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…
Discrepancies in FDA clearance, marketing of AI-, ML-enabled medical devices
Editor's Note This study from New York University and NYU Langone Health, New York City, finds discrepancies between the marketing and 510(k) clearance of artificial intelligence (AI)- or machine learning (ML)-enabled medical devices, with some devices being marketed as having capabilities not approved by the Food and Drug Administration (FDA).…
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…
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…
FDA: Class I recall of Megadyne’s Mega 2000, Mega Soft reusable patient return electrodes
Editor's Note The Food and Drug Administration (FDA), on July 11, identified the recall by Megadyne of its Mega 2000 and Mega Soft reusable patient return electrodes as Class I, the most serious. The recall was initiated after Megadyne received reports of pediatric and adult patients receiving burn injuries during…
ASA suggests patients stop popular weight loss medications before elective surgery
Editor's Note The American Society of Anesthesiologists (ASA) announced on June 29 that patients taking any of the currently popular medications for weight loss or for the treatment of type 2 diabetes should withhold the medication prior to elective surgery to "reduce the risk of complications associated with anesthesia in…
FDA: Class I recall of Arrow Endurance Extended Dwell Peripheral Catheter System
Editor's Note The Food and Drug Administration (FDA), on June 26, identified the recall by Teleflex, and their subsidiary Arrow International, of the Arrow Endurance Extended Dwell Peripheral Catheter System as Class I, the most serious. The recall was initiated because of the risk of catheter separation and leakage. If…
Pfizer warns FDA of penicillin shortage
Editor's Note Pfizer alerted the Food and Drug Administration (FDA) on June 12 that its supply of two forms of injectable penicillin—Bicillin L-A and Bicillin C-R—may run out by the end of this month, the June 13 The Hill reports. Pfizer cited a combination of factors for the shortage, including…
FDA: Class I recall of Walnut Wearable Smart Thermometers
Editor's Note The Food and Drug Administration, on June 12, identified the recall of the rechargeable Walnut Wearable Smart Thermometer as Class I, the most serious. BearCare, Inc, is recalling the thermometers after receiving reports of skin burns and irritation resulting from use of the device. The company reports five…
FDA letter on supply shortage of nonsterile, single-use pneumatic tourniquet cuffs
Editor's Note In a June 5 letter to healthcare providers, the Food and Drug Administration (FDA) says it is aware of US healthcare facilities and providers experiencing supply constraints of nonsterile, single-use pneumatic tourniquet cuffs. The cuffs are used in elective limb surgeries and in emergency and trauma settings. During…
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