Merit Medical Systems Inc. (NSDQ:MMSI) and American Regents Inc. both issued recalls.
Merit told its customers to immediately stop using one of the company’s vascular catheter sheaths.
The South Jordan, Utah-based company’s Prelude catheter introducer’s tip may detach during use, a failure that could allow the part to enter the bloodstream, according to the Food & Drug Administration.
The FDA issued a Class I recall for the device, meaning the federal agency believes there’s a possibility the device could cause serious injury or death.
Merit began the recall via its sales staff and distributors Dec. 17, 2010. The FDA posted the recall on its website Feb. 4. The recall refers specifically to the Prelude short sheath introducer, 7F-SMT, 4cm, reference number PSS-7F-4-038MT, Sterile EO, Merit, lot/serial number H179575. In total, 378 devices are affected by the action.
The watchdog agency also announced a recall of injections containing sodium thiosulfate and potassium phosphate manufactured by American Regent Inc. Sodium thiosulfate is used to treat cyanide poisoning; potassium phosphate is used in IV fluids to buck up potassium co0unts in patients who can’t drink or eat.
The FDA reported that some of vials contained translucent particulates consistent with glass delamination. If administered to patients, the injectables from the damaged vials could cause damage to blood vessels in the lung, according to the agency.
American Regent initiated a voluntary recall for the two lots of vials on Feb. 2 and Feb. 3; the FDA posted its announcement Feb. 5.
Specifically, the recall affects the company’s sodium thiosulfate injection vials, NDC # 0517-1019-05, lot# 0056 and potassium phosphates injection vials, NDC # 0517-2305-25, lot #0048.
