E1-8 STARLYTE III ISE Fluid Pack for use in the STARLYTE III electrolyte analyzer, Roche part number 03361152001. Recall # Z-0609-05; f) AVL Scientific Corp. brand 9180 SnapPak Type D, BP5206, for use only in the AVL 9180 electrolyte analyzer, Roche part number 03112357182. Recall # Z-0610-05; g) Vital Scientific brand ISE Snap Pack for use only in the ISE Module 9130, Ref no. 3203-007, Roche part number 03522032001. Recall # Z-0611-05.

REASON: A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results.

CLASS III

MANUFACTURER: Cryolife, Inc., Kennesaw, GA, by letter on December 17, 2004. Firm initiated recall is ongoing.

PRODUCT: a) CryoValve, Pulmonary Valve & Conduit. Donor #62654, Model #PV00. Recall # Z-0580-05; b) CryoValve, Aortic Valve and Conduit. Donor #62654, Model #AV00. Recall # Z-0581-05.

REASON: Records noted that the infant donor's mother had tested positive for Hepatitis B.

MANUFACTURER: Teleflex Medical, Bannockburn, IL, by letter dated January 14, 2005. Firm initiated recall is ongoing.

PRODUCT: Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube; an Rx, ETO sterilized, single use device inserted into the patient's trachea via the mouth to maintain an open airway; Manufactured in Mexico, Catalog number (REF) V5-10316 (8.0 mm). Recall # Z0582-05.

REASON: Some of the primary labels have the internal diameter (ID) and outer diameter (OD) numbers reversed, i.e. ID 10.9 mm and OD 8.0 mm instead of the actual ID 8.0 and OD 10.9 mm, mislabeling the size of the tracheal tube.

MANUFACTURER: Cordis Corporation, Miami Lakes, FL, by letter dated April 30, 2004. Firm initiated recall is complete.

PRODUCT: Vistabritetip IG Introducer, Introducer Guide. Labeled as sterile, sterilized with ethylene oxide gas. For single use only. Catalog number 4038553S. Recall # Z-0588-05.

REASON: The product is labeled as Straight Catheter but the package contains Contralateral Guide shaped Catheters. Please visit our websites at www.mdiconsultants.com for more information on mdi’s services, staff and items of interest.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 23, 2005:

CLASS II

MANUFACTURER: Hospira, Inc., Lake Forest, IL, by letter on November 10, 2004 or by telephone on November 11, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Angiographic Syringe, 10 cc Thumb Ring with Rotator Reservoir. Recall # Z-0617-05; b) Angiographic Syringe, 12 cc Thumb Ring with Rotator Reservoir. Recall # Z-0618-05; c) Angiographic Syringe, 12 cc Thumb Ring with Rotator Non-Reservoir. Recall # Z-0619-05; d) Angiographic Syringe, 12 cc Palm Pad with Rotator Reservoir. Recall # Z-0620-05; e) Catheterization Kits containing Angiographic Syringes with Rotator Connector. Recall # Z-0621-05

REASON: Syringes could possibly allow air to enter the patient's vascular system.

CLASS III

MANUFACTURER: Medtronic Neurosurgery, Goleta, CA, by letters on February 28, 2005. Firm initiated recall is ongoing.

PRODUCT: a) MurphyScope, Bayonet, Malleable, Catalog # 2121-157. Recall # Z-0615-05; b) MurphyScope, Curved, Malleable, Catalog # 2125-163. Recall # Z-0616-05.

REASON: Products are mislabeled. Each designated lot contains the other model. Bayonet type contains Curved and vice versa.

MANUFACTURER: Integra Neuro Sciences, San Diego, CA, by letter on January 21, 2005. Firm initiated recall is ongoing.

PRODUCT: a) LICOX Complete Brain IMC Probe Kit, Model IM3.ST C. Recall # Z-0622-05; b) LICOX temperature probe, Model C8.B. Recall # Z-0623-05.

REASON LICOX Model C8.B temperature probes may exhibit progen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever.

MANUFACTURER: Heraeus Kulzer Inc., South Bend, IN, by letter on or about November 1, 2003. Firm initiated recall is complete.

PRODUCT: a) Heraeus Kulzer brand P2 Magnum 360 Heavy 3X (2x360), catalog number 66009585 Dental impression material. Recall # Z-0624-05; b) Heraeus Kulzer brand P2 Magnum 360 Trial Kit, Heavy+Light, catalog number 66009583. Recall # Z-0625-05; c) Heraeus Kulzer brand P2 Magnum 360 Monophase 3X (2x360), catalog number 66009584. Recall # Z-0626-05; d) Heraeus Kulzer brand P2 Magnum 360 Trial Kit Monophase, catalog number 66009582. Recall # Z-0627-05.

REASON: Packaging defects could result in improper mixing ratios and unusable impressions. Please visit our websites at www.mdiconsultants.com for more information on mdi’s services, staff and items of interest.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of March 30, 2005:

CLASS I

MANUFACTURER: Heartsine Technologies, Inc., San Clemente, CA, by telephone and letters on February 14, 2005. Firm initiated recall is ongoing.

PRODUCT: Heartsine Samaritan AED Defibrillators -- Models: SAM 001, SAM 002,SAM 003. Recall # Z-0641-05.

REASON: The affected Automatic External Defibrillators (AED) announce a fault warning and shut themselves off before a shock can be delivered to the patient. This is reportedly due to slow capacitor charging rates which are interpreted by the AED software as a fault condition.

CLASS II

MANUFACTURER: Bioteque America Inc., Langhorne, PA, by telephone on February 23, 2005 and by letter dated February 24, 2005. Firm initiated recall is ongoing.

PRODUCT: Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile tyvck pouch. Recall # Z-0027-05.

REASON: Product is marked without a 510(k).

MANUFACTURER: Becton Dickinson Infusion Therapy, Sandy, UT, by telephone and letters dated January 10, 2005. Firm initiated recall is complete.

PRODUCT: a) BD Exacta 8.5 Fr Percutaneous Sheath IntroducerTray. Ref. No 680124. Recall # Z-0628-05;b) Careflow 14Ga x 20cm 2-lumen Central Venous Catheter Tray. Ref. No. 681714. Recall # Z-0629-05;c) Careflow 7Fr x 20cm 3-lumen Central Venous Catheter Tray. Ref. No. 681725. Recall # Z-0630-05;d) BD Exacta 6Fr Percutaneous Sheath Introducer Tray. Recall # Z-0631-05.

REASON: Various procedure trays and kits may have an insufficient seal, thus compromising sterility.

MANUFACTURER: Diasorin Inc., Stillwater, MN, by letter on January 22,2004. Firm initiated recall is ongoing.

PRODUCT: DiaSorin Anti-Cardiolipin IgA ELISA kit for the detection in human serum or plasma of antoantibodies specific for Cardiolipin IgA. Catalog No.: 7800. Recall # Z-0632-05.

REASON: DiaSorin Anti-Cardiolipin IgA kit's positive control is out of acceptable limits.

MANUFACTURER: Millar Instruments, Inc., Houston, TX, by e-mail on January 14, 2005 and letter on January 20, 2005. Firm initiated recall is ongoing.
PRODUCT: Mikro-Tip Disposable Angiographic Catheter. Recall # Z-0635-05.
REASON: Wire braiding protruding from the catheter.

MANUFACTURER: Boston Scientific, San Jose, CA, by letters on February 14, 2005. Firm initiated recall is ongoing.

PRODUCT: Constellation Advanced Mapping Catheter, Model numbers 8031, 8038, 8060, 8075. Recall # Z-0639-05.

REASON: The coating on the product's surface can generate debris, which could then move from the heart towards the brain, resulting in Ischemic events.

MANUFACTURER: Philips Medical Systems Sales and Service Region No. America, Bothell, WA, by letter on December 21, 2004. Firm initiated recall is ongoing.

PRODUCT: Xcelera R1.2. Cardiology image and information management solution software. Recall # Z-0640-05.

REASON: Loss of image data from image repository and archive requiring patients to undergo repeat imaging.

MANUFACTURER: Recalling Firm: Cypress Medical Products, Ltd., McHenry, IL, by telephone on May 3, 2004, and by telephone and letters dated March 3, 2005. Manufacturer: Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA. Firm initiated recall is ongoing.

PRODUCT: a) Manual Mechanical Wheelchair, 18" seat, maximum patient weight: 250 lbs.; Made in China; the wheelchairs were sold in the following configurations: reorder 16-7901: Fixed Full Arm, Fixed Footrest reorder 16-7902: Fixed Full Arm, Swing Footrest reorder 16-7903: Fixed Full Arm, Elevating Adjustable Legrest reorder 16-7904: Removable Desk Arm, Swing Footrest reorder 16-7905: Removable Desk Arm, Elevating Adjustable Legrestreorder 16-7906: Removable Full Arm, Elevating Adjustable Legrest. Recall # Z-0642-05;b) Manual Mechanical Wheelchair, 16" seat, maximum patient weight: 250 lbs.; Made in China; the wheelchairs were sold in the following configurations: reorder 16-7910: Fixed Full Arm, Swing Footrest reorder 16-7911: Fixed Full Arm, Elevating Adjustable Legrest reorder 16-7912: Removable Desk Arm, Swing Footrest reorder 16-7913: Removable Desk Arm, Elevating Adjustable Legrest reorder 16-7914: RemovableFull Arm, Elevating Adjustable Legrest. Recall # Z-0643-05;c) Manual Mechanical Wheelchair, 24" seat, maximum patient weight: 450 lbs.; Made in China; the wheelchairs were sold in the following configurations: reorder 16-7920: Removable Desk Arm, Swing Footrest reorder 16-7921: Removable Desk Arm, Elevating Adjustable Legrest reorder 16-7922: RemovableFull Arm, Elevating Adjustable Legrest. Recall # Z-0644-05;d) Manual Mechanical Wheelchair, 20" seat, maximum patient weight: 350 lbs., Made in China; the wheelchairs were sold in the following configurations: reorder 16-7942: Removable Desk Arm, Swing Footrest reorder 16-7943: Removable Desk Arm, Elevating Adjustable Legrest reorder 16-7944: Removable Full Arm, Elevating Adjustable Legres. Recall # Z-0645-05;e) Manual Mechanical Wheelchair, 22" seat, maximum patient weight: 350 lbs.; Made in China; the wheelchairs were sold in the following configurations: reorder 16-7952:Removable Desk Arm, Swing Footrest reorder 16-7953: Removable Desk Arm, Elevating Adjustable Legrest reorder 16-7954: Removable Full Arm, Elevating Adjustable Legrest. Recall # Z-0646-05.

