Medical devices, 2016: every recall, from FDA

Medical device recall Plum A+ Infusion Pump with Hospira MedNet Software The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named

Medical device recall Plum A+3 Infusion Pump System The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named

Medical device recall Plum A+3 Infusion Pump The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named

Medical device recall Plum A+3 Infusion Pump with Hospira MedNet Software The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named

Medical device recall GE Healthcare SIGNA Creator, SIGNA Explorer GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could result in… Class IIFDA’s classSep 14, 2016in FDA’s Enforcement Report12 statesnamed in where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereArizona, California, Connecticut, Florida, Illinois, Massachusetts, Missouri, Mississippi, North Carolina, Puerto Rico, Texas and Wisconsin

Medical device recall UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System There is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 where the Primary Identifier is configured to Tube Position ID. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedSep 14, 2016ClassClass IIStatusTerminatedWherePuerto Rico

Medical device recall Integra Cranial Access Kits, Catalogue Nos Integra LifeSciences has been notified of a medical device recall by Adaptive Surgical, LLC involving their Riverlon” Nylon 3-0 Sutures that are packaged in… Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide

Medical device recall 2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems. Elevating Monitor Suspension separated from the lifting column bracket Class IIFDA’s classSep 14, 2016in FDA’s Enforcement Report14 statesnamed in where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereAlabama, Colorado, Georgia, Illinois, Indiana, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New York, Ohio, Pennsylvania and South Dakota

Medical device recall BrightView X The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide

Medical device recall BrightView XCT The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide

Medical device recall BrightView XCT Upgrade The firm became aware of an issue where during a non-Auto Body Contouring (ABC), non-circular, rel-180 scan, the detector may come in contact with the patient. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide

Medical device recall PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP” Introducer Sheath… Terumo Medical is initiating this recall due to complaints of valve leakage that have been related to a manufacturing issue. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data There is a potential for data loss associated with empty path names resulting from HL-7 updates when the cache disk is almost full. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial… Shipping carton labeling error. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Indiana, Kentucky, North Carolina, Ohio and Tennessee named

Medical device recall Radial Artery Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial… Shipping carton labeling error. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Indiana, Kentucky, North Carolina, Ohio and Tennessee named

Medical device recall ADVIA Centaur¿ PSA Assay Communication provided to emphasize that the PSA values should be interpreted in accordance with current clinical guidelines for defining biochemical… Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Georgia named

Medical device recall Achillon Minimally Invasive Device for Achilles Tendon Rupture Treatment The Achillon Suture System is a… Data from internal studies suggests there may be a potential that the secondary package seal integrity does not provide the level of sterility intended for… Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Microtek Franz Angiography Drape with Radiation Shield Ecolab is recalling 2 models of Angiography Drapes with Radiation Shields because the sterile packaging may contain small holes in the film of the pouch. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereCalifornia, Minnesota, New York and Ohio

Medical device recall Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture Sterility compromised due to breach in sterile packaging Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide

Medical device recall The Connecting Bracket (Fixture) Device Post Market Surveillance cases reported to Maquet showing instances in which the welded joint between the square mount and the first fixable swivel joint of… Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Iowa, Indiana, Missouri, Utah and Wisconsin named

Medical device recall MENTOR 2” Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast… Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide

Medical device recall MENTOR 2” Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture Tabs Breast… Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Pacemakers: Accolade MRI DR Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuration were shipped to US customers and implanted. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement Report5 statesnamed in where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereMassachusetts, Minnesota, New Hampshire, Pennsylvania and Texas

Medical device recall Affinity Four Birthing Bed Recalled by FDA on Sep 14, 2016 Class IIFDA’s classSep 14, 2016in FDA’s Enforcement Report16 statesnamed in where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereCalifornia, Florida, Indiana, Kansas, Louisiana, Michigan, Missouri, North Carolina, New York, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Washington and Wyoming

Medical device recall Hard Tissue Replacement (HTR) Implant Potential sterility deficiency. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement Report8 statesnamed in where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereArizona, California, Florida, Missouri, New Hampshire, Pennsylvania, Texas and Virginia

Medical device recall Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small… Class IIFDA’s classSep 14, 2016in FDA’s Enforcement Report9 statesnamed in where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Connecticut, Georgia, Minnesota, North Carolina, Ohio and Oregon

Medical device recall Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replacement of… Following a FDA inspection showing that the firm failed to validate the design and process of its implants. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNorth Carolina, New York and Oregon

Medical device recall Axiom 2.8 implants Sterile The Axiom REG implants are used as artificial root structures for replacement of… Following a FDA inspection showing that the firm failed to validate the design and process of its implants. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNorth Carolina, New York and Oregon

Medical device recall Intermediate carton label reads in part as: “Bard-Parker***Stainless Steel Surgical Blades***#12B***QTY 150 After receiving a complaint the firm disclosed that Conventional Stainless Steel Surgical Blade catalog number 371712 lot 0088464 was incorrectly identified in… Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6) Sorin Group USA, Inc. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereIllinois, Missouri and Texas

Medical device recall Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X) The tip of the cannula should be bent at either a 45 or 90 degree angle. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereIllinois, Missouri and Texas

Medical device recall e.cam and Symbia E gamma camera systems with patient beds To detect or image the distribution of… “We have received reports of patients hair being caught in the e.cam and Symbia E patient bed up/down drive. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named

Medical device recall WECK¿ Horizon” Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 Misbranded: Incorrect etching on the device. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, Illinois, Kentucky, Michigan, New York and Oklahoma named

Medical device recall The system provides the ability to transmit patient data files for storage, viewing and analysis at Display of SpO2 and Non-Invasive Blood Pressure (NIBP) Measurements May Freeze Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedSep 14, 2016ClassClass 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, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named

Medical device recall Nylon Surgical Suture for human use and vet use Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Idaho, Massachusetts, New York and Oregon named

Medical device recall Polypropylene Surgical Sutures, brand Webglo, for vet use Polypropylene Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Idaho, Massachusetts, New York and Oregon named

Medical device recall Neural Signal Amplifier Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal… Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Patient Cable Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopotential Signal Processing System because the Neural Signal… Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide

Medical device recall SureSight Obturator Introducer Localization Systems (ILS) for ATEC in MRI Tip Breakage at the glue joint between the obturator body and tip Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) The SPY… Novadaq is informing SK6000 PAQ users that a pinhole through the drape pouch film material was identified in some SK6000 PAQs during shipping validation… Class IIFDA’s classSep 14, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereFlorida, Michigan and Virginia

Medical device recall Certegra Workstation used in conjunction with Medrad Stellant CT Injection System CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal events, such as: smoke and sparks of fire. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that… The purpose of the recall is to replace data transmission cable (USB-cable) connecting the lnnocor device with an external computer. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereDistrict of Columbia and Massachusetts

Medical device recall Allura Xper with release R8.2: Allura Xper FD10, 722026 Increase in the failure rate of certain low-voltage DC power supplies (DCPS) Class IIFDA’s classSep 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereNationwide, and Georgia named

Medical device recall UNIQ 1.0: UNIQ FD10, 722026 Increase in the failure rate of certain low-voltage DC power supplies (DCPS) Class IIFDA’s classSep 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereNationwide, and Georgia named

Medical device recall Centricity Laboratory Core Lab System 4.1 The Centricity Laboratory System is intended to be an information… The Centricity Laboratory removes free-text notes on a master panel when the user deletes the slave panel. Class IIFDA’s classSep 7, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereGeorgia, Minnesota, New York, Ohio, Tennessee and Texas

Medical device recall Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150… Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. Class IIFDA’s classSep 7, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 7, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia and Illinois named

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