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Recall Archives 19 FDA RecallsJuly 1, 2006 - December 37, 2006
The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 27, 2006 CLASS I MANUFACTURER: Medical Plastics Devices Inc, Point Claire, Quebec, Canada, by telephone on October 17, 2006 and by letter on October 18, 2006. Firm initiated recall is ongoing. PRODUCT: a) One Touch Basic/Profile Blood Glucose test strips, Recall # Z-0261-2007; b) One Touch Ultra Blood Glucose Test Strips, Recall # Z-0262-2007 REASON: Counterfeit Glucose Test Strips. MANUFACTURER: Milwaukee Notions, Inc., Union Grove, WI, by telephone beginning October 10, 2006. Firm initiated recall is ongoing. PRODUCT: OneTouchBasic/Profile and OneTouch Ultra- Blood Glucose test strips. For use with ONE TOUCH Brand Meters, Recall # Z-0263-2007 REASON: Counterfeit CLASS II MANUFACTURER: AGA Medical Corporation, Golden Valley MN, by facsimile or e-mail dated September 29, 2006. Firm initiated recall is ongoing PRODUCT: Amplatzer Cardiac Septal Occluder Delivery Systems labeled as follows: a) AMPLATZER Delivery System, Order no. 9-DEL-5F-180/60, 9-DEL-6F-45/60, 9-DEL-6F-180/80, 9-DEL-7F-45/60, 9-DEL-7F-45/80, 9-DEL-7F-180/80, 9-DEL-8F-45/60, 9-DEL-8F-45/80, 9-DEL-8F-180/80, 9-DEL-9F-45/80, 9-DEL-9F-180/80, 9-DEL-10F-45/80, 9-DEL-12F-45/80. [Breakdown of order no. '9-DEL-5F-180/60' is as follows: 9-DEL, French size (5F) - degree angle curve (180) / usable length in cm (60).] b) the following devices are not approved for US distribution: AMPLATZER TorqVue Delivery System, order no. 9-ITV06F45/60, 9-ITV07F45/60, 9-ITV07F45/80, 9-ITV08F45/60, 9-ITV08F45/80, 9-ITV09F45/80, 9-ITV10F45/80, 9-ITV12F45/80, 9-ITV05F180/60, 9-ITV06F180/80, 9-ITV07F180/80, 9-ITV08F180/80, 9-ITV09F180/80. The Delivery System is comprised of a delivery sheath, delivery cable, dilator, loading device and pin vise, Recall # Z-0255-2007; Amplatzer Cardiac Septal Occluder delivery system Exchange Systems labeled as follows: a) AMPLATZER Exchange System, Order no. 9-EXCH-6F-180/80, 9-EXCH-8F-180/80, 9EXCH-9F-45/80, 9-EXCH-12F-45/80. [Breakdown of order no. '9-EXCH-6F180/80' is as follows: 9-EXCH, French size (6F) - degree angle curve (180) / usable length in cm (80).] and b) the following devices are not approved for US distribution: AMPLATZER TorqVue Exchange System, Order no. 9-EITV09F45/80, 9-EITV12F45/80, 9-EITV06F180/80, 9-EITV08F180/80. The Exchange System is comprised of a delivery sheath, delivery cable, dilator, loading device and pin vise. Recall # Z-0256-2007; AMPLATZER TorqVue (cardiac septal occluder) Delivery System with Pusher Catheter Order no. 9-TVSP7F-180/80, 9-TVSP8F-180/80, 9-TVSP9F-180/80. [Breakdown of order no. '9-TVSP-7F-180/80' is as follows: 9-TVSP, French size (7F) - degree angle curve (180) / usable length in cm (80).] Sterile EO. Single Use Only. CAUTION: Investigational device limited by U.S. Law to Investigational Use. The AMPLATZER TorqVue Delivery System with Pusher Catheter consists of a radiopaque delivery sheath, translucent loading device, dilator, plastic vise, delivery cable, and pusher catheter. The delivery system also includes a high pressure Hemostasis valve with a swivel luer connector. The loading device, also with a full thread swivel luer connector, allows a positive fit and seal between sheath and loader. The translucent loader allows for visualization of the device and potentially the presence of air during transfer of device to the sheath, Recall # Z-0257-2007
MANUFACTURER: Medrad Inc, Indianola, PA, by telephone and letter dated November 20, 2006. Firm initiated recall is ongoing. PRODUCT: a) Invasive Blood Pressure Interface Cables: a)
Medrad 9500 Multigas monitor for MRI, REASON: Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible to interference if exposed to static magnetic field strengths exceeding 300 gauss. In certain orientations, the transducer causes the invasive blood pressure readings on the physiological monitor to display inaccurate readings. MANUFACTURER: Recalling Firm: Guidant Corporation, Saint Paul, MN, by letter, dated October 9, 2006. Manufacturer: Guidant-Ireland, Clomel, County Tipperary, Ireland. Firm initiated recall is ongoing. PRODUCT: Guidant CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219) ,CONTAK RENEWAL 4 RF (model H230), and CONTAK RENEWAL 4 RF HE (model H239) cardiac resynchronization therapy defibrillator (CRT-D), Recall # Z-0269-2007 REASON: Shock Effectiveness: there is a potential for malfunction of a high voltage wire, which could compromise effectiveness of shock therapy. While no energy is lost, defibrillation thresholds may be higher (and safety margin may be reduced) because the shocking vector has changed. MANUFACTURER: Recalling Firm: Arrow International Inc., Reading, PA, by letter on September 29, 2006. Manufacturer: Arrow International, Inc., Mount Holly, NJ. Firm initiated recall is ongoing. PRODUCT: a) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber catheter. Latex Free A Port Ref Product No. AP-01007; Recall # Z-0270-2007; b) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Ref Product No. AP-01013 Latex-Free Low Profile Port, Recall # Z-0271-2007; c) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A(2) Port, 17 Fr. Introducer Kit REF Product No. AP-06535, Recall # Z-0272-2007; d) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A(2) Port, 10 Fr. Introducer Kit Ref Product No. AP-06530, Recall # Z-0273-2007; e) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A(2) Port , 12 Fr. Introducer Kit. Ref Product Code: AP-06528, Recall # Z-0274-2007; f) Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port, 10 Fr. Introducer Kit. Ref Product No. AP-06520, Recall # Z-0275-2007; g) Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile B Port, 6 Fr. Introducer Kit. Ref Product No. AP-06046, Recall # Z-0276-2007;h) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 10 Fr. Introducer Kit. Ref Product No. AP-06042, Recall # Z-0277-2007; i) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 9 Fr. Introducer Kit. Ref Product No. AP -06040, Recall # Z-0278-2007; j) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 6 Fr. Introducer Kit Ref. Product No. AP-06036, Recall # Z-0279-2007; k) Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 10 Fr. Introducer Kit Ref Product No. AP-06022, Recall # Z-0280-2007; l) Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 9 Fr. Introducer Kit Ref Product No. AP-06020, Recall # Z-0281-2007; m) Implantable Vascular Access system --Infusion Ports with Silicone Rubber Catheter. Latex-free A Port. 9 Fr. Introducer Kit. Ref. Product No. AP-06018, Recall # Z-0282-2007; n) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 6 Fr. Introducer Kit. Ref. Product No. AP-06016, Recall # Z-0283-2007; o) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-free A Port. 10 Fr. Introducer Kit. Ref. Product No. AP-06015, Recall # Z-0284-2007;p) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. 6 Fr. Introducer Kit. Ref Product No. AP-06014, Recall # Z-0285-2007;q) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. 9 Fr. Introducer Kit Ref Product No. AP-06013, Recall # Z-0286-2007; r) Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. Ref Product No. AP-01510, Recall # Z-0287-2007 REASON: Catheter has separated from the infusion port body. MANUFACTURER: Mallinckrodt Inc., Cincinnati OH, by letter dated November 7, 2006. Firm initiated recall is ongoing. PRODUCT: OptiVantage DH Power Injection System, Recall # Z-0288-2007 REASON: The flow rate programmed on the console may be changed without automatically updating the flow rate programmed on the power head. The injector will always inject in accordance with the parameters shown on the power head. If this lack of synchronization occurs and is not noticed by the clinician, contrast would be injected at a higher or lower flow rate than desired. MANUFACTURER: Recalling Firm: Kavo America Corp, Lake Zurich IL, by letter, telephone and email on November 22, 2006. Manufacturer: Kaltenbach & Voigt Gmbh & Co. KG, Biberach, Germany. Firm initiated recall is ongoing. PRODUCT: KaVo QUATTROcare Spray, 500 ml aerosol can; a maintenance spray for lubrication of KaVo turbines, air motors, straight and contra-angle dental handpieces. For use with the KaVo QUATTROcare maintenance unit only; Made in Germany The spray was produced under the following labels: a) KaVo QUTTROcare Spray AMERICA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany, single can: item #04117630, type 2106, 6-pack: item #04117640, type 2106A b) KaVo QUTTROcare Spray CANADA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany; Distributed by SciCan, 1440 Don Mills Rd, Toronto, Ontario, Canada M3B 3P9, single can: item #04117680, type 2107, 6-pack: item #04117690, type 2107A c) KaVo QUTTROcare Spray, Kaltenbach & Voigt GmbH, Postfach 1454, D-88396 Biberach/Riss Germany, single can: item #04117590, type 2108, 6-pack: item #04117720, type 2108A, Recall # Z-0289-2007 REASON: The QUATROcare Spray cans may allow the gas (propane) to escape from the can under certain circumstances. In rare cases, when an ignition source is nearby, this escape of gas may lead to the emission of smoke and possibly flames from the can which could lead to property damage or personnel injury. MANUFACTURER: Recalling Firm: Medtronic Neurological, Minneapolis, MN by letter dated July 2006. Manufacturer: Medtronic Puerto Rico Operations Co., MedRel, Juncos, PR. Firm initiated recall is ongoing. PRODUCT: Medtronic Kinetra Dual Program Neurostimulator for Deep Brain Stimulation, model 7428. Rx only. The dual program model 7428 Kinetra Neurostimulator generates electrical signals that are transmitted to the brain. These signals are delivered from the neurostimulator to the brain via DBS extension or DBS leads. The neurostimulator consists of electronic circuitry and a battery, which are hermetically sealed in a titanium case. The operation of the neurostimulator is supported by a clinician programmer, a therapy controller, and a control magnet, Recall # Z-0290-2007 REASON: A subset of Kinetra implantable neurostimulators may experience a failure of wire connections between the electronic hybrid circuit and battery which may lead to sudden cessation of therapy. Sudden cessation of therapy can result in the immediate return or worsening of underlying symptoms due to the progression of the disease state. MANUFACTURER: Recalling Firm: Datex - Ohmeda, Inc., Madison WI, by letter in September 2006 Manufacturer: GE Healthcare Finland Oy, Helsinki, Finland. Firm initiated recall is ongoing. PRODUCT: Datex Ohmeda Compact Absorber, Disposable, REF 427002100, white to violet and REF 427002000, Pink to white. Used with GE Healthcare ADU anesthesia systems. GE Healthcare Finland Oy, Helsinki, Finland +358 10 39411, Recall # Z-0291-2007 REASON: Certain Compact Absorbers may have an increased resistance to gas flow due to an improperly manufactured foam filter. The increased resistance can cause an elevated pressure at the ventilator end of the inspiratory circuit, but the pressure at the patient may be reduced. This could result in patient hypoventilation and hypoxia. MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by on site visit between January 2004 and September 2005. Firm initiated recall is ongoing. PRODUCT: Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188, Recall # Z-0294-2007 REASON: The flow meter could malfunction resulting in loss of touchscreen control of the gas system, but the alternate mechanical control will remain operable. MANUFACTURER: Medtronic Emergency Response Systems, Inc., Redmond WA, by letter dated December 2006 another in January 2007. Firm initiated recall is ongoing. PRODUCT: LIFEPAK 20 automatic external defibrillator, Recall # Z-0295-2007 REASON: LIFEPAK 20 may lock-up when attempting to power-up on DC within 2 seconds after removing AC power. MANUFACTURER: St Jude Medical CRMD, Sylmar, CA, by letter on October 12, 2006, and by press release on October 13, 2006. Firm initiated recall is ongoing. PRODUCT: a) St. Jude Medical APS III Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3500/3510, Recall # Z-0296-2007; b) St. Jude Medical Merlin PCS Programmer, used in combination with St. Jude Medical bradycardia and tachycardia devices. Model 3650, Recall # Z- 0297-2007; c) St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers), Recall # Z-0298-2007 REASON: St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and Elective Replacement Indicator (ERI) status. MANUFACTURER: Smiths Medical PM, Inc., Waukesha WI, by letter dated November 3, 2006. Firm initiated recall is ongoing. PRODUCT: BCI 3404 Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor. Smiths Medical PM, Inc. This device is designed to provide full featured monitoring capabilities in a tabletop design. The system features an ECG cable interface, an SpO2 probe interface, display of patient and waveform data via an EL panel, power status LED, and the function keypad area consisting of six keys (on/off, waveform/trend, alarm silence, menu/enter, up arrow & down arrow). The monitor has a serial port that is used for data communications to a printer or computer and for analog outputs, Recall # Z-0300-2007 REASON: An error occurred at the board manufacturing site which may affect the following parameters: - An electrical noise observed on the SpO2 pleth waveform generating and displaying erratic heart rates. % SpO2 reading displays dashes. The ECG waveform may appear noisy, ECG readings appear accurate. -Respiration waveform may appear noisy and the respiration readings will be displayed as dashes. MANUFACTURER: Recalling Firm: Draeger Medical, Inc., Telford, PA, The recalling firm issued a recall letter to the US customers November 17, 2006. Manufacturer: Draeger Medical Systems Inc., Danvers, MA. Firm initiated recall is ongoing. PRODUCT: a) Infinity Docking Station (IDS) Delta and Kappa Series patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375, Recall # Z-0301-2007; b) Infinity Docking Station (IDS) Gamma/Gamma XL and Infinity Vista Series patient Monitors. Model numbers 4715319, 5206110, 5732388, and 7489375, Recall # Z-0302-2007; c) Infinity Docking Station (IDS) (transportable patient monitor) Repair Kit, part number 7262814, Recall # Z-0303-2007 REASON: Top cover of assembly may separate. The situation can result in the monitor falling, which could result in an injury to the clinician or patient. MANUFACTURER: Varian Medical Systems Inc., Palo Alto CA, by letter on September 21, 2006. Firm initiated recall is ongoing. PRODUCT: 4D Integrated Treatment Console and Varis 1.4g Medical Charged Particle Radiation Therapy System; All 4D Integrated treatment console versions 8.0.15 and below (excluding v7.0.31) and all Varis Non-Varian Treatment versions 6.6.5027 and below, Recall # Z-0304-2007 REASON: Selecting an empty space next to the ''Override'' or ''Acquire Actual'' buttons may result in mistreatment to the patient. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 20, 2006 CLASS I MANUFACTURER: Discount Diabetic Supply, Oxford MS, by telephone on October 19, 2006 and by letter on October 30, 3006. Firm initiated recall is ongoing. PRODUCT: One Touch Ultra test strips, LifeScan, a Johnson & Johnson Co., 50 test strips, 2 vials of 25 test strips, Recall # Z-0206-2007 REASON: Counterfeit-Blood glucose test strips were reported to be counterfeit. MANUFACTURER: Medishop, Inc., Brooklyn, NY, by letters dated October 17, 2006. Firm initiated recall is ongoing. PRODUCT: OneTouch®/Basic®/Profile® Blood Glucose Test Strips, 50 Test Strips per box. Part Number 020-848, LIFESCAN, a Johnson & Johnson company. (The product is labeled in English, Greek and Portuguese), Recall # Z-0207-2007 REASON: Counterfeit-The product is reported to be counterfeit CLASS II MANUFACTURER: Recalling Firm: Advanced Medical Optics, Inc., Santa Ana CA, by letter and telephone on November 13, 2006. Manufacturer: A.M.O. Puerto Rico Manufacturing, Inc., Anasco, PR. Firm initiated recall is ongoing. PRODUCT: AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses, Recall # Z-0148-2007 REASON: The lenses are incorrectly labeled as 11 diopter lenses; these lenses are actually 22.5 diopters. MANUFACTURER: Terumo Cardiovascular Systems, Corp., Ann Arbor, MI, by letter dated September 14, 2006 and September 17, 2006. Firm initiated recall is ongoing. PRODUCT: a) Terumo Perfusion System 9000, 100v, with color screen; Model 9000; Catalog No. 164280, Recall # Z-0233-2007; b) Terumo Perfusion System 9000, 220/240v, with color screen; Model 9000; Catalog No. 164290, Recall # Z-0234-2007; c) Terumo Perfusion System 9000, 115v, with color screen; Model 9000; Catalog No. 164300, Recall # Z-0235-2007; d) Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400, Recall # Z-0236-2007; e) Terumo Perfusion System 8000 Base, 5 pump, 115v; Model 8000; Catalog No. 16401, Recall # Z-0237-2007;. f) Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000; Catalog No. 16405, Recall # Z-0238-2007; g) Terumo Perfusion System 8000 Base, 5 pump, 220240v; Model 8000; Catalog No. 16406, Recall # Z-0239-2007; h) Terumo Perfusion System 8000 Base, 4 pump, 100v, Model 8000; Catalog No. 16409, Recall Z-0240-2007; i) Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000; Catalog No. 16410., Recall # Z-0241-2007; j) Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268, Recall # Z-0242-2007 REASON: The hand crank handle may separate and detach from the unit during use. MANUFACTURER: Smiths Medical ASD, Inc., Rockland, MA, by letter on or about November 6, 2006. Firm initiated recall is ongoing. PRODUCT: a) Level 1® Normothermic I.V. Fluid
Administration Set REF D-60HL, Recall # Z-0250-2007; REASON: IV Fluid Administration Set may have a blockage of the recirculating warming fluid channel within the disposable administration set, causing an alarm condition of over-temperature during priming. MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letters on September 8, 2006. Manufacturer: Becton Dickinson Vacutainer Micrope, San Lorenzo, PR. Firm initiated recall is ongoing. PRODUCT: BD Vacutainer Luer-Lok Access Device Holder with Pre-Attached Multiple Sample Adapter Sterile, Do Not Reuse, Keep away from heat, Rx only Ref # 364902 200 (4X50) BD, Recall # Z-0253-2007 REASON: Reports of failure of the Luer Lok Access Device to lock securely to certain catheter devices because the male luer taper surface is not within the specification. MANUFACTURER: Recalling Firm: Stryker Biotech, Hopkinton, MA, by letter on August 25, 2006. Manufacturer: Howmedica International S de RL, Limerick, Ireland. Firm initiated recall is ongoing. PRODUCT: Calstrux™ (Previously known as TCP Putty)- Absorbable Bone Void Filler, packaged in: Catalog Number: 400-05: quantity-5cc Catalog Number: 400-10: quantity 10cc Catalog Number: 400-15: quantity 15cc, Recall # Z-0254-2007 REASON: Lack of Labeling Precautions. Calstrux™ should not be used in combination with other products and the volume used should approximate the size of the defect. Adverse reactions have been reported with over filling the defect site or combination product usage, including localized induration, swelling, inflammation, wound drainage, infection and device migration. MANUFACTURER: Recalling Firm: Advanced Medical Optics,
Inc., Santa Ana, CA, by letter on October 31, 2006. Manufacturer: A.M.O.
