Reported May 20, 2020 · Terminated
TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Usage: provides…
Cardiac Assist, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardiac Assist, Inc · 240 Alpha Dr · Pittsburgh, PA · 15238-2906
Is this the product you have?
- TandemHeart pump is assembled into kitsTandemHeart Kit - TS62/A15
- Product5710-6215 -
- Product Usageprovides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system
- Lot codes and dates
- Serial Numbers00142681 00142683 00142949 00142950 00142951
- Amount recalled
- 5
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
Failure to prime due to an assembly error
This product could cause temporary or reversible health problems — stop using it.
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