FDA, CDC issue alerts on Stӧckert 3T Heater-Cooler System
Editor's Note The Food and Drug Administration (FDA) on October 13 updated its Safety Alert on the Stӧckert 3T Heater-Cooler System by LivaNova to provide new information from the Centers for Disease Control and Prevention (CDC) about Mycobacterium chimaera infections associated with the use of the system in US patients…
Action steps for safe use of reprocessed single-use medical devices
In the United States and globally, the use of reprocessed medical devices labeled and marketed by their original equipment manufacturers as “for single use only” has become commonplace. Large health systems have saved many millions of dollars annually and diverted many hundreds of tons of medical waste by using reprocessed…
FDA issues Safety Alert for St Jude defibrillators
Editor's Note The Food and Drug Administration on October 11 issued a Safety Alert for implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) by St Jude Medical (Little Canada, Minnesota). In some cases, full battery drainage can occur in a day to a few weeks after the patient…
FDA: Nurse Assist recalls IV Flush Syringes
Editor's Note The Food and Drug Administration (FDA) on October 5 announced the recall by Nurse Assist of its IV Flush Syringes because of a potential link to Burkholderia cepacia bloodstream infections. The syringes are being recalled until a thorough investigation can be completed by the FDA, Centers for Disease…
FDA: Vascular Solutions recalls Twin-Pass Dual Access Catheters
Editor's Note The Food and Drug Administration on October 5 announced the recall by Vascular Solutions, Inc, (Minneapolis, Minnesota) of its Twin-Pass Dual Access Catheters used in catheterization procedures. The catheters have been recalled because of the potential for excess manufacturing material to remain at the tip of the catheter…
FDA: Recall of Baxter 50 mm 0.2 micron filters
Editor's Note The Food and Drug Administration on October 3 announced the recall by Baxter International (Deerfield, Illinois) of its 50 mm 0.2 micron filters because of the potential for a missing filter support membrane and for potential presence of particulate matter. The filter is a bacteria and particulate filter…
Joint Commission: NAN alert on medication leaking from BD syringes
Editor's Note The Joint Commission on September 28 reported on an alert the National Alert Network (NAN) issued on medications leaking from Becton-Dickinson (BD) syringes (predominantly 10 mL). Leaks have extended past the first and second rib of the stopper, and appear to occur as medication is drawn into the…
FDA: Class I recall of DePuy Synthes power tool system battery adaptors
Editor's Note The Food and Drug Administration (FDA) on September 28 identified the recall by DePuy Synthes (a Johnson & Johnson company) of its Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II as Class I, the most serious. The recall is due to the potential…
FDA extends UDI compliance date for certain Class II devices
Editor's Note In a September 6 letter to device labelers, the Food and Drug Administration (FDA) said it is extending unique device identifier (UDI) requirements for certain Class II devices from September 24, 2016 to September 24, 2018. The extension applies to repackaged single-use devices and device convenience kits. The…
FDA classifies recall of Roadrunner UniGlide Hydrophilic Wire Guides as Class I
Editor's Note The Food and Drug Administration (FDA) on September 6 classified the recall of the Roadrunner UniGlide Hydrophilic Wire Guides by Cook Medical (Bloomington, Indiana) as Class I, the most serious. All serial and lot numbers are being recalled, and the product line is being discontinued because of concern…
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