Puerto Rico Manufacturing, Inc., Anasco PR. Firm initiated recall is
ongoing. REASON: These specific serial numbers of lenses are being recalled because AMO has received reports of post-implantation cloudiness related to some lenses contained in this grouping. MANUFACTURER: Medline Industries, Inc, Mundelein, IL, by telephone on November 21, 2006. Firm initiated recall is ongoing. PRODUCT: Medline Premium Wet Skin Prep Tray, Sterile, Latex Free; a single use surgical convenience tray, EO sterilized; Reorder DYND70660; 20 trays per case; Recall # Z-0268-2007 REASON: The product, labeled as sterile, had not gone through the sterilization process at the time of shipment CLASS III MANUFACTURER: Biogenex Laboratories, San Ramon, CA, by letter on approximately October 3, 2006. Firm initiated recall is ongoing. PRODUCT: Super Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP, REF/Cat. No. QP300-XAK, Kit containing reagent vials, Recall # Z-0217-2007 REASON: Mislabeling: The product's "contents section " labeling (outer box) is mislabeled incorrectly printed as ''1 x 100 mL Alk Phos Label'' which should read ''1 x 100 mL HRP Label''. A second, smaller label, incorrectly reads "RTU MultiLink HPR/AEC" which should be labeled as "RTU MultiLink HPR". The reagent vials in the box are correctly labeled. MANUFACTURER: Smiths Medical ASD, Inc., Gary, IN, by letter on November 17, 2006. Firm initiated recall is ongoing. PRODUCT: Custom 5.5 mm Bivona® Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S, Recall # Z-0260-2007 REASON: Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 13, 2006 CLASS II MANUFACTURER: Accumetrics, Inc., San Diego, CA, by letter or e-mail on September 5, 2006 – September 13, 2006. Firm initiated recall is ongoing. PRODUCT: VerifyNow P2Y12 Assay Device Kit, Part Number 85054, Recall # Z-0228-2007 REASON: The VerifyNow P2Y12 assay can report an erroneous result instead of an error message when a sample with low hematocrit is run. MANUFACTURER: BioMerieux, Inc., Durham, NC, by a field corrective action notification August 28, 2006. Firm initiated recall is ongoing. PRODUCT: BioMerieux BacT/Alert SN Anaerobic Culture Bottle-REF 259790, Recall # Z-0243-2007 REASON: Recovery Compromised-during manufacturing ambient air (including oxygen) was inadvertently introduced into the culture bottles, changing their reduction/oxidation potential thus leading to a compromised recovery of some obligate anaerobes and longer detection times. MANUFACTURER: Recalling Firm: Teleflex Medical, Bannockburn, IL, by letters dated October 31, 2006. Rusch Manufacturing (U.K.), Teleflex Medical, Armagh, N. Ireland. Firm initiated recall is ongoing. PRODUCT: Neoprene Pecan Shaped Breathing Bag. Bag with 15 mm neck insert, size 1 liter, a rebreathing bag. Made in UK, Catalog Number (REF) 21176AP, Recall # Z-0244-2007 REASON: Mislabeling-The rebreathing bag is incorrectly labeled as a 1 liter. The rebreathing bag is actually a ½ liter bag. MANUFACTURER: Abbott Laboratories, Santa Clara, CA. by letter on September 18, 2006. Firm initiated recall is ongoing. PRODUCT: Abbott brand CELL-DYN 22 Calibrator, a whole blood calibrator used to calibrate CELL-DYN hematology systems. Model Number: 99120-01, Recall # Z-0246-2007 REASON: Potential for on-market instability in the whole blood calibrator which could lead to inaccurate platelet (PLT) test results. MANUFACTURER: Dade Behring, Inc., West Sacramento, CA., by telephone and letters on September 27, 2006. Firm initiated recall is ongoing. PRODUCT: Dade Behring brand MicroScan Prompt Inoculation System-D; Catalog # B1026-10D, Recall # Z-0247-2007 REASON: Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing. MANUFACTURER: Recalling Firm: Arjo, Inc., Roselle, IL, by letters on October 30, 2006. Manufacturer: Medibo, N.V., Hanmont, Achel, Belgium. Firm initiated recall is ongoing. PRODUCT: a) Sling Rope/Connector Assembly Kits for the
Sara and Sara Nova standing and raising aids; the kit is comprised of 2 x
200 cm ropes, 2 knobs, 2 sling connectors, 2 socket cap screws, 2 nylon
nuts and 2 spacers; Arjo Inc., 50 N. Gary Avenue, Roselle, IL 60172; Model
KS1006, Recall # Z-0248-2007; REASON: The sling ropes were manufactured with insufficient rope length past the knot to prevent the knot from coming loose. CLASS III MANUFACTURER: Ortho-Clinical Diagnostics, Rochester NY, by letters on October 9, 2006. Firm initiated recall is ongoing. PRODUCT: VITROS® Chemistry Products LIPA Slides GEN 48, Coating 3235, REF/Catalog No. 166 8409 (60 slides per cartridge and 5 cartridges per box - 300 slides per box) and REF/Catalog No. 829 7749 (18 slides per cartridge and 5 cartridges per box - 90 slides per box). LIPA Slides are processed by higher volume (or mainframe) VITROS® Chemistry Systems typically used in hospital laboratories. 510(k) #: K845027 (18 January 1985). Shelf life: Cat. # 166 8409: 12/01/07, Cat. # 829 7749: 12/01/07-1/01/08, Recall # Z-0245-2007 REASON: The firm identified circumstances in which biased results or calibration failures can be observed when using any lot of VITROS® LIPA slides if they have been stored on the VITROS® Chemistry Systems for more than 2 days. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of December 6, 2006 CLASS II MANUFACTURER: Lone Star Medical Products, Inc, StaffordTX., by letters on October 6, and November 8, 2004, and by telephone November 9 through November 12, 2004. Firm initiated recall is ongoing. PRODUCT: a) Lone Star Medical Products, Inc. 1100 Series
Aluminum Retractor Rings, REASON: Ni-Cr Plated 1100 Series Retractors with a chromium finish were replaced by Retractors with a hard-anodized finish after complaints of peeling were received. MANUFACTURER: Recalling Firm: Nihon Kohden America Inc, Foothill Ranch,CA, by telephone and fax starting September 1, 2006. Manufacturer: Nihon Kohden Corp., Shinjuku-ku, Tokyo, Japan. Firm initiated recall is ongoing. PRODUCT: Nihon Kohden Electric Stimulator, Model number: MS-210BK (Optional accessories of MEB-2200A -Neuropack Evoked Potential and EMG Measuring System), Recall # Z-0218-2007 REASON: When the device is subject to physical shock, such as a drop to the floor, it may output a different value from the preset value. This may result in a superficial burn on the patient if the stimulation is done for a long time. MANUFACTURER: Computerized Medical Systems, Inc., Saint Louis, MO, by letters dated November 9, 2006. Firm initiated recall is ongoing. PRODUCT: AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system, Model #DS300, Recall # Z-0221-2007 REASON: The In/Out adjustment knob can be over-turned, ultimately causing the incorrect placement of radioactive seeds in the patient. MANUFACTURER: Inverness Medical Professional Diagnostics, Scarborough, ME, by letter on September 29, 2006. Firm initiated recall is ongoing. PRODUCT: NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use Product Code: 852-00, Recall # Z-0222-2007. REASON: Mislabeled product: Outer kit label reads NOW Legionella Urinary Antigen Test, inside contains S.pneumonia test pouches. MANUFACTURER: Data Innovations, Inc., South Burlington,VT., by letter dated October 25, 2006. Firm initiated recall is ongoing. PRODUCT: a) Roche Modular Drive (rchmdlri), analytical
laboratory data interface, Recall # Z-0223-2007; REASON Software of modular driver may incorrectly report patient results as Quality Control Results. MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by Customer Safety Advisory on October 12, 2006. Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing. PRODUCT: a) Magnetom Trio magnetic resonance imaging,
Model number 7387074, Recall # Z-0225-2007; REASON: Possible excessive RF exposure/may burn. MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by press release and letters dated October 19, 2006. Firm initiated recall is ongoing. PRODUCT: CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use), 3116239 (12 strip pack-patient self test), Non-U.S. Catalog Numbers 11937642190 [packaged 48 strips per box] and 11937634190 (packaged 12 strips per box), Recall # Z-0227-2007 REASON: Erroneous Test Results: Monitor may display "error" message or report falsely elevated patient results caused by insufficient amounts of active ingredient (thromboplastin) in the test strips. MANUFACTURER: Recalling Firm: Dentsply Friadent Ceramed, Lakewood, CO., by letter on November 17, 2006. Manufacturer: Dentsply Friadent GmbH, Mannheim, Germany. Firm initiated recall is ongoing. PRODUCT: a) XiVE S plus Screw Implant D3.0/L11, Model Number 26-0122, Friadent GmbH. (dental implant), Recall # Z-0230-2007; b) XiVE S plus Screw Implant D3.0/L13, Model Number 26-0123, Friadent GmbH. (dental implant), Recall # Z-0231-2007; c) XiVE S plus Screw Implant D3.0/L15, Model Number 26-0125, Friadent GmbH. (dental implant), Recall # Z-0232-2007 REASON: Sterility of dental implants may be compromised due to cracks in packaging/caps on vials. CLASS III MANUFACTURER: Recalling Firm: Laborie Medical Technologies, Williston,VT, by telephone on October 4-5, 2006. Manufacturer: Smiths Medical, DublinOH. Firm initiated recall is ongoing. PRODUCT: Laborie Transducer Cartridge with Luer Lock Reference: DIS130, Recall # Z-0229-2007 REASON: Mislabeling: Product labeled with incorrect "Use Before" date and pouch labels missing lot number. (Incorrect dates-2006/07 or 2006/08; correct Use by dates-2009/08 for Lot 36H03M005 and 2009/07 for Lot 36G20M041 The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 29, 2006 CLASS II MANUFACTURER: Abbott Diagnostic International, Ltd., BarcelonetaPR, by letter on September 8, 2006. Firm initiated recall is ongoing. PRODUCT: Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100, Recall # Z-0117-2007 REASON: Increase in complaints regarding controls out of range, calibration errors, and discrepant patient results with the AxSYM Troponin-I ADV assay. MANUFACTURER: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on October 19, 2006. Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing. PRODUCT: Modularis URO urological table, Model number 5531012, Recall # Z-0168-2007 REASON: Potential pinch point with the patient table MANUFACTURER: Recalling Firm: Plus Orthopedics USA, San Diego,CA., by letter on July 30, 2003. Manufacturer: Plus Orthopedics AG, Rotkreuz, Switzerland. Firm initiated recall is complete. PRODUCT: REASON: There exists the possibility that incomplete bony support or insufficient cementing of the implanted device can result in fatigue fracture of the UC-PLUS Solution Femoral Component. MANUFACTURER: Exactech, Inc., GainesvilleFL., by fax, e-mail and telephone on August 31, 2006. Firm initiated recall is ongoing. PRODUCT: Optetrak, B-series cemented finned tibial tray, size 2f/2t. Catalog # 220-04-02, Recall # Z-0196-2007 REASON: Improperly machined parts: The Cemented Finned Tibial Trays could not seat the size 2 mating trial or polyethylene insert. MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea,CA., by letters the week of July 24, 2006. Manufacturer: Applied Cytometry, Sheffield, UK. Firm initiated recall is ongoing. PRODUCT: Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1, Recall # Z-0197-2007 REASON: Mis-identification-If a panel or protocol is added to an existing worklist but the tube location is not specified, the CXP Acquisition software will run the last specified tube through the remaining protocols and will generate results and printouts of these runs leading to a Mis-Identification condition. MANUFACTURER: Iris Sample Processing, Westwood, MA, telephoned on September 29, 2006 . Firm initiated recall is ongoing. PRODUCT: StatSpin Express 3 Centrifuge with RTX8 Rotor Model: M502, Recall # Z-0198-2007 REASON: Rotor may crack and separate causing device to fail. A failed rotor not successfully contained may seriously injure the laboratory worker. MANUFACTURER: Dako Colorado, Inc., Fort Collins, CO, by telephone on October 2, 2006 and by letter on October 20, 2006. Firm initiated recall is ongoing. PRODUCT: Eridan Automated Slide Stainer and Support Cart, REF E300 and E300SC1, (Catalog No. (ER 00130, 00331, 00230, 00431), Recall # Z-0199-2007 REASON: Automated slide staining device may not stain speciman slides correctly, and therefore slides cannot be used for patient diagnosis. MANUFACTURER: Gambro Renal Products, Inc., LakewoodCO, by fax on May 12, 2006 and by letter on May 16, 2006. Manufacturer: Gambro Dasco S.p.A. Monitor Division, Medolla, Italy. Firm initiated recall is complete. PRODUCT: Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700, Recall # Z-0200-2007 REASON: Defective Heat Exchanger/membrane; this may result in perforation of the membrane thus allowing the presence of infectious organisms and/or pathogens to pass from patient to patient. MANUFACTURER: Datex - Ohmeda, Inc., Madison,WI, by letter dated September 15, 2006. Firm initiated recall is ongoing. PRODUCT: Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an electronic vaporizer which delivers the anesthetic agent desflurane, Recall # Z-0201-2007 REASON: There is a possibility of a vaporizer power failure, with audible and visual alarms, when using the Tec 6 Plus Desflurane Vaporizer. MANUFACTURER: Access Point Medical LLC, St. Louis, MO, by telephone and letters dated March 9, 2006. Firm initiated recall is ongoing. PRODUCT: REASON: The canes were made of unacceptable materials and could break. MANUFACTURER: Medtronic Vascular, Santa Rosa, CA, by letters on November 1, and November 3, 2006, and by telephone and email week of October 30, 2006. Firm initiated recall is ongoing. PRODUCT: Pioneer Catheter (Crosspoint TransAccess Catheter); Model TA-XP-001, Recall # Z-0208-2007 REASON: Sterility may be compromised as evidenced by a loss of package integrity. MANUFACTURER: Zimmer, Inc., Warsaw, IN, by letter dated October 12, 2006. Firm initiated recall is complete. PRODUCT: Zimmer NexGen Complete Knee Solution Legacy Knee Tibial Component, 3 degree, fluted, size 4, stemmed option, for cemented use only, tivanium TI-6AL-4V alloy/UHMWPE, sterile; Catalog no. 05-5998-038-02, Recall # Z-0209-2007 REASON: The polyethylene tibial articular surface may not lock into some of the tibial plates. MANUFACTURER: Zimmer, Inc., Warsaw, IN, by letter dated October 19, 2006. Firm initiated recall is ongoing. PRODUCT: Zimmer Trabecular metal shoulder instrumentation proximal provisional humeral stem, 48 degrees, 9/10 mm diameter, nonsterile; REF 4309-18-10, Catalog no. 00-4309-018-10, Recall # Z-0210-2007 REASON: The instrument may fracture at the threaded end during intramedullary trialing and leave the distal pilot trial in the humeral canal. MANUFACTURER: Recalling Firm: AGFA Corp., Greenville, SC, by service bulletin on September 1, 2006 and by telephone and email on October 13, 2006. Manufacturer: AGFC Corp., Mortsel, Belgium. Firm initiated recall is ongoing. PRODUCT: CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405), Recall # Z-0219-2007 REASON: Users may experience one or more of four (4) problems; 1. Image quality problem with full leg full spine exams. 2. Unable to print 2 or more images on 1 film. 3. Possible image loss when printing. 4. Study date and time not showing up on Imexius Web. MANUFACTURER: Recalling Firm: Konica Minolta Medical Imaging USA, Inc., Wayne, NJ, by letters, fax, email and telephone on October 10, 2006. Manufacturer: Konica Medical and Graphic Cor, Shinjuku-Ku, Tokyo, Japan. Firm initiated recall is ongoing. PRODUCT: Konica Minolta PrintLink III Model - ID/IV, product code no. 0770, 0771 Medical Imaging Communication Device Model IV - product code 5000230 Model ID, product code 5000330, Recall # Z-0220-2007 REASON: The power supply of a unit located in Japan overheated and caused a smoke condition and a small amount of flame coming off the unit. CLASS III MANUFACTURER: Smiths Medical ASD, Inc., Keene, NH, by letters on October 27, 2006. Firm initiated recall is ongoing PRODUCT: Protex Continous Epidural anesthesia tray, Ref 4948-17, Recall # Z-0211-7 REASON: Misbranded: Tray label states 26G x 5/8 inch, needle is 25 G x 1 inch. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 22, 2006 CLASS II MANUFACTURER: Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter on October 612, 2006. Manufacturer: Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated recall is ongoing. PRODUCT: REASON: Potential for generator to lock-up. Fluoroscopy and x-ray is no longer possible, and system must be restarted to be able to continue. MANUFACTURER: Data Innovations, Inc., South Burlington, VT, by an email listserv notification and by letter dated 8/17/06. Firm initiated recall is ongoing. PRODUCT: Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen Management and using Results/Edit/ReleaseScreen (R/E/R), Recall # Z-0167-2007 REASON: Patient results may be associated with an incorrect specimen. MANUFACTURER: Recalling Firm: Baxter Healthcare Renal Div, Mc Gaw Park, IL, by letters dated September 6, 2006. Manufacturer: Baxter Healthcare Corporation, Largo FL. Firm initiated recall is ongoing. PRODUCT: Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R, Recall # Z-0169-2007 REASON: The Meridian pump is less likely to detect small pressure changes, which may indicate the presence of a post-pump tubing kink, when using pre-pump arterial pressure monitoring. MANUFACTURER: Bemis, Sheboygan Falls, WI, by letters on August 23, 2006, and September 13, 2006. Firm initiated recall is ongoing. PRODUCT: 5 Qt. Wallmount Sharps Container, Model 150, Regular Size; colors 202 Beige, 030 Red, 040 Yellow, 24 count containers, Recall # Z-0170-2007 REASON: The 5 Quart Wall Safes are shipped as two pieces (bottom & top) that customers are unable to assemble because of excess warp in the back wall of the container. MANUFACTURER: Recalling Firm: Medtronic Sofamor Danek USA Inc., Memphis, TN, by letter on October 20, 2006. Manufacturer: Lenox-Maclaren Surgical Corp., Louisville, CO. Firm initiated recall is ongoing. PRODUCT: Medtronic Sofamor Danek, Bone Fragmentor, Ref Number 9150111- Device, Recall # Z-0176-2007 REASON: Metal bone fragmentor was causing metal shavings to be released into the resultant fragmented tissue during use. MANUFACTURER: Linvatec Corp., Largo, FL, by letter on December 20, 2005. Firm initiated recall is ongoing. PRODUCT: ConMed Linvatec Sternum Saw Collet Nut, Catalog Number 5059-09: Used on ConMed Linvatec Sternum Saw Handpieces (ConMed Linvatec, Hall. Versipower, Versipower Plus Handpieces) and sold individually, Recall # Z-0179-2007 REASON: The Sternum Saw Collet Nut that is used to insert and hold the saw blade in place may not always allow for the easy insertion of a saw blade into the handpiece for use. The nut needs to be in a certain position in order for the blade to be inserted and this may delay the operation of the device especially in emergency situations. MANUFACTURER: Olsen Medical, Louisville, KY, by letter and e-mail August 29 - 30, 2006. Firm initiated recall is ongoing. PRODUCT: MIDAS TOUCH Electrosurgical/102 mm (4 inch) Blade Electrodes, Disposable, Sterile Single Use Device, Part #30-0012 and Model #30-0002. The electrodes are individually packaged in Tyvek bags with 12 packages per case, Recall # Z-0182-2007 REASON: Testing conducted by the firm indicates that electrodes identified with certain part numbers may fall out from the electrosurgical pencil or handle presenting the potential for harm or injury to the patient and/or user. MANUFACTURER: Recalling Firm: Philips Medical Systems, Andover MA., by letter on September 21, 2006. Manufacturer: Philips Medizin Systeme Boblingen Gmbh, Hewlett-Packard Strasse 2, Boblingen, Germany. Firm initiated recall is ongoing. PRODUCT: REASON: Unexpected pulse oximetry (Sp02) readings (100%) over time when a sensor is not attached to the patient. In addition, with a sensor attached to a patient, an incorrect high Sp02 may be displayed when a pulse rate is in a range of 185BPM. MANUFACTURER: Sorenson Medical, Inc., West Jordan, UT, by
letter on October 10-11, 2006. Firm initiated recall is ongoing. MANUFACTURER: Recalling Firm: Eatonform Inc., Dayton OH, by letter on September 28, 2006. Manufacturer: Specialized Printed Forms, Caledonia NY. Firm initiated recall is ongoing. PRODUCT: Doc-U-Dose Prescription Management System, Item 8-PKIT. The product is packaged and distributed in cartons. Each carton contains 1,000 sets of four packets or 4,000 individual packets per carton, Recall # Z-0189-2007 REASON: The poly film may separate along the sealed seams of the packets of the Doc-U-Dose Prescription Management System causing the medications to unintentionally fall out of the packets prior to delivery to patient/consumers. MANUFACTURER: Zimmer Spine, Inc., Minneapolis MN., by letters beginning October 12, 2006. Firm initiated recall is ongoing. PRODUCT: Zimmer Spine ST360 Distal Thread Reduction Guide Pins, Part number: 07.00684.00. Non-Sterile. The Distal Thread Reduction Guide Pin is a reusable instrument that is part of a set of instruments used to perform reduction surgeries with the ST360 Spinal Fixation System. The ST360 Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. Implants of this system consist of hooks and/or screws connected to rods and are intended to be removed after solid fusion has occurred. This system includes polyaxial screws of varying diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, fixed and adjustable transverse connectors, Recall # Z-0190-2007. REASON: Recall is due to an issue with the thread timing. MANUFACTURER: Trionix Research Laboratory, Inc., Twinsburg, OH, by telephone on/about November 2, 2006. Firm initiated recall is ongoing. PRODUCT: BIAD Classic 24 (24 inch collimator). The collimator is a component of the Trionix Biad Full Imaging System, Recall # Z-0193-2007 REASON: The ball screw on the unit which supports the detector head (which weights approximately 800 lbs.) could snap resulting in the detector head dropping on the patient. MANUFACTURER: Varian Medical Systems Inc., Palo Alto, CA, by letters on August 31, 2006. Firm initiated recall is ongoing. PRODUCT: Clinac High Energy Medical Linear Accelerator, Medical Charged-particle radiation therapy system; Model #s: 2100(C, C/D EX) and 2300 C, C/D EX), Recall # Z-0194-2007: REASON: The chain holding the device gantry in position may break. MANUFACTURER: Ekos Corp., Bothell, WA, by letter, dated October 2, 2006. Firm initiated recall is ongoing. PRODUCT: Lysus Transport Stand (infusion stand), part number 4896-003, Recall # Z-0195-2007 REASON: Carts distributed without an additional caution label directly on the cart, alerting users to tipping hazard. CLASS III MANUFACTURER: Recalling Firm: Asahi Medical Co., Ltd., Northbrook, IL, by letters on October 12, 2006. Manufacturer: Asahi Kasai Medical Co., Ltd., Oita Prefecture, Japan. Firm initiated recall is ongoing. PRODUCT: MANUFACTURER: Recalling Firm: Boston Scientific Target, Fremont, CA., by letters on October 6, 2006. Manufacturer: Boston Scientific Cork, LTD, Cork, Ireland. Firm initiated recall is ongoing. PRODUCT: Boston Scientific brand Renegade 18 Fiber braided microcatheter, Catalog #: 18257, UPN: M001182570, Recall # Z-0177-2007 REASON: Incorrect expiration date: The product's exterior box date may be labeled with a longer than actual expiration date (the pouch label is correct) MANUFACTURER: Michigan Instruments, Inc., Grand Rapids, MI, by letter dated September 14, 2006. Firm initiated recall is ongoing. PRODUCT: Michigan Instruments Thumper Mechanical CPR Device, Model 1007, Part number 15000, Recall # Z-0178-2007 REASON: Failure to initiate compressions when turned on. MANUFACTURER: EBI, L.P., Parsippany NJ, by letter on
