Medical devices, 2012: every recall, from FDA

Medical device recall PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportKansasthe one state its words name PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereKansas

Medical device recall Spine Frontier Inspan compressors Inspan Compressors may break at weld causing a loss of compression Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Florida, Massachusetts, Missouri, Oklahoma, Puerto Rico and Texas named

Medical device recall CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system Captiva Spine recalled their CapLOX II Final Torque Driver, Indicator due to the device prematurely breaking Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Minnesota named

Medical device recall The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection The firm initiated the recall for Laser Loupes because the ink used to mark which laser frequency each laser Loupe protects against may wipe off. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere,… The color code on label conflicts with the liner size (liner size 24 should be green, not yellow) Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Indiana, North Carolina, Ohio and Utah named

Medical device recall The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D Zimmer Trilogy¿ Acetabular System Shell with Cluster Holes, Porous,56 MM O.D., sterile; is missing polar hole threads. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Connecticut, Kansas, Massachusetts, Maryland, Minnesota, Missouri, New York, South Dakota, Texas and Wisconsin named

Medical device recall S-Lift Implant Guides (also known as S-LIF) Compressor When using the optional S-LIFT (also known as S-LIF) Implant Guides without stops, there is a known risk of moving the Implant Guides, and possibly the… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts and Texas named

Medical device recall KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Florida, Indiana, Kentucky, Missouri, North Carolina, New Jersey, New York, Pennsylvania, Tennessee, Texas and Wisconsin named

Medical device recall KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD¿… The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Florida, Indiana, Kentucky, Missouri, North Carolina, New Jersey, New York, Pennsylvania, Tennessee, Texas and Wisconsin named

Medical device recall KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD¿… The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Florida, Indiana, Kentucky, Missouri, North Carolina, New Jersey, New York, Pennsylvania, Tennessee, Texas and Wisconsin named

Medical device recall KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿… The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Florida, Indiana, Kentucky, Missouri, North Carolina, New Jersey, New York, Pennsylvania, Tennessee, Texas and Wisconsin named

Medical device recall KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal… The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Florida, Indiana, Kentucky, Missouri, North Carolina, New Jersey, New York, Pennsylvania, Tennessee, Texas and Wisconsin named

Medical device recall KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal… The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Florida, Indiana, Kentucky, Missouri, North Carolina, New Jersey, New York, Pennsylvania, Tennessee, Texas and Wisconsin named

Medical device recall KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal… The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Florida, Indiana, Kentucky, Missouri, North Carolina, New Jersey, New York, Pennsylvania, Tennessee, Texas and Wisconsin named

Medical device recall KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal… The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Florida, Indiana, Kentucky, Missouri, North Carolina, New Jersey, New York, Pennsylvania, Tennessee, Texas and Wisconsin named

Medical device recall KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case “Size 3 / Child ClearSeal… The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Florida, Indiana, Kentucky, Missouri, North Carolina, New Jersey, New York, Pennsylvania, Tennessee, Texas and Wisconsin named

Medical device recall KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case “Size 4 / Adult ClearSeal… The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Florida, Indiana, Kentucky, Missouri, North Carolina, New Jersey, New York, Pennsylvania, Tennessee, Texas and Wisconsin named

Medical device recall IMRIS ORT100 (Part Number 110470-000) and ORT200 (Part Number 112216-00), are tables used in both the Neuro… IMRIS Inc. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Tennessee, Utah and Virginia named

Medical device recall Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High).… HORIBA Medical Irvine Technical Support received reports from some customers that have experienced high recover values for Hemoglobin when using Minotrol 16… Class IIIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 28, 2012ClassClass IIIStatusTerminatedWhereNationwide

Medical device recall 0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated sodium chloride is… The firm inventoried and distributed 0.9% Sodium Chloride Saline bags as 0.45% Sodium Chloride Saline bags for use with the VITEK 2 system. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia and Wisconsin named

Medical device recall Styker Orthobiologics Vita Plasma Separator, a component of Vitagel Surgical Hemostat When preparing plasma using VitaPrep, it was reported that a small amount of blood collected in the bottom of the centrifuge cup following the centrifugation… Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named

Medical device recall 4.5mm PLEO Osteotomy Guide Complaint received from sales representative that the drill guide tubes would not screw into replenishment instrument. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Indiana, Michigan, North Carolina, Ohio and Texas named

Medical device recall SenTec V-Sign Membrane Changer (VS-MC), 9 pieces A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportMissourithe one state its words name PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereMissouri

Medical device recall SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. Class IIFDA’s classNov 28, 2012in FDA’s Enforcement ReportMissourithe one state its words name PublishedNov 28, 2012ClassClass IIStatusTerminatedWhereMissouri

