Medical devices, 2017: every recall, from FDA

Medical device recall D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X 10MM, RES 74692410… The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos… Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage… Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall various polyethylene implants Custom parts Product Usage: Custom Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Software version 4.44A utilized on the BD MAX System The BD MAX System software version 4.44A contains a software anomaly that has the potential to affect some Open System Reagent (OSR) customers utilizing User… Class IIFDA’s classApr 26, 2017in FDA’s Enforcement Report17 statesnamed in where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Illinois, Minnesota, Missouri, Montana, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Washington and Wisconsin

Medical device recall Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not… Avid Medical Inc has received a complaint was received from an end-user indicating the vacutainer component 519700 (BD: 367863) expiring 12/16 was discovered… Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNo state named

Medical device recall BD Viper LT software, version 3.00H BD has confirmed reports that lower than expected RFU values were generated on customer BD Viper LT Systems after the installation of software version 3.00H. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNo state named

Medical device recall 216 Wilson Frame Pads Mizuho has discovered that the 5319-37 Wilson Frame Pads have a design deficiency in the construction of their mounting sleeves that may allow the patient to… Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNo state named

Medical device recall SmartTools Knee System Orthopedic Stereotaxic Instrument There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Elcam Minimal Residual Volume Luer-activated Swabable-stockcock (MRVLS) 4w gxl:w1/r rbls Product Usage:… The stopcock was found to have punctures. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set Product may overheat, melt, and burn patient. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNo state named

Medical device recall SURESTEP Tray, Bardex I.C Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement Report24 statesnamed in where it went PublishedApr 26, 2017ClassClass IIStatusCompletedWhereCalifornia, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia and Washington

Medical device recall PGCL [poly (glycolide-co-caprolactone)] Absorbable Suture, Manufacturer CP Medical, Portland OR, Sterile The tensile strength minimum as directed by USP <881> was not met over the length of the product’s shelf life. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement Report22 statesnamed in where it went PublishedApr 26, 2017ClassClass IIStatusOngoingWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Indiana, Kentucky, Louisiana, Montana, Nebraska, New Jersey, New Mexico, New York, Oklahoma, Oregon, South Carolina, Texas and Washington

Medical device recall Laerdal Compact Suction Unit ¿ 4 under the following labels: 1) 300 ml The On/Off functionality in the LCSU 4 is controlled by electronic components, one of which might be damaged. Class IIFDA’s classApr 26, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 26, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid… Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the StrataMR Locator Tool: When the StrataMR valve is set in the… FDA Class I, its most serious class Class IFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2017ClassClass IStatusTerminatedWhereNationwide

Medical device recall MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning and orientation of instrument… Unapproved change made by the supplier. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, District of Columbia, Florida, Illinois, Kentucky, Massachusetts, Minnesota, North Carolina, New York, Ohio and Pennsylvania named

Medical device recall MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument… Unapproved change made by the supplier. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, District of Columbia, Florida, Illinois, Kentucky, Massachusetts, Minnesota, North Carolina, New York, Ohio and Pennsylvania named

Medical device recall Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000… For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece… Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall HYFRECATOR 2000 HANDPIECE SHEATH, REF/Part Number 7-796-19 For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece… Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Specimen Gate Laboratory Potential for errors in patient results generated by the Specimen Gate Laboratory Software. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement Report23 statesnamed in where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Missouri, Nevada, Ohio, Oklahoma, Oregon, Tennessee, Texas and Virginia

Medical device recall iConnect Enterprise Archive (ICEA) software An error message can occur resulting in the prior studies being unavailable for viewing. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Cobas 8100 bi-directional reformatter (BRF) module with Software Version 02-xx “Roche Diagnostics Corp. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement Report16 statesnamed in where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Missouri, Nebraska, New Jersey, Ohio, Pennsylvania, South Carolina and Texas

Medical device recall Cobas 8100 uni-directional reformatter (BRF) module with Software Version 02-xx Roche Diagnostics Corp. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement Report16 statesnamed in where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Missouri, Nebraska, New Jersey, Ohio, Pennsylvania, South Carolina and Texas

Medical device recall VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical… Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagent Lots 1568, 1570, 1580 and 1590, due to background signals… Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 19, 2017ClassClass IIStatusTerminatedWherePuerto Rico

Medical device recall The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in… Merit Medical Systems, Inc. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall CADD¿ Administration Set, 21-7339-24 Smiths Medical has become aware that the drawing on the Instructions for Use (IFU) on certain yellow striped CADD¿ Administration Sets (part number… Class IIFDA’s classApr 19, 2017in FDA’s Enforcement Report43 statesnamed in where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, West Virginia and Wyoming

Medical device recall Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Custom Tubing Pack with Bioline Coating UDI code: 00607567208230 A complaint was received on January 1, 2017 stating the pigtail on line 2 of the oxygenator was assembled to the port where the yellow cap and the clear cap… Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereCalifornia

Medical device recall Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera Due to a potential manufacturing error, a rare possibility exists for a sudden drop in table height of the Combi Dockable Table Neurosurgery. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereDistrict of Columbia and Maryland

Medical device recall ViperWire Advance Peripheral Guide Wire with Flex Tip Cardiovascular Systems, Inc. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, Colorado, Florida, Georgia, Hawaii, Indiana, Kansas, Kentucky, Louisiana, Mississippi, North Carolina, New Mexico, Rhode Island, Texas and Virginia named

Medical device recall Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio… It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Georgia, Illinois, Louisiana, Massachusetts, New York, Ohio, Pennsylvania, Tennessee, Texas and Virginia named

Medical device recall Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi,… It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Georgia, Illinois, Louisiana, Massachusetts, New York, Ohio, Pennsylvania, Tennessee, Texas and Virginia named

Medical device recall Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four Oxi plus, Scio Four Oxi, Scio… It was reported that a set low O2 alarm does not go off although the measured O2 level is below the alarm limit. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Georgia, Illinois, Louisiana, Massachusetts, New York, Ohio, Pennsylvania, Tennessee, Texas and Virginia named

Medical device recall Refinity Rotational Intravascular Ultrasound (IVUS) Catheter High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400 A defective electrical component in the battery charging circuit in two lots of the ProBP 2400 may potentially cause an over-voltage battery charging condition… Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Merge Hemo software Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Kansas, Louisiana, Michigan, Missouri, Ohio, Oklahoma, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named

Medical device recall Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA. GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist… Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD. GE Healthcare has become aware of an issue where a patient other than the intended is incorrectly selected by the operator in situations where DICOM Worklist… Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Boston Scientific Imager II Angiographic Catheter, M001316581 One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement Report8 statesnamed in where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereArizona, Florida, Missouri, New Jersey, New York, Ohio, Pennsylvania and Texas

Medical device recall Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives… It was reported from a complaint that study category labels of “Prior” and “Baseline” and hanging position appeared incorrectly swapped when the hanging… Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Cataract Kit AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised. Class IIFDA’s classApr 19, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedApr 19, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Iowa, Kentucky, Massachusetts, Minnesota, Missouri, North Dakota, New Jersey, Nevada, Ohio, South Dakota, Texas, Utah, Wisconsin and Wyoming named

Medical devices, 2017

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