Medical devices, 2018: every recall, from FDA

Medical device recall DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system… A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, District of Columbia, Florida, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Minnesota, Missouri, Nevada, New York, Ohio, Oregon, South Carolina and Tennessee named

Medical device recall Zimmer Natural Nail Tibial Nail - Yellow 8.3mm The item is labeled as an 8.3mm, but it is actually a 12 mm. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereNo state named

Medical device recall The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including… Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM). Class IIFDA’s classOct 3, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereColorado, Tennessee and Texas

Medical device recall ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging Possible injury due to movement of the arm, calibration loss and communication loss. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2018ClassClass IIStatusOngoingWhereNationwide

Medical device recall Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment The implant only has one bolt in the sterile package but it should have had two. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Kansas, New Mexico, Nevada and Utah named

Medical device recall Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment The implant only has one bolt in the sterile package but it should have had two. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Kansas, New Mexico, Nevada and Utah named

Medical device recall Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542 Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visualase Thermal Therapy System may result in unaccounted spread… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement Report35 statesnamed in where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin

Medical device recall Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft… Expiration date incorrectly listed on the label Class IIFDA’s classOct 3, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereArizona, Colorado, Florida, Georgia, Louisiana, Massachusetts, Missouri, New York, South Carolina and Texas

Medical device recall Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. Class IIIFDA’s classOct 3, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedOct 3, 2018ClassClass IIIStatusTerminatedWhereCalifornia, Iowa, Nebraska, Tennessee, Texas, Virginia and Washington

Medical device recall da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System… Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereNationwide

Medical device recall ESSENTIO Pacemaker Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement Report48 statesnamed in where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia and Wyoming

Medical device recall PROPONENT Pacemaker Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement Report48 statesnamed in where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia and Wyoming

Medical device recall ACCOLADE Pacemaker Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement Report48 statesnamed in where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia and Wyoming

Medical device recall VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker) Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement Report48 statesnamed in where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia and Wyoming

Medical device recall VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker) Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement Report48 statesnamed in where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia and Wyoming

Medical device recall Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System… There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber stimulation. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereNationwide, and Florida, Utah and Virginia named

Medical device recall HipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate 38 mm Barrel 4 Hole Plate HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Missouri, New Jersey and New Mexico named

Medical device recall HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 3 Hole Plate HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Missouri, New Jersey and New Mexico named

Medical device recall HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 4 Hole Plate HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Missouri, New Jersey and New Mexico named

Medical device recall HipLOC Hip Fracture Fixation System-Hiploc System 140¿ Plate 38 mm Barrel 4 Hole Plate HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Missouri, New Jersey and New Mexico named

Medical device recall Bausch + Lomb Stellaris Elite 20 GA Vit Cutter The back cap separates from the body of the vitrectomy cutter. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement Report26 statesnamed in where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah and West Virginia

Medical device recall Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga The back cap separates from the body of the vitrectomy cutter. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement Report26 statesnamed in where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah and West Virginia

Medical device recall Bausch + Lomb Stellaris Elite 23 GA Vit Cutter The back cap separates from the body of the vitrectomy cutter. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement Report26 statesnamed in where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah and West Virginia

Medical device recall Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga The back cap separates from the body of the vitrectomy cutter. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement Report26 statesnamed in where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah and West Virginia

Medical device recall Bausch + Lomb Stellaris Elite 25 GA Vit Cutter The back cap separates from the body of the vitrectomy cutter. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement Report26 statesnamed in where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah and West Virginia

Medical device recall Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga The back cap separates from the body of the vitrectomy cutter. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement Report26 statesnamed in where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah and West Virginia

Medical device recall Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga The back cap separates from the body of the vitrectomy cutter. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement Report26 statesnamed in where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah and West Virginia

Medical device recall Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga The back cap separates from the body of the vitrectomy cutter. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement Report26 statesnamed in where it went PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maine, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah and West Virginia

Medical device recall Retractor System Elastic Stays (Part 3314-lG There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection. Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington and West Virginia named

Medical device recall Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name GE Medical Systems has discovered a small area on the bore surface of the Discovery MR750w Nuclear Magnetic Resonance Imaging System, normally accessible to… Class IIFDA’s classOct 3, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedOct 3, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named

Medical device recall Temperature sensor Foley catheter 18FR, Catalogue Number 102205101880AB Product Usage: This is sterile,… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named

Medical device recall Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB Product Usage: This is sterile, single… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named

Medical device recall Temperature sensor Foley catheter 10FR, Catalogue Number 102205101080AB Product Usage: This is sterile,… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named

Medical device recall Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI Product Usage: This is sterile, single use,… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named

Medical device recall Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI Product Usage: This is sterile, single use,… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named

Medical device recall Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product Usage: This is sterile, single use,… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named

Medical device recall Temperature Sensor Catheter 14FR, Catalogue Number 102201101463BI Product Usage: This is sterile, single use,… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named

Medical device recall Temperature Sensor Catheter 16FR, Catalogue Number 102201101663BI Product Usage: This is sterile, single use,… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named

Medical device recall Temperature Sensor Catheter 18FR, Catalogue Number 102201101863BI Product Usage: This is sterile, single use,… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named

Medical device recall Foley Catheter with temperature sensor 400TM 8FR, Catalogue Number 102201100880TY Product Usage: This is… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named

Medical device recall Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101280TY Product Usage: This is… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named

Medical device recall Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101480TY Product Usage: This is… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named

Medical device recall Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY Product Usage: This is… The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a… Class IIFDA’s classSep 26, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedSep 26, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois, North Carolina and New York named

Medical devices, 2018

The list

Nothing matches all of these.

Side by side

How to read a record

Every fact names its source.

A number never stands alone.

What needs attention is marked.

The public record comes first.