Cardiac Assist, Inc recalls TandemHeart pump is assembled into kits: TandemLung Kit - DL
Recalled Product
TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Hazard / Issue
Failure to prime due to an assembly error
Issued by
FDA
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