Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Ad-Tech Medical Instrument Corporation Mar-02-2013 Subdural Electrode – Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary (<30 days) use with recording; monitoring and stimulation equipment; for the recording; monitoring and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping. The microelectrodes are not flush with the silastic substrate; may contain sharp edges capable of abrading the cortical surface; and may have remaining pieces which may fracture and remain in the cortical tissue with the electrode is explanted.
Symbios Medical Products; LLC Mar-13-2013 GOPump Elastomeric infusion PumpKit – GOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump; part number 510076: One infusion pump comprising two; 150 mL elastomeric reservoirs; each of which connects to its own catheter. Liquid flow rate is labeled at 2 mL/hr per elastomer.The Symbios Disposable Infusion Pump Kit is a disposable; self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management Received 2 complaints out of 458 distributed pumps in this lot; where flow restrictor bead became displaced; which were reported to permit fast flow of contents.
Del Mar Reynolds Medical; Ltd. Mar-20-2013 BleaseFocus Anesthesia Workstations – Spacelabs BleaseSirius Anesthesia Workstation; BleaseFocus Anesthesia Workstation; and CAS I/II Absorber contained in Service Kits Part Number 12200902; 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. Anesthesia workstation for use in the hospital environment and locations not requiring portability. A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being delivered to the patient.
Vascular Solutions; Inc. Mar-20-2013 Guardian II and Guardian II NC Hemostasis Valve – Vascular Solutions; Inc.; Guardian II and Guardian II NC Hemostasis Valve; used in cardiopulmonary bypass. Model numbers: FH101; FH101-T; FH101-25; FH101-50; 8210; 8211; FH102; FH102-T; FH102-25; FH102-50; 8215; 8216; 8241; 8242; 8244; 8272 and 8274.Vascular Solutions Zerusa Limited.Intended to maintain hemostasis during the use of diagnostic/interventional devices during diagnostic/interventional procedures. Risk that air may be introduced into the device which may lead to an air embolism.
Smiths Medical ASD; Inc. Mar-29-2013 BCI¿ Remote Alarm Cable Normally Open /Normally Closed – Smiths Medical; BCI¿ Remote Alarm Cable (Normally Open & Normally Closed); Reorder Numbers:WW3398NO & WW3398NC.Product Usage:The BCI¿ Remote Alarm Cable is designed for use with the 9004 Capnocheck¿ Capnography (Plus or Sleep) system to transfer alarm signals from the Capnocheck¿ Capnography system to a remote alarm system. The BCI¿ Remote Alarm Cable and the 9004 Capnocheck¿ Capnography systems are intended for use in all critical environments including ventilatory applications; patient transport; and anesthesia on patients ranging from pediatric to adult. Smiths Medical has become aware that; in rare instances; the BCI? Remote Alarm Cables (BCI? Cable) are not transferring alarms when used with some remote nurse alarm systems.Smiths Medical has received no reports of any injury or death related to this issue.
Class II recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Synthes USA HQ; Inc. Mar-01-2013 Synthes Multi-Vector Distractor Body; Part Number 487.931 – Synthes Multi-Vector Distractor Body; Part Number 487.931.For mandibular bone lengthening. It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
Synthes USA HQ; Inc. Mar-01-2013 Synthes Multi-Vector Distractor; Multi-axial Mandible Distractor (Right); Part Number 487.966 – Synthes Multi-Vector Distractor; Multi-axial Mandible Distractor (Right); Part Number 487.966.For mandibular bone lengthening. It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
Synthes USA HQ; Inc. Mar-01-2013 Synthes Multi-Vector Distractor – Multi-axial Mandible Distractor (Left); Part Number 487.967 – Synthes Multi-Vector Distractor – Multi-axial Mandible Distractor (Left); Part Number 487.967.For mandibular bone lengthening. It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications.
GE Healthcare; LLC Mar-01-2013 GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Wor – GE Healthcare Volume Viewer Plus 5.x (Advantage Workstation 4.2) Volume Viewer 3.x (Advantage Workstation 4.1) Volume Analysis (Advantage Workstation 4.0) Volume Analysis (Advantage Workstation 3.1)Advantage Windows Volume Rendering Option is intended to provide fast; easy; volume visualization of three dimensional structures imaged with a computed tomography (CT) or magnetic resonance (MR) system. It is dedicated to clinical and diagnostic applications in radiology; surgery; and treatment planning. Incorrect views and measurements possible. GE Healthcare became aware of multiple potential safety issues involving the Advantage workstation; Volume Viewer Plus and Volume Analysis.
Salyer Prn Biomedical Mar-01-2013 Century Console Base – Century Console Base; Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures. Concerns that the addition of the UPS Battery Backup to the Century Console Base Shelf did not comply with the FDA premarket notification regulations.
Philips Healthcare Inc. Mar-01-2013 Philips Digital Diagnost – Philips Digital Diagnost Stationary radiographic system When the operator for a wall stand view selects an "image rotation" different from default; or such image rotation is preset in the examination database; then the resulting image may be rotated in the wrong direction. When the operator manually rotates the image back; electronic side markers (if programmed) are rotated also and as a result may be placed in a wrong position inside the image.
