medical Class II Updated 2020-05-20

Cardiac Assist, Inc recalls TandemHeart pump is assembled into kits: ProtekDuo Kit - DL2

Recalled Product

TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - 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: 00142569 00142570 00142571 00142572 00142573 00142574 00142575 00142576 00142592 00142593 00142594 00142595 00142597 00142598 00142600 00142601 00142664 00142665 00142666 00142668 00142669 00142670 00142671 00142672 00142673 00142674 00142692 00142693 00142694 00142696 00142697 00142698 00142699 00142926 00142930 00142933 00142936 00142934
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