Cardiac Assist, Inc recalls TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3
Recalled Product
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - 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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