FDA: Class I recall of Medtronic’s HVAD batteries
Editor's Note The Food and Drug Administration (FDA), on June 23, identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) batteries as Class I, the most serious. The recall for a single lot (Model Number:1650DE) of HVAD batteries was initiated because of welding defects that allow separation…
FDA monitoring pulse oximeter accuracy and limitations
Editor's Note The US Food and Drug Administration (FDA) released a safety communication update on June 21 alerting providers that the agency “continues to evaluate all available information pertaining to factors that may affect pulse oximeter accuracy and performance.” A May 2022 study published by JAMA Internal Medicine showed that…
FDA: Class I recall of one lot of Draeger SafeStar 55 Breathing System Filters
Editor's Note The Food and Drug Administration (FDA) on June 21 identified the recall by Draeger, Inc, of one lot (LT2103) of its SafeStar 55 Breathing System Filters as Class I, the most serious. The Breathing System Filter is used as part of a ventilator when a patient is under…
FDA, CDC recommend COVID-19 vaccines for children under 5 years old
Editor's Note The Food and Drug Administration (FDA) authorized COVID-19 vaccines for children as young as 6 months old, which expands eligibility to some 20 million babies, toddlers, and preschoolers, CBS News June 17 reports. After convening on Saturday, June 18, the Centers for Disease Control and Prevention (CDC) also…
FDA: Class I recall of Woodside Acquisitions’ Oral Rapid and Joysbio SARS-CoV-2 Antigen Rapid Test Kits
Editor's Note The Food and Drug Administration (FDA) on June 9 updated the Class I recall by Woodside Acquisitions Inc of its Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) that are not authorized, cleared, or approved by the FDA. The FDA…
FDA: Class I recall of Medtronic HVAD Pump Implant Kit
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…
FDA: Class I recall of Philips Respironics V60, V60 Plus Ventilators
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…
FDA: Class I recall of Atrium Medical’s iCast Covered Stent
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…
FDA: Class I recall of Arjo Sara Plus lift
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.…
FDA: Class I recall of Abbott’s Dragonfly OpStar Imaging Catheter
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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