Medical devices, 2015: every recall, from FDA

Medical device recall MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11 The software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an ID… Class IIFDA’s classSep 30, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNorthern Mariana Islands, Puerto Rico and US Virgin Islands

Medical device recall Trident 10 degrees X3 Insert 36 mm ID it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportWisconsinthe one state its words name PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereWisconsin

Medical device recall Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage: The Synthes Cranial Flap Tube Clamp System… The Synthes Cranial Flap Tube Clamp and Crimping Device for Cranial Tube Clamp had been labeled MR Safe although they do not have the testing protocols… Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist A software fix has been released to prevent automatic movement resulting in a collision safety risk for patients. Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Siemens RAPIDPoint 500 Measurement Cartridge Lactate RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results Class IIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 30, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall CD4 (SK3), FITC CD4 FITC label contains an error in the Spanish small text - it states CD8 FITC. Class IIIFDA’s classSep 30, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedSep 30, 2015ClassClass IIIStatusTerminatedWhereNationwide, and California, Connecticut, Georgia, Maryland, North Carolina, Ohio, Pennsylvania, South Dakota, Texas and Utah named

Medical device recall Temporary Total Artificial Heart (TAH-t) with Freedom Driver System SynCardia Systems, Inc. FDA Class I, its most serious class Class IFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedSep 23, 2015ClassClass IStatusTerminatedWhereNationwide, and Arkansas, California, Michigan, North Carolina, Ohio, Pennsylvania, Texas and Virginia named

Medical device recall UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a… MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexed, castable abutment cylinders for this one lot only. Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700… Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification. Class IIFDA’s classSep 23, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereCalifornia and Michigan

Medical device recall XGAUZE Trauma Dressing The XGAUZE Trauma Dressing was recalled because the packages may acquire small tears or pinholes during shipping due to use of shipping containers that lacked… Class IIFDA’s classSep 23, 2015in FDA’s Enforcement Report5 statesnamed in where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereArizona, Idaho, North Carolina, Tennessee and Virginia

Medical device recall CIVCO Shoulder Retractors, Reusable non-sterile hand grip The wrist straps used for positioning the patient are too long Class IIFDA’s classSep 23, 2015in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereKansas, Nebraska and South Carolina

Medical device recall Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000… Crystals may be observed in the R1 reagent. Class IIIFDA’s classSep 23, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedSep 23, 2015ClassClass IIIStatusTerminatedWhereCalifornia, Connecticut, Florida, Michigan, Puerto Rico and Texas

Medical device recall Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F (… Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preventing subsequent sealing of the valve when… Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006)… Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preventing subsequent sealing of the valve when… Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall NICO Myriad Console Two cables within the console were inadvertently twisted during manufacturing. Class IIFDA’s classSep 23, 2015in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Maryland and North Carolina

Medical device recall MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml Vial to vial variation in the fill volume that could affect control recovery issues and cause a control result to fall outside the suggested recovery ranges. Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is… Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery. Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia and Nevada named

Medical device recall Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is… There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation procedure resulting in damage to non-target tissue. Class IIFDA’s classSep 23, 2015in FDA’s Enforcement Report5 statesnamed in where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereCalifornia, Florida, Massachusetts, New York and Pennsylvania

Medical device recall Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medical grade liquid crystal display… Tthe medical monitor has either not turned on or has lost image during clinical use. Class IIFDA’s classSep 23, 2015in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereArizona, California, Florida, Iowa, North Carolina, Ohio and Pennsylvania

Medical device recall Aliquot Delivery Kit (Syringe and Plunger) Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Pointe Scientific Creatinine Reagent Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and reagent R2 vial is labeled as R1 (120ml). Class IIIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIIStatusTerminatedWhereNationwide

Medical device recall CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical… Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the warnings and rinsing procedure in their current labelling… Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Angiographic Injector Software Version SW 005.006_SH, resulted in the removal of purge enforcement from traditional New-Case, Power Up and Syringe Change use cases while the… Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures. An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time. Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Fujifilm Medical Endoscope for the duodenum and upper G.I The suction button on the ED-530XT endoscope may become lodged (stuck) in the active position following the use of x-ray contrast agents during ERCP procedures. Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNo state named

Medical device recall The Leica ASP200S/ASP300S Tissue Processor The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm to not function… Class IIIFDA’s classSep 23, 2015in FDA’s Enforcement Report31 statesnamed in where it went PublishedSep 23, 2015ClassClass IIIStatusTerminatedWhereArizona, California, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, Montana, North Carolina, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Washington, Wisconsin and West Virginia

Medical device recall NebuTech Nebulizer The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or during treatment. Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems B. Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall ACUSON SC2000 Ultrasound System with software versions VB10B and lower The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient name as unique patient instances when registered on the same… Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Merlin@home RF Remote Monitoring Transmitter Some devices exhibit backup VVI operation due to a backup reset. Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment… An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables… Class IIFDA’s classSep 23, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 23, 2015ClassClass IIStatusTerminatedWhereNationwide, and Washington named

Medical device recall OmniPod¿ Insulin Management System OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the… FDA Class I, its most serious class Class IFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2015ClassClass IStatusTerminatedWhereNationwide

Medical device recall MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. Class IIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Florida, Hawaii, Idaho, Indiana, Kansas, Louisiana, Massachusetts, Missouri, Mississippi, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah and Wisconsin named

Medical device recall MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators) Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. Class IIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Florida, Hawaii, Idaho, Indiana, Kansas, Louisiana, Massachusetts, Missouri, Mississippi, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah and Wisconsin named

Medical device recall Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be… The DPM 7 Monitors may display a black screen. Class IIFDA’s classSep 16, 2015in FDA’s Enforcement Report7 statesnamed in where it went PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereConnecticut, Iowa, Kentucky, Mississippi, Pennsylvania, Utah and Washington

Medical device recall 2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit Gridlock screw driver bits for the Gridlock Plating System were identified to be out of specification and have the potential for shallow engagement between the… Class IIFDA’s classSep 16, 2015in FDA’s Enforcement Report19 statesnamed in where it went PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Minnesota, Missouri, New Jersey, New York, Ohio, Oklahoma, South Carolina, South Dakota, Texas, Virginia and Wisconsin

Medical device recall ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay. Class IIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Missouri, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named

Medical device recall DermaPen Pro Derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for distributing a device without FDA clearance or approval. Class IIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named

Medical device recall Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine) Siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depressed results up to - 12.7% and -22% respectively, for a… Class IIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall CDI 500 Blood Parameter Monitoring System Inaccuracies in SvO2, temperature, pH, pCO2, pO2, Hematocrit, and Potassium readings following a software upgrade to version 1.69. Class IIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedSep 16, 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, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named

Medical device recall Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440. Class IIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereNationwide, and Georgia, Louisiana, Ohio and Texas named

Medical device recall Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks. Class IIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks. Class IIFDA’s classSep 16, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 16, 2015ClassClass IIStatusTerminatedWhereNationwide

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