Medical devices, 2014: every recall, from FDA

Medical device recall IMRIS Operating Room table (ORT200 and ORT300) One of the three pins that is used to hold the ORT200 table alignment block in place on the floor of the MR Suite went missing during testing at a health care… Class IIFDA’s classNov 5, 2014in FDA’s Enforcement Report6 statesnamed in where it went PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, North Carolina, New Hampshire, Tennessee and Utah

Medical device recall Parker Eclipse Probe Cover, Latex Free Parker Laboratories, Inc. Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall ACCU-CHEK Spirit Combo insulin infusion pump The insulin pump may lose time and date settings during a power interruption (such as a battery change) due to a faulty capacitor. Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy. CooperSurgical is recalling two lots of 900-863 because the wrong package insert (IFU) was placed into the shipper. Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and North Carolina named

Medical device recall siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used on the Dimension¿ clinical chemistry… Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with this lot resulting in the potential for a positive or… Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named

Medical device recall Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open automation platform product for… Distortion (noise interference) of the liquid level capacitance can result in air aspiration instead of liquid aspiration. Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereIllinois

Medical device recall APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and… A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt. Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Connecticut, Illinois, Washington and West Virginia named

Medical device recall Joerns EasyCare Bed Product Usage: The AC-powered adjustable hospital bed is a device intended for medical… The Easy-Care Care-Lock feature installed at the foot of the bed may potentially fail to stay engaged (locked) after the Care-Lock System has been engaged by… Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Laksell Gamma Knife Perfexion Elekta has become aware that the latches may be locked before they have been fully turned resulting in a poorly locked frame. Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named

Medical device recall Spline Twist Implant, HA 3.25mmD X 15mmL Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial. Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial. Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174 Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled. Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named

Medical device recall Esprit V1000 and V200 Ventilators A failure of a specific component may prevent the ventilators from operating on AC power or transitioning back to AC power when operating on battery. FDA Class I, its most serious class Class IFDA’s classOct 29, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 29, 2014ClassClass IStatusTerminatedWhereNo state named

Medical device recall Siemens Mammomat Inspiration mammography systems The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a safety switch which causes a failure of the functionality. Class IIFDA’s classOct 29, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereMassachusetts, New York and Virginia

Medical device recall Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119 Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced an increased rate of premature battery depletion due to… Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereNationwide, and American Samoa, Guam, Puerto Rico and US Virgin Islands named

Medical device recall Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not… Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced an increased rate of premature battery depletion due to… Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereNationwide, and American Samoa, Guam, Puerto Rico and US Virgin Islands named

Medical device recall Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or… Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or… Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or… Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall DePuy Synthes Radiolucent Retractor Particle residue on the instrument from adhesive tape which was used to bind the device during transport. Class IIFDA’s classOct 29, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereMichigan, North Carolina, New York, Pennsylvania, Tennessee, Washington and Wisconsin

Medical device recall McKesson Cardiology Hemo McKesson Cardiology Hemo front-end parameter boxes must undergo annual maintenance testing to establish the proper functioning of the parameter boxes, and to… Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip,… The affected products are missing polar boss threads. Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Iowa, Massachusetts, North Carolina, Nevada, Tennessee, Texas, Utah and Washington named

Medical device recall Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition. Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereNationwide, and Florida, Indiana, Michigan, North Carolina, New York, Ohio, Virginia and West Virginia named

Medical device recall DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition. Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereNationwide, and Florida, Indiana, Michigan, North Carolina, New York, Ohio, Virginia and West Virginia named

Medical device recall CRN Crono Syringe CRN20 with 19G x 1 “Steel Needle” Product has the potential to have a clear debris on the tip of the needle. Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Massachusetts, New York, Ohio and Pennsylvania named

Medical device recall GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640… Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package’s sterile barrier and… Class IIFDA’s classOct 29, 2014in FDA’s Enforcement Report22 statesnamed in where it went PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Utah and Washington

Medical device recall Ultra Battery 1 Estill has discovered that a fully discharged Ultra Battery 1 (TA-UB1) will reach 96.9% of its capacity during a 60 minute charging period. Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Siemens ADVIA Centaur¿ Systems HBc Total (HBcT), Reagent Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results. Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results. Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Philips IntelliVue Monitors with software revisions J.21.03, J.21.19 Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Philips Avalon Monitors with software revision J.30.58 Philips Intellivue and Avalon Fetal Monitors in time-synchronized automatic/sequence mode, the NBP automatic measurement series is stopped Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Box Label: 3 mm Cueva Electrode Kit, Sterile EO The recall has been initiated due to concerns that the applicator wand may malfunction potentially causing the inability to monitor the VII cranial nerve. Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Louisiana, New Jersey, Ohio, Washington and Wisconsin named

Medical device recall Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 The V-Series Monitor is intended… Mindray DS USA Inc. Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall St Jude Medical, 10F Fast-Cath Trio” Hemostasis Introducer St. Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereNationwide, and Florida, Indiana, Massachusetts, Maine, New York, Ohio, Rhode Island, Texas and West Virginia named

Medical device recall Microseal Augmented Incorrect dimension on four liners was detected Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportMissourithe one state its words name PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereMissouri

Medical device recall Mortara Surveyor S12 and Surveyor S19 Patient Monitors Martara Instrument, Inc. Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, District of Columbia, Florida, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, New Jersey, Nevada, New York, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin named

Medical device recall Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for… Packaging of a device was compromised Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereNationwide, and Missouri named

Medical device recall Bionector Needleless connector Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary recall of the… Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereCalifornia

Medical device recall ASK-05501-AFH1 Arrow International, Inc. Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportUtahthe one state its words name PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereUtah

Medical device recall Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers Reports of loose bolts in the detector support structure of Symbia and E.CAM systems. Class IIFDA’s classOct 29, 2014in FDA’s Enforcement Report53 statesnamed in where it went PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming

Medical device recall e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or… Reports of loose bolts in the detector support structure of Symbia and e.cam systems. Class IIFDA’s classOct 29, 2014in FDA’s Enforcement Report53 statesnamed in where it went PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming

Medical device recall Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308… Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC) Class IIFDA’s classOct 29, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereFlorida and Massachusetts

Medical device recall The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is… Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro… Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Illinois, Mississippi, North Carolina and Texas named

Medical device recall IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD Customer complaints were received for positive bias reported on the controls used on the IMMULITE /IMMULITE 1000 on the Cortisol Assay reagent lots IMMULITE… Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total… Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip. Class IIFDA’s classOct 29, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedOct 29, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Massachusetts, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia and Wisconsin named

Medical devices, 2014

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