Masimo Corp. (NDSQ:MASI) notched a win by reversing a voluntary recall of its noninvasive finger sensors while Teleflex Inc. (NYSE:TFX) subsidiary Arrow International continues to butt heads with the FDA.
Just months after Teleflex announced that Arrow had resolved all outstanding issues cited in a FDA Warning Letter regarding quality control issues, the watchdog agency has bumped up Arrow’s NextStep hemodialysis catheter recall to a Class I, a ranking reserved for products that could cause serious injury or death.
That Warning Letter was sent in October 2007, just weeks after Limerick, Pa.-based Teleflex, which ranked 39th on the MassDevice Big 100 list of the world’s largest medical device companies, completed its acquisition of Arrow, and took nearly four years to clear up.
The recent recall comes on concerns of breaking and separation of the stylet within the catheters, which are used for long-term access in adult patients needing hemodialysis or apheresis treatment.
The NextStep catheters were distributed in California, Delaware, Florida, Michigan, North Carolina and Tennessee, according to the FDA’s recall website.
Meanwhile Masimo, which ranked 86th on the MassDevice Big 100, reversed a voluntary recall on finger sensors used with its Pronto-7 handheld device, and announced that it will launch the product internationally.
The sensors had been recalled due to performance problems in low ambient temperatures, which the company has resolved. The device and its finger sensor are pending FDA 510(k) clearance, according to a press release.