Reported May 20, 2020 · Terminated
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - 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 - DL3
- Product5720-3118 -
- 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
00142562001425630014256400142565001425660014256700142568001425830014258500142587001425880014258900142602001426030014260400142607001426100014261100142653001426550014268400142685001426860014268700142688001426890014269000142701001427020014270300142704001427050014270600142927001429280014295300142954001429550014295600142957001429580014295900142962001429640014296600142967
- Serial Numbers
- Amount recalled
- 46
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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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