INDIANA– Maquet Cardiovascular, LLC is recalling Atrium Express Dry Suction Dry Seal Chest Drain in direct response to Nurse Assist LLC’s, November 6, 2023, recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, over sterility concerns. When used without the provided syringe, the Express chest drains are safe to use.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.