Welcome to Recall Roundup, where we’ll keep you updated on medical device recalls and corrections that the FDA reported over the last month. Recalls and corrections range from the least dangerous, Class III—which means a product violates FDA law but is “not likely” to be a health hazard—to the most serious in Class I, which means the product poses a high risk of serious injury or death. The agency posts a list of Class I recalls on its website after the manufacturer takes action. During November, the FDA posted nine Class 1 medical device recalls on its page, including the following. Anesthesia machine correction. The FDA warned on November 19 that Atlan A350 and Atlan 350XL anesthesia workstations, made by Draeger, have a manufacturing error that could cause mechanical ventilation to fail while they’re in use. Draeger told providers on October 15 to supervise these machines and ventilate patients manually if the machine fails. The company’s October notice said a representative would be in touch with providers for ventilator motor assembly replacement. Battery pack correction. The FDA reported November 19 that Smiths Medical CADD-Solis rechargeable battery packs can short and melt the pack casing, leaving the battery unchargeable. Smiths Medical urged users on July 16 to check their battery packs—a backup power source for the CADD-Solis ambulatory infusion pump—and report any damage. Keep reading here.—CC |