September 6, 2006. Firm initiated recall is ongoing. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 15, 2006 CLASS II CORRECTION Recall # Z-0078-2007, listed in November 8, 2006, Enforcement Report should be listed as a Class III Recall. MANUFACTURER: Recalling Firm: Ciba Vision Corp., Duluth, GA, by letter on September 13, 2006. Manufacturer: Ciba Vision Puerto Rico, Inc., Cidra, PR. Firm initiated recall is ongoing. PRODUCT: Z-0018-07 REASON: Out of specification lens curve. MANUFACTURER: Datex -- Ohmeda, Inc., Madison, WI, by letters on August 10, 2006. Firm initiated recall is ongoing. PRODUCT: GE Healthcare-Datex-Ohmeda Aisys Anesthesia Delivery System with Aladin 2 cassettes, Recall # Z-0021-2007 REASON: Vaporizer shutdown with alarm-An intermittent leak in the Aladin 2 cassette/Aisys pneumatic interface (valves) may occur that will invoke an alarm state. When this occurs 'Vaporizer Failure' will appear on the Aisys main display, with an accompanying audible alarm. Delivery of anesthetic Agent is halted; gas flow and ventilation are not affected. MANUFACTURER: Enpath Medical, Inc., Minneapolis, MN, by telephone on July 7, and July 17, 2006 and by letters on July 10, and July 18, 2006. Firm initiated recall is ongoing. PRODUCT: REASON: The internal component (Connector Block) of the Lead Adapter used to secure a lead to the adapter has exhibited varying degrees of radial cracks that could cause a temporary intermittent electrical signal disruption if lateral tension is applied to device. MANUFACTURER: Hydrocision, Inc., Billerica, MA, by email on September 6, 2006. Firm initiated recall is complete. PRODUCT: REASON: Distal tip may become detached from the device. MANUFACTURER: Recalling Firm: DePuy Spine, Inc., Raynham, MA, by letter on October 10, 2006. Firm initiated recall is ongoing PRODUCT: REASON: Sterility of device is compromised due to loss of package integrity. MANUFACTURER: Ortho-Clinical Diagnostics, Rochester, NY, by letters dated September 27, 2006 and September 28, 2006. Firm initiated recall is ongoing. PRODUCT: VITROSâ Chemistry Products GLU DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per box. VITROSâ Chemistry Products GLU DT Slides quantitatively measure glucose (GLU) concentration in serum and plasma, Recall # Z-0151-2007 REASON: Positively biased results when using the VITROSâ Chemistry Products GLU DT Slides GEN 56. MANUFACTURER: Recalling Firm: Hitachi Medical Systems America, Inc., Twinsburg, OH, by visit on August 14, 2006. Firm initiated recall is complete. PRODUCT: Hitachi Echelon Magnetic Resonance Imaging System, Recall # Z-0152-2007 REASON: Component defect/overheating device; A malfunctioning decoupling circuit in the CTL coil caused high current flow and circuit overheating. MANUFACTURER: Precision Medical, Inc., Northampton, PA, by telephone on October 4, 2006. Firm initiated recall is ongoing. PRODUCT: Precision Medical -- Easy Mate Portable Liquid Oxygen System (container), PM22010 Series, Model number: 2201, Recall # Z-0153-2007 REASON: Component assembly; the fill chuck is not assembled properly which may allow the device to come apart over time releasing its contents. MANUFACTURER: Recalling Firm: Access Point Medical LLC, St. Louis, MO, by telephone on or about June 20, 2006. Manufacturer: Danyang Changjiang Motorcycle, Danyang, China. Firm initiated recall is ongoing. PRODUCT: REASON: The fork component on the wheel of the Rollator can break due to the use of MANUFACTURER: Recalling Firm: Lumiport, LLC, Provo, UT, by email or telephone beginning September 28, 2006. Manufacturer: Ningbo Haishu Qualik Optoelectronics Corp., Ningbo, China. Firm initiated recall is ongoing. PRODUCT: DermaStyle Chroma 2-blue and red light device indicated to be used in treating skin blemishes; portable home therapy, Recall # Z-0156-2007 REASON: Incorrect charger, batteries may overheat, catch fire or explode while being charged with the charger enclosed with the device. MANUFACTURER: Recalling Firm: Maquet, Inc., Bridgewater, NJ, by letter on September 13, 2006. Manufacturer: Maquet Critical Care AB, Solna, Sweden. Firm initiated recall is ongoing. PRODUCT: Jostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crank, Article # 923391, Recall # Z-0158-2007 REASON: The hand crank necessary for the emergency manual operation of the pump is too wide diametrically to fit into the holes which they were designed to fill. MANUFACTURER: Recalling Firm: Maquet Inc, Bridgewater NJ, by letter on October 3, 2006. Manufacturer: Maquet Critical Care AB, Solna, Sweden. Firm initiated recall is ongoing. PRODUCT: Jostra HL-20 Heart Lung Machine - guiding pins, Recall # Z-0159-2007 REASON: The HL-20's pump head on the roller pump has four pairs of tube guide rolls that keep the tube in place in the raceway and roll along the inserted tube as the pump head turns. If dirt and other particles accumulate in the tube guide rolls, they cannot roll smoothly and finally they can get stuck. MANUFACTURER: Cook Endoscopy, Winston Salem, NC, by letter on October 13, 2006. Firm initiated recall is ongoing. PRODUCT: Fusion OMNI ERCP Catheter, Recall # Z-0160-2007 REASON: Injection through the flush port of these ERCP catheters may be compromised due to omission of a manufacturing activity. MANUFACTURER: USA Instruments Inc., Aurora OH, by letters dated September 20, 2006 and October 13, 2006. Firm initiated recall is ongoing. PRODUCT: a) 1.5T HD Head Neck Spine Array, Model 2416329, for GE
1.5T Excite MR System, Recall # Z-0163-2007; REASON: The firm determined that certain potential conditions for use of their medical device, outside of recommended practices, or operating manual descriptions, could result in a localized RF burn and/or electrical shock to a patient on which the device is being used. CLASS III PRODUCT: Michigan Instruments Thumper Mechanical CPR Device, Model 1007, Recall # Z-0119-2007 MANUFACTURER: Michigan Instruments, Inc., Grand Rapids, MI, by letter dated August 4, 2006. Firm initiated recall is ongoing. REASON: Failure to initiate compressions when first turned on, if improperly shut down -- Operator Manual updated to include proper shut down procedures. MANUFACTURER: Recalling Firm: Teleflex Medical, Bannockburn IL, letters dated September 27, 2006. Manufacturer: Hudson RCI Tecate S.de R.L. de C.V., Teleflex Medical, Tecate, B.C., Mexico. Firm initiated recall is ongoing. PRODUCT: REASON: Biological indicator failed. Investigation eliminated all equipment and product related factors. MANUFACTURER: Recalling Firm: Plus Orthopedics, USA, San Diego, CA, by telephone on June 27, 2006. Manufacturer: Plus Orthopedics AG, Rotkreuz, Switzerland. Firm initiated recall is ongoing. PRODUCT: Galileo Femoral Clamp TKR Slim, Model Number: SYS25 1226, Recall # Z-0149-2007 REASON: Possibility of pressure plate fractures/breakage. MANUFACTURER: Home Access Health Corp., Hoffman Estates, IL, by letters dated October 6, 2006. Firm initiated recall is ongoing. PRODUCT: Home Access-Hepatitis C Check; At Home Telemedicine Test Service for Hepatitis C ; each kit is composed of an outer box, a shrink-wrapped inner box that contains the blood collection card with an unique PIN, the instructions for use and ''Frequently Asked Questions'', a polybag component that includes two lancets, one gauze pad, one adhesive bandage and one alcohol prep pad, a specimen return envelope and a prepaid return mailer either designated as U.S. first class or FedEx; UPC 0 83170 51000 5, Recall # Z-0150-2007 REASON: Wrong Expiration Date; the kits were labeled with Expiration/Use By dates; that exceed the expiration dates of the sterile safety lancet component of the kit. MANUFACTURER: St. Jude Medical/Diag. Division, Minnetonka, MN, by letters on June 7, 2006. Firm initiated recall is complete. PRODUCT: Angio-Seal Vascular Closure Device 6F VIP Platform, model 610130. The recalled product is the 6 French model size, Recall # Z-0157-2007 REASON: The Angio Seal VIP 6F devices were incorrectly packaged with a 0.038" guidewire vs. the required 0.035" guidewire. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 8, 2006 CLASS II Class II Device Recall Extended. Z-1502-06 was reported in the September 20, 2006 Enforcement Report. The recall has been extended to include 310 more devices. MANUFACTURER: Medtronic Emergency Response Systems, Inc., Redmond, WA, by letter on August 30, 2006. On 10/19/06 the firm mailed an identical letter dated October 2006 to customers for units that were later identified as being subject to the recall. Firm initiated recall is ongoing. PRODUCT: LIFEPAK 20 external defibrillator/monitor, Recall # Z-1502-06 REASON: Devices with v38 system software do not display a "LOW BATTERY: CONNECT TO AC POWER" message when the monitor is on backup (DC) battery power and may shut down without warning. MANUFACTURER: Hardy Media Inc., Dba Hardy Diag, Santa Maria, CA, by telephone, fax and letter on August 21, 2006 and by letter September 25, 2006. Firm initiated recall is ongoing. PRODUCT: HardyCHROM 0157, Catalogue Number: G305, Packaged: 10 plates per sleeve, Recall # Z-0078-2007 REASON: This recall is being conducted due to performance failure; the product is failing to show pigment development for E. coli 0157. MANUFACTURER: Conmed Corporation, Utica, NY, by letter dated October 1, 2006. Firm initiated recall is ongoing. PRODUCT: ConMed DetachaTip® Laparoscopic Instrument: Allis
Multiple Use Grasper, 5mm x 33cm length, REF/Product Code 1-1019. --- The
product is distributed sterile in heat-sealed tray and labeled with an
expiration date that pertains only to the sterility, Recall # Z-0083-2007;
REASON: The grasper jaws broke during Laparoscopic procedures at the junction of the jaw and the tube. MANUFACTURER: Venoscope LLC, Lafayette, LA, by telephone beginning on April 28, 2006. Firm initiated recall is complete. PRODUCT: Venoscope Neonatal Transilluminator, Model NT01, Recall # Z-0116-2007 REASON: Excessive heating due to incorrect wire assembly process. MANUFACTURER: Enpath Medical, Inc., Plymouth MN, by letter on June 29, 2006 and by telephone on June 27, and July 6, 2006. Firm initiated recall is ongoing. PRODUCT: Channel Steerable Sheath in 8F Enpath part # 10775-003, BARD Part Number XD10775003 (US Distribution Only) and 9F Enpath part # 10775-004 (foreign distribution), BARD Part Number XD10775004; Recall # Z-0118-2007 REASON: Enpath has become aware that some of the Enpath Medical 8F & 9F Steerable sheath devices may have a non-conforming flushport bond that causes a leak where air may enter the flush port chamber. MANUFACTURER: First Aid Only Inc, Vancouver, WA, by letter dated August 17, 2006. Firm initiated recall is ongoing. PRODUCT: First Aid kits, First Aid Only brand, containing various products to include acetaminophen and other first aid supplies, various sizes, - travel size, all purpose, first aid response kit, on-the-road, recreational, outdoor, Recall # Z-0145-2007; First Aid kits, Pharmacist's Choice, containing acetaminophen and a variety of first aid items, all purpose first aid kit, Recall # Z-0146-2007; First Aid Kit, Nexcare brand, all purpose first aid kit containing acetaminophen and a variety of first aid supplies. Recall # Z-0147-2007 REASON: Kits contain acetaminophen tablets that were recalled due to being contaminated with mold. CLASS III MANUFACTURER: Recalling Firm: Ortho-Clinical Diagnostics, Rochester NY, by letters dated March 6, 2006. Manufacturer: Data Innovations, Inc., South Burlington, VT. Firm initiated recall is ongoing. PRODUCT: VITROS® WorkCentre, Catalog # 6802159, using enGen™ Series Automation Systems (Catalog # ENGEN). VITROS WorkCentre is Ortho-Clinical Diagnostics, Inc.'s branded version of Instrument Manager™, Recall # Z-0077-2007 REASON: Incorrect result calculations can occur (only affects derived results calculated by the VITROS WorkCentre). MANUFACTURER: Recalling Firm: Tosoh Bioscience Inc, Grove City OH, by letters on September 5, 2006. Manufacturer: Tosoh Corporation, Minato-Ku 43123, Japan. Firm initiated recall is ongoing. PRODUCT: Tosoh AIA-Pack Folate Calibrator Sets, six levels, Catalog Number-020392. The calibrators are packaged in 1 ml glass vials with 12 glass vials per box, Recall # Z-0082-2007 REASON: Reports of low calibration rate value flags; Use of the recalled product may result in failure to calibrate the instrument. MANUFACTURER: Recalling Firm: Boston Scientific Corporation, Natick, MA, by recall notification packages on August 10, 2005 Manufacturer: Boston Scientific Cork, Ltd., Cork, Ireland. Firm initiated recall is complete. PRODUCT: Renegade Hi-Flo Microcatheter Kits, Catalog/Order # 18-299, UPN M001182990, Recall # Z-0122-2007 REASON: Outer box of the product may have an incorrect expiration date listed as 2007-06, while the correct expiration date is 2007-04. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of November 1, 2006 CLASS II MANUFACTURER: Recalling Firm: Kendall a Division of Tyco Healthcare Group LP, Argyle, NY, by letter on September 12, 2006. Manufacturer: Kendall, Deland, FL. Firm initiated recall is ongoing. PRODUCT: Kendall Monoject Syringe with Hypodermic Needle, 3cc syringe with 27 ga A-Bevel Needle (3cc-27x1-1/4 A) Product # 888153744, Recall # Z-0051-2007 REASON: Incorrect needle. There is an incorrect needle configuration on the syringe. The correct needle has a 27 gage A-bevel, the needle on the syringe has no bevel, typically used for dental irrigation. MANUFACTURER: Recalling Firm: GE Healthcare, Wauwatosa, WI, by letter on June 23, 2006. Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. Firm initiated recall is ongoing. PRODUCT: ApexPro FH Telemetry System: composed of six major components (as follows); Accessories to the patient worn acquisition transceivers, the patient worn data acquisition transceivers, the transceiver access points with antenna, the network infrastructure, A computer platform running the ApexPro Telemetry Application and a computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application)., Recall # Z-0054-2007 REASON: System Warning Alarm failure: When a patient being monitored is in a pre-existing condition of continuous MESSAGE or ADVISORY level alarm preceding a SYSTEM WARNING level alarm, the SYSTEM WARNING audible alarm and flashing yellow border around the patient panel at the CIC does not occur. MANUFACTURER: Recalling Firm: Depuy Orthopaedics, Inc., Warsaw, IN, by telephone on September 14, 2006. Manufacturer: Depuy-Cork Div. Of Depuy Orthopaedics, Ringaskiddy County Cork, Ireland. Firm initiated recall is complete. PRODUCT: Depuy PFC Oval Dome Patella, Part Number 960100, 3-Peg. 32 mm, sterile, REF 96-0100, Recall # Z-0057-2007 REASON: Mislabeled units containing a size 32 mm. Patella were labeled as a 38 mm patella. MANUFACTURER: Recalling Firm: Cardinal Health, McGaw Park, IL, by letters dated September 27, 2006. Manufacturer: Cirpro De Delicias, Parque Industrial Las Virgenes, Panamericana, Apartado Postal, Mexico. Firm initiated recall is ongoing. PRODUCT: a) Convertors Tiburon Cardiovascular Split Drape
II, Sterile, for single use only; Made in Mexico. The cardiovascular
drapes were packaged under the following configurations: a) Catalog #9158
- 1 CV split drape Recall # Z-0062-2007 REASON: The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use. MANUFACTURER: Smiths Medical MD, Inc., Saint Paul, MN, by telephone, facsimile and letter on September 27, 2006. Firm initiated recall is ongoing. PRODUCT: REASON: Smiths Medical became aware that product returned
to them under recall # Z-0800-06/ Z-0807-06 was inadvertently distributed
to consignees after the recall was initiated 03/29/2006. The product was
originally recalled because Locator Wand covers, which are supplied on the
outside of PORT-A-CATH and P.A.S. PORT sterile trays, may have an
insufficient seal and product sterility could be compromised. REASON: Potential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be as intended. MANUFACTURER: Cook, Inc., Bloomington, IN, by telephone on September 21, 2006. Firm initiated recall is ongoing. PRODUCT: Cook Zilver 635 Billary Stent -- Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-4.0-40, Recall # Z-0080-2007 REASON: The side of the boxes give incorrect sizes for these stents. The label front is correct. (side label-5x40-front label-8x40). MANUFACTURER: Boston Scientific Corp., Spencer, IN, by letter dated September 21, 2006. Firm initiated recall is ongoing. PRODUCT: Boston Scientific 10 Fr (3.3 mm) Flexima Regular APDL All Purpose Drainage catheter set, REF/catalog no. 27-135. Universal Product Number (UPN) M001271350, Recall # Z-0081-2007 REASON: Sterility compromised/package integrity: the bottom of the Tyvek pouch may not have been sealed. MANUFACTURER: Recalling Firm: Radiometer America, Inc., Westlake, OH, by telephone on July 6, 2006 and by letter dated July 21, 2006. Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is complete. PRODUCT: Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex Blood Gas Analyzer, Catalog Numbers: 914-418 and 914-426, Recall # Z-0115-2007 REASON: Incorrect FI02 (Fraction of Inspired Oxygen) values: programming issue can cause incorrect values to be transmitted to the LIS when: 1)- The FI02 result is edited in the manual sample processing mode- 2)- An existing result is opened and FI02 is then edited and sent….In both cases RADIANCE will transmit the original FI02 value, not the value that was edited. CLASS III MANUFACTURER: Guidant Corporation, Saint Paul, MN, by visits on June 5, 2006. Firm initiated recall is ongoing. PRODUCT: Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A portable cardiac rhythm management system designed to be used with Guidant implantable pulse generators, Recall # Z-0002-2007 REASON: Final software load did not occur prior to shipment of select programmers. MANUFACTURER: Invacare Corporation, Sanford, FL, by e-mail on September 27, 2006. Firm initiated recall is ongoing. PRODUCT: AC-powered Adjustable Hospital Bed. (ICCG Bed) Affected Model numbers: IH820-3MDLX, IHSC900DLX, IH820-3MDLX-QS, IH820-3MPDLX-QS, SC900-80WDLX-QSP, SC900-80PDLX-QSP, IH820-3MDLX-AE-333PS, SC90080GDLX-AE-366PA, SC90080GDLX-AE-333PS, IH820-3MDLX-AE-366PS, IH820-3MDLX-AE-333PA, IH820-3MDLX-AE-366PA and SC90080GDLX-AE-366PS, Recall # Z-0063-2007 REASON: The incorrect caution label that describes washing instructions was applied to beds distributed in the US, i.e. the specified label is P/N 1116654 (English translation); the label that was used is P/N 1119165 (French translation). MANUFACTURER: Organogenesis, Inc., Canton, MA, by fax and telephone on October 2, 2006. Firm initiated recall is ongoing. PRODUCT: Apligraf (Graftskin), Recall # Z-0068-2007 REASON: Product pH out of specification. MANUFACTURER: Recalling Firm: Sebia, Inc., Norcross, GA, by fax letter and telephone on or about August 29, 2006. Manufacturer: Sebia, Evry, France. Firm initiated recall is ongoing. PRODUCT: HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Cat. Number 4126, Recall # Z-0073-2007 REASON: The material used in packaging leaches into the product resulting in the presence of an additional artifact band above the HbA fraction. MANUFACTURER: Recalling Firm: ATS Medical, Inc., Minneapolis, MN, by fax on April 7, 2006 and by letter on May 5, 2006. Manufacturer: CryoCath Technologies, Inc., Kirkland, Canada. Firm initiated recall is complete. PRODUCT: CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, Inc., Quebec, Canada. The product consists of a cryosurgical probe (SurgiFrost 7 cm) plus Clamp (FrostByte) packaged for use with Cryosurgical console, Recall # Z-0079-2007 REASON: Incorrect Expiration Date: Three lots of the FrostByte (TM) clamp packaged with SurgiFrost 7 cm cryosurgical probes have incorrect expiration dates. These lots are labeled with a two (2) year expiration date while the correct date is one (1) year. