FDA: Class I recall of Haimen Shengbang Viral Transport Media Containers
Editor's Note The Food and Drug Administration (FDA) on August 9 identified the recall by Haimen Shengbang Laboratory Equipment Co Ltd of its Viral Transport Media Containers as Class I, the most serious. The recall was initiated because the products were distributed in the US without authorization, clearance, or approval…
FDA: Class I recall of North American Diagnostics’ COVID-19 test
Editor's Note The Food and Drug Administration (FDA) on August 1 identified the recall by North American Diagnostics of its Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits as Class I, the most serious. These tests are being recalled because they were distributed in the US without authorization, clearance, or approval…
FDA: Hospira recalls one lot of Propofol
Editor's Note The Food and Drug Administration (FDA), on July 13, posted a nationwide recall by Hospira Inc (a Pfizer Company) of one lot (DX9067) of Propofol Injectable Emulsion, USP (containing Benzyl alcohol), 100 mL single patient use glass fliptop vial. The recall was initiated because of visible particulate observed…
FDA: Class I recall of Covidien’s Palindrome, Mahurkar hemodialysis catheters
Editor's Note The Food and Drug Administration (FDA) on July 28 identified the recall by Covidien, LLC (Medtronic) of its Palindrome and Mahurkar hemodialysis catheters as Class I, the most serious. The recall was initiated because of a catheter hub defect that connects both extension catheters. There is a potential…
FDA adds AEDs, chest drains to device shortage list
Editor's Note The Food and Drug Administration (FDA) on July 19 added automated external defibrillators (AEDs) and chest drains/suction canisters and autotransfusion systems to its list of medical device shortages during COVID-19. The shortage of chest drains/suction canisters and autotransfusion systems is because of increased demand. The shortage of AEDs…
FDA: Class I recall of certain Smiths Medical Medfusion Syringe Infusion Pumps
Editor's Note The Food and Drug Administration on July 20 identified the recall by Smiths Medical of certain Medfusion 3500 and 4000 Syringe Infusion Pumps as Class I, the most serious. The recall was initiated because of eight software malfunctions that affect different serial numbers and software versions. There have…
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: 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…
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