Medical devices, 2015: every recall, from FDA

Medical device recall MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for… Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised… Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic… A drop in staining intensity over time has been observed. Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Kansas, Louisiana, North Carolina, New Jersey, Oklahoma, South Carolina, Texas and Virginia named

Medical device recall The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the… Potential for device malfunction resulting in flow when the device should not be flowing Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportFloridathe one state its words name PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereFlorida

Medical device recall Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital… GA Industries is recalling the Logicon Caries Detector, version 5.0, for Carestream Dental because it was not submitted for approval to the FDA prior to… Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Genesis Malleable Penile Prosthesis, 9.5 mm Several lots of the 9.5 mm Genesis Malleable Penile Prosthesis were mislabeled. Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide, and Florida, New York and Texas named

Medical device recall FAR-Infrared Heat Home Sauna, 2 person Indications including, but not limited to Natural pain relief,… Product distributed without 510(k) approval Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Illinois, New York, Oregon, South Dakota, Texas and Wisconsin named

Medical device recall FAR-Infrared Heat Home Sauna, 3 person Indications including, but not limited to Natural pain relief,… Product distributed without 510(k) approval Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Illinois, New York, Oregon, South Dakota, Texas and Wisconsin named

Medical device recall Portable FAR Infrared Sauna Indications including, but not limited to Natural pain relief, Negative ion… Product distributed without 510(k) approval Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Illinois, New York, Oregon, South Dakota, Texas and Wisconsin named

Medical device recall Ultraview SL Command Modules Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M was affected. Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Delaware, Georgia, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Virginia and Washington named

Medical device recall Remote Network Station Nihon Kohden America (NKA) is recalling the Remote Network Station (RNS) 9703 because it may fail to sound. Class IIFDA’s classMay 6, 2015in FDA’s Enforcement Report19 statesnamed in where it went PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereAlabama, Colorado, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, Pennsylvania and West Virginia

Medical device recall Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 inch Removable Wing, Metal… A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles. Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Insorb Subcuticular Skin Stapler A previous Turkish distributor over-labeled a portion of the lot with an expiration date of 2016-05. Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Female Driver The hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Telescopic System is 0.06 mm under the specifications. Class IIFDA’s classMay 6, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereDelaware, Florida, Nebraska and New York

Medical device recall 4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle… During a field audit it was discovered by an employee that a 16mm Trestle Luxe Screw has been both laser marked and labeled as a 14mm Trestle Luxe Screw (4.0mm… Class IIFDA’s classMay 6, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Florida, Indiana, Kansas, Kentucky, Louisiana, New Hampshire, New Jersey, Oklahoma, Oregon, Tennessee, Utah and Wisconsin

Medical device recall Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated… If a user requests slides from the LIS or TPID, then updates a request by changing the test, the TRD software will reject the update. Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide, and Indiana and Pennsylvania named

Medical device recall 2008 Series Hemodialysis Machines: 2008Kathome - 190895 2008T GEN 2 BIBAG WITHOUT CDX The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall 2008 Series Hemodialysis Machines: 2008T with the following The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall 2008 Series Hemodialysis Machines: 2008K with the following The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall 2008 Series Hemodialysis Machines: 2008K2 with the following The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Synthes Small Battery Drive (SBD) Oscillating Saw Attachment The potential exists for the Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named

Medical device recall CareFusion Vital Signs LightWand Stylet Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving… Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Introduction Pack Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving… Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier Customer complaints were received of power to the unit ceasing and the display going blank. Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove tissue, blood and other contaminants)… Should the Caviwave Pro Ultrasonic Cleaning System experience a temporary interruption in electrical power during a processing cycle, the circulation pump may… Class IIFDA’s classMay 6, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named

Medical device recall PowerLoc MAX Safety Winged Infusion Set Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum Flow rate label associated to the power injection IFU for the… Class IIFDA’s classMay 6, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereGeorgia and Minnesota

Medical device recall AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will interrupt and cancel a processing cycle should the selected… Class IIFDA’s classMay 6, 2015in FDA’s Enforcement Report48 statesnamed in where it went PublishedMay 6, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming

Medical device recall STRATIFY JCV DxSelect Focus Diagnostics is recalling the Stratify JCV Dx Select due to the use of a non-conforming batch in the manufacture of JCV DxSelect EL1950 kit lot #27333. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNo state named

Medical device recall DBX Mix, 20 cc The seal on the DBX Mix outer PETG/Aclar tray with foil lid packaging for lot identified above may not be fully intact. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Kentucky, Louisiana, North Carolina, Pennsylvania, Puerto Rico, Tennessee and West Virginia named

Medical device recall OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent… FDA Class I, its most serious class Class IFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IStatusTerminatedWhereNationwide

Medical device recall ADVIA Chemistry Lipase Reagent Siemens internal investigation confirmed that current contamination avoidance settings do not prevent carryover resulting in falsely elevated ADVIA Chemistry… Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00 Reports of inaccurate low flow readings. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereLouisiana, North Carolina and Washington

Medical device recall Equinoxe 44mm Short Humeral Head Incorrectly packaged. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Florida, Idaho, Maine, Minnesota, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Virginia and Washington named

Medical device recall TIGERPAW System II Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the… FDA Class I, its most serious class Class IFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IStatusTerminatedWhereNationwide

Medical device recall Fluid Management System P4000 To correct software bugs that could affect the ability to accurately measure fluid deficit. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement Report11 statesnamed in where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereIllinois, Louisiana, Massachusetts, Michigan, Mississippi, North Carolina, New York, Ohio, Texas, Washington and West Virginia

Medical device recall DiaSorin, PRO-Trac II Tacrolimus ELISA kit Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereCalifornia

Medical device recall Lineum HF Torque Handle Limit (Lineum) Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market… Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Torque Limiting Handle (Aspen/ Alpine) Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market… Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall 6” Trifurcated Extension Set Potential for leaking caused by insufficient bond between needleless device and female luer. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Massachusetts, New York, Ohio, Pennsylvania, Texas, Utah and Virginia named

Medical device recall Bifircated Extension Set Potential for leaking caused by insufficient bond between needleless device and female luer. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Massachusetts, New York, Ohio, Pennsylvania, Texas, Utah and Virginia named

Medical device recall 4” Microbore Double Lumen Set with Bionector Potential for leaking caused by insufficient bond between needleless device and female luer. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Massachusetts, New York, Ohio, Pennsylvania, Texas, Utah and Virginia named

Medical device recall 4” Microbore Trifurcated Ext set Potential for leaking caused by insufficient bond between needleless device and female luer. Class IIFDA’s classApr 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Illinois, Massachusetts, New York, Ohio, Pennsylvania, Texas, Utah and Virginia named

Medical devices, 2015

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