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 25, 2006: CLASS I MANUFACTURER: Recalling Firm: Medtronic Neurological, Minneapolis, MN, by letter beginning June 6, 2006. Manufacturer: Medtronic, Inc. Cardiac Rhythm Management, Minneapolis, MN. Firm initiated recall is ongoing. PRODUCT: Medtronic SynchroMed EL Programmable Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories, Recall # Z-0022-2007 REASON: The Catheter Access Port (CAP) on SynchroMed EL pumps manufactured between March and July 1999 may detach from the main body of the pump, which can interrupt drug flow to the target site. CLASS II MANUFACTURER: Recalling Firm: Extended Care Air Therapy Systems Inc, Roseville OH, by letter on April 5, 2006 and by follow-up letters in May and June Manufacturer: GF Health Products, Inc., Fond Du Lac WI. Firm initiated recall is complete. PRODUCT: ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed, Recall # Z-0026-2007 REASON: Component defect- Following assembly and distribution, two (2) bolts may bend in the bed frame, which may allow the bed to tip into the wall. MANUFACTURER: Becton Dickinson & Company, Franklin Lakes, NJ, by letter on August 24, 2006. Manufacturer: BD Preanalytical Solutions, Sumter, SC. Firm initiated recall is ongoing. PRODUCT: BD Vacutainer Push Button Blood Collection Set with Pre-attached Holder. Non-pyrogenic 100. Rx only, sterile REF 368656 23G x 3/4'' x 12'' 0.6 x 19mm x 305mm ----- REF 367352 21G x 3/4'' x 12'' 0.8 x 19mm x 305mm, Catalog number 367352, Catalog number 367352, Catalog number 367352, Catalog number 368656, Catalog number 368656, Catalog number 368656, Catalog number 368656, Catalog number 368656, Recall # Z-0034-2007 REASON: A complaint was received regarding a BD blood collection set where the blister was noticeably warped. The seal width was below minimum specification. Some blisters could adhere together and crack upon separation. Some units may have pre-activated or have defects affecting package integrity. MANUFACTURER: Recalling Firm: Medline Industries, Inc., Mundelein, IL, by letters dated July 20, 2006. Manufacturer: Changzhou Kwang Yang Motor Co., Ltd, Changzhou, Jangsu, China. Firm initiated recall is ongoing. PRODUCT: a) Medline Strider Maxi 3 Scooter; a three wheeled battery operated scooter; model MDS807600 - red and MDS807600B -- blue, Recall # Z-0036-2007; b) Medline Strider Maxi 4 Scooter; a four wheeled battery operated scooter; model MDS807650 - red and MDS807650B -- blue, Recall # Z-0037-2007 REASON: Under conditions of heavy use, signs of overheating of the main battery cables have been observed. MANUFACTURER: Eagle Parts and Products, Augusta, GA, by letters on July 11, and 28, 2006. Firm initiated recall is ongoing. PRODUCT: a) Eagle Parts and Products Model 624EZ Power Wheel Chairs with internally threaded wheel mount motors, Recall # Z-0039-2007; b) Eagle Parts and Products Model 624Mini Power Wheel Chairs with internally threaded wheel mount motors, Recall # Z-0040-2007 CO/DE Serial numbers 624EZ0010 through 624EZ0513 REASON: The wheel hub bolts may loosen resulting in the wheels coming off. MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter beginning September 30, 2006. Firm initiated recall is ongoing. PRODUCT: GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation, Catalog Numbers 887208 and 887210, Recall # Z-0041-2007 REASON: Missing, mixed or lost patient images may result after X-ray procedures. Navigational error. MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter beginning September 29, 2006. Firm initiated recall is ongoing. PRODUCT: GE OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210, Recall # Z-0042-2007 REASON: X-ray system may lose or mix images and/or lose patient data. MANUFACTURER: Recalling Firm: Bioplate Inc, Los Angeles CA, by telephone on September 14, 2006 and by letter on September 16, 2006 Manufacturer: Midwest Plastic Components, Minneapolis, MN. Firm initiated recall is ongoing. PRODUCT: Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45, Recall # Z-0043-2007 REASON: Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized. MANUFACTURER: Excelsior Medical Corp., Neptune, NJ, by letter on April 24, 2006 and April 28, 2006. Firm initiated recall is complete. PRODUCT: 0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100 under Hospira's label, Syrex, Recall # Z-0044-2007 REASON: The syringe manufacturer mixed a pre-printed heparin labeled flush syringe with the saline syringes. MANUFACTURER: Recalling Firm: Eatonform, Inc., Dayton, OH, by letters on August 2, 2006, August 4, 2006, and August 11, 2006. Manufacturer: Ward/Kraft, Inc., Fort Scott, KN. Firm initiated recall is ongoing. PRODUCT: Doc-U-Dose Prescription Management System, Item #8-PKIT, a daily activity assist device under 21 C.F.R. 890.5050. The product is distributed in cartons. There are 1,000 sets of four (4) packets, or 4,000 individual packets per carton. Each set is one day's worth of four packets, which are labeled, ''morning,'' ''noon,'' ''evening,'' and ''bedtime,'' Recall # Z-0045-2007 REASON: Certain lots of packet components of the firm's Doc-U-Dose Prescription Management System are separating from the paper along the sealed seam at the bottom of the packets causing the medications inside the separated compartments to fall completely out of the packet, or to become mixed into the wrong compartment of the packaging. MANUFACTURER: Respironics California, Inc., Carlsbad, CA, by letter on August 8, 2006. Firm initiated recall is ongoing. PRODUCT: Esprit Ventilator, Model Number V1000, Power Supply PN 1015852 and Power Supply Field Replacement Unit (FRU) PN 1018246, Recall # Z-0047-2007 REASON: This action is being initiated due to power supply snubber board failures on certain Esprit Ventilators in countries that utilize operating voltages of 200-240 Volts AC and will involve the replacement of the Esprit Ventilator power supply snubber board. Returned power supplies have shown evidence of overheating and in some cases, in which a fan also failed, have shown signs of fire damage. MANUFACTURER: Recalling Firm: Draeger Medical, Inc., Telford, PA, by letters on October 3, 2006. Manufacturer: Drager Medical AG & Co. KGAA, Luebeck, Germany. Firm initiated recall is ongoing. PRODUCT: Favius GS Anesthesia Machine. Catalog number 8604699, Recall # Z-0048-2007. REASON: One of four casters may break loose from chassis. MANUFACTURER: Del Medical Systems Group, Franklin Park, IL, by letters dated October 3, 2006. Firm initiated recall is ongoing. PRODUCT: DynaRad Phantom Portable X-Ray System; Phantom model (PH-150-CM & PH-150-G), Recall # Z-0049-2007 REASON: The x-ray tube head assembly of the Phantom Portable X-Ray System may detach from the boom arm assembly. The tube head could fall and contact the patient or operator. MANUFACTURER: Recalling Firm: Medtronic Sofamor Danek Instrument Manufacturing, Bartlett, TN, by letter dated August 1, 2006 and August 2, 2006. Manufacturer: Centex Machining, Inc., Round Rock, TX. Firm initiated recall is ongoing. PRODUCT: Implant Hollow Reamer, 14 mm, REF 8951405, Medtronic Sofamor Danek, Rx only. The product is a bone reamer which is sterilized at the point of use (hospital/clinic), Recall # Z-0050-2007 REASON: Bone reamer may not have a cutting surface on the tip. MANUFACTURER: AGA Medical Corporation, Golden Valley MN, by via fax and letter, dated June 1, 2006. Firm initiated recall is ongoing. PRODUCT: AMPLATZER PFO Occluder. Order No. 9-PFO-018. Device is not PMA approved in the US. 18mm Sterile EO. MRI Compatible. The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh, Recall # Z-0052-2007; b) AMPLATZER PFO Occluder. Order No. 9-PFO-025. Device is not PMA approved in the US. 25mm Sterile EO. MRI Compatible. The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh, Recall # Z-0053-2007 REASON: AMPLATZER PFO Occluders were mislabeled with incorrect device size. The lot M06B01-58 contains 18mm PFO Occluders but is labeled as containing 25mm devices. Lot M06B01-52 contains 25mm PFO Occluders but is labeled as containing 18mm devices. This device was not distributed within the United States and does not affect U.S. consignees. MANUFACTURER: Recalling Firm: General Electric Healthcare, Wauwatosa, WI, by letter dated August 4, 2006. Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. Firm initiated recall is ongoing. PRODUCT: GE ApexPro CH Telemetry System. The ApexPro Telemetry System is composed of 6 major components. -The patient worn data acquisition transmitters; -The receiver antenna system infrastructure; -The receivers; -The receiver subsystem; -A computer platform running the Apex Pro Telemetry Application; -A computer platform running a central station application (which may be the same computer platform running the ApexPro Telemetry Application), Recall # Z-0055-2007 REASON: When a patient being monitored with ApexPro/Apex Pro CH Telemetry with ST monitoring disabled is in a pre-existing condition of continuous MESSAGE or ADVISORY level alarm preceding a SYSTEM WARNING level alarm, the SYSTEM WARNING audible alarm and flashing yellow border around the patient panel at the CIC (Clinical Information Center) does not occur. CLASS III MANUFACTURER: Sunrise Medical, Somerset, PA, by telephone on August 24, 2006 and by letter on August 28, 2006. Firm initiated recall is ongoing. PRODUCT: DeVilbiss iFill Personal Oxygen Station model number 535D, Recall # Z-0038-2007 REASON: Potential for oxygen cylinders to not fill completely. MANUFACTURER: Smiths Medical ASD, Inc., Gary IN, by letter on August 11, 2006. Firm initiated recall is ongoing. PRODUCT: Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D. 8.7 mm, A 7.0 mm, B 0 mm, C 53.0 mm, REF 60A 160, Recall # Z-0046-2007 REASON: The length of the shaft is incorrectly stated as 7 mm, instead of the correct 17 mm, on the outer packaging, although the tray label is correct. MANUFACTURER: Recalling Firm: EM Innovations, Inc. Galloway, OH, by telephone on April 3-5, 2006 and July 11, 2006. Manufacturer: Enterprise Plastics, Kent, OH. Firm initiated recall is ongoing. PRODUCT: Stic Kit Needle Containment Device, Model EMI 82691, packaged 60 per case. Stick-on label on device and User Instruction sheet are attached to the case with a rubber band, Recall # Z-0056-2007 REASON: The firm failed to include User Instructions with the Stic Kit Needle Containment Device, when shipped. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 18, 2006: CLASS II MANUFACTURER: Thoratec Corp., Pleasanton, CA, by letters on January 26, 2004. Firm initiated recall is ongoing. PRODUCT: Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System, Model Numbers: Catalogue numbers: 100118--Short, 14mm graft: #100121--Long, 14mm graft; #100129--Long, 18mm graft, Recall # Z-0015-2007 REASON: During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for risk of embolism. MANUFACTURER: Sunrise Medical CCG, Inc., Stevens Point, WI, by telephone beginning January 2006. Firm initiated recall is ongoing. PRODUCT: Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL, U770 GNDAL, Recall # Z-0016-2007 REASON: The control box used in the actuator systems appears to have a potential to become stuck in one position resulting a non-functioning bed. MANUFACTURER: Hill-Rom, Inc., Batesville, IN, by letter dated August 10, 2006. Firm initiated recall is ongoing. PRODUCT: Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200, Recall # Z-0017-2007 REASON: The patient pendant cord represents a potential trip hazard for the patient or the caregiver. MANUFACTURER: Abbott Diagnostic International, Ltd., Barceloneta,PR, by letter, on September 7, 2006. Firm initiated recall is ongoing. PRODUCT: a) Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use, Recall # Z-0023-2007; b) FSH Calibrators (LN 9C06-01), for in vitro diagnostic use, Recall # Z-0024-2007; c) Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use, Recall # Z-0025-2007 REASON: Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted upwards over time together. MANUFACTURER: 3M Company / Medical Division, South St PaulMN, by letters on August 14, 2006. Firm initiated recall is ongoing. PRODUCT: 3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant, Recall # Z-0027-2007 REASON: 3M Comply 1248 Gas Plasma Chemical Indicator Strips were manufactured with a material that may cause some of the indicators to show an inaccurate result if not read immediately after processing. MANUFACTURER: Lumenis Inc., Santa Clara, CA, by letters and telephone on August 26, 2006. The firm initiated recall is ongoing. PRODUCT: Lumenis brand DuoTome SideLite(tm) 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01, Recall # Z-0028-2007 REASON: Device lacks the black indicator markings on the metal tip and there is the potential for fiber degradation (detachment of the metal cap, and the fiber lasing straight) during use. MANUFACTURER: Hitachi Medical Systems America Inc, Twinsburg, OH, by letter on August 16, 2006. Firm initiated recall is ongoing. PRODUCT: MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J, Recall # Z-0029-2007 REASON: Image orientation error. When a 3D Maximum Intensity Projection (MIP) image data set is transferred from the MRI system to a computer workstation via the DICOM protocol, the anatomical markers do not change between the images as they rotate. MANUFACTURER: Recalling Firm: Arrow International Inc, ReadingPA, by letter on June 20. 2006. Manufacturer: Arrow International, Inc., Mount Holly,NJ. Firm initiated recall is ongoing. PRODUCT: Arrow Double-Lumen Balloon Wedge Pressure Catheter, for sampling blood for oxygen levels and measuring pressures in the right heart, Recall # Z-0030-2007 REASON: The print identifying the two extension lines, CVP Proximal and PA Distal, are reversed. MANUFACTURER: Recalling Firm: AGFA Corp., Greenville, SC, by letter on June 28, 2006. Manufacturer: AGFA Corp., Mortsel, Belgium. Firm initiated recall is ongoing. PRODUCT: CR DX-S, Image Intensified Fluoroscopic X-ray system, Recall # Z-0031-2007 REASON: Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss. MANUFACTURER: Recalling Firm: Gambro Renal Products, Inc., Lakewood, CO, by letter on May 16, 2006. Manufacturer: Gambro Dasco S.p.A, Monitor Division, Medolla, Italy. Firm initiated recall is ongoing. PRODUCT: Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Recall # Z-0032-2007 REASON: A potential risk of infusing air or infusion fluid to the patient during dialysis. Also, a possibility of an incorrect scale reading of the amount of patient fluid removal. MANUFACTURER: AGFA Corp., Greenville, SC, by letter on August 8, 2006. Firm initiated recall is ongoing. PRODUCT: IMPAX® 5.2 Systems with CAD Capability (Computer Assisted Diagnosis), Recall # Z-0033-2007 REASON: Failed CAD displayed as 'No Findings'. MANUFACTURER: Haemonetics Corp., Eastern Maine Medical Center, Braintree, MA, by letters on July 28, 2006. Firm initiated recall is complete. PRODUCT: SmartSuction Harmony Powered Suction Device, Model number: HAR-E-115-US, Recall # Z-0035-2007 REASON: Faulty circuit board may short circuit and cause electric shock to operator. CLASS III MANUFACTURER: Recalling Firm: Integrated Orbital Implants Inc, San Diego,CA, by email on February 27, 2006. Manufacturer: Interpore Cross International Inc, IrvineCA. Firm initiated recall is complete. PRODUCT: Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S, Recall # Z-0012-2007 REASON: The end label on the outer box was mislabeled on 9 of a 10 unit lot. The end label says ''22 mm'' and the implants are actually ''20 mm''. The main label on the cardboard box applied by the contract packager is correct in identifying the product as ''20 mm''. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 11, 2006: CLASS II MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on April 28, 2006. Firm initiated recall is ongoing. PRODUCT: MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system, Recall # Z-0704-06 REASON: Radiation exposure rate could exceed specifications during fluoroscopic x-ray procedure. MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on August 14-15, 2006. Firm initiated recall is ongoing. PRODUCT: a) GE OEC 9900 Elite Digital Mobile C-Arm X-ray system, Recall # Z-1301-06; b) GE OEC 9800 Fluoro C-Arm X-ray system, Recall # Z-1302-06; c) RUS Tool Version Software, Recall # Z-1303-06 REASON: X-ray systems could provide output which exceeds the 20 R/minute limit. MANUFACTURER: General Electric Med Systems, LLC, Waukesha, WI, by GE Field service representative visit beginning on September 22, 2006. Firm initiated recall is ongoing. PRODUCT: GE Precision RX/I System, Recall # 1485-06 REASON: Automatic exposure control (AEC) automatically resets allowing another exposure without requiring manual reset as specified in 21 CFR 1020.31 (a)(3)(iv). MANUFACTURER: Smith & Nephew, Inc., Endoscopy Division, Andover, MA, by letter and telephone on May 22, 2006. Firm initiated recall is ongoing. PRODUCT: Smith & Nephew Hip Positioning System Ref: 72200624 with System Components. Perineal Post 72200631 Universal Hip Distractor 72200626 Knee Holder 72200627 Well Leg Holder 72200632 Supine Table Extension 72200629, Recall # Z-1514-06 REASON: The Perineal Post may crack or break and the Universal Hip Distractor (carriage) may not maintain adequate traction for the duration of the procedure. MANUFACTURER: Pointe Scientific, Inc., Canton, MI, by letters dated June 9, 2006 and June 21, 2006. Firm initiated recall is ongoing. PRODUCT: a) Ammonia/alcohol Control Set for the quantitative determination of ammonia/alcohol in blood. Catalog number A7504-CTL, Recall # Z-1543-06; b) Alcohol Reagent Set for the quantitative determination of ethyl alcohol in serum. Imported and marketed in India. Catalog number A7504-150-S, Recall # Z-1544-06; c) Alcohol Standard, 100 mg/di, Catalog # A7504-STD, Recall # Z-1545-06; d) Alcohol Control, Catalog # 7-A7504-CTL, Recall # Z-1546-06; e) Alcohol Control, Level 1. Catalog # 7-A7504-CTL-L1, Recall # Z-1547-06; f) Alcohol Control, Level 2. Catalog # 7-A7504-CTL-L2, Recall # Z-1548-06; g) Alcohol Standard, Catalog # 7-A7504-STD, Recall # Z-1549-06 REASON: Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability. MANUFACTURER: GE OEC Medical Systems, Inc., Salt Lake City, UT, by letter on May 31, 2006. Firm initiated recall is ongoing. PRODUCT: GE 4 inch Anterior Cervical Post, GE Part Number: 1006385 or 1006385-NAV, (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems), Recall # Z-0001-07 REASON: Weld defect -- the weld between the post body and the screw was not properly formed and can fail, even when minimal force is used. MANUFACTURER: Thoratec Corp., Pleasanton, CA, by letters on August 26, 2006. Firm initiated recall is ongoing. PRODUCT: Thoratec brand TLC-11 Portable Ventricular Assist Device (VAD) Driver, Recall # Z-0004-07 REASON: Sticky valve disk -- The valve disk has an increased tendency to stick during operation causing noise and pressure/vacuum alarms. MANUFACTURER: Stryker Instruments, Division of Stryker Corporation, Portage, MI, by letter dated September 8, 2006. Firm initiated recall is ongoing. PRODUCT: a) Stryker Navigation System, eNite System with Dell laptop computer model D800, Stryker # 7700-300-000, Recall # Z-0005-07; b) Stryker Navigation System Remote Planning Station with Dell laptop computer model D800, Stryker # 7700-010-000, Recall # Z-0006-07; c) Stryker Navigation System, Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064, Recall # Z-0007-07; d) Stryker Navigation System, Navigation Laptop System with Dell laptop computer model D800, Stryker # 6000-200-000, Recall # Z-0008-07 REASON: A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire. MANUFACTURER: Recalling Firm: Smith & Nephew, Inc., Memphis, TN, by letter and telephone on August 29, 2006. Manufacturer: Southeastern Technology, Inc., Murfreesboro, TN. Firm initiated recall is ongoing. PRODUCT: a) Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817, Recall # Z-0009-07; b) Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486, Recall # Z-0010-07; c) Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105, Recall # Z-0011-07 REASON: Tibial punches were not manufactured to specification and could break at the tip during use. CLASS III MANUFACTURER: Axis-Shield Diagnostics, Ltd., Dundee, Scotland, UK, by letter beginning November 11-16, 2005. Firm initiated recall is ongoing. PRODUCT: Axis-Shield DIASTAT Anti-CCP test kit, code FCCP200, Recall # Z-0003-07 REASON: The preservative sodium azide used in the Kit Negative Control (part number FCOM175 was at the wrong concentration -- the Kit Negative Control contains 0.2% sodium azide rather than the intended 0.1%. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of October 4, 2006: CLASS II MANUFACTURER: Terumo Cardiovascular Systems Corp., Tustin, CA, by letters on June 23, 2006. Firm initiated recall is ongoing. PRODUCT: Terumo Khuri Myocardial PH Monitoring System, Catalog number 7205, Recall # Z-1517-06 REASON: Lack of Assurance of Sterility: These specific lots of sensors lack supporting documentation for sterilization assurance. MANUFACTURER: Kerr Corp., Orange CA, by letter on August 14, 2006 and by fax on August 16, 2006. Firm initiated recall is ongoing. PRODUCT: RempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number 28637, Recall # Z-1524-06 REASON: Low Bonding performance: The affected lots of product may not activate properly, which may cause lower than expected bonding performance (due to a low level of chemical cure initiator in the lots manufactured). MANUFACTURER: Recalling Firm: Becton Dickinson and Co., Franklin Lakes, NJ, by letters on July 28, 2006. Manufacturer: BD Medical -- Diabetes Care, Holdrege, NB. Firm initiated recall is ongoing. PRODUCT: BD 1mL Safety Glide Allergy and Tuberculin Syringes. Reorder Number 305945 and 305950, Recall # Z-1525-06 REASON: BD received reports of needle assembly disengagement from the syringe. MANUFACTURER: Ogenix Corporation, Cleveland, OH, by telephone on March 24, 2006. Firm initiated recall is complete. PRODUCT: Clinical Users Guide (CUG) accompanying the EpiFLO SD, Part #01-100-1000000. The EpiFLO is packaged in a sealed poly-bag that contains: 1) one sterile tyvek packaged pouch containing the cannula, 2) one non-sterile EpiFLO generator, and 3) IFU (instructions for use). Five (5) of these packages are then placed in a cardboard box. There is an Ogenix label on the poly bag, on the EpiFLO generator, and on the cardboard box. The EpiFLO SD is intended to provide transdermal sustained oxygen delivery, Recall # Z-1526-06 REASON: Conflicting instructions are provided in the Instructions for Use (IFU) and the Clinical Users Guide (CUG) which accompany the EpiFLO device. Consequently, the firm removed the CUG from distribution. MANUFACTURER: Recalling Firm: International Medsurg Connection, Inc., Schaumburg, IL, by telephone on August 16, 2006 and follow-up letter dated August 24, 2006.Manufacturer: Texstrip Manufacturing, Sdn Bhd, Selangor Daru Pehsan, Malaysia. Firm initiated recall is ongoing. PRODUCT: a) Allegiance Esmark 4” x 108” Bandage, Latex Free, Sterile; 36 bandages per case; Individually wrapped for single patient use, Contents Sterile if Unopened, Undamaged; Catalog 24593-043A, Recall # Z-1527-06; b) Allegiance Esmark 4” x 144” Bandage, Latex Free, Sterile; 36 bandages per case; Individually wrapped for single patient use, Contents Sterile if Unopened, Undamaged; Catalog 24593-044A, Recall # Z-1528-06; c) Allegiance Esmark 6” x 108” Bandage, Latex Free, Sterile; 36 bandages per case; Individually wrapped for single patient use, Contents Sterile if Unopened, Undamaged; Catalog 24593-063A, Recall # Z-1529-06; d) Allegiance Esmark 6” x 144” Bandage, Latex Free, Sterile; 36 bandages per case; Individually wrapped for single patient use, Contents Sterile if Unopened, Undamaged; Catalog 24593-064A, Recall # Z-1530-06; REASON: The bandages labeled as sterile had not been sterilized prior to distribution. MANUFACTURER: Recalling Firm: Codman & Shurtleff, Inc., Raynham, MA, by telephone and fax on August 4, 2006. Manufacturer: Codman Sarl, Lelocle, Switzerland. Firm initiated recall is ongoing. PRODUCT: a) Codman External Drainage System 3 CSF (EDS 3) With Ventricular Catheter Catalog Number: 82-1730, Recall # Z-1533-06; b) Codman External Drainage System 3 CSF (EDS 3) Without Ventricular Catheter Catalog Number: 82-1731, Recall # Z-1534-06 REASON: Sterility of device is compromised due to package seal defects. MANUFACTURER: Recalling Firm: Respironics Novametrix, LLC, Wallingford CT, by letter on August 28, 2006. Manufacturer: Respironics California, Inc., Carlsbad, CA. Firm initiated recall is ongoing. PRODUCT: NICO Model 7300 Cardiopulmonary Management System, Recall # Z-1535-06 REASON: Audible alarm may not sound during an alert condition MANUFACTURER: Recalling Firm: Micrus Endovascular
Corporation, San Jose, CA, by letters on September 8, 2006.
