Medical devices, 2014: every recall, from FDA

Medical device recall Reusable laparoscopic instruments are Additional caution statements have been added to the Instructions For Use for monopolar electrodes. Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System Correction due to the detection of a motor sensor failure in the Patient Cart instrument arms of the da Vinci Xi (IS4000) Surgical Systems after a… Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I Product was distributed past its expiration date. Class IIFDA’s classOct 8, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereCalifornia, Delaware, Indiana, Missouri, New Jersey, New York and Oregon

Medical device recall Array LaserLink Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system may project an erroneous pattern display on the… Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall The Rejuvenator Chamber The firm is distributing the Rejuvenator device without an approved 510(k). Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Florida, Georgia, Mississippi and Tennessee named

Medical device recall Verigene BC-GP Kit (Catalog number 20-005-018) There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor… Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kentucky, Maryland, Minnesota, Montana, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin named

Medical device recall Verigene BC-GN Kit (Catalog number 20-005-021) There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor… Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kentucky, Maryland, Minnesota, Montana, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin named

Medical device recall Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2 The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm Persona… Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 42 states named PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named

Medical device recall SPECTRUM Pump One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of… Class IIFDA’s classOct 8, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 8, 2014ClassClass IIStatusTerminatedWhereNo state named

Medical device recall Artis zee and Artis zeego systems There is a potential problem with Artis zee and Artis zeego systems running software version VC21B and being used in conjunction with the Large Display, in… Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are dedicated angiography… There is a potential problem with the AXIOM Artis or Artis zee system in connection with the hand switch operated at the patient table which may result in… Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall CareFusion EnVe and ReVel Ventilators CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due to misconnection by the operator. FDA Class I, its most serious class Class IFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedOct 1, 2014ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Nebraska, New Hampshire, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington and Wisconsin named

Medical device recall STAT 2 Flow Controller ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended. FDA Class I, its most serious class Class IFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 1, 2014ClassClass IStatusTerminatedWhereNationwide, and Oregon and Washington named

Medical device recall 83” (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer,… ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended. FDA Class I, its most serious class Class IFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 1, 2014ClassClass IStatusTerminatedWhereNationwide, and Oregon and Washington named

Medical device recall 98” (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item… ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended. FDA Class I, its most serious class Class IFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 1, 2014ClassClass IStatusTerminatedWhereNationwide, and Oregon and Washington named

Medical device recall 0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used in… Unit packages may exhibit open seals which impacts package integrity and potentially product sterility. Class IIFDA’s classOct 1, 2014in FDA’s Enforcement Report20 statesnamed in where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereArizona, California, Iowa, Illinois, Indiana, Massachusetts, Maryland, North Carolina, Nebraska, New York, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin

Medical device recall VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G… VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower than expected VITROS Anti-HCV test results due to an… Class IIFDA’s classOct 1, 2014in FDA’s Enforcement Report9 statesnamed in where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereConnecticut, Florida, Georgia, Massachusetts, Maryland, New Jersey, New York, Pennsylvania and Virginia

Medical device recall EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455 The voluntary recall is due to the needle set not meeting its specifications. Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and West Virginia named

Medical device recall BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306553). Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall DePuy Synthes TI Vectra Plates: TI Vectra-One” Plate 2 Level / 34 mm part 04.613.184 3337672 TI Vectra” Plate… DePuy Synthes is initiating a voluntary medical device recall of certain lots of the TI Vectra Plates, which is a part of the DePuy Synthes Vectra Anterior… Class IIFDA’s classOct 1, 2014in FDA’s Enforcement Report13 statesnamed in where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Illinois, Kansas, Louisiana, Massachusetts, North Carolina, Nebraska, Oregon, South Carolina, Texas and Virginia

Medical device recall The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene… A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified. Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia and Washington named

Medical device recall The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene… A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified. Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Missouri, Mississippi, North Carolina, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia and Washington named

Medical device recall Circular Lock Screws, part # G826 The recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Genesys Spine that a portion (less than 20%) of the Circular… Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Missouri, New Jersey, Nevada, New York, Tennessee and Texas named

