PLS set itself is delivered sterile and compliant, this issue relates to maintaining sterility after opening the pls set and removal of components (5) and (14) from the pls set tray for use in a later stage of extracorporeal circulation application. The packaging material of these two components may be inadequate to maintain the sterile barrier after removal from the primary sterile packaging (open tyvek on the tray) if not consumed immediately during the priming process. Recall start date: November 2, 2022
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