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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 ˝ 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 initiate |