Z-0897-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 13, 2022
- Initiation Date
- February 18, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 32 units; OUS 30 units
Product Description
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 for Recall
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.
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.
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)