REASON: The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair.

CLASS III

MANUFACTURER: DiaSorin Inc., Stillwater, MN, by letters on October 20, 2004. Firm initiated recall is ongoing.

PRODUCT: ETI-MP IgM Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of specific IgM antibodies to Mycoplasma pneumoniae in human serum. Test kit for 192 determinations. Catalog No. 4700. For In Vitro Diagnostic use. Recall # Z-0633-05.

REASON: 2 lots of ETI-MP IgM assay kits showed a decline in Optical Density (OD) reading of the positive control and calibrators, P10 and P50. The decline in OD of the positive control and calibrators (P10 & P50) would cause the assay validation criteria to fail.

MANUFACTURER: DiaSorin, Stillwater, MN, by letter. Firm initiated recall is ongoing.

PRODUCT: DiaSorin GammaCoat Androstenedione - [125I] RIA Kit Catalog No. CA-1725. for the quantitative determination of androstenedione levels in serum. Recall # Z-0634-05.

REASON: Standards used in the GammaCoat Androstenedione Radioimmunoassay Kit appeared yellowish in color and were gelatinous upon reconstitution.

MANUFACTURER: DiaSorin, Inc., Stillwater, MN, by letters on January 10, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Lp(a) Diluent packaged into 60 mL bottles, Catalog #23817, 480 mL bulk catalog # 95046B;
b) 60 mL bottles can be part of DiaSorin Lp(a) Antibody Reagent Kits Catalog # 86084, for use in DiaSorin Antibody Reagent Set for Lp(a) SPQ Test System. Recall # Z-0636-05.

REASON: QC testing of the Antibody Reagent Set for Lp(a) SPQ Test System it was discovered that the background was failing high of the specification. Through substitution testing it was determined that the Lp(a) diluent, part #238017 was the cause of the failing background specification.

MANUFACTURER: DiaSorin, Inc., Stillwater, MN, by letters dated February 14, 2005. Firm initiated recall is ongoing.

PRODUCT: Liaison 25 OH Vitamin D Assay, catalog # 310900. Recall # Z-0637-05.

REASON: Results of an internal inspection show Lot 114439E to have calibrator 1 and calibrator 2 switched in their position in the integral. This results in an inability to calculate a curve, due to the reversal of calibrator values.

MANUFACTURER: DiaSorin, Inc., Stillwater, MN, by letters dated February 14, 2005. Firm initiated recall is ongoing.

PRODUCT: Liaison 25 OH Vitamin D Assay, Manufacturer part # 310900. Recall # Z-0638-05.

REASON: An internal inspection indicates that calibrator 2 and conjugate are switched in their positions in the integral. This will result in calibrator 1 RLU's similar to that of background RLU, and calibrator 2 RLU's near expected range. A curve can not be calculated from this data.
Please visit our websites at www.mdiconsultants.com for more information on mdi’s services, staff and items of interest.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 23, 2005:

CLASS II

MANUFACTURER: Dade Behring, Inc., Newark, DE, by letter on December 3, 2004. Firm initiated recall is ongoing.

PRODUCT: Advanced D-Dimer. Fibrinogen and fibrin split products, Catalog numbers OQWM11 AND OQEM13. Recall # Z-0538-05.

REASON: Decrease in product stability after reconstitution and reduced stability on board certain instrument systems.

MANUFACTURER: Zimmer Austin, Inc., Austin, TX, by letter on December 17, 2004. Firm initiated recall is ongoing.

PRODUCT: Most Options System Porous and Non-Porous Revision Stem Adapters. Catalog Numbers: 5000-50-100 and 5000-50-200. Recall # Z-0539-05.

REASON: Risk of adapter disassociation from mating components when assembled improperly or when subjected to high-stress femoral applications.

MANUFACTURER: Plus Orthopedics, San Diego, CA, by telephone and personal visit, on January 4, 2005. Firm initiated recall is complete.

PRODUCT: UltraCongruent Tibial Insert Model 0214703 Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm. Recall # Z-0540-05.

REASON: Knee tibial insert is mislabeled completely as different device.

MANUFACTURER: Ups Supply Chain Solutions, Alpharetta, GA, by letters dated February 4, 2005. Firm initiated recall is ongoing.

PRODUCT: Rapid Syphilis Test Kit, per insert, contents of the kit are 1 Rapid Syphilis test cassette, 1 alcohol swab, 1 buffer container, 1 lancet (needle), 1 zipped bag, 1 pipette (plastic) (included with cassette). There is no firm identified on the product packaging. Recall # Z-0542-05.

REASON: The kits are not approved for use in the United States.

CLASS III

MANUFACTURER: Diagnostic Products, Corp, Los Angeles, CA, by telephone, email or fax on January 24 and 25, 2005. Firm initiated recall is ongoing.

PRODUCT: IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB 2, L2KVB6. Recall # Z-0537-05.

REASON: A low CPS limit was not incorporated in the kit barcode for IMMULITE 2000 Vitamin B12 L2KVB 2, 6 kit lot 186 only.

MANUFACTURER: Diamedix Corp., Miami, FL, by letter on December 23, 2004. Firm initiated recall is ongoing.

PRODUCT: Legionella ELISA Test System. The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert. Recall # Z-0541-05.

REASON: The kits may lose activity, after one or two usages, causing the OD values for the Cut-Off Calibrator and/or Positive Control to be recovered below their specified ranges.

MANUFACTURER: Biolase Technology, Inc., San Clemente, CA, by firm representative visit, on January 17, 2005. Firm initiated recall is ongoing.

PRODUCT: Waterlase MD, dental laser unit, Model #6200218. Recall # Z-0543-05.

REASON: Reports that the Waterlase MD, a dental laser unit, water bottle broke under pressure during installation.

MANUFACTURER: Bausch & Lomb, Inc., Rochester, NY, by letters dated February 4, 2003. Firm initiated recall is ongoing.

PRODUCT: SofLens 66 Toric Visibility Tinted Contact Lenses for Daily Wear, sold in cartons containing 6 lenses each. Cartons/blister packs are labeled with --3.25 DS, -1.25DC, 170 degree Axis. Recall # Z-0544-05.

REASON: Portion of lot contains lenses with incorrect refractive power.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 16, 2005:

CLASS I

MANUFACTURER: Becton Dickinson & Co., Sparks, MD, by telephone on January 10, 2005. Firm initiated recall is ongoing.

PRODUCT: BD ProbeTec? ET Urine Processing Kit, 4x25, catalog 440454, packaged in a carton containing 4 storage bags identified as BD ProbeTec? ET Urine Processing Pouches, 25 pouches/bag. Recall # Z-0455-05.

REASON: An in-vitro diagnostic kit reagent may cause false negative clinical results in patients tested for sexually transmitted infections.

CLASS II

MANUFACTURER: Cardiac Science, Inc., Minnetonka, MN, by telephone on November 12, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Powerheart AED G3 Automated External Defibrillator Model 9300E. Recall # Z-0398-05; b) Powerheart AED G3 Automated External Defibrillator Model 9300A (Automatic). Recall # Z-0399-05.

REASON: AEDs may contain an electronic component that does not meet its full operating specifications. The AEDs with this suspect electronic component may not function properly and may interfere with the AED's ability to delivery therapy. In the event that charge noise is present it will delay the first defibrillation shock in the 3 shock sequence.

MANUFACTURER: S S C O R Inc., Sun Valley, CA, by letter, on January 6, 2005. Firm initiated recall is ongoing.

PRODUCT: a) SSCOR Suction Device Model 2310BV. Recall # Z-0411-05; b) SSCOR Suction Device Model 2310V. Recall # Z-0412-05; c) SSCOR Suction Device Model 2310BV-230. Recall # Z-0413-05; d) SSCOR Suction Device Model 2314. Recall # Z-0414-05; e) SSCOR Suction Device Model 2314B. Recall # Z-0415-05; f) SSCOR Suction Device Model 2315. Recall # Z-0416-05.

REASON: Reports from medical professionals that SSCOR suction device has not performed as intended. Firm's investigation disclosed that the condition in question is caused by regulators that result in inadequate suction.

MANUFACTURER: Smiths Medical MD, Inc., Saint Paul, MN, by telephone and e-mail on November 11, 2004, and by letter on November 16, 2004. Firm initiated recall is ongoing.

PRODUCT: Deltec branded PORT-A-CATH II Single-Lumen Low Profile Polysulfone/Titanium Venous Access System, Pre-assembled with PolyFlow, Ployurethane Catheter, 2.6mm (7.8 Fr) O.D. x 1.6 mm I.D., 8.5 Fr Introducer Set. Immediate package states Contents of unopened and undamaged individual product packages are STERILE and non-pyrogenic. Check package integrity before use. Destroy after use. Do not resterilize. Latex free. Recall # Z-0442-05.

REASON: The catheter became disconnected from the port while implanted in the patient.

MANUFACTURER: Nellcor Puritan Bennett, Inc., Carlsbad, CA, by letters on December 16, 2004. Firm initiated recall is ongoing.

PRODUCT: Internal Battery for Puritan Bennett 700 Series Ventilator. Recall # Z-0444-05.

REASON: Wires on battery may loosen causing disconnection.

MANUFACTURER: Nellcor Puritan Bennett, Inc., Carlsbad, CA, by letter on December 17, 2004. Firm initiated recall is ongoing.

PRODUCT: Puritan Bennett Ventilator System. Model 740 and 760 series. Recall # Z-0445-05.

REASON: Capacitor weakness in backup alarm system might fail causing lack of backup alarm to function in the event of total power loss.

MANUFACTURER: Warsaw Orthopedic, Inc., Warsaw, IN, by letters dated December 27, 2004 and January 12, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Atlantis Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-123. Recall # Z-0446-05; b) Atlantis Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-125. Recall # Z-0447-05; c) Atlantis Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-127. Recall # Z-0448-05; d) Atlantis Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-140. Recall # Z-0449-05; e) Atlantis Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-142. Recall # Z-0450-05; f) Atlantis Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-145. Recall # Z-0451-05.

REASON: The hex head of the screw driver may be too large to fit the screw heads of the bone screws included in the kit.

