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…
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…
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