FDAFDA · Food and drugs·Recall number Z-1950-2020
TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Published May 20, 2020 · Recall initiated: March 6, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failure to prime due to an assembly error
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardiac Assist, Inc
- Distributor
- US Nationwide distributions.
- Lot
- Serial Numbers: S/N 00142612 00142614 00142657 00142658 00142659 00142660 00142661 00142663 00142937 00142938 00142941 00142942 00142970 00142971 00142972
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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