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 C
Check against the official notice below — it lists the full affected range.
Maquet Medical Systems USA is recalling the Cardiohelp-i Transport Guard, a blood oxygenation and carbon dioxide removal system used in extracorporeal bypass procedures. The Transport Guard may have a loose cylindrical pin that could jam the locking mechanism, preventing the Guard from opening. Alternatively, if the pin becomes fully disengaged, the Transport Guard could completely disassemble, potentially delaying patient support if a product exchange becomes necessary. The recall affects 32 units distributed across the United States (in Florida, Kentucky, New Hampshire, New Jersey, New York, Pennsylvania, Texas, and Virginia) and 30 units distributed internationally in Belgium, Canada, Germany, Hungary, Luxembourg, Malaysia, Mexico, Poland, Slovakia, South Africa, South Korea, and Taiwan.
The affected products are identified by specific serial numbers on the Cardiohelp-i unit (Part Number 701072780), which include serial numbers 90413945 through 90414319 as listed in the recall notice. The recall record does not specify a remedy or recommended action for consumers who may have affected units.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 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. Quantity: US: 32 units; OUS 30 units Lot/code info: 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)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.