FDA: Class I recall of American Contract Systems' COVID Test Kit Nonsterile, Clean Catch Urine Kit
Editor's Note The Food and Drug Administration (FDA) on July 14 identified the recall of American Contract Systems’ COVID Test Kit Nonsterile and Clean Catch Urine Kit as Class I, the most serious. The recall was initiated because the Kits were assembled in an uncontrolled facility by people without proper…
FDA: Class I recall of Getinge Flow-c, Flow-e Anesthesia Systems
Editor's Note The Food and Drug Administration (FDA) on July 6 identified the recall by Getinge USA Sales Inc of its Flow-c and Flow-e Anesthesia Systems as Class I, the most serious. The recall was initiated after reports of cracked or broken on/off switchs on the systems’ suction units. If…
FDA allows for pharmacists to prescribe Paxlovid to treat COVID-19
Editor's Note The US Food and Drug Administration (FDA) announced on July 6 that it would alter its emergency use authorization for the Paxlovid pill—Pfizer’s oral antiviral pill used by some to treat COVID-19—to allow pharmacists to prescribe the treatment to recently affected individuals directly. According to Fierce Pharma July…
FDA: Class I recall of GE Healthcare’s CARESCAPE R860 Ventilator
Editor's Note The Food and Drug Administration (FDA) on June 28 identified the recall by GE Healthcare of its CARESCAPE R860 Ventilator as Class I, the most serious. The recall was initiated because the ventilator backup batteries, including replacement backup batteries, may run out before they are expected to do…
FDA: Class I recall of Baxter’s Volara system with in-line ventilator adaptor
Editor's Note The Food and Drug Administration (FDA) on June 23 identified the recall by Baxter Healthcare Corporation of its Volara system with in-line ventilator adaptor as Class I, the most serious. The Volara system is used to clear mucus out of airways, expand lungs, and treat or prevent pulmonary…
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…
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