Medical device recall No packaging When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate. Class IIFDA’s classOct 1, 2014in FDA’s Enforcement Report19 statesnamed in where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereArkansas, California, Florida, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia and Vermont

Medical device recall Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in… Faded and wrong markings on bone screw Countersink/Depth Gauge instruments in Mini Screw Set. Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Illinois, Maine, North Carolina, Nebraska, New Mexico, Ohio, Oklahoma, Oregon, Tennessee, Texas, Virginia and Washington named

Medical device recall The Ysio Systems with software version VC10 The Ysio enables radiographic and tomographic exposures of the… Siemens discovered that an unlikely error may occur on the Ysio system with fixed detector in the wall stand. Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result… Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in… Class IIFDA’s classOct 1, 2014in FDA’s Enforcement Report25 statesnamed in where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, Virginia, Washington and Wisconsin

Medical device recall The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic… Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in… Class IIFDA’s classOct 1, 2014in FDA’s Enforcement Report25 statesnamed in where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, Virginia, Washington and Wisconsin

Medical device recall The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result… Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in… Class IIFDA’s classOct 1, 2014in FDA’s Enforcement Report25 statesnamed in where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, Virginia, Washington and Wisconsin

Medical device recall The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic… Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in… Class IIFDA’s classOct 1, 2014in FDA’s Enforcement Report25 statesnamed in where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, Virginia, Washington and Wisconsin

Medical device recall The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous… Nanosphere has received several reports relating to an increased rate of Processing Errors during procedures performed on the Processor SP caused by Tips in… Class IIFDA’s classOct 1, 2014in FDA’s Enforcement Report25 statesnamed in where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereArizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, Virginia, Washington and Wisconsin

Medical device recall Fresenius Naturalyte Liquid Bicarbonate Concentrate Product Number: 08-4000-LB The concentrate is formulated… Product was held at temperature above the labeled recommended storage temperature Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportTexasthe one state its words name PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereTexas

Medical device recall UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative,… Beckman Coulter is recalling the Sample Probe Cable because nonconforming sample probe cables may been installed on newly manufactured and/or recently serviced… Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named

Medical device recall RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a… Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification. Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts, Minnesota, New York and Puerto Rico named

Medical device recall CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used… The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Kentucky, Louisiana, Michigan, Missouri, Nebraska, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas and Utah named

Medical device recall Justright Surgical, JustRight 5mm Stapler JustRight Surgical is recalling specific lots of JustRight 5mm Stapler and Reload products because they may deliver poor distal staple formation, past the end… Class IIFDA’s classOct 1, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereCalifornia, Colorado and New York

Medical device recall Justright Surgical, JustRight 5mm Reload, REFJR-REL25-2.0, Sterile, EO JustRight Surgical is recalling specific lots of JustRight 5mm Stapler and Reload products because they may deliver poor distal staple formation, past the end… Class IIFDA’s classOct 1, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereCalifornia, Colorado and New York

Medical device recall ABX PENTRA Magnesium RTU Reagent Horiba Medical is recalling the ABX PENTRA Magnesium RTU Reagent because the on-board stability claims has been updated. Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Minstrel (with scale) Product Usage: is a mobile passive hoist ArjoHuntleigh received three reports where the bolt under the scale unscrewed from the scale. Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts named

Medical device recall eye-pak 7407 Tray Support Cover The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot be assured. Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Fuze Manual Tilt Wheelchair The hex bolt head might shear and cause the axle plate to detach from the lower frame of the wheelchair and could collapse the wheels while in use. Class IIFDA’s classOct 1, 2014in FDA’s Enforcement Report17 statesnamed in where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereArizona, California, Georgia, Kentucky, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia and Washington

Medical device recall UltraStream Chronic Hemodialysis Catheter Standard Kit UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation. Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical device recall UltraStream Exchange Kit UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation. Class IIFDA’s classOct 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 1, 2014ClassClass IIStatusTerminatedWhereNationwide

Medical devices, 2014

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