Medtronic Inc. Cardiac Rhythm Disease Management Mar-05-2013 Medtronic DPL – Medtronic DPL Single Stage Venous Cannula with Metal Tip; used in cardiopulmonary bypass procedures. Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318; 69320; 69322; 69324; 69328; 69331. Potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula.
Philips Medical Systems (Cleveland) Inc Mar-05-2013 Philips Medical System Extended Brilliance Workspace (EBW); Computed Tomography – Philips Medical System Extended Brilliance Workspace (EBW); Computed Tomography X-Ray System. The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment; patient; and equipment supports; components and accessories. Incorrect values may be displayed. Philips is issuing a software update (version 4.5.5) to the Extended Brilliance Workspace (EBW) systems currently running software version(s) 4.0.2; V4.5.2 or V4.5.3; addressing a number of non-conformances.
Siemens Medical Solutions USA; Inc Mar-05-2013 ARTISTE" syngo¿ RT Therapist (RRT) – SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3; ARTISTE Model; Part No. 08162815; Digital linear accelerators; MOSAIQ OIS system; Distributed by SIEMENS Healthcare IM CR RO; CR Radiation Oncology; Manufactured by SIEMENS AG; MEDICAL SOLUTIONS; GERMANY. Siemens became aware of a potential safety issue when using the "In-session resumption" feature of the syngo RT Therapist (RTT) 4.3 software. The RTT will send again the previously completed beam or segment for delivery to the control console; thus repeating the already delivered Monitor Units of the same beam or segment.
Bard Access Systems Mar-06-2013 Hickman and Leonard Catheters – Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (pediatric product code 0600580; adult product code 0600600).Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequate peripheral venous access. Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer being included with the kit.
Bard Access Systems Mar-06-2013 Hickman and Leonard Catheters – Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (product code 0600630).Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequate peripheral venous access. Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer being included with the kit.
Steris Corporation Mar-06-2013 AMSCO C and AMSCO 400 Steam Sterilizers – AMSCO C and AMSCO 400 Steam Sterilizers designed for sterilization of heat and moisture-stable materials used in healthcare facilities. The control boards alarm set points and temperature tolerances allowed for erroneous activation of the AD (analog/digital) alarm as temperature fluctuated during operation. When this alarm occurs; the sterilizer locks up and cannot be used until serviced; causing Customer nuisance.
Churchill Medical Systems; Inc. Mar-06-2013 Lifeguard Infusion Set with Smartsite; 20Ga; 1 – Lifeguard Infusion Set with Smartsite; 20Ga; 1; CLGY-2010Huber type needle set used for the infusion of medical fluids into implantable ports. The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however; the product label states the pouch contains a 22Ga set.
Atricure Inc Mar-06-2013 Isolator Linear Pen; Electrosurgical cutting and coagulation device and accessories – Atricure Inc.; Max1 Isolator Transpolar Pen. Model A000163. Used to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the AtriCure Ablation and Sensing Unit or for temporary cardiac pacing; sensing; recording; and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device. Products from lot no. 41865 may have been sent out with Incorrect Instructions for Use (IFU) labeling.
Beckman Coulter Inc. Mar-06-2013 AU5800 Clinical Chemistry Analyzer – Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Glucose; Magnesium; and Potassium. Due to a software data storage limitation which only occurs under certain conditions; measurements of the Reagent Blank (RB) or Calibration (CAL) sample results are not saved and the software reverts to a previously stored; acceptable RB/CAL result.
Ethicon Endo-Surgery Inc Mar-07-2013 PROXIMATE Skin Staple Extractor – PSX PROXIMATE Skin Staple Extractor;ETHICON ENDO-SURGERY; LLC.For routine skin closure in a wide variety of surgical procedures. Damage to the packaging may have compromised the sterility of the device.
Sorin Group USA; Inc. Mar-08-2013 Implantable Defibrillation Lead – Isoline Implantable Defibrillation Lead; Model Isoline 2CR5; 2CR6 and 2CT6.These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias Isoline defibrillation leads distributed may have internal insulation breach.
Keystone Dental Inc Mar-08-2013 Straight Esthetic 4.0 mm 1mm Cuff Abutment – Genesis Straight Esthetic 4.0 mm 1mm Cuff AbutmentPart Number: G71200Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae. Mislabeled: Genesis Straight Esthetic 5.0mm Contour ;3mm cuff labeled as Genesis Straight Esthetic 4.0 mm; 1 mm cuff abutment;
Biomet; Inc. Mar-08-2013 Stright Ringloc Button Latch Inserter Handle – REF S313152 Straight Acetabular Inserter Handle Ringlocnon-sterileOrthopedic manual surgical instrument The Straight Ringloc Button Latch Inserter Handle may have been manufactured at the higher end of the tolerance causing interference with the Ringloc cup. The inserter handle may lock onto the cup during impaction. If alternative inserters are not available this could cause a surgical delay greater than 30 minutes.
Innominata Dba Genbio Mar-08-2013 BIO-RAD ANTI-BORRELIA (LYME) MICROPLATE EIA Kit – ANTI-BORRELIA (LYME) MICROPLATE EIA Kit; Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL; Positive Control-228 – 532 U/mL; and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease. Multiple incidents of low-reacting assay plates.
