Reported Apr 13, 2022 · Ongoing
Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system…
Maquet Medical Systems USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Medical Systems USA · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- 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 Number701072780 (Cardiohelp-i)
- Lot codes and dates
- 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
9041394590414225904142269041422790414228904142299041423290414233904142349041423590414236904142379041428390414284904142859041428690414287904142889041428990414292904142939041429490414295904142969041429790414309904143109041431190414312904143179041431890414319
- UDI04058863074863 (Cardiohelp-i)
- Amount recalled
- US: 32 units; OUS 30 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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