MANUFACTURER: International Chemical, Inc., Amherst, NY, by telephone in October 2004, and on December 27, 2004, and by letter on January 10, 2005. Firm initiated recall is ongoing.

PRODUCT: a) OTC Pregnancy Test labeled "CHOICE Pregnancy Test Kit" (PA-410A), midstream, no cups or droppers. Label reads: "One Step, Easy to Use, Positive result as early as 1 minute, Over 99% accurate." Each box contains one home test kit. Recall # Z-0452-05; b) OTC Pregnancy Test Kit labeled "CHOICE Pregnancy Test Kit" (PA-320), cassette type with cup and dropper. Label states: "Easy to Use, Easy Reading, Positive result as early as 1 minute, Over 99% accurate." Each box contains one home test kit. Recall # Z-0453-05.

REASON: Poor sealing of pouches and degradation of product. Invalid test results and false negatives are possible.

MANUFACTURER: Boston Scientific Scimed, Maple Grove, MN, by telephone on October 29, 2004 and November 2, 2004, and by letter on November 1, 2004. Firm initiated recall is ongoing.

PRODUCT: Run Way 6F Cardiovascular Guide Catheter. Recall # Z-0454-05.

REASON: The Runway guide catheter do not meet internal product specifications. Specifically, the affected catheters have exposed or protruding braid wires in the inner lumen of the catheter tip. This condition could have the potential to damage a POBA or Stent Delivery System balloon.

MANUFACTURER: Ethicon Endo-Surgery, Cincinnati, OH, by letters dated November 21, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Endopath EZ45 Endoscopic Linear Cutter (EZ45B). Recall # Z-0457-05; b) Endopath EZ45 No Knife Linear Stapler (NK45B). Recall #Z-0458-05; c) Endopath EZ45 Endoscopic Linear Cutter (EZ45G). Recall #Z-0459-05; d) Endopath EZ45 Endoscopic Linear Cutter (ET45B). Recall #Z-0460-05; e) Endopath EZ45 Endoscopic Linear Cutter (ET45G). Recall #Z-0461-05; f) Endopath EZ45 No Knife Linear Stapler (NK45G). Recall #Z-0462-05.

REASON: The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue.

MANUFACTURER: Smiths Medical ASD, Inc., Keene, NH, by visit on April 1, 2004. Firm initiated recall is complete.

PRODUCT: Custom Order Value Pack General Anesthesia Kit, Catalog Number: VP1279, Labeled in part: Contents: 1-Adult Disposable Anesthesia Breathing Circuit **1-Breathing Bag Non-Latex**. Recall # Z-0463-05.

REASON: Mislabeled: Product labeled as non-latex actually contains a latex breathing bag.

MANUFACTURER: Smiths Medical MD, Inc., Saint Paul, MN, by facsimile letter on December 3, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number 8C390 (Reorder No. 21-0325-01) 121 inch length/307cm, 28ml priming volume, 20 drops/ml, 0 injection sites. Recall # Z-0464-05; b) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number 8C220 (Reorder No. 21-0323-01) 107 inch length/272 cm, 26ml priming volume, 20 drops/ml, 1 standard injection site. Recall # Z-0465-05; c) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 3 Model Numbers are used for this same Burette Administration Set described as 110 inch length/279 cm, 16.5ml priming volume, 20 drops/ml, 3 standard injection sites. Model Number I8C1230J (Reorder No. 21-0301-25) for product distributed to Japan. Model Number I8C1230 (Reorder No. (21-0318-25) for product distributed Internationally. Model Number 8C1230 (Reorder No. 21-0305-01) for product distributed within the United States. Recall # Z-0466-05; d) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 2 Model Numbers are used for this same Specialty Administration Set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 0 injection sites, PVC Cassette, non-PVC lined tubing, non-PVC drip chamber. Model Number I8C290 (Reorder No. 21-0317-25) for product distributed Internationally. Model Number 8C290 (Reorder No. 21-0304-01) for product distributed within the United States. Recall # Z-0467-05; e) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 2 Model Numbers are used for this same Burette Administration Set described as 110 inch length/279 cm, 16.5ml priming volume, 60 drops/ml, 3 standard injection sites. Model Number I8C1630 (Reorder No. 21-0319-25) for product distributed Internationally. Model Number 8C1630 (Reorder No. 21-0306-01) for product distributed within the United States. Recall # Z-0468-05; f) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number AK2304 (Reorder No. 21-0308-01) 118 inch length/300 cm, 19ml priming volume, 60 drops/ml, 3 standard injection sites and 0.22 micron air-eliminating filter. Recall # Z-0469-05; g) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CC2102 (Reorder No. 21-0309-01) 112 inch length/285 cm, 50ml priming volume, 12 drops/ml (at filter), 1 SureSite Prepierced injection site, 150 micron blood filter, 2 non-vented spikes. Recall # Z-0470-05; h) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CJ4303 (Reorder No. 21-0313-01) 110 inch length/279 cm, 16.5ml priming volume, 20 drops/ml, 3 SureSite Prepierced injection sites. Recall # Z-0471-05; i) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 2 Model Numbers are used for this same Primary Administration Set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 2 standard injection sites. Model Number I8C230 (Reorder No. (21-0345-25) for product distributed Internationally. Model Number 8C230 (Reorder No. 21-0324-01) for product distributed within the United States. Recall # Z-0472-05; j) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. 2 Model Numbers are used for this same Primary Checkvalve Set for secondary (piggyback) Administration described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 2 standard injection sites. Model Number I8C4220 (Reorder No. 21-0349-25) for product distributed Internationally. Model Number 8C4220 (Reorder No. 21-0328-01) for product distributed within the United States. Recall # Z-0473-05; k) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number AC2029 (Reorder No. 21-0330-01) Speciality Administration Low Adsorption Filter Set has 105 inch length/267 cm, 27.5ml priming volume, 20 drops/ml, 0 injection sites, 0.22 micron air-eliminating filter, PVC Cassette, non-PVC lined tubing, non-PVC drip chamber. Recall # Z-0474-05; l) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CC1201 (Reorder No. 21-0333-01) Primary Checkvalve for Secondary (piggyback) Administration Set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml and 2 SureSite Prepierced Injection sites. Recall # Z-0475-05; m) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CC1301 (Reorder No. 21-0334-01) Primary Checkvalve for Secondary (piggyback) Administration Set described as 115 inch length/292 cm, 27ml priming volume, 20 drops/ml and 3 SureSite Prepierced Injection sites. Recall # Z-0476-05; n) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CC2204 (Reorder No. 21-0336-01) Speciality Administration Filter Set has 107 inch length/272 cm, 28ml priming volume, 20 drops/ml, 2 SureSite Prepierced Injection sites and 0.22 micron air-eliminating filter. Recall # Z-0477-05; o) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CC3217 (Reorder No. 21-0338-01) Speciality Administration Checkvalve Filter Set has 107 inch length/272 cm, 27.5ml priming volume, 20 drops/ml, 2 SureSite Prepierced Injection sites and 0.22 micron air-eliminating filter. Recall # Z-0478-05; p) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CC4203 (Reorder No. 21-0339-01) 105 inch length/267 cm, 25.5ml priming volume, 20 drops/ml,2 SureSite Prepierced Injection Sites. Recall # Z-0479-05; q) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number CF4203 (Reorder No. 21-0340-01) 105 inch length/267 cm, 25ml priming volume, 60 drops/ml, 2 SureSite Prepierced Injection Sites. Recall # Z-0480-05; r) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number LC4203 (Reorder No. 21-0341-01) 105 inch length/267 cm, 25ml priming volume, 20 drops/ml, 2 needleless Injection Sites. Recall # Z-0481-05; s) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number NJ4303 (Reorder No. 21-0426-01) described as 110 inch length/279 cm, 16.5ml priming volume, 20 drops/ml, 3 Luer-Activated Valve injection Sites Burette set. Recall # Z-0482-05; t) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number NK4303 (Reorder No. 21-0427-01) described as 110 inch length/279 cm, 16.5ml priming volume, 60 drops/ml, 3 Luer-Activated Valve injection Sites Burette set. Recall # Z-0483-05; u) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number NC1301 (Reorder No. 21-0428-01) Primary Checkvalve for Secondary (piggyback) Administration set described as 115 inch length/292 cm, 27ml priming volume, 20 drops/ml, 3 Luer-Activated Valve injection Sites. Recall # Z-0484-05; v) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number NJ2304 (Reorder No. 21-0433-01) Burette Administration Set described as 110 inch length/279 cm, 20ml priming volume, 20 drops/ml, 3 Luer-Activated Valve Injection Sites. Recall # Z-0485-05; w) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number 8C4209 (Reorder No. 21-0327-01) Primary one-way Checkvalve below pump Administration set described as 115 inch length/292 cm, 27.5ml priming volume, 20 drops/ml and 3 injection Sites.Recall # Z-0486-05; x) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number I8C820 (Reorder No. 21-0346-25) Primary Administration set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml and 1 injection Site. Recall # Z-0487-05; y) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number I8C825 (Reorder No. 21-0347-25) Specialty Administration set described as 109 inch length/277 cm, 26ml priming volume, 20 drops/ml and 1 injection Site. Recall # Z-0488-05; z) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number I8C4240J (Reorder No. 21-0352-25) Specialty Administration set described as 107 inch length/272 cm, 27.5ml priming volume, 20 drops/ml and 2 injection Sites and 0.22 micron filter. Recall # Z-0489-05; aa) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number RC4106 (Reorder No. 21-0402-25) Primary Administration set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml and 1 Needleless Injection Site. Recall # Z-0490-05; bb) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number RC42124 (Reorder No. 21-0441-25) Specialty Administration set described as 109 inch length/277 cm, 26ml priming volume, 20 drops/ml and 1 Needleless injection Site, 15 micron filter. Recall # Z-0491-05; cc) Deltec branded Administration Sets for use with Deltec 3000 and 3100; Graseby 500, 505 and AVI Volumetric Infusion Pump Systems. Model Number RC1201 (Reorder No. 21-0442-25) Primary Checkvalve Administration set described as 105 inch length/267 cm, 25ml priming volume, 20 drops/ml and 2 Needleless Injection Sites. Recall # Z-0492-05;

REASON: Administration Sets which are used with selected infusion pump systems may have a defect within the fluid path above the upper chamber of the set cassette which does not allow the pump valve to close completely and can allow fluid to leak past and may cause an inaccurate infusion rate.

