Medical devices, 2019: every recall, from FDA

Medical device recall Infusion Pump I.V Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedOct 23, 2019ClassClass 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, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named

Medical device recall Siemens Atellica CH 930 Analyzer Atellica CH 930 Analyzer - Erroneous Indices for Hemolysis and Lipemia in Software versions 1.19.2 and below Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Electrosurgical Tip Cleaner The sterile barrier of some devices may have been affected Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Idaho, Illinois, Louisiana, Maryland, New York, Ohio, Oklahoma, Texas, Virginia and Wisconsin named

Medical device recall Cautery Tip Cleaner The sterile barrier of some devices may have been affected Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Idaho, Illinois, Louisiana, Maryland, New York, Ohio, Oklahoma, Texas, Virginia and Wisconsin named

Medical device recall Roche Diagnostics cobas Integra Albumin Gen.2 Due to low Quality Control recovery and invalid Calibration. Class IIIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedOct 23, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin named

Medical device recall Cobas c Bilirubin Total Gen.3 Due to low Quality Control recovery and invalid Calibration. Class IIIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedOct 23, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin named

Medical device recall Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for… The action was initiated due power supply failure. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and New York and Utah named

Medical device recall Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for… The action was initiated due power supply failure. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and New York and Utah named

Medical device recall V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for… The action was initiated due power supply failure. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and New York and Utah named

Medical device recall Selectra ProM Analyzer The action was initiated due power supply failure. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and New York and Utah named

Medical device recall Selectra ProS Analyzer The action was initiated due power supply failure. Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 23, 2019ClassClass IIStatusTerminatedWhereNationwide, and New York and Utah named

Medical device recall Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid… Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate Class IIFDA’s classOct 23, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 23, 2019ClassClass IIStatusOngoingWhereNationwide

Medical device recall V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an… The action is being initiated because the cooling indicator board was improperly installed. Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide, and New York named

Medical device recall BioEnvelope, surgical mesh envelope Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device. Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named

Medical device recall CanGaroo Envelopes labeled as the following: 1 Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device. Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named

Medical device recall Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer GE Healthcare has become aware of a potential safety issue that can occur if the canopy seals are not cleaned appropriately. Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Online TDM Vancomycin Gen.3 Inaccurately Low Sample Results Class IIFDA’s classOct 16, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming

Medical device recall Online TDM Vancomycin Gen.3 ( 200 tests) Inaccurately Low Sample Results Class IIFDA’s classOct 16, 2019in FDA’s Enforcement Report53 statesnamed in where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming

Medical device recall AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer… AssayTips part of the AssayTip/AssayCup Tray Tips used on the cobas e 801 module- may have an Abnormal Internal Structure and lead to Incorrect patient results Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide

Medical device recall SPIFE ImmunoFix-6 Kit The plates do not have wells punched for the controls in the patient 1 area. Class IIFDA’s classOct 16, 2019in FDA’s Enforcement Report7 statesnamed in where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereIndiana, Kentucky, Massachusetts, Ohio, Oregon, Tennessee and Texas

Medical device recall Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE. The incorrect sensor was used in the assembly of the camera in the scanner instrument which can potentially generate whole slide images that impact analysis… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNo state named

Medical device recall STRATAFIX Spiral PDS Plus Violet 18 The product does not meet certain internal strength testing specifications. Class IIFDA’s classOct 16, 2019in FDA’s Enforcement Report18 statesnamed in where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, North Carolina, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Utah and Washington

Medical device recall STRATAFIX Spiral PDS Plus Violet 27 The product does not meet certain internal strength testing specifications. Class IIFDA’s classOct 16, 2019in FDA’s Enforcement Report18 statesnamed in where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, North Carolina, New Jersey, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Utah and Washington

Medical device recall CareFusion MaxPlus Clear Needleless Connector After disconnection of a luer, the valve of the connector remains recessed; not fully closing, either temporarily or permanently. Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide

Medical device recall EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK Exactamed 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 3 mL oral dispensers. Class IIIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIIStatusTerminatedWhereNationwide

Medical device recall 20” 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets” Product # RMS22606 - Product Usage: RMS… Mislabeled needle lengths Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Iowa, Illinois, Massachusetts, Maryland, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Tennessee, Texas and Virginia named

Medical device recall K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor) Product Usage:… Instruments were developed without adequate consideration given to the need for a new regulatory filing. Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Connecticut, Florida, Illinois, Indiana, Kansas, Massachusetts, Michigan, Minnesota, Pennsylvania, Tennessee, Texas, Utah and Virginia named

Medical device recall Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter Lidstock contains a labeling error. Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide

Medical device recall BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963 Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide

Medical device recall BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965 Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide

Medical device recall BD Microtainer SST Part/Catalog No.365967 Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide

Medical device recall BD MicrotainerTubes with K2E (K2EDTA) Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide

Medical device recall BD Microtainer SST- Amber Part/Catalog Number: 365978 Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide

Medical device recall BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985 Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide

Medical device recall BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987 Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide

Medical device recall BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number:… Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially… Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide

Medical device recall AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF… The outer seam of the coil, closest to the system cable, may separate and expose the porous material internal to the coil. Class IIFDA’s classOct 16, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Delaware, Mississippi, New York and Wisconsin named

Medical device recall iTotal Hip Replacement System Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other’s packaging. Class IIFDA’s classOct 16, 2019in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 16, 2019ClassClass IIStatusTerminatedWhereMaryland and Nevada

Medical devices, 2019

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