ALung Technologies Hemolung Respiratory Assist System (RAS) with CME BodyGuard 323 Infusion Pump(EUA) - Product Usage: an off-the-shelf infusion pump and administration set to provide a 30 mL/hr continuous saline flush to the integrated blood pump bearing.

CME America BodyGuard 323 Infusion Pumps (recalled by manufacturer) is a component to the Hemolung for EUA, and the infusion pump may have a delivery inaccuracy

ALung issued email notification "Recalled CME BodyGuard 323 Infusion Pump to Sapphire Pump Exchange" on 12/18/20 . Letter notifies users of the CME/Sapphire Infusion Pump exchange. Provided with this email are the instructions that will come with the infusion pump package. We wanted to give you a preview of what is coming prior to the packages arriving. Once received, we ask that you promptly remove the current CME pump, package and ship back to ALung. These are needed to be returned to the manufacturer by the end of the year. Reminder you may need to contact biomed for the electrical safety testing of the new Sapphire pump! Please follow your internal protocols.