Medical devices, 2015: every recall, from FDA

Medical device recall Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated… Medcomp has initiated the recall of Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III,… Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments. Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Florida, Georgia, Illinois, Maryland, Michigan, Mississippi, North Dakota, New York, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas and Virginia named

Medical device recall Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to… Several shipments of Vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees Celsius (C) were not delivered to customers within the… Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Florida, Iowa, Illinois, Kansas, Louisiana, Massachusetts, Michigan, Missouri, North Carolina, New York, Ohio, Pennsylvania, Texas, Virginia, Wisconsin and West Virginia named

Medical device recall Syngo.plaza. A Picture Archiving and Communication System (PACS) intended to display, process, read, report,… Possibly incomplete archived studies during pre-fetch. Class IIFDA’s classApr 8, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereFlorida, Massachusetts and Wisconsin

Medical device recall Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage… Complaints of device fragmentation after the catheter was implanted in the biliary system. Class IIFDA’s classApr 8, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Ohio and Wisconsin

Medical device recall Medtronic Dual Chamber Temporary External Pacemaker Possible performance issue when used with specific AA-sized (LR6) batteries. Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation. This lot of the RECLAIM Assembled Implant Inserter Adaptor Instrument may fracture during surgery and there is the potential for plastic pieces to be left in… Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and California named

Medical device recall Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling Potential breach of the sterile barrier packaging. Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia named

Medical device recall Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology, Brilliance iCT, Brilliance… Philips discovered that a software defect exists in marketed product wherein the sign indication of the longitudinal position of some types of scan is inverted. Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Connecticut, Delaware, Florida, Georgia, Iowa, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Vermont, West Virginia and Wyoming named

Medical device recall Brand Name: Persona¿ Anterior Referencing Sizer with Locking Boom The Persona Anterior Referencing Sizer is a… Zimmer, Inc is voluntarily recalling 22 lots of Persona¿ Anterior Referencing Sizer with Locking Boom, part number 42-5099-088-10. Class IIFDA’s classApr 8, 2015in FDA’s Enforcement Report28 statesnamed in where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Massachusetts, Maine, Michigan, Minnesota, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia and Wisconsin

Medical device recall Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 Product Usage:… Product is mislabeled as Double Swivel Connector with Suction Port and is actually Double Swivel Connector without Suction port. Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Indiana, Kentucky, Michigan, Pennsylvania and Tennessee named

Medical device recall GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM Failures of the 4.8mm of the GAP Endo-Exo Medullary System have been identified at the level of the distal cortical screw holes. Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, New York and Puerto Rico named

Medical device recall ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation Device #7 PE Ziploop… The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were not processed following a standard work process, which resulted… Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Georgia, North Carolina, New Mexico, Oklahoma and Texas named

Medical device recall Ziploop Button Product Usage: The Ziploop Button is a non-resorbable system intended to aid in ACL… The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were not processed following a standard work process, which resulted… Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Georgia, North Carolina, New Mexico, Oklahoma and Texas named

Medical device recall Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO Medtronic is conducting a voluntary recall of all former Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems due to potential for a sterility breach… Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named

Medical device recall Autoject E1 Fixed needle device The syringe carrier is missing components: a damper and spring. Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Florida, Georgia, Illinois, Missouri, North Carolina, Oklahoma, Tennessee and Texas named

Medical device recall YC-1800 OPHTHALMIC YAG LASER SYSTEM Dear Doctor letter and Quick Reference Guide is being sent to users of the YC-1800 to reiterate important safety and cleaning information after complaints of… Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall LIS27T - Lacrimal Intubation Set Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, District of Columbia, Florida, Georgia, Illinois, Kentucky, Maryland, Michigan, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah and Virginia named

Medical device recall ACCU-CHEK Connect Diabetes Management App Roche Diabetes Care has become aware of an issue with the Accu-Chek Connect diabetes management app that could potentially lead to inaccurate bolus advice… Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNo state named

Medical device recall BD FACSCalibur The circuit breakers on some BD FACSCalibur instruments may have the incorrect rated amperage (20 amps instead of 2 amps) causing the circuit breaker to fail… Class IIFDA’s classApr 8, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNew Jersey, Oklahoma and Texas

Medical device recall Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO Edwards Lifesciences is recalling Fem-Flex II Pediatric Femoral Arterial Cannula sizes 8, 10, 12 French because of the potential of tissue damage caused by a… Class IIFDA’s classApr 8, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Bio-PLASTY Cannula (Needle) Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution Class IIFDA’s classApr 8, 2015in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Massachusetts, New Jersey, Texas and Washington

Medical device recall Bio-MAC Cannula (Needle) Set Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution Class IIFDA’s classApr 8, 2015in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Massachusetts, New Jersey, Texas and Washington

Medical device recall Bio-CORE Cannula (Needle) Set Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution Class IIFDA’s classApr 8, 2015in FDA’s Enforcement Report7 statesnamed in where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Massachusetts, New Jersey, Texas and Washington

