Medical devices, 2019: every recall, from FDA

Medical device recall COBRA FUSION 150 Ablation System There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary… Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin

Medical device recall COBRA FUSION 150 Ablation System (International Only) There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary… Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement Report37 statesnamed in where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin

Medical device recall Genius Knee Cemented Tibial Component Product Usage: Knee replacement component Product mix up Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, New York and Tennessee named

Medical device recall Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component Product mix up Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNationwide, and Florida, New York and Tennessee named

Medical device recall Edward Lifesciences, Edwards Commander Delivery System This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereNo state named

Medical device recall HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.) A stray strand of stainless-steel cable may protrude from the heat shrink sleeving on the Balance Cable of the Ez Arm. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement Report8 statesnamed in where it went PublishedFeb 20, 2019ClassClass IIStatusOngoingWhereCalifornia, Massachusetts, Minnesota, Pennsylvania, Texas, Virginia, Washington and Wisconsin

Medical device recall OMNI K1 Broach Handle There is a potential for the inner pin of the handle to become loose and fall out. Class IIFDA’s classFeb 20, 2019in FDA’s Enforcement Report4 statesnamed in where it went PublishedFeb 20, 2019ClassClass IIStatusTerminatedWhereCalifornia, Georgia, South Carolina and Utah

Medical device recall Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. FDA Class I, its most serious class Class IFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedFeb 13, 2019ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named

Medical device recall Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. FDA Class I, its most serious class Class IFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedFeb 13, 2019ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named

Medical device recall Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. FDA Class I, its most serious class Class IFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedFeb 13, 2019ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named

Medical device recall Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. FDA Class I, its most serious class Class IFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedFeb 13, 2019ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named

Medical device recall Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. FDA Class I, its most serious class Class IFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedFeb 13, 2019ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named

Medical device recall Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. FDA Class I, its most serious class Class IFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedFeb 13, 2019ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named

Medical device recall Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. FDA Class I, its most serious class Class IFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedFeb 13, 2019ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named

Medical device recall Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. FDA Class I, its most serious class Class IFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedFeb 13, 2019ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named

Medical device recall Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. FDA Class I, its most serious class Class IFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedFeb 13, 2019ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named

Medical device recall Portex Unit Dose 5 ml Normal Saline Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. FDA Class I, its most serious class Class IFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedFeb 13, 2019ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named

Medical device recall Portex Unit Dose 15 ml Normal Saline ¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. FDA Class I, its most serious class Class IFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedFeb 13, 2019ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named

Medical device recall Portex 5ml Normal Saline Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. FDA Class I, its most serious class Class IFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedFeb 13, 2019ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named

Medical device recall Medline Prefilled 550 ml Sterile¿¿ ¿ Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents. FDA Class I, its most serious class Class IFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedFeb 13, 2019ClassClass IStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named

Medical device recall NeuViz 128 Multi-slice CT Scanner System with software version 1.0.8.5010O+P04 Vi .0.8.521 9+PO1 Multi-Slice… For surview scan length more than 500mm,if the user aborts or skips the reconstructed surview, the image may have the wrong field of view (FOV). Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 13, 2019ClassClass IIStatusTerminatedWhereKansas, Massachusetts and Oklahoma

Medical device recall Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and… On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation and on the gantry display may not be the actual… Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 13, 2019ClassClass IIStatusOngoingWhereNationwide

Medical device recall CoaguChek XS PT Test Potential for abnormally high INR test results with the CoaguChek XS PT Test Strips for customers who purchased products directly from Terrific Care LLC dba… FDA Class I, its most serious class Class IFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 13, 2019ClassClass IStatusTerminatedWhereNationwide

Medical device recall BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1 A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 installed on a computer workstation with windows 10 operating… Class IIIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportMarylandthe one state its words name PublishedFeb 13, 2019ClassClass IIIStatusTerminatedWhereMaryland

Medical device recall GE Healthcare Centricity Universal Viewer Breast Imaging Centricity Universal Viewer is a device that… When switching back & forth between multiple UV instances in the Windows taskbar, the patient images displayed on the mammo high resolution monitors may not… Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedFeb 13, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Massachusetts, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont and Wisconsin named

