Medical devices, 2014: every recall, from FDA

Medical device recall Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and… Particulate matter found inside the fluid path. FDA Class I, its most serious class Class IFDA’s classNov 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 12, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named

Medical device recall Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml Particulate matter found inside the fluid path. FDA Class I, its most serious class Class IFDA’s classNov 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 12, 2014ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named

Medical device recall Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be associated with rapid emptying of the fill polymer syringe… FDA Class I, its most serious class Class IFDA’s classNov 12, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 12, 2014ClassClass IStatusTerminatedWhereNo state named

Medical device recall Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line Class IIFDA’s classNov 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Defect in the luer connector can compromise the seal on the female side of the connector. Class IIFDA’s classNov 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Terumo Cardioplegia Delivery Set Defect in the luer connector can compromise the seal on the female side of the connector. Class IIFDA’s classNov 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Terumo Custom Cardiovascular and Perfusion Procedure Kits Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line. Class IIFDA’s classNov 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Terumo Custom Cardioplegia Delivery Set Defect in the luer connector can compromise the seal on the female side of the connector. Class IIFDA’s classNov 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Terumo Custom Cardioplegia Delivery Sets Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line Class IIFDA’s classNov 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F. Class IIFDA’s classNov 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with… The product is non-sterile. Class IIFDA’s classNov 12, 2014in FDA’s Enforcement Report9 statesnamed in where it went PublishedNov 12, 2014ClassClass IIStatusTerminatedWhereAlabama, Florida, North Carolina, New Jersey, New York, Pennsylvania, South Carolina, Texas and Wisconsin

Medical device recall Siemens Calibrator E Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master… Class IIFDA’s classNov 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedNov 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Georgia, Idaho, Illinois, Indiana and Puerto Rico named

Medical device recall UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is Non-injury complaints from Europe identified a malfunction that made it possible for a handpiece to start by itself when the power source is connected. Class IIFDA’s classNov 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedNov 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall CADD-Solis Medication Safety Software, Administrator CD, Version 3.1 Smiths Medical has identified an issue with a single batch (Lot Number 2752712) of CADD"-Solis Medication Safety Software Administrator 3.1 CDs. Class IIFDA’s classNov 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedNov 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Colorado, Connecticut, Georgia, Michigan, Minnesota, North Carolina, New Hampshire, South Carolina, Texas, Virginia and Wisconsin named

Medical device recall Prescription eyeglass safety lenses Prescription eyeglass safety lenses did not meet specifications. Class IIFDA’s classNov 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedNov 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, California, Louisiana, Maryland, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Mexico, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Virginia, Wisconsin and West Virginia named

Medical device recall COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological Error in the software. Class IIFDA’s classNov 12, 2014in FDA’s Enforcement ReportGuamthe one state its words name PublishedNov 12, 2014ClassClass IIStatusTerminatedWhereGuam

Medical device recall Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System If the laser system is turned on and the user adjusts, installs or removes the XPL pulsed light handpiece, there is a potential risk of an electrical shock Class IIFDA’s classNov 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Stryker SmartLife Large Aseptic Housing The SmartLife Aseptic Housings are being recalled in that the top section of the housing may separate from the bottom section due to insufficient welding. Class IIFDA’s classNov 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedNov 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Delaware, Georgia, Illinois, Kansas, Kentucky, Maryland, Michigan, Minnesota, Montana, New Mexico, New York, Pennsylvania, Texas, Wisconsin and Wyoming named

Medical device recall Stryker SmartLife Small Aseptic Housing The SmartLife Aseptic Housings are being recalled in that the top section of the housing may separate from the bottom section due to insufficient welding. Class IIFDA’s classNov 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedNov 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Delaware, Georgia, Illinois, Kansas, Kentucky, Maryland, Michigan, Minnesota, Montana, New Mexico, New York, Pennsylvania, Texas, Wisconsin and Wyoming named

Medical device recall Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product… Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC) Class IIFDA’s classNov 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Access 2 Immunoassay Systems Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the Access 2 Immunoassay systems because it may experience a “MFC… Class IIFDA’s classNov 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall UniCel DxC 600i SYNCHRON Access Clinical Analyzer Beckman Coulter is recalling the Small Form Factor Console PC (SFF PC) (B23083) for use with the DxC 600i analyzer because it may experience a “MFC Exception”… Class IIFDA’s classNov 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353 St. Class IIFDA’s classNov 12, 2014in FDA’s Enforcement Report6 statesnamed in where it went PublishedNov 12, 2014ClassClass IIStatusTerminatedWhereCalifornia, Georgia, New Jersey, New York, Oregon and Pennsylvania

Medical device recall Cardiopulmonary bypass connector The single leg of the PAY connector has been observed to become detached. Class IIFDA’s classNov 12, 2014in FDA’s Enforcement Report6 statesnamed in where it went PublishedNov 12, 2014ClassClass IIStatusTerminatedWhereIllinois, Maryland, Missouri, Pennsylvania, Texas and Utah

