FDA: Class I recall of Skintact DF29N Multi-function Defibrillation Electrodes
Editor's Note The Food and Drug Administration (FDA) on October 14 categorized the recall by Leonhard Lang of its Skintact DF29N Multi-function Defibrillation Electrodes as Class I, the most serious. The electrode is being recalled because of a connector compatibility issue with the Welch Allyn automatic external defibrillator (AED), model…
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…
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…
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 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…
FDA: Sagent Pharmaceuticals recalls one lot of Oxacillin for Injection
Editor's Note The Food and Drug Administration (FDA) on August 19 announced the recall by Sagent Pharmaceuticals, Inc (Schaumburg, Illinois), of one lot of Oxacillin for Injection, USP, 10 g (NDC 25021-163-99) Lot OXT512 (Exp Date March 2017). The recall was initiated because of a user complaint of a vial…
FDA issues safety alert on Custom Ultrasonics reprocessors
Editor's Note The Food and Drug Administration (FDA) on August 17 issued a Safety Alert on the System 83 Plus Automated Endoscope Reprocessors by Custom Ultrasonics (Warminster, Pennsylvania), recommending that healthcare facilities stop using them to reprocess duodenoscopes. The system may still be used for reprocessing endoscopes other than duodenoscopes.…
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