Reported May 20, 2020 · Terminated
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary…
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 kitsProtekDuo Kit - DL29
- Product5720-2916 -
- 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 Numbers
0014256900142570001425710014257200142573001425740014257500142576001425920014259300142594001425950014259700142598001426000014260100142664001426650014266600142668001426690014267000142671001426720014267300142674001426920014269300142694001426960014269700142698001426990014292600142930001429330014293600142934
- Serial Numbers
- Amount recalled
- 38
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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