MANUFACTURER: Ethicon, Inc., Somerville, NJ, by letter on December 14, 2004. Firm initiated recall is ongoing.

PRODUCT: Versapoint, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). The product subject of this recall is the connector cable which goes between the electrosurgical generator and the electrode used for surgery. Specifically, the recall focuses on the hand grip on the electrode, formed by overmolding a polymer onto the cable, which deforms upon sterilization. Product code 00480. Recall # Z-0493-05.

REASON: Deformation of the Verspoint Hysteroscopic System Connector Cable hand grips when autoclaved causing possible non-sterile electrodes.

MANUFACTURER: Medtronic Emergency Response Systems, Inc., Redmond, WA, by letters on January 15, 2005, and January 17, 2005. Firm initiated recall is ongoing.

PRODUCT: Lifepak 12 defibrillator/monitors biphasic. Recall # Z-0495-05.

REASON: The monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so.

MANUFACTURER: Stelkast Co., McMurray, PA, by telephone on September 24, 2004. Firm initiated recall is complete.

PRODUCT: Proven Porous CR Femur, Implantable orthopedic device. Recall # Z-0496-05.

REASON: Sterility may be compromised. The inner pouch of the implant packaging was sticking out beyond the seal of the outer pouch.

MANUFACTURER: Cook, Inc., Bloomington, IN, by letter dated December 20, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=22mm, B=112mm, C=82mm, D=11mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-22-82. Recall # Z-0498-05; b) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=26mm, B=112mm, C=82mm, D=12mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-24-82. Recall # Z-0499-05; c) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=24mm, B=112mm, C=82mm, D=12mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-26-82. Recall # Z-0500-05; d) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=24mm, B=112mm, C=82mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-28-82. Recall # Z-0501-05; e) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=30mm, B=112mm, C=82mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-30-82. Recall # Z-0502-05; f) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=32mm, B=112mm, C=82mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-32-82. Recall # Z-0503-05; g) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=22mm, B=126mm, C=96mm, D=11mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-22-96. Recall # Z-0504-05; h) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=24mm, B=126mm, C=96mm, D=12mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-24-96. Recall # Z-0505-05; i) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=26mm, B=126mm, C=96mm, D=12mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-26-96. Recall # Z-0506-05; j) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=28mm, B=126mm, C=96mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-28-96. Recall # Z-0507-05; k) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=30mm, B=126mm, C=96mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-30-96. Recall # Z-0508-05; l) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=32mm, B=126mm, C=96mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-32-96. Recall # Z-0509-05; m) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=22mm, B=141mm, C=111mm, D=11mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-22-111. Recall # Z-0510-05; n) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=24mm, B=141mm, C=111mm, D=12mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-24-111. Recall # Z-0511-05; o) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=26mm, B=141mm, C=111mm, D=12mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-26-111. Recall # Z-0512-05; p) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=28mm, B=141mm, C=111mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-28-111. Recall # Z-0513-05; q) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=30mm, B=141mm, C=111mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-30-111. Recall # Z-0514-05; r) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=32mm, B=141mm, C=111mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-32-111. Recall # Z-0515-05; s) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=22mm, B=155mm, C=125mm, D=11mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-22-125. Recall # Z-0516-05; t) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=24mm, B=155mm, C=125mm, D=12mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-24-125. Recall # Z-0517-05; u) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=26mm, B=155mm, C=125mm, D=12mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-26-125. Recall # Z-0518-05; v) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=28mm, B=155mm, C=125mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-28-125. Recall # Z-0519-05; w) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=30mm, B=155mm, C=125mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-30-125. Recall # Z-0520-05; x) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=32mm, B=155mm, C=125mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-32-125. Recall # Z-0521-05; y) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=26mm, B=170mm, C=140mm, D=12mm, E=18.0f, F=.035", G=40cm); Reorder number TFBB-26-140. Recall # Z-0522-05; z) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=28mm, B=170mm, C=140mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-28-140. Recall # Z-0523-05; aa) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=30mm, B=170mm, C=140mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-30-140. Recall # Z-0524-05; bb) Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One Shot Introduction System (A=32mm, B=170mm, C=140mm, D=12mm, E=20.0f, F=.035", G=40cm); Reorder number TFBB-32-140. Recall # Z-0525-05;

REASON: The firm has received complaints of difficulty in releasing the barbed suprarenal stent from the top cap that constrains it, which may result in misplacement of the graft.

MANUFACTURER: Hu-Friedy Manufacturing Co., Inc., Chicago, IL, by telephone on January 7, 2005 and by letter on January 10, 2005 and January 21, 2005. Firm initiated recall is ongoing.

PRODUCT: a) Dental Explorer #2 D/E, Mfr. Part Code/Product Code 101-0913, distributed under the Henry Schein label. Product is labeled in part, HENRY SCHEINÆ 101-0913 Explorer #2 D/E. +H658101091306. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). Recall # Z-0526-05; b) Dental Explorer #23 S/E, Mfr. Part Code/Product Code 100-3620, distributed under the Henry Schein label. The product is labeled in part, HENRY SCHEINÆ 100-3620 Explorer-Single End #23 SE. +H658100362003. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). Recall # Z-0527-05; c) Dental Explorer D/E #5, Mfr. Part Code/Product Code 100-8008, distributed under the Henry Schein label. The product is labeled in part, HENRY SCHEINÆ 100-8008 Explorer-Double End #5. Bar Code: +H658100800808. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). Recall # Z-0528-05. d) Dental Explorer Single End #7, Mfr. Part Code/Product Code 100-7409. Distributed under the Henry Schein label. The product is labeled in part, HENRY SCHEINÆ 100-7409 Explorer -- Single End #7 SE. Bar Code: +H65810074090C. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). Recall # Z-0529-05.

REASON: Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own label distributor, and forwarded to the importer of record & specification setter of the dental explorers.

MANUFACTURER: Interpore Cross International, Inc., Irvine, CA, by letters on January 18, 2005. Firm initiated recall is complete.

PRODUCT: Spinal Implant, Catalog number: 1000-3000 through 1000-3015 (9 catalog numbers). Recall # Z-0530-05.

REASON: Mislabeled. International Product Information Data Sheet was inadvertently released with the products distributed in the US. International sheet contained an indication for use statement which was not cleared in the USA. This indication is, "nexus, A Geo Structure is indicated for use in an open approach using bone graft materials in patients with degenerative disc disease (DDD) (C2-S1) whose condition required the use of interbody fusion. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s)."

CLASS III

MANUFACTURER: Weck, Research Triangle Park, NC, by letter on October 31, 2001. Firm initiated recall is complete.

PRODUCT: Weck, Endo5, Hem-o-lok? ML, Ref 544965, Hem-o-lok ML Endoscopic Clip Applier, Non-Sterile Clean and sterilize before use. Weck Closure Systems?. Catalog #544965. Recall # Z-0393-05.

REASON: The flush port on some appliers was occluded with an epoxy resin during manufacturing.

MANUFACTURER: Advanced Bionics Corporation, Sylmar, CA, by letter on November 11, 2004. Firm initiated recall is ongoing.

PRODUCT: Charger Assembly, Model # SC-5300, of the Precision Spinal Cord Stimulation System. Recall # Z-0396-05.

REASON: A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit.

MANUFACTURER: Stryker Endoscopy, San Jose, CA, by letter on November 30, 2004. Firm initiated recall is ongoing.

PRODUCT: Video cart shelf system for organizing with three styles: standard, multispecialty, and auxiliary. Isolation Transformer provides power to devices, also sold separately. Recall # Z-0417-05.

REASON: A problem with the design of the transformers may cause the transformers' circuit breakers to trip, which could result in loss of power to connected medical devices.

MANUFACTURER: Weck, Research Triangle Park, NC, by letter on/about May 21, 2003. Firm initiated recall is complete.

PRODUCT: Weck Electrosurgical Coagulation Suction Tube (with stylet), REF 809600, Cannula 6" -- 11 French, Rx Only, Sterile. Catalogue #809600. Recall # Z-0418-05.

REASON: Some stylets were not bent sufficiently during the packaging process to preclude them from sliding back into the cannula during shipment.

MANUFACTURER: Harry J. Bosworth Co., Skokie, IL, by telephone on September 23, 2004. Firm initiated recall is ongoing.

PRODUCT: Bosworth TruRepair Fast Bonding Repair Acrylic; the box contains one 8 oz. bottle of TruRepair liquid resin and two -- 6 oz. bottles of TruRepair Powder. Catalog 092160. Recall # Z-0419-05.

REASON: The TruRepair denture repair kit contains Trusoft liquid resin instead of the TruRepair liquid resin. If the Trusoft liquid is used the repair material will not set up.

MANUFACTURER: Harry J. Bosworth Co., Skokie, IL, by letters on October 13, 2004 and December 26, 2004. Firm initiated recall is ongoing.

PRODUCT: Bosworth Tray Aways #3 Disposable Impression Trays; styrene plastic perforated medium upper impression tray. 12 trays per bag; catalog 0921885. UPC +D68109218850G. Recall # Z-0420-05.

REASON: The tray mold was improperly made such that the plastic trays do not conform to the shape of the patient's mouth.

MANUFACTURER: Harry J. Bosworth Co., Skokie, IL, by telephone on September 2, 2004 and by letters on October 13, 2004 and December 26, 2004. Firm initiated recall is ongoing.

PRODUCT: Bosworth Superbite Zinc Oxide Eugenol Bite Registration Paste Kit; the kit consists of one 3.25 oz. tube of Accelerator -- Blue, and one 7.5 oz, tube of Base -- White, which are mixed as needed to make the registration paste. Catalog 0921815. Recall # Z-0421-05.

REASON: The accelerator component of the kit hardens in the tube and cannot be used to prepare a workable impression paste.

MANUFACTURER: Ethicon Endo-Surgery, Cincinnati, OH, by letter, dated December 10, 2004. Firm initiated recall is ongoing.

PRODUCT: Mammotome EX Holster. Recall # Z-0440-05.

REASON: A capacitor of the wrong value was used. With the improper capacitor, the speed is reduced. This may lead to failure to completely close. If it does occur, the result may be a decrease in sample size, some tearing of the tissue or no specimen at all (dry tap).

MANUFACTURER: Power Surgical Solutions, Fort Worth, TX, by letter on January 3, 2005. Firm initiated recall is ongoing.