Manufacturer: Lake Region Manufacturing, Inc., Chaska, MN. Firm
initiated recall is ongoing. MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., IndianapolisIN, by letter dated September 15, 2006. Manufacturer: Roche Diagnostics GmbH, PenzbergIndiana, Germany. Firm initiated recall is ongoing. PRODUCT: Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Material No. 03253678122), Recall # Z-1550-06 REASON: Gel-like particle formation; may result in a clot settling in the analyzer measuring cell, which will create a low signal and may cause incorrectly high or low QC and/or patient results depending on the assay method. CLASS III MANUFACTURER: Recalling Firm: Medline Industries Inc., Mundelein, IL, by letters dated July 20, 2006. Manufacturer: Kwang Yang Motor Co., Ltd., Kaohsiung, Taiwan, Republic of China. Firm initiated recall is ongoing. PRODUCT: a) Medline Strider Midi 3 Scooter; a three wheeled battery operated scooter; model MDS807500 -- red and MDS807500B -- blue, Recall # Z-1522-06; b) Medline Strider Midi 4 Scooter; a four wheeled battery operated scooter; model MDS807550 - red and MDS807550B -- blue, Recall # Z-1523-06 REASON: The P&G Solo 60A electronic control unit on the Midi Scooters may overheat. MANUFACTURER: Conva Tec, Skillman, NJ, by letter on July 31, 2006. Firm initiated recall is ongoing. PRODUCT: a) ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm (box of 15) 1 ¾” 45mm; REF 175772; UPC 00031 75772, Recall # Z-1531-06; b) ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm (box of 60) 1 ¾” 45mm; REF 413145; UPC 0034 131445, Recall # Z-1532-06 REASON: Cartons may contain one or more units that are 1 ½” size rather than 1 ¾” size as indicated on the label. MANUFACTURER: Medtronic Neurological, Minneapolis, MN, by a product Hold Order issued August 2, 2006. Firm initiated recall is ongoing. PRODUCT: a) Medtronic 3777 Lead Kit, 1x8 Low Impedance Lead Kit for Spinal Cord Stimulation (SCS), Recall # Z-1536-06; b) Medtronic 3778 Lead Kit, 1x8 Compact Low Impedance Lead Kit for Spinal Cord Stimulation (SCS), Recall # Z-1537-06 REASON: Model 3777 Standard Octad Lead (Lot V009545) and Model 3778 Compact Octad Lead (Lot V009546) were mispackaged. The result of this error is that lead kits labeled 3777 lot V009545 may contain a 3778 compact-spaced lead, while those labeled 3778 lot V009546 may contain a 3777 standard-spaced lead. The result of this error is an overall increase or decrease of 14 mm in the electrode coverage. MANUFACTURER: Recalling Firm: Boston Scientific, Maple Grove, MN, by letter, dated August 31, 2006. Manufacturer: Boston Scientific Corporation, Miami, FL. Firm initiated recall is ongoing. PRODUCT: a) Boston Scientific PT2 Light Support Guide Wire 185cm J-Tip, Catalog Number 38931-01. Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped 'J' tip. Made in USA, Recall # Z-1538-06; b) Boston Scientific PT2 Light Support Guide Wire 300cm J-Tip, Catalog Number 38931-02 . Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped 'J' tip. Made in USA, Recall # Z-1539-06; c) Boston Scientific PT2 Moderate Support Guide Wire 185cm J-Tip, Catalog Number 38931-03 . Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped 'J' tip. Made in USA, Recall # Z-1540-06; d) Boston Scientific PT2 Moderate Support Guide Wire 300cm J-Tip, Catalog Number 38931-04. Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped 'J' tip. Made in USA, Recall # Z-1541-06 REASON: The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 27, 2006 CLASS II MANUFACTURER: General Electric Med Systems LLC, WaukeshaWI, by letter, dated November 24, 2005 was hand delivered to all customers beginning May 15, 2006. Firm initiated recall is ongoing. PRODUCT: GE Precision 500D Radiographic and Fluoroscopic Imaging System, Stationary X-ray System consisting of an X-ray generator; angulating table with x-ray Tube, collimator and image intensifier; wall stand; Overhead tube suspension; operator console and digital archive system, Recall # Z-1304-06 REASON: Systems are non-compliant with Federal Performance Standard Title 21, Code of Federal Regulation (CFR), 1020.32(a)(1) in that the systems allow the production of x-rays when the primary protective barrier is not in position to intercept the entire cross section of the useful beam MANUFACTURER: Hill-Rom, Inc., Batesville, IN, letter dated August 18, 2006. Firm initiated recall is ongoing. PRODUCT: Hil-Rom Affinity Three Birthing Bed, Model P3700, Recall # Z-1503-06 REASON: The cable on the auxiliary outlet may become pinched, which may result in an electrical short with melting of the plastic transformer and the emission of smoke. MANUFACTURER: Recalling Firm: Therakos, Inc., Exton, PA, by letter dated July 18, 2006. Manufacturer: Harmac Medical Products, Inc., Buffalo, NY. Firm initiated recall is ongoing. PRODUCT: Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument, Catalog number XT125, Recall # Z-1504-06 REASON: Centrifuge Bowl may leak. MANUFACTURER: Recalling Firm: Becton Dickinson & Co, SparksMD, by e-mail, faxed letters, and certified courier on August 17, 2006 Manufacturer: Oxoid, Ltd, Basingstoke, UK. Firm initiated recall is ongoing. PRODUCT: BD™ BBL™ Staphyloslide Latex Test Kit, Catalog # 240952 (100 tests/kit) and Catalog # 240953 (500 tests/kit), packaged in a kit configuration with test reagents and labware, Recall # Z-1505-06 REASON: False Negative Staphylococcus aureus results which could prevent infected patients from receiving antimicrobial treatment; due to the failure of the Positive Control to react within 20 seconds. The failure is due to reduced reactivity of the latex component. MANUFACTURER: Conmed Electrosurgery, Centennial,CO, by letter on September 1, 2006 and September 7, 2006. Firm initiated recall is ongoing. PRODUCT: a) Conmed System 2500 Electrosurgical Unit, REF 60-8011-SYS, Recall # Z-1507-06; b) Conmed System 5000 Electrosurgical unit, REF 60-8005-SYS, 60-8015-SYS, 60-8018-SYS, 60-8005-001, 60-8005-003, Recall Z-1508-06 REASON: Wrong size capacitor installed in electrosurgical generator could malfunction, causing muscle stimulation or delay in therapy. MANUFACTURER: Invacare Corp., Elyria, OH, by telephone on June 23, 2006 and by letter dated June 26, 2006. Firm initiated recall is ongoing. PRODUCT: a) Solara 2G manual wheelchair, Recall # Z-1509-06; b) Solara Spree GT manual wheelchair, Recall # Z-1510-06; c) Solara Spree XT (SPRXT) manual wheelchair, Recall # Z-1511-06 REASON: The wheelchairs with the Travel Ready Option (TRRO) may contain incorrectly finished oval tie down brackets. The inner edge of the bracket may cause the tie-down straps (used to tie down the chairs during transport) to fray or be cut. MANUFACTURER: Recalling Firm: Boston Scientific, Maple Grove,MN, by letters dated July 21, 2006. Manufacturer: Boston Scientific Corporation, etterkenny, Ireland. Firm initiated recall is ongoing. PRODUCT: Boston Scientific Cutting Balloon Ultra2 Monorail Device, Recall # Z-1512-06 REASON: Lack of assurance of sterility (pre-sterilization bioburden limits exceeded) MANUFACTURER: Styker Medical Division of Styker Corp., Portage, MI, by letter dated August 29, 2006. Firm initiated recall is ongoing. PRODUCT: Stryker Power-Pro Powered Ambulance Cot, Model 6500, Recall # Z-1513-06 REASON: The head section wheel assembly may flex outward from the cot because the head section wheel bolts, which hold the assembly upright, may back out. MANUFACTURER: Bayer Healthcare, LLC (Diagnostics Division), Tarrytown, NY, by e-mail on August 4, 2006. Firm initiated recall is ongoing. PRODUCT: ADVIA Centaur CP System, Automated Immunoassay Analyzer, Part/Catalogue Number 086-A001, Recall # Z-1516-06 REASON: Sample/Patient mis-identification (software defect) the system can associate a test result and sample identification (SID) with an incorrect patient name when the Patient Demographics feature is used and the Patient Identification (PID) field is left blank. MANUFACTURER: Recalling Firm: Beckman Coulter Inc, BreaCA, by letter was sent on July 28, 2006. Manufacturer: Beckman Coulter Inc, Florence, KY. Firm initiated recall is ongoing. PRODUCT: UniCel Dxl 800 Access Immunoassay Systems Wash Buffer, Part Number 8547197 Wash Buffer, Recall # Z-1518-06 REASON: The neck of the wash buffer cube can be extended higher than intended possibly causing the system to aspirate air instead of buffer before the buffer container is empty without the system immediately indicating that the supply is empty. This may lead to incorrect assay results. MANUFACTURER: Kerr Corp, Orange, CA, by letter on August 29, 2006. Firm initiated recall is ongoing. PRODUCT: OptiBond Solo Plus Self-Etch Adhesive System, Part Number 31966, Recall # Z-1521-06 REASON: Mis-pack/mis-label: The OptiBond Self Etch Primer and OptiBond Solo Plus Adhesive in the chambers were mis-packaged/mis-labeled in reverse order. Application of these products in reverse order may result in compromised bond strength. CLASS III MANUFACTURER: Recalling Firm: J. Jamner Surgical Instruments, Inc., Hawthorne, NY, by letter dated April 24, 2006. Manufacturer: Rebstock, Durbheim, Germany. Firm initiated recall is ongoing. PRODUCT: Ruggles(tm) Leyla Ball Joint Clamp, MODEL/CATALOG #: R2383. The Leyla Ball Joint Clamp is part of the Table Mounting Hardware that is used with the Leyla Retractor System. The Leyla Table Mounting Hardware consists of the Ball Joint Clamp, the Rigid Holding Rod, the Coupling Head, and the Coupling Head Turn Table. The Ball Joint Clamp is available individually or as part of the Table Mount Set. The Table Mounting Hardware are attachments to operating room surgical tables. The product is supplied non-sterile and may be packaged individually or as part of the Table Mount Set, Recall # Z-1506-06 REASON: The Ruggles(tm) Leyla Ball Joint Clamp may not properly tighten onto the Rigid Holding Rod. Although this condition can be observed during assembly, if the device were to be used during surgery, any attachments to the Rigid Holding Rod could move. MANUFACTURER: Recalling Firm: Porex Surgical, Inc., Newnan, GA, by telephone, on July 11, 2006 and follow-up letter on July 12, 2006. Manufacturer: G. E. Silicones, Lic, Waterford, NY. Firm initiated recall is ongoing. PRODUCT: Porex Nostril Retainers, Catalog #7241, Size 4, Recall # Z-1515-06 REASON: Device contains a trace amount of amine via introduction through an intermediate supplied by a third party raw material. MANUFACTURER: Biogenex Laboratories, San RamonCA, by letter on September 5, 2006. Firm initiated recall is ongoing. PRODUCT: Anti-CD45 Cocktail antibody in 6 ml vials; Cat. No. AM371-5M, Recall # Z-1519-06 REASON: Mislabeling: Anti-CD45 cocktail antibody mislabeled as Ki-67. MANUFACTURER: Oasis Medical, Inc., Glendora, CA, by fax and certified mail on July 5, 2006. Firm initiated recall is ongoing. PRODUCT: OASIS® Medical SOFT PLUG® Extended Duration Plug, Reference 6403, Recall # Z-1520-06 REASON: Labeled with an incorrect diameter. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 20, 2006 CLASS I MANUFACTURER: Recalling Firm: Disetronic Medical System, Fishers, IN, by press release and letter dated July 13, 2006. Manufacturer: Disetronic Medical Systems AG, Burgdorf, Switzerland. Firm initiated recall is ongoing. PRODUCT: Disetronic D-TRONplus Insulin Pump Battery Pack; Ref/Catalog no. 04697014001, Recall # Z-1413-06 REASON: The battery may turn the pump off without warning due to a design change in the battery. MANUFACTURER: Medtronic Neurological, Minneapolis,MN, by letter on July 20, 2006. Firm initiated recall is ongoing. PRODUCT: a) Medtronic Intrathecal Catheter, Model 8731, (part of infusion systems using Medtronic implantable pumps) The catheter is designed for use in the intrathecal space, Recall # Z-1414-06;b) Medtronic Intrathecal Catheter Distal Revision Kit, Model 8598, (provides replacement parts for the distal section of the 8731 Intrathecal Catheter), Recall # Z-1415-06 REASON: Tip dislodgement during implantation-Medtronic is recalling Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit because the platinum-iridium tip may be dislodged by the guide wire during implantation. MANUFACTURER: Cardinal Health 303 Inc DBA Alaris Products, San Diego, CA, by letters dated August 15, 2006. Firm initiated recall is ongoing. PRODUCT: Alaris® SE Pump (formerly Signature Edition® Infusion Pump); Model Numbers: 7000, 7100, 7101, 7130, 7131, 7132, 7200, 7201, 7230, 7231, and 7232, Recall # Z-1484-06. REASON: This recall was initiated because of a potential for over infusion with all models of the Alaris® SE Pumps (formerly the Signature Edition® Infusion Pumps) caused by key bounce. CLASS II MANUFACTURER: Recalling Firm: Becton Dickinson & Company, Franklin Lakes,NJ, by letters on June 21, 2006. Manufacturer: BD Preanalytical Solutions, Sumter,SC. Firm initiated recall is ongoing. PRODUCT: a) BD Vacutainer Blood Collection Assembly with BD Blunt Plastic Cannula; Catalog #303380, Recall # Z-1461-06;b) BD Vacutainer Luer Adapter; Catalog #367290 and #367300, Recall # Z-1462-06;.c) BD Direct Draw Adapters, Catalog Number 364896, Recall # Z-1463-06 REASON: Firm received complaints indicating failure of the Non-Patient (NP) sleeve to function properly. This sleeve covers the cannula and prevents leakage during blood collection. MANUFACTURER: Recalling Firm: Philips Medical Systems, AndoverMA, by letter dated July 21, 2006. Manufacturer: Philips Medizin Systeme Boblingen Gmbh, Boblingen, Federal Republic of Germany. Firm initiated recall is ongoing. PRODUCT: IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient monitoring system. Model: M3001A, Recall # Z-1487-06 REASON: Patient monitor may display inaccurate reading when the Disposable Sp02 Sensor is not attached MANUFACTURER: Recalling Firm: Cobe Cardiovascular, Inc, Arvada, CO, by telephone and e-mail on August 4, 2006. Manufacturer: Sorin Group Italia Srl, Mirandola Modena, Italy. Firm initiated recall is ongoing. PRODUCT: a) dideco Preassembled Surgical Wash Set, Compact , Cobe part numbers WS55C, WS125C, WS225C, Recall # Z-1488-06;b) dideco Preassembled Surgical Wash Set, Electa Essential , Cobe part numbers WS55E, WS125E, WS175E, WS225E, Recall # Z-1489-06; c) Cobe STAT PAC, Autotransfusion Set (Made with Compact Wash Sets), Cobe Product Codes: AS4C12, AS4C22, ASCBC12C, ASCBC22C, ASCBFC22C, Recall # Z-1490-06;d) Cobe STAT PAC Autotransfusion Set (made with Electa Wash Set), Cobe Product Codes: ASCBFE22, ASCBE22, AS9E55, AS9E22, AS9E12, AS4E55, AS4E22, AS4E17, Recall # Z-1491-06 REASON: Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood. MANUFACTURER: Recalling Firm: Cordis Corporation, Miami Lakes, FL, by letter on July 21, 2006. Manufacturer: Lake Region Mfg Co, Inc, ChaskaMN. Firm initiated recall is ongoing. PRODUCT: a) CORDIS SV-5 Steerable Guidewire, 180 cm., 5 Steerable Guidewires, ENDOVASCULAR, Catalog # 503558, Recall # Z-1492-06; b) CORDIS-SV-5 Steerable Guidewire, 300 cm.,5 Steerable Guidewires, Cordis a Johnson Johnson Company ,ENDOVASCULAR, Catalog # 503558X, Recall # Z-1493-06; c) CORDIS SV-8 Steerable Guidewire, 180 cm, 5 Steerable Guidewires, ENDOVASCULAR, Catalog # 503658, Recall # Z-1494-06; d) CORDIS SV-8 Steerable Guidewire, 300 cm., 5 Steerable Guidewires, ENDOVASCULAR, Catalog # 503658X, Recall # Z-1495-06 REASON: Tip separation-Cordis SV-5 and SV-8 Steerable Guidewires may have a potential for guidewire fracture resulting in tip separation. MANUFACTURER: Recalling Firm: Skytron, Div. The KMW Group, Inc, Grand Rapids, MI, by a service bulletin on August 12, 2005. Manufacturer: Mizuho Medical Co, Ltd., Tokyo, Japan. Firm initiated recall is ongoing. PRODUCT: a) Skytron General Purpose Surgical Table; Model 6600, Recall # Z-1496-06; b) Skytron General Purpose Surgical Table, battery model; Model 6600B, Recall # Z-1497-06 REASON: The release levers can inadvertently release under load while the leg section is positioned at a ninety degree angle causing the leg section to drop. MANUFACTURER: Greiner Bio-One North America, Inc., Monroe, NC, by fax on August 2, 2006. Firm initiated recall is ongoing. PRODUCT: Greiner bio-one, Vacuette® Tube * 9C Coagulation Sodium, Citrate 3.2%, * 3.5mL * blue cap-black ring * 24 racks of 50, 1200 pcs in total * non-ridged * Sandwich Tube * 454332 * B050609 * 2007-05 * Sterile *, Recall # Z-1498-06 REASON: Coagulation tubes found with no additive. MANUFACTURER: Boston Scientific Corp, Spencer,IN, by letter on August 10, 2006. Firm initiated recall is ongoing. PRODUCT: Boston Scientific vanSonnenberg Sump with 'J' Tip, 30 cm, 14Fr (4.7 mm), for percutaneous abscess and fluid drainage, single use only, sterile; UPN M001202010, REF/Catalog No. 20-201, Recall # Z-1499-06 REASON: Lack of assurance of sterility, as the sterile barrier is weak and may be damaged on one edge. MANUFACTURER: Xiros Plc, Leeds, United Kingdom, by telephone and letters on June 1, 2006. Firm initiated recall is ongoing. PRODUCT: a) Neoligaments Staple Impactor, 6 mm Staple Impactor: 202-3001, Recall # Z-1500-06; b) Neoligaments Staple Impactor, 8 mm Staple Impactor: 202-3010, Recall # Z-1501-06 REASON: The impactors are being recalled for modification so that they can be disassembled fully for cleaning and sterilization, on suspicion that the assembled items retain contamination after cleaning and may not be effectively sterilized by the recommended hospital sterilization cycles. MANUFACTURER: Medtronic Emergency Response Systems, Inc., Redmond, WA, by letter on August 30, 2006. Firm initiated recall is ongoing. PRODUCT: LIFEPAK 20 external defibrillator/monitor, Recall # Z-1502-06 REASON: Devices with v38 system software do not display a "LOW BATTERY: CONNECT TO AC POWER" message when the monitor is on backup (DC) battery power and may shut down without warning. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 13, 2006 CLASS I MANUFACTURER: Recalling Firm: Bausch & Lomb, Rochester, NY, by press release on April 13, 2006 and by letters on April 14, 2006. Manufacturer: Bausch & Lomb, Greenville, SC. Firm initiated recall is ongoing. PRODUCT: Bausch & Lomb * ReNu® with MoistureLoc®, Multi-purpose soft contact lens solution * Sterile, Recall # Z-1201-06 REASON: Reports of Fusarium Infections among contact lens wearers CLASS II MANUFACTURER: Recalling Firm: Radiometer America Inc., Westlake, OH, by letter in November 2005. Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall ongoing. PRODUCT: D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor). Model #D826, Part Number: 904-308, Recall # Z-1436-06 REASON: Excessive Drift-the membrane units of the device cause the electrode to exceed performance standards for drift in the first two or more calibrations MANUFACTURER: Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter on June 26, 2006. Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing. PRODUCT: FP1000 Cell Preparation System Part Number 624922, Recall # Z-1466-06 REASON: During the cleaning cycle performed during the shutdown procedure of the Beckman Coulter FP1000 Cell Preparation System, fluid (diluted bleach) may drip from the probe in the location of the back reagent rack potentially resulting in bleach and/or water dripping into the reagents contaminating them and resulting in possible incorrect results. MANUFACTURER: Zimmer Inc., Warsaw, IN, by letter dated August 2, 2006. Firm initiated recall is ongoing. PRODUCT: a) Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 14, 135 mm stem length, tivanium Tl-6AL-4V alloy, sterile, w/calcicoat ceramic coating; Cat. no. 65-7861-14-04 (65786101404), Recall # Z-1467-06;b) Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 14, 135 mm stem length, tivanium TI-6AL-4Valloy, sterile; Cat. no. 7861-14-04 (00786101404), Recall # Z-1468-06;c) Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 15, 140 mm stem length, tivanium TI-6AL-4V alloy, sterile; Cat. no. 7861-15-04 (00786101504), Recall # Z-1469-06;d) Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 17, 150 mm stem length, tivanium TI-6AL-4V alloy, sterile; Cat. no. 7861-17-04 (00786101704), Recall # Z-1470-06;e) Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit,collarless, 12/14 neck taper - standard body -extended neck offset, size 14, 149 mm stem length, sterile, tivanium TI-6AL-4V alloy/tantalum, sterile; Cat. no. 00-7864-014-20 (00786401420), Recall # Z-1471-06;f) Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit, collarless, 12/14 neck taper - standard body -extended neck offset, size 15, 160 mm stem length, sterile, tivanium TI-6AL-4V alloy/tantalum, sterile; Cat. no. 00-7864-015-20 (00786401520), Recall # Z-1472-06;g) Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit, collarless, 12/14 neck taper - standard body -standard neck offset, size 16, 171 mm stem length, sterile, tivanium TI-6AL-4V alloy/tantalum, sterile; Ref. no. 00-7864-016-00 (Cat. no. 00786401600), Recall # Z-1473-06;h) Zimmer MAYO Conservative hip prosthesis femoral stem, porous, 12/14 neck taper, large+, tivanium TI-6AL-4V alloy, sterile; REF. 8026-13-05 (Cat. no. 00802601305), Recall # Z-1474-06;i) Zimmer MAYO Conservative hip prosthesis femoral stem, porous, 12/14 neck taper, extra large, tivanium TI-6AL-4V alloy, sterile, REF. 8026-14 (Cat. no. 00802601400), Recall # Z-1475-06;j) Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, extended, 46 mm neck offset, spout body, size D, 35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9990-20-46 (Cat. no. 00999002046), Recall # Z-1476-06;k) Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, extended, 46 mm neck offset, cone body, size C, 55 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9993-19-55 (Cat. no. 00999301955), Recall # Z-1477-06;l) Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, standard, 40 mm neck offset, cone body, size C, 35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9996-19-35 (Cat. no. 00999601935), Recall # Z-1478-06;m) Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, standard, 40 mm neck offset, cone body, size C, 45 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9996-19-45 (Cat. no. 00999601945), Recall # Z-1479-06; n) Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, standard, 40 mm neck offset, cone body, size F, 35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9996-23-35 (Cat. no. 00999602335), Recall # Z-1480-06 REASON: Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly. MANUFACTURER: Cordis Neurovascular, Inc., Miami Lakes, FL, by letter on August 14, 2006. Firm initiated recall is ongoing. PRODUCT: a) Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters, Recall # Z-1482-06; b) Cordis Neurovascular Pre-Shaped Prowler Select Infusion Catheters, Recall # Z-1483-06 REASON: Sterility (package integrity) compromised-Cordis Neurovascular, Inc. discovered, during internal testing, that some catheters within the affected lots of CNV preshaped PROWLER and pre-shaped PROWLER SELECT Infusion Catheters may have a pinhole or tear in the Mylar pouch, which may result in a compromise of the sterility inside the pouch. MANUFACTURER: Recalling Firm: Invacare Corporation, ElyriaOH, by letter on or about July 20, 2006. Manufacturer: Kuschall Ag, Witteswil, Switzerland. Firm Initiated recall is ongoing. PRODUCT: Kuschall's K3/K4 Series of Manual Wheelchair, Model Airlite, Recall # Z-1486-06 REASON: If the user has chosen to install optional anti-tippers on the chair, the anti-tipper as designed may not be able to bear the stress of repeated or quick loads placed on it, causing the bolt to bend or break. CLASS III MANUFACTURER: Hardy Media Inc Dba Hardy Diag, Santa MariaCA, by telephone on June 28, 2006. Firm initiated recall is ongoing. PRODUCT: BHI Agar with Vancomycin, for in vitro diagnostic use. Catalog # G14, Recall # Z-1451-6 REASON: This recall is being conducted due to the performance failure nearing the end of the product shelf life. MANUFACTURER: CryoCath Technologies Inc., Kirkland, Canada, by letter on August 4, 2006. Firm initiated recall is ongoing. PRODUCT: 7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc. Recall # Z-1452-06 REASON: Outer cartons of catheters were mislabeled with two different reference numbers. The front of the package showed the correct reference number; 207F1, however the section on the top of the box incorrectly referenced 207F3. All inside labels (inside the box and affixed on device pouches) showed the correct reference number, 207F1 MANUFACTURER: Recalling Firm: Radiometer America Inc., Westlake, OH, by a Field Action memo on April 7, 2006. Manufacturer: Radiometer Medical ApS, Akandevej 21,Bronshoj, Denmark. Firm initiated recall is ongoing. PRODUCT: TCM4 Series Monitoring System (Base Unit) Model: 391-876 (affected device), transcutaneous oxygen monitor; Compact Flash cards - Model #: 914-698 (Defective Device Component), Recall # Z-1453-06 REASON: System shut down-When the TCM Monitor is turned on and the booting process begins, the device stops after the memory count and will not proceed further. MANUFACTURER: Recalling Firm: Radiometer America Inc., Westlake, OH, by e-mail dated October 31, 2005. Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is complete. PRODUCT: S1730 Calibration Solution 2, 200 mL, packed in single unit plastic bottles, REF 944-025, used with ABL700 Series Blood Gas Analyzers. Part #944-025, Recall # Z-1460-06 REASON: Calibration solution for ABL700 Blood Gas Analyzers is labeled with an incorrect bar code. The bar code identified on the Cal Solution 2 product is actually the bar code for the rinse solution. MANUFACTURER: Recalling Firm: Konica Minolta Medical Imaging USA, Inc., Wayne, NJ, by telephone on July 14, 2006. Manufacturer: Konica Minolta Medical & Graphic, Inc., Tokyo, Japan. Firm initiated recall is terminated. PRODUCT: Regius Model 370 Digital Radiography Konica Minolta, Recall # Z-1481-06 REASON: A hand grip column, even though locked in position, moved downward about 3 cm while a patient was holding the hand grip for lateral exposure. When the hand grip moved down, the patient who was holding it lost his or her balance and almost fell. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of September 6, 2006 CLASS II MANUFACTURER: Recalling Firm: Guidant Corporation, Saint Paul MN, by letters dated June 23, 2006 and press release on June 26, 2006, FDA issued a statement on July 11, 2006. Manufacturer Firm: Guidant-Ireland, Clomel, Ireland. Firm initiated recall is ongoing. PRODUCT: a) Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0484 and 0485); DDD (models 0985, 0986); SR (models 1195, 1198); and DR (models1294, 1295, 1296). Intermedics NEXUS Entra family of pacemakers includes the following: SSI (model 1326); DDD (model 1426); SR (model 1398) and DR (model 1466, 1494). The INSIGNIA I Entra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Entra pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. The INSIGNIA and NEXUS I Entra adaptive-rate models have an accelerometer, which is a motion sensor that responds to patient activity. Sterilized with gaseous ethylene oxide, Recall # Z-1293-06;b) Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and DR (models1290, 1291). Intermedics NEXUS I Ultra family of pacemakers includes the following: SR (model 1390) and DR (model 1490, 1491). The Intermedics NEXUS I Ultra (models 1390, 1490, 1491) are not available in the US. The INSIGNIA I Ultra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Ultra pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. These pacemakers include ventricular Automatic Capture which automatically measures the ventricular pacing threshold and adjusts the pacing output to 0.5 V above the measured threshold. Two sensors are available: these adapt the pacing rate to the patient's changing metabolic demand. Minute ventilation responds to changes in respiration, and the accelerometer responds to patient activity (motion). INSIGNIA and NEXUS I Ultra models can use either the accelerometer or minute ventilationsensor, or a blend of both accelerometer and minute ventilation. Sterilized with gaseous ethylene oxide. Recall # Z-1294-06; c) Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (models1194); and DR (models1297, 1298). Intermedics NEXUS I Plus family of pacemakers includes the following: DR (model 1467, 1468). The INSIGNIA I Plus pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Plus pacemakers are multiprogrammable pacemakers from Intermedics. The familyconsists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. Two sensors are available: these adapt the pacing rate to the patient's changing metabolic demand. Minute ventilation responds to changes in respiration, and the accelerometer responds to patient activity (motion). INSIGNIA and NEXUS I Plus models can use either the accelerometer or minute ventilation sensor, or a blend of both accelerometer and minute ventilation. Sterilized with gaseous ethylene oxide, Recall # Z-1295-06;d) Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482), VDD (model 882), DDD (model 982), SR (model 1192 and DR (model 1292). Intermedics NEXUS I AVT family of pacemakers includes the following: VDD (model 1428), DDD (model 1432), SR (model 1392) and DR (model 1492). The INSIGNIA I AVT pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I AVT pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. These pacemakers include ventricular Automatic Capture which automatically measures the ventricular pacing threshold and adjusts the pacing output to 0.5 V above the measured threshold. The INSIGNIA and NEXUS I Plus adaptive-rate models have an accelerometer, which is a motion sensor that responds to patient activity. Sterilized with gaseous ethylene oxide. ****The following devices are not available in the US, Recall # Z-1296-06;e) Guidant VENTAK PRIZM VR (model 1860) and VENTAK PRIZM DR (model 1861) Automatic Implantable Cardioverter Defibrillator (AICD), Dual Chamber, Sterilized with gaseous ethylene oxide. Implantable cardioverter defibrillators (ICDs) are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy. Therapies include both low- and high-energy shocks using either a biphasic or monophasic waveform. Bradycardia pacing, including adaptive-rate features, is available to detect and treat bradyarrhythmias and to support the cardiac rhythm after defibrillation therapy. VENAK PRIZM 2 devices offer dual-chamber bradycardia features (atrial and /or ventricular pacing and sensing), and VENTAK PRIZM 2 VR devices offer single-chamber bradycardia features (ventricular pacing and sensing), Recall # Z-1297-06;f) CONTAK RENEWAL TR (models H120, H125) and CONTAK RENEWAL TR2 (models H140, H145). CONTAK RENEWAL TR2 devices are not available in the US. The devices are designed to provide cardiac resynchronization therapy by providing biventricular electrical stimulation to synchronize the right and left ventricular contractions. The device also provides adaptive-rate bradycardia therapy. The pulse generator has independent, programmable outputs for the atrium, right ventricle and left ventricle, Recall # Z-1298-06;g) VITALITY (models 1870, 1871, T125, T127, T135) and VITALITY 2 (models T165, T167, T175, T177). Implantable Cardioverter Defibrillators (ICD), are designed to detect and terminate ventricular tachycardia (VT) and ventricular fibrillation (VF) and provide bradycardia therapy (atrial and ventricular pacing). Therapies include both low- and high-energy shocks using either a biphasic or monophasic waveform. Vitality 2 devices also offer a wide variety of antitachycardia pacing schemes to terminate slower, more stable ventricular tachyarrhythmias. Bradycardia pacing, including adaptive-rate features, is available to detect and treat bradyarrhythmias and to support the cardiac rhythm after defibrillation therapy. Devices denoted with DR offer dual-chamber bradycardia features (atrial and/or ventricular pacing and sensing), and the devices denoted with VR offer single-chamber bradycardia features (ventricular pacing and sensing), Recall # Z-1299-06 REASON: Guidant has determined that low-voltage capacitors from a single component supplier may malfunction in a manner that can lead to premature battery depletion or loss of pacing output without warning in the affected devices. MANUFACTURER: Bayer Healthcare, LLC (Diagnostics Division), TarrytownNY, by Support Bulletins on March 16, 2006. Firm initiated recall is ongoing. PRODUCT: ADVIA 2120 systems --Automated Complete Blood Cell and Differential Cell Counter, Recall # Z-1376-06 REASON: The ADVIA 2120 has reported ; highly intermittent low results on all primary results: White Blood Cells (WBC), Red Blood Cells (RBC), Hemoglobin (HGB) and Platelets (PLT) and an abnormal baso cytogram. MANUFACTURER: Recalling Firm: Radiometer America Inc,
WestlakeOH, by letter dated February 2, 2005. Manufacturer Firm:
Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is
complete. REASON: Alarm may be silenced- Rapid switching, on and off, of the TCM4 monitor may cause the built-in acoustical alarm to remain silent when tripped. MANUFACTURER: Biogenex Laboratories, San RamonCA, by letters on June 5, 2006. Firm initiated recall is ongoing. PRODUCT: a) BioGenex brand Hepatitis B Virus Core Antigen Antibody, Cat. No. AR082-5R and PU082-UP, Recall # Z-1438-06; b) BioGenex brand Hepatitis B Virus Surface Antigen Antibody, Cat. No. AM364-5M and MU364-UC, Recall # Z-1439-06 REASON; Misbranding-The product labeling (label and insert) is misbranded in that the product does not comply with the labeling requirements for an Analyte Specific Reagent (ASR). MANUFACTURER Beckman Coulter, Inc., Brea, CA, by letter the week of May 15, 2006. Firm initiated recall is ongoing. PRODUCT: UniCel DxC 600/600PRO/600i/800/800PRO Synchron Clinical Systems, Part Numbers: A20463-Software version 1.0, A27331-Software version 1.2, A29764-Software version 1.4, Recall # Z-1440-6 REASON: Incorrect Reagent Status-When a new cartridge of Infinity Lithium Reagent is loaded on to the UniCel DxC System, the Reagent Status screen will incorrectly show 'Days Left' as 21. The correct Reagent Status for a new Lithium reagent cartridge is 14 days. Lithium reagent used past 14 days may produce low quality control and/or patient results. MANUFACTURER: Recalling Firm: Diagnostica Stago, Inc., Parsippany NJ, by letter on July 18, 2006. Manufacturer: Diagnostica Stago, Franconville, France. Firm initiated recall is ongoing. PRODUCT: Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay, Recall # Z-1441-06 REASON: Decrease in sensitivity; This could result in a false negative result for patients with weak to moderate lupus anticoagulants. MANUFACTURER: Recalling Firm: Radiometer America Inc, WestlakeOH, letter on June 29, 2006. Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing. PRODUCT: SafeClinitubes, Capillary caps (purple), 905-787. The defective capillary caps may be included in capillary tube kits as follows: Clinitubes Kits: 942-890 (D941P-240-85x1), Lot Code: R0048; Clinitubes Kits: 942-892 (D957P-70-100x1), Lot Codes: R0045 through R0050; Clinitubes Kits: 942-893 (D957P-70-125x1), Lot Codes: R0058 through R0063; Clinitubes Kits: 942-898 (D957P-70-70x1), Lot Code: R0019. Each of the kits listed above contains one (1) bag of Capillary Caps, 905-787, Recall # Z-1442-06 REASON: Leaking Capillary Caps- The dimensions and shapes of the capillary caps do not fit the capillary tubes correctly. This can cause the capillary tubes to leak. MANUFACTURER: Recalling Firm: Radiometer America Inc, WestlakeOH, letter on July 18, 2006. Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing. PRODUCT: safePICO Samplers, self-filling arterial blood samplers. The syringe blood samplers are individually packed in plastic pouches and distributed in cartons. Each carton contains ten (10) boxes and each box contains 100 pouches. The product subject to recall is identified with the following Part Numbers/Order No: 956-610, 956-612, 956-614, 956-616, and 956-623, Recall # Z-1443-06 REASON: Leaking Tip Caps- Tip caps may leak; after air has been expelled from the syringe through the vented safe tip caps. MANUFACTURER: Recalling Firm: Delphi Medical Systems, TroyMI, by letter dated March 29, 2005. Manufacturer: Delphi Medical Systems Colorado Operations, LongmontCo. firm initiated recall is ongoing. PRODUCT: Delphi IVantage Volumetric Ambulatory Infusion Pump/System; Ref nos. 12864051FRE, Rev. 8 and 12864051DEL, Rev. 8, Recall # Z-1445-06 REASON: Potential for under-infusion without alarm; Cassette rollers stop moving , but the pump shaft continues rotating without alarm. MANUFACTURER: Recalling Firm: Becton Dickinson & Co., Franklin Lakes, NJ, by letter on July 1, 2005. Manufacturer: Becton Dickinson Caribe, Ltd., San Lorenzo, PR. Firm initiated recall is complete. PRODUCT: BD Unopette -- System Tests (Erythrocyte Fragility Test Kit). Catalog # 365830, Recall # Z-1446-6 REASON: Formulation problems. Lower pH of the solutions may increase Red Blood Cell hemolysis. MANUFACTURER: Bayer Healthcare, LLC (Diagnostics Division), TarrytownNY, issued a Support Bulletin on/about February 17, 2006. Firm initiated recall is ongoing. PRODUCT: a) ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer -- human serum, plasma and urine tests, Recall # Z-1448-06; b) ADVIA 1200 Chemistry System, Automated Clinical Chemistry Analyzer -- human serum, plasma and urine tests, Recall # Z-1449-06; c) ADVIA 2400 Chemistry System, Automated Clinical Chemistry Analyzer -- human serum, plasma and urine tests, Recall # Z-1450-06 REASON: Low QC recovery observed on carbamazepine (CARB) results immediately following a Gentamicin (GENT) assay or - Digoxin (DIG) assay. When GENT or DIG precedes CARB, the CARB test result is artificially low (as much as --25%). PHNY was determined to also exhibit a similar carryover effect on CARB. All others were found not to produce the same reagent probe-based carryover effect. MANUFACTURER: Pointe Scientific, Inc., Canton, MI, by letter dated June 12, 2006. Firm initiated recall is ongoing. PRODUCT: a) Product Description: Liquid AutoHDL Cholesterol Reagent Set, Catalog Nos. HH945-240, HH945-480, H7545-40, H7545-80, H7545-320 and H7545-1000. A homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma, Recall # Z-1454-06;b) AutoHDL Cholesterol Reagent Set for the quantitative determination of high density lipoprotein (HDL) cholesterol in serum or plasma, Imported and Marketed in India; Catalogs HH7545-80, Recall # Z-1455-06, c) AutoHDL Cholesterol R1 Reagent Set, a homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma, Catalogs HH445-R1, Recall # Z-1456-06; d) AutoHDL Cholesterol R2 Reagent Set, a homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma, Catalogs HH445-R2, Recall # Z-1457-06; e) Auto HDL reagent, sold by Pointe Scientific; Catalog no. 3-H7545-L, Recall # Z-1458-06;. f) Auto HDL Cholesterol reagent in bottles of 320 ml and 1000 ml, Catalog nos. 7-H7545-320 and 7-H7545-1000, Recall # Z-1459-06 REASON: Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. MANUFACTURER: Bayer Healthcare, LLC (Diagnostics Division), TarrytownNY, by e-mail on April 4, 2006. Manufacturer: Bayer Healthcare, LLC Diagnostics Division, NorwoodMA. Firm initiated recall is ongoing. PRODUCT: a) RapidLab® 1200 Systems, Model 1245-Blood gases, electrolyte and blood pH test system, Part No. 05061537, Recall # Z-1464-06;b) RapidLab® 1200 Systems, Model 1265- Blood gases, electrolyte and blood pH test system, Part No. 05063769; Recall # Z-1465-06 REASON: Invalid CO-oximeter values; Bayer HealthCare determined that under very specific conditions, the RapidLab® 1245 or RapidLab® 1265 systems may report invalid CO-oximeter values to an LIS, Rapidlink®, or Rapidcomm(tm) data management system. CLASS III MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by telephone and letter dated July 21, 2006. Firm initiated recall is ongoing. PRODUCT: Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902, 911, 912, 917, Modular and Cobas c 501 clinical chemistry analyzers; Roche Catalog/Part Number 10825441001/US #722-4402, Recall # Z-1447-06 REASON: Expired product (dated 2006.06) was shipped as replacement for recalled product. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 30, 2006: CLASS II MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by
letter dated June 30, 2006. Firm initiated recall is ongoing. MANUFACTURER: Steris Corporation, Montgomery, AL, by letter on June
22, 2006. Firm initiated recall is ongoing. MANUFACTURER: Recalling Firm: INO Therapeutics, Inc., Clinton, NJ, by
letter on July 5, 2005 and by email and telephone on July 7, 2006.
