Medical devices, 2021: every recall, from FDA

Medical device recall The Fresenius APD Luer-Lock Adapter Exposed to freezing temperatures due to refrigerated truck malfunctions Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportTexasthe one state its words name PublishedJul 28, 2021ClassClass IIStatusTerminatedWhereTexas

Medical device recall The MTS Set is a single-use, sterile (EO), non-pyrogenic, optional accessory that provides additional… Exposed to freezing temperatures due to refrigerated truck malfunctions Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportTexasthe one state its words name PublishedJul 28, 2021ClassClass IIStatusTerminatedWhereTexas

Medical device recall 050-95012 Sterile Stay Safe Cap The Indications for Use/Intended Use for the Fresenius Sterile Stay Safe¿ Cap… Exposed to freezing temperatures due to refrigerated truck malfunctions Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportTexasthe one state its words name PublishedJul 28, 2021ClassClass IIStatusTerminatedWhereTexas

Medical device recall Disposable Replacement Backflush Brush Needles Mislabeled: 1281.B1D Disposable Replacement Backflush Brush Needles label states (20 gauge/0.9 mm) instead of the correct size of 23 gauge/0.6 mm and the… Class IIFDA’s classJul 28, 2021in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 28, 2021ClassClass IIStatusTerminatedWhereIllinois, Indiana, Missouri and Pennsylvania

Medical device recall Hemotherm CE Dual Reservoir Cooler/Heater There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including… Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named

Medical device recall SoftGenomics version 4.1.15.6 SoftGenomics is a laboratory workflow and information management system to be… Software showing wrong results reported, PDF not match HIS. Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJul 28, 2021ClassClass IIStatusTerminatedWhereCalifornia

Medical device recall Infant Heel Warmer with Attachment Tab, Nonsterile, Active Product A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may… Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJul 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, 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, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named

Medical device recall Infant Heel Warmer without Attachment Tab, Nonsterile, Active Product A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may… Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJul 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, 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, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named

Medical device recall AVSM3 SNF, Vital Signs Monitor The monitor is intended to be used to monitor noninvasive blood pressure… In some cases the equipment fails to power up and/or key or button unresponsive or not working. Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportWisconsinthe one state its words name PublishedJul 28, 2021ClassClass IIStatusTerminatedWhereWisconsin

Medical device recall Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Barcode label extended expiration date. Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 28, 2021ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Massachusetts and Utah named

Medical device recall SoftCytogenetics Software is given wrong results going out to HIS on test that had reruns. Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Minnesota and New Jersey named

Medical device recall NEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Standard packed within NEFA kit has been assigned incorrectly. Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJul 28, 2021ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Connecticut, New York, Ohio, Pennsylvania, Tennessee and Texas named

Medical device recall Cortoss Bone Augmentation Material 5cc Cartridge The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution. Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Cortoss Bone Augmentation Material 10cc Cartridge The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution. Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IIStatusTerminatedWhereNationwide

Medical device recall Medtronic Reveal LINQ LNQ11 / PA96000 Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed “ON”, but are no longer able to detect and report Brady and… Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 28, 2021ClassClass IIStatusOngoingWhereNo state named

Medical device recall DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging… Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJul 28, 2021ClassClass IIStatusOngoingWhereNationwide, and California, Georgia, Illinois, Kansas, Louisiana, Minnesota, Mississippi, Texas and Virginia named

Medical device recall Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody Product distributed for use as an In-vitro Diagnostics without FDA clearance Class IIFDA’s classJul 28, 2021in FDA’s Enforcement Report18 statesnamed in where it went PublishedJul 28, 2021ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Florida, Hawaii, Idaho, Illinois, Kentucky, Minnesota, Montana, North Carolina, New Hampshire, New York, Pennsylvania, South Carolina, Virginia and Wisconsin

Medical device recall Cell Marque Antibodies, MSH6 Product distributed for use as an In-vitro Diagnostics without FDA clearance Class IIFDA’s classJul 28, 2021in FDA’s Enforcement Report18 statesnamed in where it went PublishedJul 28, 2021ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Florida, Hawaii, Idaho, Illinois, Kentucky, Minnesota, Montana, North Carolina, New Hampshire, New York, Pennsylvania, South Carolina, Virginia and Wisconsin

Medical device recall Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch. Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedJul 28, 2021ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named

Medical device recall 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00… Telepack may not power on when using the 3AA battery cradle. Class IIIFDA’s classJul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IIIStatusTerminatedWhereNationwide

Medical device recall Stimulen Collagen Moisturizing Lotion, ST9555B Dose audit failure after sterilization process Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 28, 2021ClassClass IIStatusOngoingWhereNo state named

Medical device recall Version: 1.2.0 The firm is aware of a issue with ultrasound software that results in unintended video frames being included. Class IIFDA’s classJul 28, 2021in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 28, 2021ClassClass IIStatusTerminatedWhereArizona, Connecticut, Delaware, Illinois and New York

Medical device recall Exactech Connexion GXL acetabular polyethylene liners used in the following systems Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant… Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IIStatusOngoingWhereNationwide

Medical device recall Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators. The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and… FDA Class I, its most serious class Class IFDA’s classJul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 21, 2021ClassClass IStatusOngoingWhereNationwide

Medical device recall A-Series BiPAP Hybrid A30 (not The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and… FDA Class I, its most serious class Class IFDA’s classJul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 21, 2021ClassClass IStatusOngoingWhereNationwide

Medical device recall A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and… FDA Class I, its most serious class Class IFDA’s classJul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 21, 2021ClassClass IStatusOngoingWhereNationwide

Medical devices, 2021

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