Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product Code/REF Number: 701072780 (Cardiohelp-i)

Reason: Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mechanism causing the Transport Guard to not open or, if the locking pin is fully disengaged from the assembly, a full disassembly of the Transport Guard may occur, resulting in a delay of support if a product exchange is necessary.

Code information: Serial Numbers for the Cardiohelp-i (Part Number 701072780)as the Transport Guard (701072525) is packaged with the Cardiohelp-i and is not labelled individually Serial Numbers: 90413945, 90414225, 90414226, 90414227, 90414228, 90414229, 90414232, 90414233, 90414234, 90414235, 90414236, 90414237, 90414283, 90414284, 90414285, 90414286, 90414287, 90414288, 90414289, 90414292, 90414293, 90414294, 90414295, 90414296, 90414297, 90414309, 90414310, 90414311, 90414312, 90414317, 90414318, 90414319. UDI: 04058863074863 (Cardiohelp-i)

Distribution pattern: US Nationwide Distribution: FL, KY, NH, NJ, NY, PA, TX, VA Foreign: Belgium, Canada, Germany, Hungary, Luxemburg, Malaysia, Mexico, Poland, Slovakia, South Africa, South Korea, and Taiwan.