Keystone Dental Inc Mar-08-2013 Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment – Genesis Straight Esthetic 5.0 mm 3. mm Cuff AbutmentPart Number: G71205Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae. Mislabeled: Genesis Straight Esthetic 4.0mm Contour ;1mm cuff labeled as Genesis Straight Esthetic 5.0 mm; 3mm cuff abutment
Stryker Howmedica Osteonics Corp. Mar-08-2013 Stryker Howmedica Osteonics Corp. – Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100 Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use.
Medtronic Navigation; Inc. Mar-08-2013 Medtronic – Medtronic O-arm Imaging SystemProduct Usage:image-intensified fluoroscopic x-ray system; mobile Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction
Genesys Orthopedic Systems; LLC Mar-08-2013 Fixed Cervical Screws – 3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate SystemProduct Usage: is intended for anterior screw fixation to the cervical spine. Manufacturing residue may be present on the cervicalscrews. Use of this product may result in patient infection; delayed fusion or non-fusion (pseudarthrosis); inflammatory response; or revision surgery.
Integra LifeSciences Corp. Mar-08-2013 Integra CEM Nosecones – Integra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System; CUSA handpiece; and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired; either simultaneously or independently. There is a potential for erosion of the CUSA EXcel tip used with the Nosecone. Specifically; the potential for tip erosion occurs when using a CUSA CEM Nosecone if the side of the tip; rather than the annulus of the tip; is in contact with the tissue. This erosion can potentially lead to tip breakage. There were no reports of a patient injury associated with these complaints.
Instratek; Incorporated Mar-08-2013 Trigger Finger Blades – Endotrig Trigger Release Sterile Micro Hook BladeProduct Usage:The blade is intended to release A-1 pulley in endoscopic trigger release procedures. Instratek; Inc.has received multiple complaints of the 1052 Trigger Finger Release Blades which could not be advanced into the cannula through which it is used during trigger finger release procedures.
Siemens Medical Solutions USA; Inc. Mar-09-2013 ACUSON S2000 Automated Breast Volume Scanner (ABVS); – ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541Distributed by Siemens Medical Solutions USA Inc.business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image. On some ACUSON S2000 ABVS systems; the inside of the transducer pod may contain sharp edges.
Abbott Medical Optics Inc (AMO) Mar-09-2013 Sensar Foldable IOL with OptiEdge – AMO Sensar Intraocular Lenses (IOLs); Model AR40e; Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction. Two production orders of these IOLs that contain mislabeled IOLs.
Elekta; Inc. Mar-10-2013 Digital Imager; Radiation Therapy – Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1; R4.2.1; and R4.5.1 Used as part of radiation therapy treatment process. The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name.
Spine Smith Partners LP Mar-10-2013 Cynch Lordotic T-PLlF Implant – Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft; for use with supplemental fixation. Implants were incorrectly laser marked as 23mm instead of 28mm.
Synthes USA HQ; Inc. Mar-11-2013 Synthes Spine Click X Pedicle Screw – Synthes Spine 5.2mm Titanium Click ‘ X Pedicle Screw Dual Core 40 mm Thread Length; Part Number 487.072.Intended to provide precise and segmental stabilization of the spine in skeletally mature patients. Lot number 7542279; of the 45 mm Click ‘X Pedicle Screw (Part number 487.072); was incorrectly etched as "Click ‘X Pedicle Screw 05.2 L40 TAN violet" although the actual length of the screw is 45 mm.
Vygon Corporation Mar-11-2013 Churchill Medical Systems; Inc. A Vygon Company – All sizes of CMS-CT6T225 6F Triple Lumen CT PICC – Churchill Medical Systems; Inc. A Vygon Company – All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components; Peripherally Inserted Central Catheter. Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.
Bacterin International; Inc. Mar-11-2013 Elutia Hubless Coated Silicone Wound Drain – Bacterin Elutia; Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless; Full-Fluted Coated with Silver Sulfadiazine STERILE; Box of 10 Part #7118. Indicated for use in surgical wound drainage. A portion of a silicone wound drain was found to be cracked.
GE Healthcare; LLC Mar-11-2013 GE Healthcare; Innova 2100 IQ; Innova 3100 IQ; Innova 4100 IQ – GE Healthcare; Innova 2100 IQ; Innova 3100 IQ; Innova 4100 IQ. Cardiovascular X-ray imagingsystems. For use in generating fluoroscopic images of human anatomy. Exposed high voltage wires inside the cabinet . On a cable located in the system cabinet; two of the shrink tubings covering the 400V live cable leave an area potentially unprotected.
GE Healthcare; LLC Mar-11-2013 Optima MR450w; Discovery MR450; Discovery MR750; Signa HDx; Signa HDxt; Signa HDi; Signa Vibrant; an – Optima MR450w; Discovery MR450; Discovery MR750; Signa HDx; Signa HDxt; Signa HDi; Signa Vibrant; and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner. An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports.
Draeger Medical; Inc. Mar-11-2013 Draeger Infinity Acute Care System (IACS) Monitoring Solution – Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system. The displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccurate measurements. This can happen if the Dual Hemo MCable is used in a non-vertical position; a vertical position but upside down; or laying it on the floor or on the patient bed.