Manufacturer: Datex -- Ohmeda, Inc., Madison, WI. Firm initiated recall
is ongoing. MANUFACTURER: Recalling Firm: Zimmer, Inc., Warsaw, IN, by letter
dated July 20, 2006. Manufacturer: Zimmer Trabecular, Allendale, NJ.
Firm initiated recall is ongoing. MANUFACTURER: Recalling Firm: BioCare Systems, INC., Parker, CO, by
telephone beginning June 8, 2006, followed by a letter on June 23, 2006.
Manufacturer: Cui Stack, Inc., Beaverton, OR. Firm initiated recall is
ongoing. MANUFACTURER: A & E Industries, Ltd., Guangdong, Chin, by letter on
June 30, 2006. Firm initiated recall is ongoing. MANUFACTURER: Recalling Firm: COBE Cardiovascular, Inc, Arvada, CO,
by Letter on June 26, 2006. Manufacturer: Senior Operations, Inc.,
Bartlett, IL. Firm initiated recall is ongoing. MANUFACTURER: Recalling Firm: Nellcor Puritan Bennett, Pleasanton,
CA, by letters on July 12, 2006. Manufacturer: MMJ S. A. de C.V., Cd
Juarez, Mexico. Firm initiated recall is ongoing. MANUFACTURER: Conmed Corporation, Utica, NY, by letters dated March
27, 2006, by facsimile and/or e-mail. Firm initiated recall is ongoing. MANUFACTURER: MicroVision Medical Holding B.V., Amsterdam,
Netherlands, by letter dated July 21, 2006. Firm initiated recall is
ongoing. MANUFACTURER: Recalling Firm: Radiometer America, Inc., Westlake, OH,
by letter dated January 12, 2005. Manufacturer: Radiometer Medical ApS,
Bronshoj, Denmark. Firm initiated recall is ongoing. MANUFACTURER: Recalling Firm: Wako Chemicals, USA Inc., Richmond, VA,
by telephone and e-mail letter dated July 6, 2006. Manufacturer: Wako
Pure Chemical Industries Ltd., Osaka, Japan. Firm initiated recall is
ongoing. MANUFACTURER: Sunrise Medical CCG, Inc., Stevens Point, WI, by
telephone on November 16, 2005. Firm initiated recall is complete. MANUFACTURER: Recalling Firm: Richard Wolf Medical Instruments Corp.,
Vernon Hills, IL, by telephone on July 7, 2006 Manufacturer: V. Krutten
Gmbh, Idstein, Germany. Firm initiated recall is ongoing. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 23, 2006: CLASS II MANUFACTURER: Boston Scientific Corp., Spencer, IN, by letters dated
June 2, 2006. Firm initiated recall is ongoing. MANUFACTURER: Edwards Lifesciences Llc, Irvine, CA, by telephone and
letter dated July 7, 2006. Firm initiated recall is ongoing. MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis,
IN, by letter dated July 14, 2006. Manufacturer: Division, Hitachi Ltd.,
Hitachinaka-Ibaraki, Japan. Firm initiated recall is ongoing. MANUFACTURER: Recalling Firm: Philips Medical Systems North America
Co., Phillips, Bothell, WA, by letter on July 1, 2006. Manufacturer:
Philips Medical Systems Nederlands, Best, Netherlands. Firm initiated
recall is ongoing. MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis,
IN, by letter dated June 22, 2006. Manufacturer: Roche Diagnostics GmbH,
Mannheim, Germany. Firm initiated recall is ongoing. MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis,
IN, by letter dated July 17, 2006. Manufacturer: Precision System
Science Co., Ltd., Chiba, Japan. Firm initiated recall is ongoing. MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN, by letter
dated June 28, 2006. Firm initiated recall is ongoing. MANUFACTURER: Recalling Firm: Roche Diagnostics Corp., Indianapolis,
IN, by letter dated July 25, 2006. Manufacturer: Roche Diagnostics Gmbh,
Mannheim, Germany. Firm initiated recall is ongoing. MANUFACTURER: Recalling Firm: Radiometer America Inc., WestlakeOH, by
letter dated September 29, 2005. Manufacturer: Radiometer Medical ApS,
Bronshoj, Denmark. Firm initiated recall is ongoing. MANUFACTURER: Pointe Scientific, Inc., Lincoln Park, MI, by letter
dated June 9, 2006. Firm initiated recall is ongoing. MANUFACTURER: Recalling Firm: Varian Medical Systems,
CharlottesvilleVA, by letter on 4/17/06 and continuing through 5/1/06.
Manufacturer: Varian Medical Systems, Haan, Germany. Firm initiated
recall is ongoing. MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc,
ConcordCA, by letter on June 22, 2006. Manufacturer: Impac Medical
Systems Inc, Mountain View,CA. Firm initiated recall is ongoing. CLASS III MANUFACTURER: Recalling Firm: Radiometer America Inc., WestlakeOH, by
E-Mail on September 19, 2005, and by telephone on or around September
20, 2005. MANUFACTURER: Recalling Firm: ABX Diagnostics, Inc., Irvine, CA, by
letter and telephone on March 24, 2006. Manufacturer: Horiba ABX,
Montpellier, France. Firm initiated recall is ongoing. MANUFACTURER: Recalling Firm: Invacare Corp., Elyria, OH, by letter
dated June, 2006. Manufacturer: Viscount Vehicle Co. LTD, Taiwan,
Republic of China. Firm initiated recall is ongoing. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 16, 2006: CLASS II MANUFACTURER: Medisurg Research & Management Corp, NorristownPA, by
fax on April 28, 2006. Firm initiated recall is ongoing. MANUFACTURER: Recalling Firm: Abbott Diabetes Care, Inc. AlamedaCA,
by letters on May 22, 2006. Manufacturer: Flextronics International,
Shenzhen, China, Firm initiated recall is ongoing. MANUFACTURER: Tekia, Inc., Irvine, CA, by telephone, on July 2, 2004
and July 8, 2004. Firm initiated recall is ongoing. MANUFACTURER: Recalling Firm: Arthrocare, Corp., Sunnyvale, CA, by
letters on June 29, 2006. Manufacturer: Arthrocare, Corp., Aurora de
Heredia, Costa Rica. Firm initiated recall is ongoing. MANUFACTURER: Recalling Firm: Radiometer America Inc, WestlakeOH, by
letter on June 17, 2005 Manufacturer: Radiometer Medical ApS, Bronshoj,
Denmark. Firm initiated recall is complete. MANUFACTURER: Recalling Firm: Radiometer America Inc, WestlakeOH, by
letter on June 9, 2005 Manufacturer: Radiometer Medical ApS, Bronshoj,
Denmark. Firm initiated recall is complete. MANUFACTURER Recalling Firm: Radiometer America Inc, WestlakeOH, by
letter on March 22, 2006 Manufacturer: Radiometer Medical ApS, Bronshoj,
Denmark. Firm initiated recall is ongoing. MANUFACTURER: Pointe Scientific, Inc., Lincoln Park, MI, by letter
dated June 7, 2006. FDA initiated recall is ongoing. MANUFACTURER: Recalling Firm: Zimmer Caribe, Inc., Warsaw, IN, by
letters letter dated June 26, 2006 and June 28, 2006. Firm initiated
recall is ongoing. CLASS III MANUFACTURER: Recalling Firm: Radiometer America Inc, WestlakeOH, by
telephone on June 17, 2005. Manufacturer: Radiometer Medical ApS,
Bronshoj, Denmark. Firm initiated recall is complete. MANUFACTURER: Recalling Firm: Radiometer America, Inc., Westlake, OH,
by memo and visits beginning on October 31, 2005. Manufacturer:
Radiometer Medical Aps, Bronshoj, Denmark. Firm initiated recall is
complete. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of August 9, 2006: CLASS II MANUFACTURER: Kensey Nash Corp., Exton, PA, by letter on April 17,
2006. Firm initiated recall is complete. MANUFACTURER: Recalling Firm: Beckman Coulter, Inc., Brea, CA, by
letter the week of April 10, 2006. Manufacturer: Beckman Coulter, Inc.,
Chaska, MN. Firm initiated recall is ongoing. MANUFACTURER: Applied Biotech, Inc., San Diego, CA, by fax dated May
31, 2005. Firm initiated recall is ongoing. MANUFACTURER: Recalling Firm: Radiometer America, Inc., Westlake, OH,
by letter dated May 24, 2005. Manufacturer: Radiometer Medical, Bronshoj,
Denmark. Firm initiated recall is complete. The following is condensed
list of medical devices involved in recalls listed by the FDA
Enforcement Report as of August 2, 2006: MANUFACTURER: Recalling Firm: Welch Allyn Inc.,
Skaneateles Falls, NY, by letters dated June 30, 2006. Manufacturer: MRL,
Inc., A Welch Allyn Company, Buffalo, IL. Firm initiated recall is
ongoing. CLASS II MANUFACTURER: Recalling Firm: Philips Medical Systems
North America Co. Phillips, Bothell, WA, by letter on April 6, 2006.
Manufacturer: Philips Medical Systems, Best, Netherlands. Firm initiated
recall is ongoing. MANUFACTURER: Kimberly-Clark Corporation, Roswell, GA, by telephone
and letter on May 18, 2006. Firm initiated recall is ongoing. MANUFACTURER: SCC Soft Computer, Palm Harbor, FL, by letter on
October 27, 2004. Firm initiated recall is complete. MANUFACTURER: Recalling Firm: Hamilton Medical, Inc., Reno, Nevada,
by a Medical Device Field Correction on June 1, 2006. Manufacturer:
Hamilton Medical AG, Bonaduz, Switzerland. Firm initiated recall is
ongoing. MANUFACTURER: SCC Soft Computer, Palm Harbor, FL, by letter on
January 9, 2001. Firm initiated recall is complete. MANUFACTURER: Brainlab AG, Kirchheim B. Muenchen, Germany, by letters
on June 2, 2006 and June 7, 2006. Firm initiated recall is ongoing. MANUFACTURER: Recalling Firm: Hebron International, Inc., Atlanta,
GA, by letters on May 22, 2006. Manufacturer: Mi Gwang Contact Lens Co.,
Ltd., Kyungsan, Korea. Firm initiated recall is ongoing. MANUFACTURER: St. Francis Medical Technologies, Inc., Alameda, CA, by
letters on May 22, 2006. Firm initiated recall is ongoing. MANUFACTURER: Recalling Firm: Beckman Coulter, Inc., Brea, CA, by
letter on May 22, 2006. Manufacturer: Applied Cytometry, Sheffield,
United Kingdom. Firm initiated recall is ongoing. MANUFACTURER: Recalling Firm: Radiometer America, Inc., Westlake, OH,
by letter dated May 22, 2006. Manufacturer: Radiometer A/S, Copenhagen,
Denmark. Firm initiated recall is ongoing. MANUFACTURER: Recalling Firm: Radiometer America, Inc., Westlake, OH,
by letter dated May 1, 2006. Manufacturer: Radiometer A/S, Copenhagen,
Denmark. Firm initiated recall is ongoing. MANUFACTURER: Recalling Firm: Radiometer America, Inc., Westlake, OH,
by letters dated March 2, 2005. Manufacturer: Radiometer A/S,
Copenhagen, Denmark. Firm initiated recall is complete. MANUFACTURER: Recalling Firm: Microcuff Gmbh, Weinheim, Germany, by
telephone in April 2006, and by letter on June 29, 2006. Manufacturer:
Unomedical Industries, Kedah, Malaysia. Firm initiated recall is
ongoing. MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by
firm representative visit, beginning on September 30, 2005. Firm
initiated recall is complete. MANUFACTURER: Recalling Firm: Varian Medical Systems,
Charlottesville, VA, by letter on May 1, 2006. Manufacturer: Varian
Medical Systems, Haan, Germany. Firm initiated recall is ongoing. MANUFACTURER: Zimmer Inc., Warsaw, IN, by letter dated June 30, 2006.
Firm initiated recall is ongoing. MANUFACTURER: Recalling Firm: Guidant Corporation, Saint Paul, MN, by
letter dated May 12, 2006. Manufacturer: Guidant-Ireland, Clomel,
Ireland. Firm initiated recall is ongoing. MANUFACTURER: Boston Scientific Corp., Spencer, IN, by letter dated
June 30, 2006. Firm initiated recall is ongoing. CLASS III MANUFACTURER: Recalling Firm: Baxter Healthcare Renal Div., Mc Gaw Park,
IL, by letters dated June 21, 2006. Manufacturer: Baxter Healthcare
Corporation, Largo, FL. Firm initiated recall is ongoing. MANUFACTURER: Recalling Firm: Nicolet Biomedical Div. of Viasys
Healthcare, Madison, WI, by telephone and letter on April 28, 2006.
Manufacturer: Tyco Healthcare Uni-Patch, Wabasha, MN. Firm initiated
recall is ongoing. MANUFACTURER: AGFA Corp., Greenville, SC, by firm representative
visit for software upgrade, on June 30, 2006. Firm initiated recall is
ongoing. MANUFACTURER: Terumo Cardiovascular System Corp., Ann Arbor, MI, by
letter dated October 19, 2005. Firm initiated recall is complete. The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 26, 2006: CLASS II MANUFACTURER: Recalling Firm: Teleflex Medical, Bannockburn, IL, by letters dated June 15, 2006. Manufacturer: Truphatek, Ltd., Netanya, Israel.Firm initiated recall is ongoing. PRODUCT: Green Spec Fiberoptic Laryngoscope Handle -- Stubby/Short; a battery operated fiberoptic laryngoscope handle for use with green coded fiberoptic systems and single use laryngoscope blades; catalog number 004413300, Recall # Z-1225-06 REASON: Teleflex Medical has identified that the product may malfunction, causing the handle to heat up.There is a potential for the heated handle to burn the user. MANUFACTURER: Smith & Nephew, Inc., Andover, MA, by letter on June 19, 2006. Firm initiated recall is ongoing. PRODUCT: a) TriVex 100SV Resector Kit, 4.5 Part Number:7205876,Recall # Z-1226-06;b) TriVex 200LV Resector Kit, 5.5 Part Number:7209271,Recall # Z-1227-06;c) 4.5 mm TriVex System Resector Kit (blade and tubing), 3 per box, Part Number: 7209514, Recall # Z-1228-06;d) 5.5 mm TriVex System Resector Kit (blade and tubing), 3 per box, Part Number: 7209514, Recall # Z-1229-06 REASON: The sterility seal of the package trays may have incomplete seals compromising the sterility of the device. MANUFACTURER: Smith & Nephew, Inc., Andover, MA, by letter dated June 19, 2006. Firm initiated recall is ongoing. PRODUCT: a) Dyonics Electroblade, 4.5 Full Radius, Valleylab Generator-Compatible Part Number: 7205961, Recall # Z-1230-06;b) Dyonics Electroblade 4.5 ELITE, Full Radius, Valleylab Generator- Compatible Part Number: 7209700, Recall # Z-1231-06; c) Dyonics Electroblade 4.5 Full Radius, VULCAN Generator-Compatible Product number: 7209855, Recall # Z-1232-06; d) Dyonics Electroblade 4.5 ELITE, Full Radius, VULCAN Generator-Compatible Part Number: 7209983, Recall # Z-1233-06 REASON: Sterility seal of the package tray may have gaps/voids compromising the sterility of the device. MANUFACTURER: Recalling Firm: 3M Company/Medical Division, South St Paul, MN, by telephone between February 7 and February 8, 2006 and by letters dated February 9, 2006. Manufacturer: 3M Healthcare Markets, Brookings, SD.Firm initiated recall is ongoing. PRODUCT: 3M Nexcare First Aid High Performance Gauze Pad. Individually wrapped and sterile. Catalog # 434-10. Made in USA, UPC 05113166774, Recall # Z-1234-06 REASON: After reviewing manufacturing records it has been determined that these lots inadvertently were not sterilized after packaging in individual boxes labeled as sterile product. MANUFACTURER: W. L. Gore and Assoc., Inc., Flagstaff, AZ, by letters to be hand delivered on May 18, or May 19, 2006.Firm initiated recall is ongoing. PRODUCT: a) GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3410, 34mm x 10cm, Recall # Z-1236-06; b) GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm, Recall # Z-1237-06 REASON: Two lots of uniquely different product were switched and mislabeled. 34mm x10 cm were labeled as 34mm x 15cm and vice versa. MANUFACTURER: Recalling Firm: Aksys, Ltd., Lincolnshire,
IL, by Field Correction Recall on June 26, 2006. Manufacturer: Delphi
Medical Systems Colorado Corporation, Longmont, CO.Firm initiated recall
is ongoing. REASON: The hemodialysis device was being marketed with a modified treatment length that exceeds the treatment length for which the device was originally designed. MANUFACTURER: Cordis Corporation, Miami Lakes, FL, by letter in June 2006. Firm initiated recall is ongoing. PRODUCT: Cordis INFINITI 6 French Diagnostic Catheter.Used to deliver radiopaque contrast medium to selected sites in the vascular system.Catalog 534-6xxT. That is: 534614T, 534615T, 534617T, 534618T, 534619T, 534620T, 534621T, 534622T, 534623T, 534624T, 534625T, 534627T, 534628T, 534629T, 534635T, 534637T, 534641T, 534642T, 534643T, 534644T, 534645T, 534646T, 534647T, 534648T, 534649T, 534660T, 534670T, 534672T, 534674T, Recall # Z-1240-06 REASON: The tip of the catheter may separate from the body during operation. MANUFACTURER: Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter sent week of April 17, 2006. Manufacturer: Beckman Coulter, Inc., Miami, FL.Firm initiated recall is ongoing. PRODUCT: Coulter LH500 Hematology Analyzer; Part Numbers 178832, 178833 and 178834, Recall # Z-1245-06 REASON: Beckman has confirmed that erroneous results could be reported when the workstation data base crashes. MANUFACTURER: Recalling Firm: Instrumentation Laboratory Co., Lexington, MA, by letters on March 7, 2006. Manufacturer: Instrumentation Lab Co., Orangeburg, NY.Firm initiated recall is ongoing. PRODUCT: a) HemosIL RecombiPlasTin. Prothrombin Time Test.