PRODUCT: Medtronic Midas Rex Legacy Telescoping Dissection Tool, Model TDQ-130D. Recall # Z-441-05.

REASON: Device is missing the sub-collet component within the dissecting tool package.

MANUFACTURER: Baxter Healthcare, Corp., Round Lake, IL, by letters dated December 20, 2004. Firm initiated recall is ongoing.

PRODUCT: Anesthesia Set, product code 2C9216; a sterile fluid path consisting of a 72'' long PVC with DEHP tubing with a green stripe, inner diameter of 0.040'', priming volume 1.7 mL, with a luerlock connector with fixed collar; 60 sets per case. Recall # Z-0443-05.

REASON: The anesthesia set was incorrectly labeled as an anti-siphon set, but the set does not contain an anti-siphon component.

MANUFACTURER: BioMerieux, Durham, NC, by letter on September 17, 2004. Firm initiated recall is ongoing.

PRODUCT: BacT/Alert? (BTA) Classic instruments. Recall # Z-0456-05.

REASON: Over heating of memory board.

MANUFACTURER: Smiths Medical ASD, Inc., Rockland, MA, by letter on December 15, 2004. Firm initiated recall is ongoing.

PRODUCT: Equator Forced Air Convective Warming System, Reference Number EQ 5000. Recall # Z-0497-05.

REASON: Warmer heater coil may come in contact with the filter housing, causing a small area of the plastic housing to melt.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 9, 2005:

CLASS I

MANUFACTURER: Bio-Med Devices, Inc., Guilford, CT, by fax on December 7, 2004, and by press release on December 8, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Bio Med Devices Patient Breathing Circuit Catalog Number: 80011 Labeled in part: ":PATIENT BREATHING CIRCUIT =-=-= CONTENTS: 1-PATIENT HOSE 2mmIDx42" 1-PRESSURE GAGE LINE 3/16"IDx54" 1-PATIENT HOSE 22mmIDx24" 3-ADAPTERS 22mm x 22mm 1-PATIENT HOSE 22mmIDx6" 1-ADULT PRESSURE TEE 1-EXHALATION VALVE w/HOLDING ARM & 1-TEMPERATURE ADAPTER 22mmID x 22mm COLLECTION HEAD 2-CUFF 1û4"ID x 5/4" 1-EXHALATION VALVE LINE 1/8"IDx52" Recall # Z-0423-05; b) Bio Med Devices Patient Breathing Circuit Catalog Number: 80015 Labeled in part: DO NOT REUSE DISPOSABLE DISPOSABLE PATIENT BREATHING CIRCUIT =-=-=-=-=-=-CONTENTS: 1-PATIENT SMOOTH BORE HOSE 1-ADAPTER 22mmx22mm 22mmIDx72" w/CLIPS 1-ADULT PRESSURE TEE w/.140 HOLE 1-LINE 1/8"IDx84" 1-TEE 1/8"x1/8"x1/8" 1-LINE 1/8"IDx24" 1-HOLDING ARM 1-LINE 1/8"IDx2" 1-CUFF 1û4"IDx2". Recall # Z-0424-05; c) Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A Labeled in part: ONE SET - SINGLE USE CATALOG NO. 8002A PATIENTBREATHING CIRCUIT =-=- CONTENTS: 1-PATIENT HOSE 22mmIDx42" 1-PRESSURE GAGE LINE 1-PATIENT HOSE 22mmIDx6" 1-EXHALATION VALVE w/HOLDING ARM& COLLECTION HEAD 48" w/CUFF 1û4"ID 1-ADULT PRESSURE TEE w/CUFF 1-EXHALATION VALVE LINE 1/8"IDx48" 2-ADAPTERS 22mmx22mm. Recall # Z-0425-05; d) Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A-7 Labeled in part: ONE SET - SINGLE USE ATALOG NO. 8002A-7 PATIENT BREATHING CIRCUIT =-=-=-=-CONTENTS: 1-PATIENT HOSE 22mmIDx60" 1-EXHALATION VALVE LINE 1/8"IDx90" 1-PATIENT HOSE 22mmIDx18" 1-PATIENT HOSE 22mmIDx6" 1-PRESSURE GAGE LINE 84" w/CUFF 1û4"ID 1-EXHALATION VALVE w/HOLDING ARM & COLLECTION HEAD 1-ADULT PRESSURE TEE w/CUFF 3-ADAPTERS 22mmx22mm. Recall # Z-0426-05; e) Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A-9 Labeled in part: ONE SET - SINGLE USE CATALOG NO. 8002A-9 PATIENT BREATHING CIRCUIT == CONTENTS: 1-PATIENT HOSE 22mmIDx60" 1-EXHALATION VALVE LINE 1/8"IDx108" 1-PATIENT HOSE 22mmIDx36" 1-PATIENT HOSE 22mmIDx6" 1-PRESSURE GAGE LINE 1-EXHALATION VALVE w/HOLDING ARM & COLLECTION HEAD 102" w/CUFF 1û4"ID 1-ADULT PRESSURE TEE w/CUFF 3-ADAPTERS 22mmx22mm. Recall # Z-0427-05; f) Pneumotach, Disposable (B) Catalog Number: 4408 Labeled in part: SINGLE USE CATALOG NO.4408 PNEUMOTACH, DISPOSABLE (B) =-=-=-= CONTENTS: 1- PNEUMOTACH HEAD ASSEMBLY 1- PARATUBE 60"2- TUBING FITTINGS 1- 22x22mm ADAPTER. Recall # Z-0428-05; g) Bio-Med Patient Breathing Circuit Product Number: 3030-5 Labeled in part: ONE SET - SINGLE USE CATALOG NO. 3030-5 PATIENT BREATHING CIRCUIT =- CONTENTS: 1-PATIENT HOSE 22mmIDx60" 1-PRESSURE GAGE LINE 1/8"IDx72" 1-PATIENT HOSE 22mmIDx6" 1-EXHALATION VALVE w/COLLECTION HEAD 1-ADULT PRESSURE TEE w/CUFF 1-EXHALATION VALVE LINE 1/8"IDx72 2-ADAPTERS 22mmx22mm. Recall # Z-0429-05; h) Bio-Med Dental Breathing Circuit Product Number: DENTL. Recall # Z-0430-05.

REASON: Adapters may be occluded potentially preventing inhalation.

CLASS II

MANUFACTURER: Medtronic Inc., Neurological & Spinal Division, Columbia Heights, MN, by telephone on November 19, 2004. Firm initiated recall is ongoing. - 3 -

PRODUCT: Model 8561 Lioresal (Baclofen injection) Intrathecal Refill Kit is designed for refilling the Medtronic SynchroMed family of pumps. The 8561 kit contains a 1-20 ml ampule of 500 mcg/ml Baclofen injection along with a sterile refill kit tray and sterile drug preparation tray. Lioresal drug ampules contained within Medtronic Lot N0016487 bear the primary manufacturer's label and lot number 007J2583. The drug box is labeled with Lot 017H1925. Medtronic packages a manufacturer's labeled ampule into a protective drug box. A lot number and drug lot expiration date are printed on the outside of the drug box. The filled and labeled drug box is placed inside a larger kit assembly that contains other components necessary to complete a pump refill. Only the large kit assembly ("Lioresal Refill Kit") will display the Medtronic lot number (N0016487). The Model 8561 refill kit does not have a product code for itself; it is approved under PMA P860004. PMA P860004 is classified as: pump infusion, implanted, programmable under product code LKK. Recall # Z-0391-05.

REASON: Outer package of Lioresal Intrethecal Refill Kit, Model 8561, identifies the kit to contain 1-20 ml ampule of baclofen injection for intrathecal administration, 500 mcg/ml (10 mg/20 ml). Lot N0016487 incorrectly contains 1-20 ml ampule of baclofen concentration 2000 mcg/ml (40 mg/20 ml).

MANUFACTURER: Baxter Healthcare, Corp, Round Lake, IL, by letters dated December 8, 2004. Firm initiated recall is ongoing.

PRODUCT: Logix-CM Compounder Software, catalog 2M8400. Recall # Z-0392-05.

REASON: A software anomaly in the Logix CM software could result in a drug mixture being compounded without one of the ingredients if two drugs have the same identifier in Logix and another order entry program being used with the Logix software.

MANUFACTURER: Baxter Healthcare, Corp, Round Lake, IL, by letters dated December 20, 2004. Firm initiated recall is ongoing.

PRODUCT: Logix-CM Compounder Software, catalog 2M8400. Recall # Z-0394-05.

REASON: Logix-CM software version 3.0.4 has not completed its official release process.

MANUFACTURER: Baxter Healthcare, Renal Division, Mc Gaw Park, IL, by letters on May 28, 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, Altra Touch 1000, Baxter Tina and Baxter Aurora. Recall # Z-0395-05.

REASON: The air detector may not detect air bubbles consistently at the selected limit.

MANUFACTURER: Baxter Healthcare Renal Division, Mc Gaw Park, IL, by notice on December 23, 2004. Firm initiated recall is ongoing.

PRODUCT: HomeChoice PRO Automated Peritoneal Dialysis Systems. Recall # Z-0397-05.

REASON: A software anomaly may allow concentrated solution to be infused into the patient when the HomeChoice unit is used with Physioneal Clear-Flex PD products

MANUFACTURER: Spacelabs Medical Inc., Issaquah, WA, by letter on January 7, 2005 and January 14, 2005. Firm initiated recall is ongoing.

PRODUCT: Ultraview Universal Clinical Workstation System, Model 90385. Recall # Z-0422-05.

REASON: Weakness of the swivel base for the universal clinical workstation may result in the unit falling from its mounted position endangering users and patients.

MANUFACTURER: Harvard Clinical Technology, Natick, MA, by letter and telephone on November 3, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Harvard 2 Dual Channel Syringe Infusion Pump P/N 2001-001. Recall # Z-0431-05; b) Harvard 1 Single Channel Syringe Infusion Pump P/N 2003-001. Recall # Z-0432-05.

REASON: Potential pump motor/encoder assembly failure may cause over infusing medication in patients.

MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letter on December 14 and 16, 2004. Firm initiated recall is ongoing

PRODUCT: B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers. List numbers 8C89-01 and 3M74-01. Recall # Z-0435-05.

REASON: Falsely elevated B-hCG results can occur when running B12 and B-hCG assays on the same analyzer due to carryover B-12 results are not impacted.