Medical device recall Ascension Modular Radial Head (MRH) Radial Head Implant The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant). Class IIIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportMissourithe one state its words name PublishedFeb 13, 2019ClassClass IIIStatusTerminatedWhereMissouri

Medical device recall MEDTRONIC CARELINK 2090 programmer There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device… Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedFeb 13, 2019ClassClass IIStatusTerminatedWhereGeorgia

Medical device recall MEDTRONIC CARELINK 29901 Programmer for Medtronic and Vitaron Devices The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use in the interrogation and programming of… Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedFeb 13, 2019ClassClass IIStatusTerminatedWhereGeorgia

Medical device recall Henry Schein CU 1000 Halogen Curing Light Tip of the curing light was too hot causing a heat sensation in the patients. Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedFeb 13, 2019ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Guam, Hawaii, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named

Medical device recall ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a… Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results due to a reagent carryover when testing on board with specific… Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 13, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a… Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results due to a reagent carryover when testing on board with specific… Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedFeb 13, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall BARD SureStep Foley Tray System Bardex I.C Some SureStep” Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased… Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedFeb 13, 2019ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Illinois, Indiana, Kentucky, Mississippi, Nebraska, New Mexico, Nevada, Oklahoma, Pennsylvania, Texas and Virginia named

Medical device recall Product: ABL800 FLEX with Crea From three incidents in Denmark and Sweden, comparison studies on patient blood samples carried out for quality assurance demonstrated that creatinine… Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement Report31 statesnamed in where it went PublishedFeb 13, 2019ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia

Medical device recall ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System Inability or difficulty in unbuckling/releasing the proning arm buckle might delay patient access in an emergency situation such as cardiac arrest. Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 13, 2019ClassClass IIStatusTerminatedWhereNo state named

Medical device recall SureStep(TM) FOLEY TRAY SYSTEM, Preconnected Closed System Foley Tray potential for urine leakage around the vent on the vented sample port Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 13, 2019ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Richard Wolf Bronchoscope Tubes There is a potential deficiency of the TEXAS Bronchoscope Tube product. Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 13, 2019ClassClass IIStatusOngoingWhereNationwide, and Maryland, New York and Pennsylvania named

Medical device recall Naera Hospital Bassinet It was identified that the volume of air inside the mattress may expand in regions of high altitude which may result in an unintended gap between the plateau… Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 13, 2019ClassClass IIStatusTerminatedWhereNationwide

Medical device recall “J” Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy… Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy… Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 13, 2019ClassClass IIStatusTerminatedWhereNationwide, and New Jersey named

Medical device recall J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and… Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy… Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 13, 2019ClassClass IIStatusTerminatedWhereNationwide, and New Jersey named

Medical device recall J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and… Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy… Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 13, 2019ClassClass IIStatusTerminatedWhereNationwide, and New Jersey named

Medical device recall Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga x 10cm 14MTWX x 12.5 cm Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy… Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 13, 2019ClassClass IIStatusTerminatedWhereNationwide, and New Jersey named

Medical device recall Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments… Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy… Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 13, 2019ClassClass IIStatusTerminatedWhereNationwide, and New Jersey named

Medical device recall Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy… Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 13, 2019ClassClass IIStatusTerminatedWhereNationwide, and New Jersey named

Medical device recall Aguja de Aspiration con Profundidad Ajustable Tipo I 15ga x 5 cm - Product Usage: Manual surgical instruments… Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy… Class IIFDA’s classFeb 13, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 13, 2019ClassClass IIStatusTerminatedWhereNationwide, and New Jersey named

Medical device recall Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz… These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. FDA Class I, its most serious class Class IFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 6, 2019ClassClass IStatusTerminatedWhereNo state named

Medical device recall Edwards Lifesciences Swan Ganz Thermodilution Catheter These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. FDA Class I, its most serious class Class IFDA’s classFeb 6, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 6, 2019ClassClass IStatusTerminatedWhereNo state named

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