Editor's Note The Food and Drug Administration (FDA) on June 8 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) Pump Implant Kit as Class I, the most serious. The HVAD System is used as a bridge to cardiac transplants. The Kit was recalled because of a…

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Editor's Note The Food and Drug Administration on June 3 identified the recall by Philips Respironics of all V60 and V60 Plus Ventilators as Class I, the most serious. The recall was initiated because an internal power fluctuation may cause the ventilator to shut down unintentionally with or without any…

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Editor's Note The Food and Drug Administration (FDA) on June 2 identified the recall by Atrium Medical Corporation of its iCast Covered Stent System as Class I, the most serious. The recall was initiated because of increased complaints about the separation of the balloon or catheter hub from the delivery…

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Editor's Note The Food and Drug Administration (FDA) on May 27 identified the recall of the ArjoHuntleigh Polska Sara Plus floor lift as Class I, the most serious. The recall was initiated because of the risk of smoke or fire if the lift is used when the battery is low.…

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Editor's Note The Food and Drug Administration (FDA) on May 26 identified the recall of Abbott Medical’s Dragonfly OpStar Imaging Catheter as Class I, the most serious. Abbott is recalling certain lots of the imaging catheter because the marker band farthest from the catheter tip (proximal marker) may become loose…

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Editor's Note ECRI on May 25 announced the three winners and three finalists of its 2022 Alerts Impact Award for excellence in recall management. The annual award is given to those who have demonstrated strong success in implementing recall management programs in their healthcare organizations. The winners are: Eskenazi Health,…

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Editor's Note The Food and Drug Administration (FDA) on May 16 identified the recall of Woodside Acquisitions Inc’s Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) as Class I, the most serious. The tests are being recalled because they were distributed to…

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Editor's Note In this study, researchers from Yale School of Medicine, New Haven, Connecticut, find that face-mask compliance remained suboptimal among healthcare workers (HCWs) despite a facility-wide mandate for universal masking during the COVID-19 pandemic. Of 1,561 observations during a 4-week baseline period after universal masking was mandated, median weekly…

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Editor's Note In a May 18 position statement, ECRI recommends that it’s time to move to a regularly scheduled COVID-19 vaccine booster model. “Moving to a regular vaccine schedule will increase clarity and confidence about what actions to take and when, compared to the current piecemeal, wait-and-see approach,” says Marcus…

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Editor's Note The Food and Drug Administration (FDA) on May 9 identified the recall by Mesa Biotech, Inc, of certain Accula SARS-CoV-2 Tests as Class I, the most serious. The recall was initiated because certain lots of the PCR test have an increased risk of giving false positive results because…

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