MANUFACTURER: Medivance, Inc., Louisville, CO, by telephone and letter on January 5/6, 2005. Firm initiated recall is ongoing.

PRODUCT: Arctic Sun Temperature Management System, Catalog No. 2000-02 (115 volt) and 2000-03 (230 volt). Recall # Z-0436-05.

REASON: Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature.

MANUFACTURER: Cordis Corp., Miami Lakes, FL, by letter on January 12, 2005. Firm initiated recall is ongoing.

PRODUCT: Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents. Recall # Z-0437-05.

REASON: Six of 370 stents released to market had a slightly below the required polymeric coating weight. All other specifications were met.

MANUFACTURER: Hospira, Inc., Morgan Hill, CA, by letter on September 8, 2004. Firm initiated recall is ongoing.

PRODUCT: a) The Hospira Plum A + I.V. Infusion pump is a cassette-based, multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV sets. Recall # Z-0438-05; b) The Hospira Plum A + 3 I.V. Infusion pump is a cassette-based, multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV sets. Recall # Z-0439-05.

REASON: The batteries in Plum A+ and Plum A+3 I.V. infusion pumps may fail prematurely when the pump is operating solely on battery power.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of February 2, 2005:

CLASS II

MANUFACTURER: Stryker Endoscopy, San Jose, CA, by telephone on December 16, 2004, and advisory notice on December 27, 2004. Firm initiated recall is complete.

PRODUCT: Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm Part Numbers: 234-010-078; 234-010-080. Recal # Z-0401-05.

REASON: The label on the outside of the shipping box has an incorrect description of the screw diameter.

MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated December 29, 2004. Firm initiated recall is ongoing.

PRODUCT: Hill-Rom brand VersaCare Bed; product P3200. Recall # Z-0402-05.

REASON: A potential trip hazard exists when the fracture frame adaptor bracket is installed on the bed without the fracture frame

MANUFACTURER: Boston Scientific Corporation, Natick, MA, by letters dated November 22, 2004. Firm initiated recall is ongoing.

PRODUCT: a) VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen. Catalog #45-450, UPN #M001454500; sold as individual catheters. DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient's skin. Recall # Z-0403-05; b) VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit, Catalog #45-451, UPN #M001454510, DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient's skin. Each KIT contains catheter, cap; tape measure, 60 cm length; stylet; stylet guide/flush assembly; attachable suture wing; StatLock Catheter Securement Device, Instructions for Use; Peelaway Sheath Introducer; 10 mL Syringe; CSR Wrap. Recall # Z-0404-05; c) VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit, Catalog #45-452; UPN #M001454520. DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient's skin. Each KIT contains: Catheter; caps; tape measure, 60 cm length;stylet; stylet guide/flush assembly; attachable suture wing; statlock catheter securement device; instructions for use; 21 gauge, 1.5 inch introducer needle with echogenic tip; 30 cm floppy tip guidewire; 5cm peelable introducer sheath with locking dilator; 10 ml syringe; scalpel, CSR wrap. Recall # Z-0405-05; d) VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in kits, Catalog #45-454, UPN #M001454540; DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin. Each KIT contains: catheter; cap; tape measure, 60 cm length; stylet; stylet guide/flush assembly; attachable suture wing; statlock catheter securement device; instructions for use; 21 gauge, 2.75 inch introducer needle with echogenic tip; 60 cm guidewire with floppy tip platinum tip; 10cm peelable introducer sheath with locking dilator; 10 mL syringe, scalpel; exact length measurement chart. Recall # Z-0406-05; e) VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen: CUSTOM KIT ‚ Catalog #60M120521, UPN # M00160M1205210; DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient's skin. Recall # Z-0407-05; f) PASV PICC CUSTOM KIT, 3F, single lumen ‚ Catalog # 60M195071, UPN # M00160M1950710. DEVICE DESCRIPTION: Each kit contains a radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient's skin. Recall # Z-0408-05; g) VAXCEL WITH PASV PICC, 3F, single lumen. CUSTOM KIT - Catalog # 60M210624, UPN #M00160M2106240. DEVICE DESCRIPTION: Each kit contains a radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient's skin. Recall # Z-0409-05; h) PASV PICC, 3F, single lumen, CUSTOM KIT. Catalog #60M220991, UPN #M00160M2209910. DEVICE DESCRIPTION: Each kit contains a radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient's skin. Recall # Z-0410-05.

REASON: Catheter separation immediately distal to the nose of the suture wing.

MANUFACTURER: Harvard Clinical Technology, Natick, MA, by letter on November 3, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Harvard 2 Dual Channel Syringe Infusion Pump P/N 20001-001. Recall # Z-0431-05; b) Harvard 1 Single Channel Syringe Infusion Pump P/N 2003-001. Recall # Z-0432-05; c) Harvard 2 Syringe Pump, Model Number 2005-001. Recall # Z-0433-05.

REASON: Potential pump motor/encoder assembly failure may cause over infusing medication in patients.

MANUFACTURER: Abbott Laboratories, Inc., Irving, TX, by letter on December 14, and 16, 2004. Firm initiated recall is ongoing.

PRODUCT: B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers, List numbers 8C89-01 and 3M74-01. Recall # Z-0435-05.

REASON: Falsely elevated B-hCG results can occur when running B12 and B-hCG assays on the same analyzer due to carryover. B-12 results are not impacted.

MANUFACTURER: Medivance Inc., Louisville, CO, by telephone and letter on January 5‚6, 2005. Firm initiated recall is ongoing.

PRODUCT: Arctic Sun Temperature Management System. Catalog No. 2000-02 (115 volt) and 2000-03 (230 volt). Recall # Z-0436-05.

REASON: Potential for an inaccuracy of the primary patient temperature reading that is used to monitor and control patient temperature.

CLASS III

MANUFACTURER: Cordis Corporation, Miami Lakes, FL, by letter on December 7, 2004. Firm initiated recall is ongoing.

PRODUCT: VISTA Brite Tip RDC(1) Guiding Catheter. Product Code 67021055, Percutaneous Catheter. Recall # Z-0434-05.

REASON: The product was manufactured such that the distal end had an "RDC" shape rather than the "RDC(1)" shape. The RDC shape has a larger curve.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 19, 2005:

CLASS I

MANUFACTURER: Arrow International, Inc., Reading, PA, by letters dated November 23, 2004 and December 7, 2004 and by press release on December 3, 2004. Firm initiated recall is ongoing.

PRODUCT: NeoPICC 1.9 FR Catheter. Percutaneous Implanted long term intravascular catheter. Product is shipped in cases of 5 units. Catalog numbers S1PIC1-9-S, S1PIC1.9-N, S1PIC1.9-SMK, and S1PIC1.9-C. Recall # Z-0349-05.

REASON: Complaints of vessel erosion when using this product.

CLASS II

*****CORRECTION*****
Recall # Z-0263-05, from Enforcement Report dated December 15, 2004, Product was described as "Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotropin (HCG) test system." The correct product description is "Immulite 2500 Automated Immunoassay Analyzer, Homocysteine (HCY) test system."
From Enforcement Report dated December 22, 2004,
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-0274-05. The correct Recall number is Z-0395-05.

MANUFACTURER: Proctor & Gamble Co, Cincinnati, OH, by letter on November 11, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Spinbrush Pro Whitening Ex Soft battery operated toothbrush, UPC 7 66878 00191 3. Recall # Z-0375-05; b) Spinbrush Pro Whitening Medium battery operated toothbrush, UPC 7 66878 00193 7. Recall # Z-0376-05; c) Spinbrush Pro Whitening Ex Soft refill heads for battery powered toothbrushs, UPC 7 66878 00192 0. Recall # Z-0377-05; d) Spinbrush Pro Whitening Medium refill heads for battery powered toothbrushs, UPC 7 66878 00194 4. Recall # Z-0378-05

REASON: Market withdrawal of Crest Spinbrush Pro-Whitening. The firm has determined that there is a quality issue in certain production that may allow the circular brush at the tip of the brush head to become detached over time in a very small number of brushes.

MANUFACTURER: Fischer Imaging Corp., Denver, Co, by letter on July 9, 2004. Firm initiated recall is ongoing.

PRODUCT: Mammo Test Breast Biopsy System. Recall # Z-0379-05.

REASON: X-ray tube actuator shaft may fail, allowing the mechanism to drop without warning

MANUFACTURER: Pride Mobility Product Corp., Exeter, PA, by a safety alert notification dated July, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Victory Motorized Vehicle, 3 wheel. Recall # Z-0380-05;
b) Victory Motorized Vehicle, 4 wheels. Recall # Z-0381-05.

REASON: Intermittent operation.

MANUFACTURER: Omron Healthcare, Inc., Bannockburn, IL, by Removal Notices dated November 2, 2004. Firm initiated recall is ongoing.

PRODUCT: Medication Bottle (U22-3), a component of the MicroAir Vibrating Mesh Nebulizer, Model NE-U22V/NE-22VAC. Recall # Z-0382-05.

REASON: A potential failure of the vibrating mechanism of the medication bottle which causes a failure to transmit vibration and results in no nebulization.

MANUFACTURER: Roche Diagnostics, Corp., Indianapolis, IN, by telephone, letter and fax beginning on December 3, 2004, and by press release on December 8, 2004. Firm initiated recall is ongoing.

PRODUCT: Roche brand Cardiac Reader. Recall # Z-0383-05.

REASON: Potential for false negative Troponin T or falsely decreased Troponin T and Myoglobin results.

MANUFACTURER: Baxter Healthcare Corp, Round Lake, IL, by letters dated November 19, 2004. Firm initiated recall is ongoing.

