Medical devices, 2015: every recall, from FDA

Medical device recall Concave Reamer Head, 16 mm The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereColorado, Illinois, Michigan, North Carolina, Ohio, Tennessee and Washington

Medical device recall Central Line >34 Weeks Kit The print plate artwork for this lot was found to state: Central Line <34 Weeks Kit displaying an incorrect sign in front of the 34. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedSep 2, 2015ClassClass IIStatusTerminatedWherePennsylvania

Medical device recall CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266 Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24-month… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes Contain 0.1% Benzalkonium Chloride in the 5/8 bandages inside the assortment which is not listed as an active ingredient in the product label. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportRhode Islandthe one state its words name PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereRhode Island

Medical device recall Wheel caster set screw for Ferno iNX Wheeled Stretcher The firm discovered an improperly installed set screw in one caster arm assembly on a unit in production. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereArizona, Colorado, Iowa, Maryland, Ohio, Pennsylvania and Washington

Medical device recall PICC Kits with Peel-Away Sheath Component the catheter peel-away component hub tabs may prematurely detach. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall HardyCHROM MRSA Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the methicillin-sensitive Staphylococcus aureus (MSSA) QC… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereIllinois, Maryland, New Jersey, New York, Ohio, Pennsylvania and Virginia

Medical device recall Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported to occasionally be difficult to remove from the sterilization… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile Tornier has initiated a voluntary recall for the Salto Talaris Tibial Guide (part number MJU333) due to a complaint that occurred during physician training,… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report5 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereCalifornia, Maine, North Carolina, Pennsylvania and Texas

Medical device recall Zippie IRIS Wheelchair Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Quickie IRIS Wheelchair Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# 3574704) were labeled as 100mm models (CB5LT) while the… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide, and Michigan, New Mexico, Nevada and Texas named

Medical device recall Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a… Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Colorado, Delaware, Florida, Hawaii, Idaho, New York, Pennsylvania, South Dakota, Tennessee and Texas named

Medical device recall Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software is a picture… Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Colorado, Delaware, Florida, Hawaii, Idaho, New York, Pennsylvania, South Dakota, Tennessee and Texas named

Medical device recall MiniCap Extended Life PD Transfer Set Extra Short Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide, and American Samoa, District of Columbia, Guam, Northern Mariana Islands and Puerto Rico named

Medical device recall MiniCap Extended Life PD Transfer Set Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide, and American Samoa, District of Columbia, Guam, Northern Mariana Islands and Puerto Rico named

Medical device recall CAPD Solution Transfer Set with Locking Connector Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider… Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide, and American Samoa, District of Columbia, Guam, Northern Mariana Islands and Puerto Rico named

Medical device recall Synthes Application Instrument for Sternal ZIPFIX The end cap may loosen and detach making the instrument non-functional. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall 0.9% Sodium Chloride Injection, USP, 10mL Procedures for the acceptance and control of in-process product have not been adequately established. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement Report10 statesnamed in where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Massachusetts, Maryland, Pennsylvania, Tennessee, Texas, Utah, Virginia and West Virginia

Medical device recall OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02… Software bug was found where there was no difference in Total and Corneal high-order aberrations, but differences were found in Internal high-order aberrations. Class IIFDA’s classSep 2, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall American Science & Engineering Inc,Gemini Cabinet X-ray system. During factory testing, we discovered that Gemini systems could, in rare circumstances, experience a fault that leads to a state in which X-rays are being… Class IIFDA’s classAug 26, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereConnecticut, District of Columbia, Delaware, Florida, Georgia, Maryland, Maine, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Pennsylvania, Tennessee, Texas and Virginia

Medical device recall Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Volume Control Plus (VC+) Mode with active humidification. FDA Class I, its most serious class Class IFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2015ClassClass IStatusTerminatedWhereNationwide

Medical device recall PS500 of an IACS Workstation Critical Care (Evita Infinity V500) The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected. FDA Class I, its most serious class Class IFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2015ClassClass IStatusTerminatedWhereNationwide

Medical device recall Alaris Syringe Pump Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syringe module. FDA Class I, its most serious class Class IFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2015ClassClass IStatusTerminatedWhereNationwide

Medical device recall HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr The double swivel connector may crack or separate on the endobronchial tube. FDA Class I, its most serious class Class IFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2015ClassClass IStatusTerminatedWhereNationwide

Medical device recall HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr The double swivel connector may crack or separate on the endobronchial tube. FDA Class I, its most serious class Class IFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2015ClassClass IStatusTerminatedWhereNationwide

Medical device recall HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack The double swivel connector may crack or separate on the endobronchial tube. FDA Class I, its most serious class Class IFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2015ClassClass IStatusTerminatedWhereNationwide

Medical device recall HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel The double swivel connector may crack or separate on the endobronchial tube. FDA Class I, its most serious class Class IFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2015ClassClass IStatusTerminatedWhereNationwide

Medical device recall Alaris Medley LVP Frame Membrane Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death. FDA Class I, its most serious class Class IFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedAug 26, 2015ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin named

Medical device recall Alaris Medley LVP Bezel Assembly Administration of inappropriate quantities of fluid can result, with the potential to cause injury or death. FDA Class I, its most serious class Class IFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedAug 26, 2015ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Wisconsin named

Medical device recall Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters Potential breach of the sterile barrier packaging. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named

Medical device recall Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit Potential breach of the sterile barrier packaging. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named

Medical device recall Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size #2 9mm (5531-G-209) was reported to be in a pack that was… Class IIFDA’s classAug 26, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereOhio, Rhode Island, South Carolina and West Virginia

Medical device recall RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray Electrostatic energy may be stored in Systems that can cause a short-cicuit which, in turn, can generate an Electomagnetic Pulse which might disturb the… Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing, Rehabilitation,… Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, New Jersey, New York, Oklahoma, Tennessee, Texas and Washington named

Medical device recall Winco Care Cliner Standart - Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use,… Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, New Jersey, New York, Oklahoma, Tennessee, Texas and Washington named

Medical device recall Winco Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use,… Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, New Jersey, New York, Oklahoma, Tennessee, Texas and Washington named

Medical device recall Winco Care Cliner X-Large - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use,… Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, New Jersey, New York, Oklahoma, Tennessee, Texas and Washington named

Medical device recall Winco Drop Arm Care Cliner Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis… Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, New Jersey, New York, Oklahoma, Tennessee, Texas and Washington named

Medical device recall Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis… Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, New Jersey, New York, Oklahoma, Tennessee, Texas and Washington named

Medical device recall Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis… Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, New Jersey, New York, Oklahoma, Tennessee, Texas and Washington named

Medical device recall Winco Designer Care Cliner - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use,… Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, New Jersey, New York, Oklahoma, Tennessee, Texas and Washington named

Medical device recall Winco Designer Care Cliner w/Swing Arms - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home… Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards. Class IIFDA’s classAug 26, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedAug 26, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, New Jersey, New York, Oklahoma, Tennessee, Texas and Washington named

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