Synthes USA HQ; Inc. Mar-11-2013 Large Combination Clamp component of Synthes External Fixation System – Large Combination Clamp/Large External Fixation System; Part Number 390.005Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation. The L1 hex nuts; used to tighten the Large Combination Clamp; were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts.
Synthes USA HQ; Inc. Mar-12-2013 Synthes Titanium Midface Distractor – Synthes Titanium Midface Distractor; MR Conditional; Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones. There is the potential for the anterior footplates to not fit onto the Titanium Midface Distractor Assembly as the tab of some distractors may be oversized.
Philips Medical Systems (Cleveland) Inc Mar-13-2013 Brilliance 6; 10; 16; 40; 64; Big Bore and the iCT; iCT SP; Ingenuity CT and MX8000 Dual v. EXP – Brilliance 6; 10; 16; 40; 64; Big Bore and the iCT; iCT SP; Ingenuity CT and MX8000 Dual v. EXP are Computed Tomography X-Ray Systems.These devices are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment; patient; and equipment supports; components and accessories. Philips Healthcare received reports from the field stating the patient table on a system had an unexpected downward movement while a patient was on the table. Philips has determined the cause was a malfunction of the vertical brake.
GE Healthcare; LLC Mar-13-2013 GE Healthcare Advantx; Innova2000; Innova3100; Innova4100; Innova2100IQ; – GE Healthcare Advantx; Innova2000; Innova3100; Innova4100; Innova2100IQ;Innova3100IQ; and Innova4100IQ equipped with Video MonitorSuspension Cardiovascular X-ray imaging systems. Model numbers 2236709; 2353620 ;2223039-2; and 2270677-2. A locking nut might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx; Innova 2000; Innova 2100IQ; Innova 3100; Innova 3100IQ; Innova 4100; and Innova 4100IQ Cardiovascular X-ray imaging systems.
Smith & Nephew Inc Mar-13-2013 INTERNAL HEX RECON SCREW – INTERNAL HEX RECON SCREW; TI-6AL-4V; REF 7162380; TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW; QTY: (1); 6.4 MM; 80 MM; TITANIUM; Smith & Nephew; Inc. Orthopedic. Bone screw for intramedullary rod fixation. 75 mm screws were packaged and labeled using an 80 mm screw outer box and label; while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label.
Smith & Nephew Inc Mar-13-2013 INTERNAL HEX RECON SCREW – INTERNAL HEX RECON SCREW; TI-6AL-4V; REF 7162375; TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW; QTY: (1); 6.4 MM; 75 MM; TITANIUM; Smith & Nephew; Inc. Orthopedic. Bone screw for intramedullary rod fixation. 75 mm screws were packaged and labeled using an 80 mm screw outer box and label; while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label.
Natus Neurology Incorporated Mar-13-2013 Nicolet EEG Wireless Amplifier – Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier.Product Usage:The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire; store; and transmit electrophysiological signals in a wired or wireless mode for the Nicolet Neurodiagnostic system. Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off button. The overheating may result in discomfort ranging from too hot up to the potential for a burn.
Diagnostica Stago; Inc. Mar-14-2013 Diagnostica Stago Inc. – Vial Label:1) LIATEST VWF:Ag Buffer – 5 ml Diagnostica Stago2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica StagoModel; catalogue; number 00518 – 58978 – 58979Kit Label:LIATEST VWF:AgDIAGNOSTICA STAGO S.A.S.92600 Asni¿res sur Seine (France)Coagulation Assay Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.
Hill-Rom; Inc. Mar-14-2013 TotalCare SpO2RT¿ 2 bed – TotalCare SpO2RT2 bed. Product Usage: Bed; flotation therapy; powered bed may be used in a variety of settings including; but not limited to; acute care; including critical care; step down/progressive care; medical/surgical; high acuity sub-acute care; post anesthesia care unit (PACU); and sections of the emergency department (ED). The TotalCare SpO2RT¿ 2 Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution. In certain situations a software problem with the TotalCare SpO2RT? 2 bed may occur that can lead to inadvertent loss of sufficient surface cushionpressure to adequately support the patient. This may increase the likelihoodof skin irritation for patients at higher risk of developing pressure-related skin conditions. A correction to the software program is currently being developed andtested;
Philips Medical Systems (Cleveland) Inc Mar-14-2013 Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems – Brilliance 64 and Ingenuity Computed Tomography X-Ray SystemsThe Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment; patient; and equipment supports; components and accessories. This field change order is being released to update software and customer release notes to the affected installed base.
Siemens Medical Solutions USA; Inc Mar-14-2013 Siemens Somatom CTs equipped with software syngo CT2010A; syngo CT2010B; syngo CT2011A and CT2012B – Siemens Somatom CTs equipped with software syngo CT2010A; syngo CT2010B; syngo CT2011A and CT2012B.Computed tomography x-ray system. Sporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality.
Exactech; Inc. Mar-15-2013 Proximal Tibial Spacer – Optetrak Logic Comprehensive Knee Prosthesis System; Proximal Tibial Spacer and screws; size 3.5; 8mm; Catalog # 02-012-42-3508. A dimensional mismatch was identified which can potentially allow for interference between devices.
