FDAFDA · Food and drugs·Recall number Z-1954-2020
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.
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: 00142473 00142606
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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