PRODUCT: Baxter labeled 6060 Solution Sets with AutoClamp; For use with model 6060 multi-therapy pumps only; a prescription, sterile, non-pyrogenic fluid pathway; A) the following sets were made in Costa Rica: a) Baxter Solution Set, 76” (1.9 m), Volume 3.7 mL, Cassette with AutoClamp Device, Male Luer Lock Adapter, product code 2M9856 and 2M9856K; b) Baxter Solution Set, 109” (2.8 m), Volume 4.8 mL, Cassette with AutoClamp Device, Male Luer Lock Adapter, product code 2M9857; c) Baxter Solution Set, 112” (2.9 m), Volume 7.9 mL, Cassette with AutoClamp Device, 1.2 Micron Downstream Filter, Male Luer Lock Adapter, product code 2M9858 and 2M9858K; d) Baxter Solution Set, 112” (2.9 m), Volume 7.9 mL, Cassette with AutoClamp Device, 0.22 Micron Downstream Filter, Male Luer Lock Adapter, product code 2M9859; e) Baxter Solution Set, 76” (1.9 m), Volume 3.7 mL, Non-DEHP Tubing, Cassette with AutoClamp Device, Male Luer Lock Adapter, product code 2M9860; f) Baxter Solution Set, 112” (7.9 m), Volume 3.7 mL, Non-DEHP Tubing, Cassette with AutoClamp Device, 1.2 Micron Downstream Filter, Male Luer Lock Adapter, product code 2M9861; g) Baxter Solution Set, 112” (7.9 m), Volume 3.7 mL, Non-DEHP Tubing, Cassette with AutoClamp Device, 0.22 Micron Downstream Filter, Male Luer Lock Adapter, product code 2M9862; h) Baxter Solution Set, 111” (2.9 m), Volume 7.4 mL, Cassette with AutoClamp Device, 1.2 Micron Downstream Filter, Male Luer Lock Adapters, product code 2M9874K; i) Baxter Solution Set, 75” (1.9 m), Volume 3.1 mL, Cassette with AutoClamp Device, Male Luer Lock Adapters, product code 2M9875K; j) Baxter Epidural Set, 115” (2.9 m), Volume 5.0 mL, Cassette with AutoClamp Device, Male Luer Lock Adapter, product code 2L9003; k) Baxter Epidural Set, 112” (2.9 m), Volume 7.9 mL, Cassette with AutoClamp Device, 0.22 Micron Downstream Filter, Male Luer Lock Adapter, product code 2L9004; l) Baxter Epidural Set, 92” (2.3 m), Volume 6.7 mL, Cassette with AutoClamp Device, 0.22 Micron Downstream Filter, Male Luer Lock Adapters, product code 2L9005; m) Baxter Solution Set with Spike, 88” (2.2 m), Volume 4.1 mL, Non-DEHP Tubing, Cassette with AutoClamp Device, Male Luer Lock Adapter, product code 2L9006. Recall # Z-0385-05.B) Sabraset Administration Sets with AutoClamp; for use with model 6060 multi-therapy pumps only; a prescription, sterile, non-pyrogenic fluid pathway; the following sets were made in Mexico: a) Sabraset 56050 – 100 Administration Set with 100 mL Bag and Cassette, 56”, Volume 3 mL, 100 mL Bag with Fill Port, Cassette with AutoClamp Device, Slide Clamp, Male Luer Lock Adapter; b) Sabraset 56050 – 250 Administration Set with 2500 mL Bag and Cassette, 53”, Volume 3 mL, 250 mL Bag with Fill Port, Cassette with AutoClamp Device, Slide Clamp, Male Luer Lock Adapter. Recall # Z-0386-05.

REASON: A missing platen assembly in the cassette of the solution sets results in the infusion pump being unable to occlude the tubing of the set. This can lead to free-flow of the solution and a possible overdose of medication to the patient.

MANUFACTURER: Zimmer Orthopaedic Surgical Products, Statesville, NC, by letters on October 27, 2004 and November 11, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Zimmer™ Orthopaedic Surgical Products, Disposable Cuff, 42in (107cm), Single Port, Single Bladder Sterile. The cuff is a sterile, single use product equipped with an integral fill line. The product is packed 10 cuffs per unit. Cat #60-7075-007-00. Recall # Z-0388-05;b) Zimmer™ Orthopaedic Surgical Products, Disposable Cuff, 12” (30cm), Single Port, Single Bladder Sterile. The cuff is a sterile, single use product equipped with an integral fill line. The product is packed 10 cuffs per unit. Cat #60-7075-002-00. Recall # Z-0389-05;c) Zimmer™ Orthopaedic Surgical Products, Disposable Cuff, 12” (30cm), Dual Port, Single Bladder Sterile. The cuff is a sterile, single use product equipped with an integral fill line. The product is packed 10 cuffs per unit. Cat #60-7070-002-00. Recall # Z-0390-05.

REASON: The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.

CLASS III

MANUFACTURER: Ortho-Clinical Diagnostics, Rochester, NY, by letters dated November 22, 2004. Firm initiated recall is ongoing.

PRODUCT: Vitros CRP (C-Reactive Protein) Slides. Catalog # 1926740 contains 250 slides, Catalog #809 7990 contains 90 slides. Recall # Z-0387-05.

REASON: Results may be negatively biased due to a non-linear response at the upper end of the Reportable (Dynamic) Range.

The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of January 12, 2005:

CLASS II

MANUFACTURER: GE Healthcare Technologies, Waukesha, WI, by field service representative beginning on December 27, 2004. Corrections should be completed by May 2005. Firm initiated recall is ongoing.

PRODUCT: Proteus XR/a Radiographic X-ray System; Precision 500D Radiographic/Fluoroscopic X-ray System Use: Diagnostic Radiology. Recall # Z-0219/0220-05.

REASON: The units are defective under 21 CFR 1003.2 in that they fail to operate as required by 21 CFR 1020.31(g) ‚ Positive Beam Limitation (PBL).

MANUFACTURER: Edwards Lifesciences Research Medical Inc, Midvale, UT, by letter on November 22, 204. Firm initiated recall is ongoing.

PRODUCT: EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11". Model EX24D. Recall # Z-0306-05.

REASON: Aortic cannula may delaminate and leak where it is bonded to the tip. This could occur during cardiopulmonary bypass surgery.

MANUFACTURER: Precision Medical, Inc. Northampton, PA, by letters on November 15, 2004. Firm initiated recall is ongoing

PRODUCT: a) Easy Go Vac Aspirator, Model PM65. Portable suction unit. Recall # Z-0307-05;
b) Easy Go Vac Aspirator, Model PM65HG. Portable suction unit. Recall # Z-0308-05.

REASON: Battery charger can be overcharged and overheat.

MANUFACTURER: Ormco Corporation, Glendora, CA, by letters from November 18 thru November 23, 2004. Firm initiated recall is ongoing.

PRODUCT: Titanium Orthos Bracket. Recall # Z-0309-05.

REASON: Misassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed.

MANUFACTURER: Medtronic Xomed, Inc., Jacksonville, Fl, by letter on October 29, 2004. Firm initiated recall is ongoing.

PRODUCT: Brand name: NIMô EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 NIMô EMG Reinforced Endotracheal Tube REF 82-29306, 82-29307, 82-29308. All products are packaged one unit per box. Recall # Z-0310-05.

REASON: The firm received six reports of tubes with wires "out of channel" two of which involved injuried patients. In one case in Germany it was reported that the patient had soreness of the throat and was discharged after four days. In the next case the patient had a tracheal wound. It was not clear what caused the wound.

MANUFACTURER: Medical Industries America Inc, Adel, IA, by telephone on September 3, 2004 and on September 10, 2004. Firm initiated recall is ongoing.

PRODUCT: RemRest Non-Invasive Continuous Positive Airway Pressure System, Model 903. Recall # Z-0326-05.

REASON: Units could show an error code and stop functioning.

MANUFACTURER: Abbott Laboratories, Columbus, OH, by letter, dated November 12, 2004. Firm initiated recall is ongoing.

PRODUCT: a) 14 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners (15cm) for Endoscopic Removal (list #00226). Single Use Sterile Gastrostomy Kits. Recall # Z-0327-05;b) 18 French Ross Flexiflo Lap J Laparoscopic Jejunostomy Kit with Brown/Mueller T-Fastener Set (List #51174) Assorted Single Use Sterile Jejunostomy Kits. Recall # Z-0328-05. c) 14 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners (15cm) for Endoscopic Removal (list #00227). Recall # Z-0329-05; d) 18 French Ross Flexiflo Over the Guidewire Gastrostomy Basic Kit with T-Fasteners for Endoscopic Removal (list # 00228). Recall # Z-0330-05; e) 18 French Ross Flexiflo Over the Guidewire Gastrostomy Kit with T-Fasteners for Endoscopic Removal (list # 00238). Recall # Z-0331-05;
f) 18 French Ross Introducer Complete Gastrostomy Kit with Brown/Mueller T-Fastener Set (list # 50190).
Recall # Z-0332-05; g) 22 French Ross Versa-PEG Complete Gastrostomy Kit, an Over-the-Wire PEG Method Featuring Tube Removal without Endoscopy (list # 50520). Recall # Z-0333-05; 20 French Ross Over-the-Guidewire Basic h) Gastrostomy KIt with Reinforced Webbed Bumper for Endoscopic Removal (Basic) (list # 50728). Recall # Z-0334-05; i) 20 French Ross Flexiflo Over-the-Guidewire Complete Gastrostomy KIt with Reinforced Webbed Bumper for Endoscopic Removal (list #50738). Recall # Z-0335-05; j) 20 French Ross Inverta-PEG Over-the-Guidewire Basic Gastrostomy KIt with Roll-Tip Bumper (list # 51490). Recall # Z-0336-05; k) 20 French Flexiflo Inverta-PEG Pull Technique Basic Gastrostomy KIt with Roll-Tip Bumper (list # 52000). Recall # Z-0337-05; l) 10 French Ross Flexiflo Lap J Laparoscopic Jejunostomy Kit with Brown/Mueller T-Fastner Set (list #51442). Recall # Z-0338-05.

REASON: Gastrostomy and Jejunostomy primary placement kits which may contain components that may not have been adequately sterilized, were distributed

MANUFACTURER: Beckman Coulter Inc, Brea, CA, by letter on December 3, 2004. Firm initiated recall is ongoing.

PRODUCT: ACT diff 2 Analyzer (Automated differential cell counter). Recall # Z-0339-05.

REASON: Erroneous results issue when MONOJECT blood collection tubes are used during analysis after tubes are uncapped and recapped then analysed in the closed vial mode. Results are lower than if cap had not been removed.

MANUFACTURER: Weck, Research Triangle Park, NC, by letter on January 25, 2001. Firm initiated recall is complete.

PRODUCT: Weck, Bipolar Forceps Cord, REF 394236, 1 (One) Cord, Length 12 Feet (3.7m), Sterile, Single Use, Disposable, Weck Closure Systemsô, Catalog # 394236.
Recall # Z-0340-05.

REASON: An incorrect electrosurgical cord was included in some of the packages.