Extremity Medical LLC Mar-15-2013 Extremity Medical Disposable Instrument – 1.6 mm Guidewire – Extremity Medical – Disposable Orthopedic Surgical Instrument – 1.6 mm Guidewire – Reference Number 101-00006 – Non-Sterile. Contained in Extremity Medical Surgical Kits including CompressX; Hallu.X; IO Fix and XMCP. Used in the selection of screw size when used with appropriate depth gauge. The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge; the measurement reading will not correspond with the desired screw length. The selected screw size based on the depth gauge reading will be about 2 mm longer than intended.
Siemens Healthcare Diagnostics; Inc. Mar-15-2013 Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107) – Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test. Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA3085. Quality Control (QC) materials have not exhibited low recovery of the same magnitude.Internal method regression testing versus LC/MS has shown an average 25% low bias compared to LC/MS across the assay range. Individual patients; particularly samples with lower TACR values
Ebi; Llc Mar-15-2013 Biomet Spine Polaris 5.5 Button Lock Screw Inserter. – Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical; pedicle screw spinal fixation device. Increased risk of failure at the driver tip during screw insertion or removal.
Synthes USA HQ; Inc. Mar-15-2013 Synthes Variable Angle LCP Dorsal Distal Radius System – Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate; Part Number 02.115.431.Indicated for: Dorsally displaced fractures; Open joint reconstruction; and Corrective osteotomies after distal radius malunion. It was discovered that one of the VA-LCP Dorsal Distal Radius Plates was incorrectly etched as Part Number 02.115.431 (110 degree) instead of the correct Part Number 02.115.231 (90 degree).
Beckman Coulter Inc. Mar-15-2013 Creatinine – Creatinine; Part Numbers OSR6178; OSR6678Product Usage: System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers. The recall was initiated by Beckman Coulter because they are including additional information and instructions in the Creatinine (OSR6x78) IFU and Setting Sheet; relating to calibration stability and quality control frequency to assure product performance.
DePuy Spine; Inc. Mar-18-2013 CONFIDENCE SPINAL CEMENT SYSTEM KIT – DePuy CONFIDENCE SPINAL CEMENT SYSTEM KITCatalog Number: 283913000.Delivery of CONFIDENCE Spinal Cement; which is indicated for fixation of pathological fractures. Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
DePuy Spine; Inc. Mar-18-2013 CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT – DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KITCatalog Number: 283910000.Delivery of CONFIDENCE Spinal Cement; which is indicated for fixation of pathological fractures. Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
DePuy Spine; Inc. Mar-18-2013 CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT – DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KITCatalog Number: 283907000.Delivery of CONFIDENCE Spinal Cement; which is indicated for fixation of pathological fractures. Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
DePuy Spine; Inc. Mar-18-2013 CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT – DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KITCatalog Number:283905000.Delivery of CONFIDENCE Spinal Cement; which is indicated for fixation of pathological fractures. Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
Stryker Howmedica Osteonics Corp. Mar-18-2013 Triathlon – Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and the "R" and "L" markings on the Right Sizer are reversed.
Boston Scientific CRM Corp Mar-18-2013 SQ-RX – Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias. An internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Should this occur; the defibrillator would not be able to deliver therapy or communicate with the Q-TECH Model 2020 programmer; and would be unable to emit tones or otherwise respond to magnet application.
Molded Products Inc Mar-18-2013 Sterile Access & Return Line Set – Sterile Access & Return Line Set; 36" Length; Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing. The recalled product leaks at the connection site.
Allen Medical Systems; Inc. Mar-18-2013 Ankle Traction Boot – Allen Traction Boot; Modular; OT 1000 Traction Device Boot Assembly; Fracture Table Orthopedic Leg Holders; non-invasive medical devices designed to attach to orthopedic fracture tables to aid clinical staff in applying traction to the leg of a patient during surgical procedures. Some units may have been assembled incorrectly which could result in the boot breaking free from the mounting base and allowing the patient’s leg to fall.
Alphatec Spine; Inc. Mar-18-2013 IILICO MIS Posterior Spinal Fixation System – ILLICO Straight CP TI Rod; -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine; Inc. The ILLICO¿ MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The rods were incorrectly laser etched as ILLICO? Straight CP Tl Rods; 110mm; when they were in fact manufactured to 100mm in length.
DePuy Orthopaedics; Inc. Mar-19-2013 Specialist 2 – Specialist 2 IM Rod; Non-Sterile and associated Surgical Techniques:Sigma HP Instruments Classic Surgical Technique;0612-89-510Sigma HP Instruments Balanced Surgical Technique; 0612-88-510Sigma HP Instruments Fixed Reference Surgical Technique; 0612-87-510PFC Sigma Knee Systems Primary Cruciate-Retaining & Cruciate-Substituting Procedure Surgical Technique;SP2-007Product Usage:The SP2 IM Rod is used in both primary and revision Sigma knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection. This rod is included in both the SP2 and HP instrument kits. Potential for the IM rod to break; leaving fragments in the patient. Surgical Techniques guidance has been updated until design changes can be made to reduce likelihood of potential failure.
