FDA: Class I recall of Hamilton-C6 Intensive Care Ventilator
Editor's Note The Food and Drug Administration (FDA) on August 29 identified the recall by Hamilton Medical AG of its Hamilton-C6 Intensive Care Ventilator as Class I, the most serious. The recall was initiated because of potential water ingress between the indicator board and the ventilator’s main board that may…
FDA: Class I recall of Intera 3000 Hepatic Artery Infusion Pump
Editor's Note The Food and Drug Administration on August 29 identified the recall by Intera Oncology of its Intera 3000 Hepatic Artery Infusion Pump as Class I, the most serious. The company is recalling the pumps after receiving reports from clinicians that the pumps were delivering medication faster than expected.…
FDA: Class I recall of Medtronic’s HeartWare HVAD system batteries
Editor's Note The Food and Drug Administration on August 25 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) system batteries as Class I, the most serious. Medtronic is recalling the batteries because they may experience electrical faults that cause them to unexpectedly fail. A similar recall…
FDA: Hospira recalls another lot of Propofol
Editor's Note The Food and Drug Administration (FDA) on August 22 posted the Hospira Inc (a Pfizer company) recall of one lot of Propofol Injectable Emulsion (containing Benzyl alcohol), 100 mL single patient use glass fliptop vials, lot EA7470. The recall was initiated because of visible particulates observed in two…
FDA: Class I recall of BD Intraosseous Infusion System
Editor's Note The Food and Drug Administration (FDA) on August 11 classified the recall by Becton Dickinson (BD) of its Intraosseous Infusion System, which includes Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, and Intraosseous Powered Drivers, as Class I, the most serious. The recall was initiated for three separate…
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…
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