Medical device recall Thyroglobulin Bond Ready to Use Primary Antibody Thyroglobulin does not function as intended up to the expiry date on the product labelling. Class IIFDA’s classNov 12, 2014in FDA’s Enforcement Report30 statesnamed in where it went PublishedNov 12, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin

Medical device recall Proteus 235 Proton Therapy System for cancer treatment. While the Proteus 235 is in the pencil beam scanning (PBS) treatment mode, on rare occasions, Low Level Radio Frequency (LLRF) pulsed dee voltage (i.e.,… Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Illinois, New Jersey, Pennsylvania, Tennessee and Washington named

Medical device recall The GemStar Power Supply is an accessory for the GemStar Infusion Pump The GemStar Infusion pump may not receive direct current (DC) power from the power supply. FDA Class I, its most serious class Class IFDA’s classNov 5, 2014in FDA’s Enforcement Report49 statesnamed in where it went PublishedNov 5, 2014ClassClass IStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming

Medical device recall Covidien Puritan Bennett 980 Ventilator A software issue may lead to ventilator inoperative situations. FDA Class I, its most serious class Class IFDA’s classNov 5, 2014in FDA’s Enforcement Report17 statesnamed in where it went PublishedNov 5, 2014ClassClass IStatusTerminatedWhereCalifornia, Colorado, Florida, Georgia, Kentucky, Massachusetts, Minnesota, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah and Wisconsin

Medical device recall Spirotome” Soft-Tissue Biopsy Needle Set MEDINVENTS, the manufacturer of the Spirotome" Soft-Tissue Biopsy Needle Set distributed by Cook Medical, has initiated a voluntary recall of these… Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Hawaii, Iowa, Illinois, Massachusetts, Maryland, Michigan, Missouri, New Mexico, Pennsylvania, Texas, Virginia, Vermont and Wisconsin named

Medical device recall Equate Moisture Last Multi-Purpose Solution, 2 pack, 12 fl Product lot did not meet the specification for its disinfectants at the time of manufacture. Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Mississippi, North Carolina, New Hampshire, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia and Wisconsin named

Medical device recall Dimension Vista¿ HbA1c In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension Vista® CSA… Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system… Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur… Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only.… Ferritin Analytical Sensitivity and Calibrator C Realignment with kit lots ending in 22 and 23 used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur… Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Lipase Reagent, 7D80 Package inserts have incorrect SmartWash parameters for Triglyceride. Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access… An internal finding identified the presence of pinholes/cuts in some of the Tyvek pouches of the vacuum tubing sets included as an accessory to Acrobat V… Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall SAM Junctional Tourniquet (SJT) Auxiliary SAM Junctional Tourniquet (SJT) Auxiliary strap, model SJT 102 and SJT 112, is recalled because the snap hook on auxiliary strap broke during training… Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and North Carolina, New Mexico, Ohio, Oregon and Texas named

Medical device recall ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random… Routine quality monitoring system has identified that a limited number of lots were manufactured with the cylinder axis outside the allowable specification. Class IIIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2014ClassClass IIIStatusTerminatedWhereNationwide

Medical device recall HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HbA1c calibrator lot. Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Animas Vibe Insulin Infusion Pump Animas determined that the Hebrew language translation in the Vibe Insulin Infusion Pump was incorrect and could lead to potential patient confusion. Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Animas Vibe Insulin Infusion Pump and System Animas determined that keypad wear over time was contributing to an increased complaint rate associated with damaged keypads on the Vibe Insulin Infusion Pump… Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Biatain Super Non-Adhesive Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled. Class IIIFDA’s classNov 5, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 5, 2014ClassClass IIIStatusTerminatedWhereMissouri and Rhode Island

Medical device recall ThermoCool SmartTouch Navigation Catheters The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter. Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture CP Medical Inc. Class IIFDA’s classNov 5, 2014in FDA’s Enforcement Report10 statesnamed in where it went PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Florida, Maine, Michigan, Nebraska, Oregon, South Carolina and Washington

Medical device recall TITAN Operating Room Table Patient positioning during surgery, ranging from anesthesia induction to actual… Unintended movement of the operating table during surgical cases due to the use of damaged TITAN remotes. Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington and Wyoming named

Medical device recall DMI Duro-Med Industries Rollator Transport Chair There have been 5 customer reports of a 501-1018 series DMI Rollator Transport Chair collapsing during use. Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedNov 5, 2014ClassClass 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, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall Merge Healthcare, Merge Hemo Programmable diagnostic computer It has been reported that during use, the SpO2 value displayed on the Hemo Monitor may not update to reflect changes in the patient’s oxygen value. Class IIFDA’s classNov 5, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedNov 5, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Iowa, Illinois, Massachusetts, Missouri, Ohio, South Carolina, Tennessee and Wisconsin named

Medical devices, 2014

The list

Nothing matches all of these.

Side by side

How to read a record

Every fact names its source.

A number never stands alone.

What needs attention is marked.

The public record comes first.