AGFA Corp. Mar-19-2013 CR 10-X Image Plate 35CM X 43CM – CR MD1.0 General Set; x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate; contained in an X-Ray cassette; used to capture images from X-Ray exposures. The cassette with the image plate; once exposed; is inserted in the Agfa Digitizer CR 10-X where the image plate is taken out of the cassette and then scanned so that the scanned image can be displayed for viewing. The cassettes were shipped with the wrong IP (image plate) size bar code.
Keystone Dental Inc Mar-20-2013 Keystone PrimaConnex Tapered Implant TC – PrimaConnex Tapered Implant TC; SD Internal Connection 3.5 x 10mmCatalog Number: l5613K.Implants in support for fixed bridgework. Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled
DePuy Orthopaedics; Inc. Mar-20-2013 ReClaim Reamer Extension – ReClaim Reamer Extension;packed non-sterile; within a polyethylene bag; with a label and IFU. The ReClaim Reamer Extension is intended as an attachment device to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal. The tabs on the reamer extension device have broken. DePuy is notifying surgeons of the issue to increase the awareness and to ask surgeons and users to look for tabs before and after surgery to reduce any potential that the tabs are left in the patient. Once the root cause is determined and a design change is implemented; DePuy will conduct a formal swap-out of the affected devices.
Intio Inc Mar-20-2013 INTIO Inc. ClearStart-SVM – INTIO Inc.; ClearStart-SVM Segmentation and Volumetric Measurement System; Users Manual. Part #: UM-06-20-0003. ClearStart-SVM is used for patient assessment using CT (computed tomography) images; in order to plan potential therapies or monitor tumor response to treatment. INTIO Inc. distributed a SVM User’s Manual and it has an editing mistake that could be interpreted as promoting an unapproved use.
Becton Dickinson & Co. Mar-22-2013 BD Max ™ GBS Assay – BD MAX PCR Cartridges Catalog #437519; box of 24 cartridges labeled in part:***BD MAX PCR Cartridges; GeneOhm Sciences Canada; Inc. 2555 boul du Parc-Technologique; Quebec; Canada G1P 4S5***BD Max Group B Streptococcus (GBS) Assay is an in vitro diagnostic (IVD) test for detection of GBS DNA in Lim Broth cultures.The BD MAX" PCR Cartridge is a consumable required for the BD MAX" System. Cartridges are not sealing properly during PCR testing and may cause false results; indeterminates and/or invalid runs.
Mindray DS USA; Inc. d.b.a. Mindray North America Mar-22-2013 BS-200 Chemistry Analyzer – BS-200 Chemistry AnalyzerDesigned for clinical laboratory use. An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.
Orthohelix Surgical Designs Inc Mar-22-2013 Intraosseous Fixation System – Intraosseous Fixation System (IFS) 1.7 mm; 2.0 mm & 2.5 mm Cannulated Drill Bit.Intended to stabilize and aid in fixation of fractures. The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire.
Abbott Laboratories; Inc Mar-25-2013 ARCHITECT HBsAg Qualitative Assay; ARCHITECT HBsAg Qualitative Confirmatory Assay – ARCHITECT HBsAg Qualitative Assay; List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay; List Number 4P54The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum. Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assays (LNs 4P53 and 4P54) on the ARCHITECT i1000SR System were mistakenly made available on abbottdiagnostics.com in October 2012. Additionally; some i1000SR customers received notification through AbbottLink in November 2012 that assay files for LNs 4P53 and 4P54 were available. The AR
Biomerieux Inc Mar-25-2013 VITEK 2 60 computer system – VITEK 2 60 computer system when equipped with the following Hewlett-Packard PC models:(1) rp5700; Cat. #W0452;(2) rp5700 (refurbished); Cat. #W0452R;(3) rp5800 XPE; Cat. 413642;(4) rp5800 WES7; Cat. #413862;(5) dc7100 8-port; Cat. #W0441; (6) dc7100 8-port (refurbished); Cat. #W0441R; (7) dc7700 8-port; Cat. #W0447; (8) dc7700 8-port (refurbished); Cat. #W0447R; (9) dc7800; Cat. #W0449; and (10) dc7800 (refurbished); Cat. #W0449R.VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
Biomerieux Inc Mar-25-2013 VITEK 2 XL computer system – VITEK 2 XL computer system when equipped with the following Hewlett-Packard PC models:(1) rp5700; Cat. #W0452;(2) rp5700 (refurbished); Cat. #W0452R;(3) rp5800 XPE; Cat. 413642;(4) rp5800 WES7; Cat. #413862;(5) dc7100 8-port; Cat. #W0441; (6) dc7100 8-port (refurbished); Cat. #W0441R; (7) dc7700 8-port; Cat. #W0447; (8) dc7700 8-port (refurbished); Cat. #W0447R; (9) dc7800; Cat. #W0449; and (10) dc7800 (refurbished); Cat. #W0449R.VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
Biomerieux Inc Mar-25-2013 VITEK 2 Compact computer system – VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models:(1) dc7100 8-port; Cat. #W0441; (2) dc7100 8-port (refurbished); Cat. #W0441R; (3) dc7700 8-port; Cat. #W0447; (4) dc7700 8-port (refurbished); Cat. #W0447R; (5) dc7800; Cat. #W0449; (6) dc7800 (refurbished); Cat. #W0449R(7) rp5700; Cat. #W0452;(8) rp5700 (refurbished); Cat. #W0452R;(9) rp5800 XPE; Cat. 413642;(10) rp5800WES7; Cat. #413862;(11) d530 6-port; Cat. #W0438;(12) d530 6-port (refurbished); Cat. #W0438R; and(13) d530 4-port; Cat. #W0437.VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. There is a potential to link an isolate result to the wrong patient and then upload the results to the LIS.
