Medical devices, 2014: every recall, from FDA

Medical device recall GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to… Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named

Medical device recall Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use… Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Guam and Puerto Rico named

Medical device recall Mar Cor Purification CWP Reverse Osmosis System There exists a potential situation with the crimp connection at the pump head assembly. Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R… DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM¿ Noiles… Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, Sterile… DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM¿ Noiles… Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, Small, Sterile R… DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM¿ Noiles… Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile R… DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles… Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left , X-Small, Sterile… DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles… Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right , X-Small, Sterile… DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles… Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System. Toshiba America Medical Systems, Inc. Class IIFDA’s classMar 12, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Maryland, Minnesota, New York, Ohio, Wisconsin and West Virginia

Medical device recall Medtronic O-arm Imaging System Mobile X-ray system Review of on-system electronic product labeling and Instructions for comply with applicable Use in response to a customer inquiry uncovered gaps in compliance… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall McKesson Anesthesia Care Product Usage: The McKesson Anesthesia Care system is a computer based system which… There was an occurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record (ACR) in that it… FDA Class I, its most serious class Class IFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedMar 12, 2014ClassClass IStatusTerminatedWhereNationwide, and California, Georgia, Indiana, Kentucky, Maryland, Michigan, Ohio, Oklahoma and Washington named

Medical device recall All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads… Customers are resetting the default values outside recommended factory settings. Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as… During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. Class IIFDA’s classMar 12, 2014in FDA’s Enforcement Report22 statesnamed in where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Texas and Virginia

Medical device recall Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery… During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named

Medical device recall Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical… During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital… During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital… During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System Toshiba intitiated this recall because their investigation revealed that due to a problem of the X-ray output control software, the X-ray output conditions may… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Greatbatch Medical, Offset Cup Impactor Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Impactor since the product was first released in 2004. FDA Class I, its most serious class Class IFDA’s classMar 12, 2014in FDA’s Enforcement Report8 statesnamed in where it went PublishedMar 12, 2014ClassClass IStatusTerminatedWhereCalifornia, Indiana, Kansas, Massachusetts, New Jersey, Tennessee, Texas and Utah

Medical device recall Triton FP Infusion Pump WalkMed Infusion is initiaing a recall on their Triton FP Infusion Pump, Part Number 400000 due to the label on the right side of the pump containing an… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereIllinois, Kansas, Massachusetts and New Jersey

Medical device recall AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power. Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall MEDITECH Microbiology - Calculator/data processing module, for clinical use. Potential for patient results being removed from LAB/EMR. Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate… Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cervical Vertebrae Plate System) insert, which… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Missouri, North Carolina, New York, Ohio, Pennsylvania, Tennessee, Texas, Utah, Virginia and Washington named

Medical device recall *** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA Several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assembled incorrectly. Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Wisconsin and West Virginia named

Medical device recall Model Kodak 2100 Intraoral X-Ray System Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage. Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Model Kodak 2200 Intraoral X-Ray System Carestream received problem reports relating to apparent early failure of Kodak 2X00 Intraoral X-ray device arms leading to arm breakage. Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation. Medicamat is initiating a field correction due to misbranded marketing literature for the Punch Hair Matic SAFER. Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportTexasthe one state its words name PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereTexas

Medical device recall FMP X-alt Acetabular Liner This acetabular liner is intended for use with DJO Surgical hip systems Packaging error -- two different types and sizes of acetabular liners used during hip replacement surgery were mistakenly packaged into each other’s outer… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Louisiana and Texas named

Medical device recall Accessory shorts for the AlterG Anti-Gravity treadmill Unapproved material used by vendor in subset of shorts causing them to stretch more than usual and are uncomfortable for patient. Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO’s Robotic… The product may be mislabeled and could result in the incorrect implant being used. Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Hawaii, Idaho, Illinois, Indiana, Louisiana, Michigan, North Carolina, New Hampshire, Ohio, Oklahoma, Rhode Island, Tennessee, Texas, Washington and Wisconsin named

Medical device recall BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for… As the result of a complaint to Heraeus Kulzer’s customer service department, Heraues Kulzer is recalling Benco Tartar and Stain Solution part #1010-451, lot… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named

Medical device recall DeRoyal ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by… Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely. Class IIFDA’s classMar 12, 2014in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereAlabama, Florida, Illinois, Kansas, New Jersey, Oklahoma, Oregon, Texas, Virginia and Washington

Medical device recall PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended… Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Management System… Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is intended to manage… Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision Management System is… Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision Management… Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management System is… Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage: The Prevena Incision… Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Management… Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support… Internal testing revealed a potentially defective component on the power management board that could affect the function of certain Trilogy Ventilators… FDA Class I, its most serious class Class IFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IStatusTerminatedWhereNationwide

Medical device recall Simplexa Flu AlB & RSV Direct Assay Kits, intended for use as an aid in the differential diagnosis of… Focus Diagnostics initiated the recall of the certain Simplexa Flu AlB & RSV Direct assay kits due to the potential of false positive Flu A, Flu B and RSV… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall ABX PENTRA Multical HORIBA Medical is informing all ABX PENTRA MultiCal, N Control, and P Control customers running the Creatinine Rate Blank Method assay on the ABX PENTRA 400… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the… GE Healthcare has recently become aware of a potential safety issue with the Solar 8000M/i Patient Monitor Automatic-View-On-Alarm (AVOA) feature. Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, North Carolina, Nebraska, New Hampshire, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall GE Healthcare When performing a secondary capture generated from GSI Viewer, the header information is correct on the images. Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Connecticut, Florida, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Mississippi, New Hampshire, New Jersey, Nevada, New York, Pennsylvania, Washington and Wisconsin named

Medical device recall Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12… The bar code that is printed on the Master Carton label does not correspond to the product code fully displayed on the Master Carton label. Class IIIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMar 12, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Utah and Wisconsin named

Medical device recall Mobile X-ray System Shimadzu Corporation is recalling the Shimadzu Mobile X-ray Sytems (MUX-100 and MUX-100H) because the connecting metal plate which connects the main chassis… Class IIFDA’s classMar 12, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 12, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical devices, 2014

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