Cardiac Assist, Inc recalls TandemHeart pump is assembled into kits: TandemLife Kit Pr
Recalled Product
TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - 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
Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: 00142463 00142464 00142465 00142469 00142470 00142471 00142472 00142478 00142479 00142480 00142481 00142482 00142483
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