Each RecombiPlasTin kit consists of: RecombiPlasTin (RTF): 5 x 8 mL or 20
mL vials of lyophilized recombinant human tissue factor, synthetic
phospholipids with stabilizers, preservative and buffer; and
RecombiPlasTin Diluent (RTF Diluent): 5 x 8 or REASON: Firm received 2 complaints concerning incorrect prothrombin time (PT) results while using the reagents on samples of patients taking the antibiotic CUBICIN (Daptomycin for injection). MANUFACTURER: Recalling Firm: Celsion Corp., Columbia, MD, by letter on May 4, 2006. Manufacturer: Accellent Juarez, Inc., Juarez, Mexico.Firm initiated recall is ongoing. PRODUCT: Prolieve™ Thermodilatation® Kit, consisting of a Prolieve Thermodilatation Catheter, Prolieve Heat Exchanger cartridge and 500 ml bag of sterile water, Catalog # 880-8023, packaged in single packs, Material Number M0068808022, and five packs, Material Number M0068808023, Recall # Z-1248-06 REASON: A medical device accessory used by healthcare practitioners in the invasive treatment of (BPH) benign prostatic hyperplasia may be defective. The catheter may fail to achieve or maintain recommended pressure. CLASS III MANUFACTURER: Recalling Firm: Siemens Medical Solutions, USA, Inc., Ann Arbor, MI, by visits in April 2006. Manufacturer: Siemens Medical Solutions, USA, Inc., Malvern, PA.Firm initiated recall is ongoing. PRODUCT: KinetDx 4.0 Ultrasound Image Management System, Recall # Z-1235-06 REASON: The cardiologist's report comments may not be retained by the system due to a software bug. MANUFACTURER: Boston Scientific Corp., Spencer, IN, by letter dated May 10, 2006. Firm initiated recall is ongoing. PRODUCT: Boston Scientific Contour VL Injection Stent with Hydro Plus Coating, 6 FR (2.0 mm) x 22-30 cm (220-300 mm), sterile, UPN: M0061856300. Ureteral stent, Recall # Z-1238-06 REASON: Instructions on how to inject are not included in the package. MANUFACTURER: Abbott Laboratories, Abbott Park, IL, by
letter dated June 12, 2006. Firm initiated recall is ongoing. REASON: The CA 15-3 Controls replicates out of range high resulting in invalid runs The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 12, 2006: CLASS II MANUFACTURER: Boston Scientific Corp., Spencer, IN, by letter on May 19, 2006. Firm initiated recall is ongoing. PRODUCT: a) Boston Scientific Stonetome Stone Removal
Device, 20 mm tip, 20 mm cut wire, REASON: Lack of assurance of sterility, as the sterile barrier may fail. MANUFACTURER: Gyrus Medical, Inc., Maple Grove, MN, by telephone beginning May 15, 2006 and by letter on May 31, 2006. Firm initiated recall is ongoing. PRODUCT: GYRUS ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK. Sterile EO. The device is intended to be used with the PlasmaKinetic electrosurgical generator, software version 1.93 or greater or the PlasmaKinetic with SuperPulse electrosurgical generator, software version 2.19A or greater or the G400 electrosurgical generator. Catalog No. 2103PK and 917015PK, Recall # Z-1175-06 REASON: Gyrus ACMI has identified a product issue wherein their PlasmaSEAL Open Forceps, models 2103PK and 917015PK, may not deliver adequate hemostasis during use. Although Gyrus ACMI has had no reports of serious injury to patient, testing indicated that the possibility exists. MANUFACTURER: Recalling Firm: Stryker Endoscopy, San Jose, CA, by letter on June 2, 2006. Manufacturer: Stryker Puerto Rico, Inc., Arroyo State/Province Puerto Rico, firm initiated recall is ongoing. PRODUCT: Stryker brand Insufflation Tube Set and High Flow Insufflation Tube Set, Model Numbers: 620-030-201, 620-030-301, Recall # Z-1177-06. REASON: Device for which sterility may be compromised as evidenced by a loss of package integrity. MANUFACTURER: MDS Canada Inc. DBA MDS Nordion, Kanata, Canada, by letter on August 24, 2004. Firm initiated recall is complete. PRODUCT: MANUFACTURER: Terang Nusa Sdn Bhd, Kota Bharu, Malaysia, by letters dated May 23, 2006. Firm initiated recall is ongoing. PRODUCT: Sterile Triumph LT Latex Powder-Free Surgeons Gloves; 50 pairs of gloves per box, 4 boxes per carton. Item number MDS108070LT, size 7, Recall # Z-1185-06 REASON: The sterile glove pouches may have an open seal at the bottom of the pouch. MANUFACTURER: Arthrocare Corp., San Juan Capistrano, CA, by letter on June 7, 2006. Firm initiated recall is ongoing. PRODUCT: a) ArthroCare brand OPUS Smartstitch Suture Cartridge, Catalog Number: OM-8071. Recall # Z-1186-06 b) ArthroCare brand OPUS Smartstitch Magnum Wire Suture Cartridge, Catalog Number: OM-8075. Recall # Z-1187-6 REASON: Potential loss of product sterility due to breach of pouch seal. MANUFACTURER: Medical, Inc., West Jordan, UT, by e-mail and telephone on May 3, 3005. Firm initiated recall is ongoing. PRODUCT: ambIT Ambulatory Infusion Therapy Intermittent Pump. Catalog Number: 220245, Recall # Z-1188-6 REASON: Intermittent Infusion pump may continually dispense medication under certain conditions. MANUFACTURER: Southmedic Inc.,Barrie, Ontario, Canada, by letter on April 21, 2006. Firm initiated recall is ongoing. PRODUCT: a) Vapofils with Stainless Steel Block Ends, Item Number V0507F (Isoflurane). The vapofil is a keyed anesthetic transfer tube that transfers the anesthetic from the bottle to the vaporizer, Recall # Z-1189-06;b) Vapofils with Stainless Steel Block Ends, Item Number V0507S (Sevofluane). The vapofil is a keyed anesthetic transfer tube that transfers the anesthetic from the bottle to the vaporizer, Recall # Z-1189-06 REASON: Southmedic has initiated this recall because their Japanese distributor received field reports of leaking vapofils. Leakage may cause non-toxic spills in the hospital environment, distraction of practitioners during conduct of anesthesia and surgery, and may damage certain plastic equipment. Leakage may also expose patients to low concentrations of volatile anesthetics MANUFACTURER: Recalling Firm: Respironics, Incl, Murrysville, PA, by letter on September 19, 2005. Manufacturer: Caradyne Ltd., Galway, Ireland. Firm initiated recall is complete. PRODUCT: NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310. Recall # Z-1191-06 REASON: Gas input pressures over 62 psi may cause CPAP pressure oscillation. MANUFACTURER: Guidant Corp., Saint Paul, MN, by press release and letter on May 15, 2006. Firm initiated recall is ongoing. PRODUCT: a) Guidant CONTAK RENEWAL 3 (models H170, H173, H175), CONTAK RENEWAL 3 HE (models H177, H179) CONTAK RENEWAL 4 (models H190, H195), CONTAK RENEWAL 4 HE (models H197, H199). Cardiac Resynchronization Therapy Defibrillator (CRT-D). Sterile EO, Recall # Z-1192-06 b) VITALITY HE (model T180) Implantable Cardioverter Defibrillator (ICD). Sterile EO, Recall # Z-1193-06 c) Guidant CONTAK RENEWAL 3 AVT (models M150, M155), CONTAK RENEWAL 3 AVT HE (models M157, M159), CONTAK RENEWAL 4 AVT (models M170, M175), CONTAK RENEWAL 4 AVT HE (models M177, M179). Cardiac Resynchronization Therapy Defibrillator. Sterilized using gaseous ethylene oxide. CONTAK RENEWAK AVT models provide both atrial and ventricular tachyarrhythmia and cardiac resynchronization therapies, Recall # Z-1194-06 REASON: Guidant has received 2 reports of device malfunction associated with subpectoral implantation in an uncommon orientation (serial number facing ribs). Repetitive mechanical stress in this orientation can result in Loss of shock therapy, Loss of pacing therapy (intermittent or permanent), Loss of telemetry, Programmer warning screen upon interrogation, and beeping. MANUFACTURER: Recalling Firm: Ossur North America Inc., Aliso Viejo, CA, by press release on March 29, 2006. Manufacturer: Ossur Engineering, Inc., Albion, MI. Firm initiated recall is ongoing. PRODUCT: a) Ossur Total Knee Junior, Model Number TK 1100,
External Prosthetic knee, REASON: The company's initiation of the recall is based on a finding that some units of the Total Knee device may contain faulty pins based in the axis of the knee. Small cracks propagate through the pin cross section until the pin breaks, severely compromising the knee function. MANUFACTURER: Meridian Bioscience Inc., Cincinnati, OH, by letter on June 6, 2006. Firm initiated recall is ongoing. PRODUCT: ImmunoCard toxins A & B kit, a rapid enzyme immunoassay for the detection of Clostridium difficile Toxins A and B in Stool Samples (Catalog number 712050). An in vitro diagnostic, Recall # Z-1203-06 REASON: The product may produce non-specific reactions with negative specimens and/or the negative control reagent. These non-specific interactions may result in increased invalid test rates and/or positivity rates. MANUFACTURER: Spacelabs Medical Incorporated, Issaquah, WA, by letter on May 5, 2006. Firm initiated recall is ongoing. PRODUCT: Spacelabs Medical 1400 MHz Telemetry System,. Model 91341-09. Telemetry System consists of Model 91341-09 transmitter, 90478-1CST receiver and 90478-1CSV receiver, Recall # Z-1202-06 REASON ; Potential for patient waveforms to move to an open receiver module or to an occupied receiver causing the intermittent inappropriate monitoring of both patients for several minutes. MANUFACTURER: Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by field correction update on April 28, 2006. Manufacturer: Siemens AG, Medical Solutions, Forchheim, Germany. Firm initiated recall is ongoing. PRODUCT: 3D-I/III Ceiling Stand. Diagnostic x-ray tube mount, Recall # Z-1205-6 REASON: Firm became aware that a potential pinch point can exist between the stop level and the safety catch when rotating the x-ray tube assembly. Risk of injury to operators fingers. MANUFACTURER: Varian Medical Systems Inc., Palo Alto, CA, by letter on June 6, 2006. Firm initiated recall is ongoing. PRODUCT: Varian brand Clinac C-series Pendant Radiation delivery system. All model numbers included. Model numbers 2100, 2100C/D, 21 EX. 2300 C/D, 23 EX, 600C, 600 C/D, 2500 C, Trilogy, 6EX and Silhouette, Recall # Z-1206-06 REASON: Machine may produce unexpected motions from the couch, collimator, and gantry rotation at maximum speeds. CLASS III MANUFACTURER: Abbott Laboratories, Abbott Park, IL, by letter on March 8, 2006. Firm initiated recall is ongoing. PRODUCT: ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit consisting of microparticles, conjugate, assay diluent, pre-treatment 1, pre-treatment 2, and pre-treatment 3, Recall # Z-860-06 REASON: The 30-day onboard storage information is not included in the barcode labels for these two lots. As a result, the ARCHITECT system software is unable to track how long a reagent kit has been stored onboard the ARCHITECT instrument. MANUFACTURER: Recalling Firm: General Electric Med. Sys.
Ultrasound, West Milwaukee, WI, by letter on April 17, 2006. Manufacturer:
Kretziechnik Gesmbh, Zipf, Austria, firm initiated recall is ongoing. MANUFACTURER: Riverain Medical Group, Miamisburg, OH, by letter on May 10, 2006, firm initiated recall is ongoing. PRODUCT: a) RapidScreen RS-2000, Medical Image Analyzer, Recall # Z-1173-6; b) RapidScreen RS-Digital, Medical Image Analyzer, Recall # Z-1174-6 REASON: The device has an actual sensitivity of 58.2% and a specificity of 3.9% (false positives per image). The product is approved to have a sensitivity of 63.3% and a specificity of 5.0. Thus, there is a difference of -5.1% in sensitivity and +1.1 in specificity. MANUFACTURER: Abbott Laboratories, Abbott Park, IL, by e-mail on June 6, 2006. Firm initiated recall is ongoing. PRODUCT: ARCHITECT Ferritin Reagent; in vitro diagnostic; list numbers 6C11-20 (4 x 100 tests), 6C11-25 (1 x 100 tests) and 6C11-30 (4 x 500 tests), Recall # Z-1204-06 REASON: Some ARCHITECT Ferritin Reagent lots may not be meeting the accuracy by correlation to AxSYM claims as they are listed in the package insert (slope of 1.0 +/- 0.2). The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 5, 2006: CLASS II MANUFACTURER: Teleflex Medical, Research Triangle Park, NC, by letter dated April 18, 2006, firm initiated recall is ongoing. PRODUCT: a) Weck Hem-o-lok ML Polymer Ligating Clips; Rx,
sterile, medium large size, non-absorbable polymer ligation clips; 6 clips
per cartridge, 14 cartridges per sales unit, 12 sales units per case.
Catalog number 544230, Recall # Z-1096-06;b) Weck Hem-o-lok L Polymer
Ligating Clips; Rx, sterile, large size, REASON: The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephrectomies in living donor patients. MANUFACTURER: Adept-Med International Inc., Diamond Springs, CA, by letter on August 13, 2004, firm initiated recall is complete. PRODUCT: Adept-Med brand Glassman Viscera Retainer FISH Sterile, Item Numbers: 3204, 3202, 3203, 3202, 3201, 3200, 3206, Recall # Z-1156-06 REASON: Devices for which sterility may be compromised as evidenced by a loss of package integrity. MANUFACTURER: Suros Surgical Systems Inc., Indianapolis, IN, by telephone on May 25, 2006 and by letters on May 25, 2006 and June 19, 2006 firm initiated recall is ongoing. PRODUCT: ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09, Recall # Z-1160-06 REASON: Lack of assurance of sterility, as package may have a seal defect (improperly sealed primary packaging). MANUFACTURER: Recalling Firm: bioMerieux, Inc., Hazelwood,
MO, by telephone and letters on May 22, 2006. Manufacturer: bioMerieux,
Inc., Durham, NC, firm initiated recall is ongoing. REASON: Software problem with scanner inter-character delay which may result in false positive or false negative results after incorrect scanning of bottle IDs. MANUFACTURER: Leica Microsystems (Schweiz), Heerbrugg, Switzerland, by fax on November 15, 2005, firm initiated recall is ongoing. PRODUCT: Leica M520 Surgical Microscope; a surgical microscope with a 6:1 motorized zoom magnification, 207-470 mm motorized Multi-Foc variable objective lens with diameter and light intensity of illuminated field continuously adjustable and high power 300W xenon lamp (both main and back-up illimuniation) through fiber optic cable; Leica Microsystems (Schweiz) AG, Business Unit SOM, Max Schmidheiny-Strasse 201, CH-9435 Heerbrugg, Switzerland; Leica Microsystems Inc., 90 Boroline Road, Allendale, NJ 07401; Leica Microsystems Inc., 2345 Waukegan Road, Bannockburn, IL 60015-9792 The M520 microscope was sold with the following floor stands to form Leica Surgical Microscope Systems: a) MS-1 floor stand with manual balancing for the microscope carrier in three axes and three electromagnetic and mechanical brakes; b) MS-2 floor stand with 3 step balancing for the optical head, autobalance for the floor stand and six electromagnetic brakes; c) MS-3 floor stand with semi-automatic balancing system and six electromagnetic permanent magnetic brakes, cantilever range: 1456 mm d) ) OHS1 floor stand with semi-automatic balancing system and six electromagnetic permanent magnetic brakes, e) OH3 floor stand with fully-automatic balancing system and six electromagnetic permanent magnetic brakes, cantilever range: Max. 1520 mm f) F40 floor stand with continuously adjustable balancing system and four electromagnetic permanent magnetic brakes, Maximum reach 1496 mm, Recall # Z-1162-06 REASON: Patient Burns-The use of the surgical microscope at high light intensity and short working distances can result in patient burns. MANUFACTURER: B. Braun Medical, Inc., Cherry Hill, NJ, by telephone on May 10, 2006, firm initiated recall is complete. PRODUCT: B Braun 9F (O/S) Locking Tearway Introducers non-sterile. Catalog number 614008. The product is packaged as 50 bulk nonsterile units per pouch, 2 pouches per shipping carton. Recall # Z-1163-06 REASON: Mislabeled-9F labeled units actually contain 10F devices MANUFACTURER: Recalling Firm: St Jude Medical CRMD, Sylmar, CA, by letter on June 1, 2006 Manufacturer: Oscor Inc.,Palm Harbor, FL, firm initiated recall is ongoing. PRODUCT: a) CPS Slitter, Model 410191, Recall #
Z-1164-06;b) CPS Valve Bypass Tool (VBT), Model 410192, Recall #
Z-1165-06;c) CPS Direct SL, Models 410110, 410111, 410112, 410113, 410114,
410115, REASON: Sterility - Some of the sterile pouches in which these products are packaged may not have been properly sealed during the packaging process. MANUFACTURER: Recalling Firm: Abbott Laboratories, East Windsor, NJ, by letters on May 8, 2006 through June 7, 2006. Manufacturer: I Stat, Kanata, Ontario, Canada, firm initiated recall is ongoing. PRODUCT: i-STAT EG7+ Cartridge, Blood Gas Panel. pH, PCO2 PO2, Na K iCa, Hct, HCO3 TCO2 BE, sO2 Hb. Manufacturer, i-STAT Corp, 104 Windsor Center Drive, East Windsor, NJ 08520. Made in Canada. i-STAT Catalog Number -- 220300; Abbott List Number (US and Canada)-- 06F01-01; Abbott List Number (Rest of World) -- 06F01-02. Recall # Z-1171-06. REASON: Erroneous sodium and/or ionized calcium readings could be obtained with a patient sample. MANUFACTURER: Recalling Firm: Roche Diagnostics Corp.,
Indianapolis, IN, by letter dated June 6, 2006 Manufacturer: Reagents
Applications Inc., San Diego, CA, firm initiated recall is ongoing. REASON: Falsely low patient and control results may be reported when the reagent has been on-board for less than the 8 hour use period specified in the labeling. CLASS III MANUFACTURER: Recalling Firm: Medtronic Gastroenterology / Urology, Shoreview, MN, by letter on April 5, 2005 and April 6, 2006. Manufacturer: Catheter & Disposable Technology, Inc., Plymouth, MN, firm initiated recall is ongoing. PRODUCT: Medtronic Zinetics Manometric Catheter, Model 9012P2271. Water perfused, motility catheter, Recall # Z-1159-06 REASON: Mislabeling - The 8 ports of the manometric catheter were incorrectly labeled 1,3,5,7,8,2,4,6 from the distal to the proximal end of the catheter. The correct port configuration is sequentially 1 through 8, from the distal to the proximal end of the catheter. MANUFACTURER: Hamilton Co., Reno, NV, by letter on March 28, 2006, firm initiated recall is ongoing. PRODUCT: a) Syringe, 62RNR 2.5 Microliter Syringe, with
needle point style 3 (blunt needle point for use with HPLC injection
valves and for sample pipetting) REASON: There is an error in the marking of the graduated divisions on syringes in affected lots that shows an amount that is double the actual volume of the syringe The following is condensed list of medical devices involved in recalls listed by the FDA Enforcement Report as of July 1, 2006: CLASS II MANUFACTURER: Recalling Firm: GE Healthcare, Madison, WI, by letter dated March 21, 2006. Manufacturer: GE Healthcare Finland Oy, Helsinki, Finland. Firm initiated recall is ongoing. PRODUCT: Fresh Gas Control (A-FGC1) Unit, a component of the S/5 Anesthesia Delivery Unit. The Anesthesia Delivery Unit is designed to mix and dose respiratory gases and to ventilate the patient. The delivery unit is the basis for a flexible anesthesia system with full monitoring and data management capabilities, Recall # Z-1196-06 REASON: There exists the possibility that the ADU Fresh Gas Control unit (A-FGCI) can shut off during normal handling of the anesthesia machine and result in no anesthetic agent output. MANUFACTURER: Recalling Firm: Sammons Preston Rolyan,
Cedarburg, WI, by letters on January 25/26, 2006. Manufacturer: Midland
Manufacturing Co., Inc., Columbia, SC. Firm initiated recall is ongoing. REASON: There have been reports of structural failure on the skirt of select tables. The risk to patients presented by possible structural failure of the skirt of the table is a slow collapse of the plinth which could cause the patient to be displaced. MANUFACTURER: Vanguard Medical Concepts, Inc., Lakeland, FL, by letters on March 17, 2006. Firm initiated recall is ongoing. PRODUCT: Reprocessed Ethicon Bladeless Trocars. Model 35NLT, 35NST, 35OL, Recall # Z-1212-06 REASON: Review of complaints and testing show that the distal tip of the trocars may separate while in use. MANUFACTURER: Recalling Firm: Boston Scientific, Maple Grove, MN, by letter on May 30, 2006. Manufacturer: Boston Scientific Corp., Nuanum FK. Firm initiated recall is ongoing. PRODUCT: a) Boston Scientific IQ Guide Wire. 1) Catalog No. 38950-010, 185 cm, Straight Tip, Single Pack. 2) Catalog No. 38950-012, 185 cm, Straight Tip, 5 pack. Sterile EO. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip, Recall # Z-1213-06;b) Boston Scientific IQ Guide Wire. Catalog No. 38950-01J0, 185 cm, J-Tip, Single Pack. Sterile EO. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip, Recall # Z-1214-06;c) Boston Scientific IQ Guide Wire. 1) Catalog No. 38950-020, 300 cm, Straight Tip, Single Pack. 2) Catalog No. 38950-022, 300 cm, Straight Tip, 5 pack. Sterile EO. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip, Recall # Z-1215-06;d) Boston Scientific IQ Guide Wire. 1) Catalog No. 38950-02J0, 300 cm, J-Tip, Single Pack. 2) Catalog No. 38950-02J2, 300 cm, J-Tip, 5 pack. Sterile EO. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip, Recall # Z-1216-06;e) Boston Scientific IQ Guide Marker Wire. 1) Catalog No. 38951-010, 185 cm, Straight Tip, Single Pack. 2) Catalog No. 38951-012, 185 cm, Straight Tip, 5 pack. Sterile EO. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip, Recall # Z-1217-06;f) Boston Scientific IQ Guide Marker Wire. 1) Catalog No. 38951-01J0, 185 cm, J-Tip, Single Pack. 2) Catalog No. 38951-01J2, 185 cm,J-Tip, 5 pack. Sterile EO. Boston Scientific Guide Wires are steerableguide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip, Recall # Z-1218-06 REASON: Boston Scientific discovered through an internal inspection process that the PTFE (polytetrafluoroethylene) coating is not consistently adhering to the transition area of the distal end of the guide wires which may cause PTFE to flake off. MANUFACTURER: Kensey Nash Corp., Exton, PA, by letter on May 24, 2006 and visit. Firm initiated recall is complete. PRODUCT: a) TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 190 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit, ShieldWire (temporary occlusion balloon guidewire), and Balloon Inflation Syringe). The system is used with a standard 7F guide catheter using the standard femoral approach, Recall # Z-1219-06;b) TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 340 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit, ShieldWire (temporary occlusion balloon guidewire), and Balloon Inflation Syringe). The system is used with a standard 7F guide catheter using femoral approach, Recall # Z-1220-06;c) TriActiv System Balloon Inflation Syringe. The syringe packs/boxes contain 5 'spare' syringes, Recall # Z-1221-06 REASON: Volume control knob not able to go up to larger diameters. MANUFACTURER: International Biophysics Corp., Austin, TX, by telephone on August 16, 2005. Firm initiated recall is complete. PRODUCT: IBC Suction Handle (Sterile), a component of Blood Recovery Suction Systems, part # 1990S, Recall # Z-1222-06 REASON: Tyvek pouches containing device labeled as sterile have defective seals. MANUFACTURER: Recalling Firm: International Biophysics Corp., Austin, TX, by letter and telephone starting on April 22, 2005. Manufacturer: Hopeful Shers Ind. Co., Ltd, Fotan, Hong Kong. Firm initiated recall is complete. PRODUCT: IBC FloProbe (Non-sterile), a disposable flow probe that is used as a component of the Medtronic Bio-Console System. The Medtronic Bio-Console System is intended for use in the monitoring of the extracorporeal cardiopulmonary by pass circuit blood flow rate during open heart surgery, part # 3080N; packaged 10 per carton, Recall # Z-1223-06 REASON: Complaints received regarding the device's failure to zero out.
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