Toshiba American Medical Systems Inc Mar-25-2013 Toshiba Infinix-i X-Ray System – Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures. Lost and incorrect images. When using the "F-Rec" fluoroscopy image acquisition recording option in the "manual mode" an infrequent software error may cause images from another study to be displayed on the monitor. The acquired images may be lost requiring additional image acquisitions to be performed.
Siemens Medical Solutions USA; Inc Mar-25-2013 Siemens Axiom Artis zeego systems – Siemens Axiom Artis zeego systems with software version VC14; VC20 and VC21 in conjunction with specific technical configurationAngiographic x-ray system In the course of the firm’s product monitoring activities; a potential risk for patient or operators was determined during the operation of an Artis zeego system with software revision VC14; VC20 and VC21 in conjunction with a specific technical configuration which cannot be completely executed.
Smiths Medical ASD; Inc. Mar-26-2013 Medfusion¿ Model 3500 Syringe Pump – Medfusion Model 3500 Syringe Pump; Model #3500-415 and 3500-500.Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates. An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions.
Advanced Sterilization Products Mar-26-2013 STERRAD 200 Carriage – STERRAD 200 System Carriage; P/N 10208.Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer. Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is applied.
Siemens Medical Solutions USA; Inc Mar-26-2013 Artis Systems with Software Artis VC20x/VC21A/VD10x – Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed.Angiographic x-ray system The firm has become aware of a potential issue on Artis systems with the software Artis VC20x/VC21A/VD10x that have a DSA license installed. Under certain preconditions; executing roadmap OGP (organ program) in the DSA overlay mode may lead to imprecise registration of the DSA mask image with the roadmap image displayed on the live monitor.
Kimberly-Clark Corporation Mar-26-2013 Kimberly-Clark KIMGUARD Container Filters – KIMGUARD Container Filters; 7.5in (19cm); Round and 9in. X 9in. (23cm x 23cm); Square.Intended to be used to enclose another medical device that is to be sterilized by a health care provider. Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier.
Vital Images; Inc. Mar-27-2013 Vitrea Enterprise Suite; Vitrea; VitreaAdvanced; VitreaCore (VitalConnect) and Vitrea fX prior to ve – Vitrea Enterprise Suite; Vitrea; VitreaAdvanced; VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3; except 6.1.6; 6.2.3 and 6.3The software is a medical diagnostic system that allows the processing; review; analysis; communication; and media interchange of multidimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities; including CT; MR; D; CR; XA; US; NM; PET; etc. The software is not meant for primary image interpretation in mammography. Vital Images has found a potential error in measurement generated through the software which affects all versions of Vitrea Enterprise Suite; Vitrea; VitreaAdvanced; VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3; except 6.1.6; 6.2.3 and 6.3.This error occurs when images are rotated at the time of reconstruction by the scanner in non-90 degree increments of the transverse/axia
Biomerieux Inc Mar-27-2013 VITEK 2 AST-ST01 Streptococcus Susceptibility Card – bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card; REF 410 028.For use with VITEK 2 systems to determine the susceptibility of Streptococcus to antimicrobial agents. The product package did not contain the correct version of the package insert listing the limitations of use and performance requirements.