Medical device recall Progressive Medical PMI Endoscopic Dissector with Kittner Tip Some of the sterile packages had broken seals. Class IIFDA’s classNov 21, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedNov 21, 2012ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Indiana, Kansas, Massachusetts, Minnesota, Missouri, Nebraska, Ohio, South Carolina, Tennessee, Texas, Virginia and Wisconsin named

Medical device recall Synthes External Fixation System Tube to Tube Clamp The insert provided with the product for the specific lot number indicates that this product is MR safe. Class IIFDA’s classNov 21, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 21, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Minnesota, North Carolina and Tennessee named

Medical device recall HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system… Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being… Class IIFDA’s classNov 21, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedNov 21, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Hawaii, Kansas, Louisiana, Michigan, Missouri, Oregon, Pennsylvania, Utah and Wisconsin named

Medical device recall Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel… Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being… Class IIFDA’s classNov 21, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedNov 21, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Hawaii, Kansas, Louisiana, Michigan, Missouri, Oregon, Pennsylvania, Utah and Wisconsin named

Medical device recall Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns” Modular Perfusion System 8000 is… Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the… Class IIFDA’s classNov 21, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedNov 21, 2012ClassClass 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, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns” Modular Perfusion System 8000 is… Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the… Class IIFDA’s classNov 21, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedNov 21, 2012ClassClass 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, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns” Modular Perfusion System… Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the… Class IIFDA’s classNov 21, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedNov 21, 2012ClassClass 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, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns” Modular Perfusion System… Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the… Class IIFDA’s classNov 21, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedNov 21, 2012ClassClass 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, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns” Modular Perfusion System 8000 is… Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the… Class IIFDA’s classNov 21, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedNov 21, 2012ClassClass 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, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns” Modular Perfusion System 8000 is… Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the… Class IIFDA’s classNov 21, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedNov 21, 2012ClassClass 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, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension Component Product Usage: The… Stryker has become aware that insufficient taper torsional strength may result when a PAR extension piece is used with a forged CoCr stem. Class IIFDA’s classNov 21, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall PT Link Waterbath Dako is recalling the PT Link Waterbath because of a possible electrical hazard. Class IIFDA’s classNov 21, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedNov 21, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah and Washington named

Medical device recall TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Selected lots of the Fill Polymer Kit (European Model Number: TVFP14- B) in European distributor inventory only that potentially contain leaking stopcocks due… Class IIFDA’s classNov 21, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall ABX PENTRA Creatinine 120 CP This recall was initiated because some customers were experiencing an alarm during Creatinine calibration “REAG RANGE HIGH”. Class IIIFDA’s classNov 21, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2012ClassClass IIIStatusTerminatedWhereNationwide

Medical device recall EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG MOOG Medical Devices Group is conducting a voluntary for a limited set of serial numbers of the EnteraLite Infinity and Infinity Orange Small Volume Enteral… Class IIFDA’s classNov 21, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Gulf South Medical Supply recalled their Select Medium and Large size Vinyl Exam Gloves because they were inadvertently shipped prior to U.S. Class IIFDA’s classNov 21, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedNov 21, 2012ClassClass IIStatusTerminatedWhereNationwide, and Delaware, Kentucky, Louisiana, Maryland, New Jersey, New York, Pennsylvania, Texas, Virginia and West Virginia named

Medical device recall ATS 3000 Automatic Tourniquet System w/HOSES AND LOP SENSOR Intended to be used by qualified medical… Zimmer is conducting a voluntary removal of some Zimmer A.T.S. Class IIFDA’s classNov 21, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 21, 2012ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of… Clinical Diagnostic Solutions, Inc. Class IIIFDA’s classNov 14, 2012in FDA’s Enforcement Report32 statesnamed in where it went PublishedNov 14, 2012ClassClass IIIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Mississippi, North Dakota, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia and Wyoming

Medical device recall Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09 Abbott Point of Care (APOC) has determined that for the Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09; Lot Number 071039); i-STAT… Class IIIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedNov 14, 2012ClassClass IIIStatusTerminatedWhereNationwide, and Arizona, Georgia, Idaho, Illinois, Louisiana, Maryland, Minnesota, Missouri, North Carolina, Nevada, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia and Wisconsin named

Medical device recall Boule Con Diff US Tri Pack, 6 Vials Clinical Diagnostic Solutions, Inc. Class IIIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIIStatusTerminatedWhereNationwide

Medical device recall Boule Con-Diff Hematology Control 9 vials Clinical Diagnostic Solutions, Inc. Class IIIFDA’s classNov 14, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 14, 2012ClassClass IIIStatusTerminatedWhereNationwide

Medical device recall ABL80 FLEX CO-OX analyzer The recall was initiated because SenDx Medical Inc. Class IIFDA’s classNov 14, 2012in FDA’s Enforcement ReportOhiothe one state its words name PublishedNov 14, 2012ClassClass IIStatusTerminatedWhereOhio

Medical devices, 2012

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