Reported May 18, 2022 · Ongoing
ACS Cath Lab Pack
American Contract Systems, 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: American Contract Systems, Inc. · 2610 Ne Industrial Dr Ste 220 · Kansas City, MO · 64117-2648
Is this the product you have?
- ACS Cath Lab Pack
- Lot codes and dates
- Model FTCL83K
- Lot 982221 UDI00191072151360
- Amount recalled
- 10 packs
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Product was sterilized with a higher than specification EO concentration.
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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