Reported Sep 14, 2022 · Ongoing
Various ENT Packs
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?
- Various ENT Packs
- Lot codes and dates
Tray NumberSterilization LotLot NumberBag Serial Number 1) LSRHPENTLHA210618183821114882942 2) MREN03G210426288721114934943 3) COEN27K210810277921115093749-004
- Amount recalled
- 3 units
This recall covers 17 products
The agency filed one notice per product. You are reading one of them; the other 16 are below.
4 more are in the archive.
Where it was sold
Why it was recalled
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
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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