MANUFACTURER: Philips Medical Systems, Andover, MA, by letter on December 13, 2004. Firm initiated recall is ongoing.

PRODUCT: Philips Heartstart MRx Monitor/Defibrillator Models: M3535A (Hospital Use), M3536A (EMS Use). Recall # Z-0341-05.

REASON: In Software versions below A.02.00, with the sync function enabled and the device switched from manual to AED, there may be an unexpected delay in delivery of energy.

MANUFACTURER: Baxter Healthcare Corp., Round Lake, IL, by letters dated November 4, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Colleague Single Channel Volumetric Infusion Pumps, product code 2M8151 and 2M8151R; Made in Singapore; monochrome display screen. Recall # Z-0342-05;b) Colleague 3 Triple Channel Volumetric Infusion Pumps, product code 2M8153 and 2M8153R; Made in Singapore; monochrome display screen. Recall # Z-0343-05;c) Colleague CX Single Channel Volumetric Infusion Pumps, product code 2M8161and 2M8161R; Made in Singapore; color display screen. Recall # Z-0344-05; d) Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163 and 2M8163R; Made in Singapore; color display screen. Recall # Z-0345-05.

REASON: A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. This causes an interruption in therapy, which may result in a risk to the patient.

MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated November 29, 2004. Firm initiated recall is ongoing

PRODUCT: Hill-Rom CareAssist Bed; model P1170. Recall # Z-034605.

REASON: Warning label containing instructions for proper electrical grounding was not attached

MANUFACTURER: Exactech, Inc., Gainesville, FL, by telephone on November 2, 2004. Firm initiated recall is ongoing.

PRODUCT: Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. Recall # Z-0347-05.

REASON: Implant was identified incorrectly at the time of manufacture and was then labeled and distributed with the incorrect size information. A Cemented Trapezoid Tibial Tray labeled as 4F/4T appeared to dimensionally be a 3F/3T.

MANUFACTURER: Ocular Sciences, Inc. Albuquerque, NM, by courier on December 9, 2004. Firm initiated recall is ongoing.

PRODUCT: Sunsoft Multiples Toric, methafilcon A, clear contact lens. Recall # Z-0348-05.

REASON: Vials containing the lenses are possibly contaminated with residual hydrogen peroxide

MANUFACTURER: AGA Medical Corporation, Golden Valley, MN, by letter November 22- 24, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Amplatzer Delivery Systems (45-degree curve). order no. 9-DEL-6F-45/60. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0350-05;b) AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-7F-45/60. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0351-05;c) AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-7F-45/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0352-05;d) AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-8F-45/60. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0353-05;e) AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-8F-45/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of Delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0354-05;f) AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-9F-45/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. Recall #Z-0355-05; g) AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-10F-45/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0356-05; h) AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-12F-45/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0357-05; i) AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-5F-180/60. Product is labeled as Sterile EO.  Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0358-05;j) AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-6F-180/80. Product is labeled as Sterile EO.  Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0359-05; k) AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-7F-180/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0360-05; l) AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-8F-180/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0361-05; m) AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-9F-180/80. Product is labeled as Sterile EO. Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0362-05; n) AMPLATZER Exchange System 45-degree curve, order no. 9-EXCH-9F-45/80. Product is labeled as Sterile EO. The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Delivery System, which is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The only exception is the dilator component in the Exchange System has a larger inner lumen to allow passage over an AMPLATZER delivery cable. Recall # Z-0363-05; o) AMPLATZER Exchange System 45-degree curve, order no. 9-EXCH-12F-45/80. Product is labeled as Sterile EO. The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Delivery System, which is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The only exception is the dilator component in the Exchange System has a larger inner lumen to allow passage over an AMPLATZER delivery cable. Recall # Z-0364-05; p) AMPLATZER Exchange System 180-degree curve, order no. 9-EXCH-6F-180/80. Product is labeled as Sterile EO. The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Delivery System, which is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The only exception is the dilator component in the Exchange System has a larger inner lumen to allow passage over an AMPLATZER delivery cable. Recall # Z-0365-05;q) AMPLATZER Exchange System 180-degree curve, order no. 9-EXCH-8F-180/80. Product is labeled as Sterile EO. The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Delivery System, which is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The only exception is the dilator component in the Exchange System has a larger inner lumen to allow passage over an AMPLATZER delivery cable. Recall # Z-0366-05.

REASON: Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing. Residue was determined to be EAP (Ethoxylated alkyl Phenol).

MANUFACTURER: Baxter Healthcare Renal Div, Mc Gaw Park, IL, by letter dated December 14, 2004. Firm initiated recall is ongoing

PRODUCT: System 1000 family of Hemodialysis Instruments, including the System 1000, Arena, 1550, BM11, BM25 and Meridian; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. Recall # Z-0367-05.

REASON: Air bubbles have been observed in the tubing sets past the air detector of the instrument with no alarms. Air bubbles in the circuit can cause an air embolism

MANUFACTURER: Philips Medical Systems Sales & Service Region No. America, Bothell, WA, by letter starting on December 1, 2004. Firm initiated recall is ongoing.

PRODUCT: a) Thoravision I Thorax and Mass Chest Column. Part numbers 4512 130 07811. Recall # Z-0369-05;b) Thoravision II Thorax and Mass Chest Column. Part numbers 4512 130 07812. Recall # Z-0370-05.

REASON: X-Ray system may fall downward and could possibly hit the patient.

MANUFACTURER: Beckman Coulter Inc, Brea, CA, via telephone (or via on-site visit - Canada only) October 29 - November 1, 2004, and by letter dated November 2, 2004. Firm initiated recall is ongoing.

PRODUCT: UniCel Dxl 800 Access Immunoassay Systems (Reaction Vessels). Part Number: 386167. Recall # Z-0371-05.

REASON: Beckman Coulter has confirmed reports of rare occurrences of UniCel Dxl 800 Access Immunoassay Systems Reaction Vessels that are deformed or flattened in their packaging bags for lot 04250160. Deformed or flattened RVs could present a rish of causing jams on the UniCel Exl 800 Access Immunoassay Systems that may require service intervention and could compromise sample analysis.

MANUFACTURER: Roche Diagnostics Corp. Indianapolis, IN, a letter dated 11/19/04 Firm initiated recall is ongoing.

PRODUCT: ACCU-CHEK Inform meter; catalog No. 3035123.
Recall Z-0372-05.

REASON: A firmware bug may allow test results from other systems, recorded into the INFORM system via the OTE functionality, to be reversed from positive to negative, and vice versa.

MANUFACTURER: Dade Behring, Inc., Newark, DE, by letters dated November 12, 2004. Firm initiated recall is ongoing.

PRODUCT: StreamLab Analytical Workcell. General Purpose Laboratory Device. Recall # Z-0373-05.

REASON: Software can sample the incorrect specimen from the StreamLAB to the Dimension RxL or RxL Max Systems.

CLASS III

MANUFACTURER: BD Diagnostic Systems, Grayson, GA, by letter beginning October 20, 2004. Firm initiated recall is ongoing.

PRODUCT: a) BD, Brucella melitensis Antigen. Recall # Z-0311-05;b) BD, Salmonella O Group D Antigen (9-12) (Typhoid O).Recall # Z-0312-05;c) BD, Salmonella Somatic Polyvalent Antiserum (A,B,D). Recall # Z-0313-05;d) BD, Brucella abortus Antigen. Recall # Z-0314-05;e) BD, Salmonella Flagellar d Antigen (Typhoid H). Recall # Z-0315-05;f) BD, Salmonella O Group A Antigen (1-2-12). Recall # Z-0316-05;g) BD, Salmonella O Group B Antigen (1-4-5-12). Recall # Z-0317-05;h) BD, Salmonella Flagellar Polyvalent Antiserum (a,b,d). Recall # Z-0318-05;i) BD, Proteus OX19 Antigen. Recall # Z-0319-05;j) BD, Francisella tularensis Antigen. Recall # Z-0320-05;k) BD, Proteus Polyvalent Antiserum (OXK, OX2, OX19).Recall # Z-0321-05;l) BD, Brucella Postive Control Antiserum (AMS). Recall # Z-0322-05;m) BD, Febrile Antigen Negative Control. Recall # Z-0323-05.

REASON: Febrile Antigens and Control Antisera that were released prior to August 2003 contained the 12/2000 revised insert that had incorrect testing instructions. The Antigen Dilution instructions incorrectly state to dilute "one part antigen in fifty parts 0.85% saline (1:50)". The correct instructions should read "one part antigen in forty-nine parts 0.85% saline (1:50)".

MANUFACTURER: Diagnostic Products Corp, Los Angeles, CA, by telephone on November 19, 2004. Firm initiated recall is ongoing.

PRODUCT: Immulite 2500 insulin Kit. Recall # Z-0324-05.

REASON: Low bias of 10 to 40% at different levels of insulin in samples.

MANUFACTURER: Diamedix Corporation, Miami, FL, by letter dated October 8, 2003. Firm initiated recall is ongoing.

PRODUCT: The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay for the qualitative detection of Treponema pallidum IgG antibodies in human serum or plasma. The reagents can be used either manually or in conjunction with the MAGO Plus or APTUS Automated EIA Processors. The FDA has not cleared this product for use in screening blood or plasma donors. The kit is labeled with an expiration date of Mar 04 and requires storage at 2-8 degree Centigrade. The non conforming kit component is the Conjugate that consists of a glass bottle with red cap containing 30 ml goat anti-human IgG labeled with horseradish peroxidase. Recall # Z-0325-05.

REASON: Several customers complained that either the negative control index value exceeded the upper control limit or there was very low activity of the cut off calibrator causing patient sample test runs to be called invalid.

MANUFACTURER: Cypress Medical Products, Ltd., McHenry, IL, by telephone and letter on December 1, and December 2, 2004. Firm initiated recall is ongoing.

PRODUCT: McKesson Medi-Pak Elastic Bandages, Premium, Sterile; rolled elastic bandage, single patient use, knit, single self closure, latex-free; Made in Canada, Packaged, sterilized and inspected in the U.S.A.; the elastic bandages are packaged in paper/poly pouches, 36 bandages per case in the following sizes: Product Number 16-1033-2-STR, 2" wide; 16-1033-3-STR, 3" wide; 16-1033-4-STR, 4" wide; and 16-1033-6-STR, 6" wide. Recall # Z-0368-05.

REASON: The elastic bandages which are labeled sterile have a lack of assurance of sterility.

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