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…
FDA pulls OTC antibacterial soaps
Editor's Note The Food and Drug Administration (FDA) on September 2 issued a final rule saying that over-the-counter (OTC) antiseptic wash products containing active ingredients can no longer be marketed. The rule applies to products containing one or more of 19 ingredients, including the most commonly used triclosan and triclocarban.…
FDA issues Safety Alert for Baxter’s Vascu-Guard patch
Editor's Note The Food and Drug Administration (FDA) on September 1 issued a Safety Alert for Baxter International’s (Deerfield, Illinois) Vascu-Guard Peripheral Vascular Patch. The FDA has received multiple adverse event reports associated with use of the Vascu-Guard patch during carotid endarterectomy, including intraoperative or postoperative bleeding and hematomas as…
FDA advises testing of all donated blood, blood components for Zika
Editor's Note The Food and Drug Administration (FDA) on August 26 recommended testing of all donated blood and blood components for the Zika virus in the US and its territories. Because of much uncertainty about the nature and extent of Zika virus transmission, testing the entire blood supply will help…
FDA issues Safety Alert for programmable syringe pumps
Editor's Note The Food and Drug Administration (FDA) on August 25 issued a Safety Alert for practitioners using programmable syringe pumps to infuse medications and solutions at low rates (eg, less than 5 mL/hour, and especially at less than 0.5 mL/hour). The FDA has received more than 300 reports that…
FDA, device manufacturers make deal on user fees
Editor's Note The Food and Drug Administration and medical device manufacturers have made a deal on user fees companies pay to have the FDA review their products, the August 23 Mass Device reports. The Medical Device User Fee & Modernization Act IV will allow the FDA to collect nearly $1…
FDA expands indication for two transcatheter aortic valves
Editor's Note The Food and Drug Administration (FDA) on August 18 approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart valves for patients with aortic stenosis. The new indication is for patients who are at intermediate risk for death or complications associated with open-heart surgery. Previously,…
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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