Tag: Class I recall

FDA: Class I recall of Baxter SIGMA Spectrum, Spectrum IQ infusion pumps

Editor's Note The Food and Drug Administration (FDA), on August 1, identified the recall by Baxter Healthcare Corporation of its SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) and Spectrum IQ Infusion System with Dose IQ Safety Software (Version 9) as Class I, the most serious. The recall…

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By: Judy Mathias
August 1, 2023
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FDA: Class I recall of Abiomed Impella Left Sided Blood Pumps

Editor's Note The Food and Drug Administration (FDA), on July 27, identified the recall by Abiomed of all Impella Left Sided Blood Pumps as Class I, the most serious. Abiomed is recalling the pumps because the instructions for use do not adequately address precautions to take when treating transcatheter aortic…

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By: Judy Mathias
July 27, 2023
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FDA: Class I recall of Quidel Triage Cardiac Panels

Editor's Note The Food and Drug Administration (FDA), on July 17, identified the recall by Quidel Cardiovascular Inc of its Quidel Triage Cardiac Panels as Class I, the most serious. The recall was initiated because of reports of inaccurate tests showing lower than expected troponin levels in samples. A falsely…

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By: Judy Mathias
July 19, 2023
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FDA: Class I recall of Medtronic implantable cardioverter, cardiac resynchronization therapy defibrillators

Editor's Note The Food and Drug Administration (FDA), on July 18, identified the recall by Medtronic of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) as Class I, the most serious. Medtronic is recalling all ICDs and CRT-Ds, with glassed feedthroughs that were manufactured after 2017, as…

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By: Judy Mathias
July 18, 2023
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FDA: Class I recall of Draeger Medical’s Oxylog 3000 Plus Emergency and Transport Ventilators

Editor's Note The Food and Drug Administration (FDA), on July 13, identified the recall by Draeger Medical of its Oxylog 3000 Plus Emergency and Transport Ventilators as Class I, the most serious. The recall was initiated because of reports that the ventilator may not automatically switch back to using AC…

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By: Judy Mathias
July 14, 2023
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