Microbiologics Inc Mar-28-2013 Microbiologics KWIK-QC SLIDES – Microbiologics KWIK-QC SLIDES ( KWIK-QC Acid Fast Stain Slides and KWIK-QC Mycobacterium Slides).Slide preparations serving as quality control challenges to demonstrate satisfactory performance of staining reagents. Microbiologics Inc is initiating a voluntary recall on products KWIK-QC Acid Fast Stain Slide; SL42-10 and KWIK-QC Mycobacterium; SL43-10. These products are being recalled because the control organisms are not properly fixated on the slide; which may cause the user to unintentionally contaminate the patient area of the slide by flooding the control well with stain. This contamination could pote
Cardinal Health Mar-28-2013 Needle Counters – Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA70SSA)Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area; (Cat. No. 3FM70SSA)Product Usage:Disposal system for counting of used surgical blades and needles. Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Cardinal Health Mar-28-2013 Needle Counters – Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double Removable Numbered Foam Blocks (Cat. No. 3FF80SSA)Product Usage:Disposal system for counting of used surgical blades and needles. Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Cardinal Health Mar-28-2013 Needle Counters – Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA70SSA)Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FM70SSA)Product Usage:Disposal system for counting of used surgical blades and needles. Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Cardinal Health Mar-28-2013 Needle Counters – Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capacity; Sterile; Removable Numbered Foam Block; Double Numbered Magnets (Cat. No. 4FM100SSA)Product Usage:Disposal system for counting of used surgical blades and needles. Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Cardinal Health Mar-28-2013 Needle Counters – Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 4FS60SSA)Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips (Cat. No. 4FS61SSA)Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Numbered Magnets (Cat. No. 4MM60SSA)Product Usage:Disposal system for counting of used surgical blades and needles. Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Cardinal Health Mar-28-2013 Needle Counters – Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat. No. 3FS60SSA)Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Foam Strips; (Cat. No. 3FS61SSA)Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Double Numbered Magnets (Cat. No. 3MM60SSA)Product Usage:Disposal system for counting of used surgical blades and needles. Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Cardinal Health Mar-28-2013 Needle Counters – Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FS30SSA)Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block; Double Foam Strips (Cat. No. 4FS31SSA)Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Double Numbered Magnets (Cat. No. 4MM30SSA)Product Usage:Disposal system for counting of used surgical blades and needles. Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Cardinal Health Mar-28-2013 Needle Counters – Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA)Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 3FM40SSA)Product Usage:Disposal system for counting of used surgical blades and needles. Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Cardinal Health Mar-28-2013 Needle Counters – Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 4FA40SSA)Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Magnetic Area (Cat. No. 4FM40SSA)Product Usage:Disposal system for counting of used surgical blades and needles. Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Medtronic Inc. Cardiac Rhythm Disease Management Mar-28-2013 Archer 0.035 inch (0.89mm) Super Stiff Guidewire – Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire; Models ARCSJ200W; ARCSJ260W; and ARCDJ260W. Sterile using ethylene oxide. Product Usage:The Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta; where increased support; distal flexibility; and low surface friction of the guidewire is needed. Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire; Models ARCSJ200W; ARCSJ260W; and ARCDJ260W; where a change in the manufacturing process has been identified as the cause for potential kinking and breaking at the proximal weld end of the outer spring coil during in-vivo use.
Medtronic Inc. Cardiac Rhythm Disease Management Mar-28-2013 Archer Super Stiff Guidewire – Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm); Model ARCSJ200W.Intended to facilitate catheter placement and exchange during procedures in the aorta. Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire; model ARCSJ200W; where the PTFE (Teflon) coating has the potential to separate from the wire during in-vivo use.
Biosense Webster; Inc. Mar-28-2013 20-Pole Eco Cable – 20-Pole Eco Cable; Catalog #EM-5050-060Product Usage:The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System. Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. When a catheter is connected to an affected to an affected 20-Pole Eco Cable; the catheter will not be recognized by the impacted 54 cable serial numbers within the field.
Synthes USA HQ; Inc. Mar-28-2013 Synthes Dens Instrument Set (Dens Graphic Case); Part Number 687.030 (also known as the Anterior Col – Synthes Dens Instrument Set (Dens Graphic Case); Part Number 687.030 (also known as the Anterior Column Retractor Set)The Synthes Dens instrument Set has been designed to facilitate internal fixation of the odontoid process for the reduction of Type II and shallow Type III fractures; as proposed by Anderson and d’Alonzo. The Dens Instrument Set has been designed to facilitate the anterior internal fixation of the Dens (odontoid process). There are currently no screws specifically indicated to treat Dens fractures via anterior screw fixation therefore the affected product will be removed.
Cooper Surgical; Inc. Mar-28-2013 Diaphragm (contraceptive device) – Omniflex Diaphragm – Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65Intended for use in contraception. Incorrect size was printed on the outer product packaging.
Genetic Testing Institute;inc Mar-28-2013 LIFECODES PF4 Enhanced assay – Gen-Probe LIFECODES PF4 Enhanced assay; Catalog No. X-HAT45GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA). Lifecodes PF4 Enhanced assay; lot number 3000389; is being recalled because of observed inconsistent replicate values when testing the kit Positive Control and patient samples. The variation in reactivity can lead to invalid assays. If an invalid assay is obtained; those results should not be reported and the test should be re-run. An invalid assay would not result in significant harm to a pati
CareFusion Corporation Mar-28-2013 Pyxis – Pyxis Anesthesia System Model 2000 (PAS 2000)Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist at the point of care within the operating room. The recall was initiated because Carefusion has confirmed that when the PAS 2000 drawers due to inaccessability of drawers caused by system down time or lock-up.
Zyno Medical LLC Mar-29-2013 Zyno Z-800 Volumetric Infusion System – Z-800 Volumetric Infusion System.For intravenous infusion of parenteral fluids; blood and blood products to a human patient. Update Instruction For Use for Preventative Maintenance (PM) Schedule and addition of Odometer software to monitor accumulative fluid volume infused by the pump
Advanced Sterilization Products Mar-30-2013 STERRAD 100NX – STERRAD 100NX Sterilization System; P/N 10104Product Usage:The STERRAD 100NX Sterilization System is a general purpose; low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments. The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
Advanced Sterilization Products Mar-30-2013 STERRAD 200 – STERRAD 200 Sterilization System; P/N 10201Product Usage:The STERRAD 200 Sterilization System is a general purpose; low temperature sterilizer which uses the STERRAD 200 process to inactivate microorganisms on a board range of medical devices and surgical instruments. The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.