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 Medtronic Cobalt/Crome ICDs, CRT-Ds
Editor's Note The Food and Drug Administration (FDA) on August 19 identified the recall by Medtronic of its Cobalt XT, Cobalt, and Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) as Class I, the most serious. The devices are being recalled because of reports of short circuit-protection…
ISMP publishes new perioperative medication safety guidelines
Editor's Note The Institute for Safe Medication Practices (ISMP) on August 11 announced the publication of its first set of safe practice guidelines to support perioperative medication safety in hospitals, ambulatory surgery centers, and other procedural locations. The new guidelines: Address best practices related to labeling and storage of perioperative…
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…
Move to stretch monkeypox vaccine supply via smaller doses
Editor's Note On Tuesday, August 9, US officials announced they will modify dosing instructions for the Jynneos monkeypox vaccine to stretch the supply, US News & World Report July 10 reports. Currently, there are almost 9,500 known cases in the US, predominantly among gay and bisexual men. According to the…
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…
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