Medical device recall CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent One lot of BD CD123 PE (ASR) has been determined to contain a low amount of CD4 antibody and may result in an unexpected staining pattern. Class IIFDA’s classApr 8, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereArizona, Georgia, Missouri, Nebraska, Texas and Virginia

Medical device recall GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines Specific Aespire 7900 Anesthesia Machines have an increased likelihood of failure of the CPU circuit board. Class IIFDA’s classApr 8, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 8, 2015ClassClass IIStatusTerminatedWhereNorth Carolina and Oklahoma

Medical device recall GE Inspection Technologies x|tome|x L240 an Cabinet X-ray system It was discovered that the upper left corner-shaped lead shield in the window in one of the doors of the v|tome|x L240 installed had lost adhesion and fall out… Class IIFDA’s classApr 1, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereOhio and Pennsylvania

Medical device recall GE Inspection Technologies x|argos 160D system It was discovered that the upper left corner-shaped lead shield in the window in one of the doors installed had lost adhesion and fall out of position, which… Class IIFDA’s classApr 1, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereOhio and Pennsylvania

Medical device recall Diamondback 360 Coronary Orbital Atherectomy System The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in… FDA Class I, its most serious class Class IFDA’s classApr 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 1, 2015ClassClass IStatusTerminatedWhereNationwide, and Arizona, Florida, Georgia, Louisiana, Massachusetts, Missouri, Mississippi, New Jersey, New York, Ohio and Rhode Island named

Medical device recall da Vinci Xi Surgical System, IS4000 Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch between the positions reported by the redundant position sensors on… Class IIFDA’s classApr 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T… GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites. Class IIFDA’s classApr 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Guam and Puerto Rico named

Medical device recall Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 The Pacific Stretcher/Transfer… If the patient sits on either wing, not squarely on the center section of the Stretcher Lift, tipping and injury to the operator or patient could result. Class IIFDA’s classApr 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS VCG battery ignited in a VCG unit when recharging. Class IIFDA’s classApr 1, 2015in FDA’s Enforcement Report20 statesnamed in where it went PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Illinois, Massachusetts, Minnesota, North Carolina, North Dakota, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Washington and Wisconsin

Medical device recall MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A The gradient output supervision was permanently turned off on the MAGNETOM system, meaning that gradient outputs could exceed IEC60601-2-33 limits and… Class IIFDA’s classApr 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Intraocular Lens (IOL) Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements. Class IIFDA’s classApr 1, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereAlabama, Florida, Kansas and Oklahoma

Medical device recall RayStation Radiation Therapy Treatment Planning System An issue with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is positioned above the jaws, e.g. Class IIFDA’s classApr 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Alaris PC units CareFusion is recalling the Alaris PC unit because of an error code. Class IIFDA’s classApr 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425 Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicator because they were shipped to customers after its expiration… Class IIFDA’s classApr 1, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin… In May 2013, the original recall was initiated due to complaints the Hand Switch for the Electric Pen Drive was not labeled correctly, and the on and lock… Class IIFDA’s classApr 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Variable Angle Locking Peg, D:1.8mm x L:14.0mm Locking pegs were not locking during distal radius procedures. Class IIFDA’s classApr 1, 2015in FDA’s Enforcement Report9 statesnamed in where it went PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Kentucky, New York, Oklahoma, Pennsylvania, Texas and Virginia

Medical device recall Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining The staining intensity decreases over the shelf life. Class IIFDA’s classApr 1, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Iowa, Idaho, Illinois, Montana, North Carolina, New York, Texas and Washington named

Medical device recall ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or… The ExacTrac 6.x Patient Positioning System may incorrectly position the patient when using the ExacTrac Cone Beam CT (CBCT) with a TrueBeam-specific optional… Class IIFDA’s classApr 1, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereNo state named

Medical device recall BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum. Class IIFDA’s classApr 1, 2015in FDA’s Enforcement Report9 statesnamed in where it went PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Illinois, Massachusetts, North Dakota, New York, Ohio and Pennsylvania

Medical device recall DUAFIT(R) PIP 0o CA SIZE 2 Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder. Class IIFDA’s classApr 1, 2015in FDA’s Enforcement ReportTennesseethe one state its words name PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereTennessee

Medical device recall DUAFIT(R) PIP 0o CA SIZE 3 Dimensional non-conformity leading to the impossibility to introduce the implant in the dedicated holder. Class IIFDA’s classApr 1, 2015in FDA’s Enforcement ReportTennesseethe one state its words name PublishedApr 1, 2015ClassClass IIStatusTerminatedWhereTennessee

Medical device recall cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay False positive results for Exon 20 insertion mutations are being detected with the cobas¿ EGFR Mutation Test, kit batch T08661. Class IIIFDA’s classApr 1, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 1, 2015ClassClass IIIStatusTerminatedWhereNo state named

Medical devices, 2015

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