Reported Sep 14, 2022 · Ongoing
Various Cysto 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 Cysto Packs
- Lot codes and dates
21 of 21 products
Products covered by this recall # Product as published 1 LSRCFHCYTURC, 2105051, 883211, 15142078 2 LSRCFHCYTURC, 2106092, 853211, 44251068 3 LSRCYSTOTURF, 2106181, 834211, 44251068 4 LSRCYSTOTURF, 2108251, 775211, 44376072 5 JECY99B, 2105182, 862211, 44108484-005 6 BHCY71H, 2107011, 819211, 44247051-005 7 SLCY61, 2108111, 777211, 15093750-004 8 BHCY31D, 2107161, 810211, 44228702-005 9 BHCY31D, 2107161, 810211, 44228704-005 10 BHCY31D, 2107161, 810211, 44228703-005 11 BHCY31D, 2109032, 763211, 44333133-005 12 BHCY31D, 2109032, 763211, 44333132-005 13 BHCY31D, 2109032, 763211, 44333131-005 14 BHCY31D, 2109032, 763211, 44333300-005 15 BHCY31D, 2109032, 763211, 44333398-005 16 BHCY31D, 2110051, 726211, 44351428-005 17 BHCY31D, 2110051, 726211, 44351427-005 18 BHCY31D, 2110051, 726211, 44351426-005 19 BHCY31D, 2110051, 726211, 44351425-005 20 UTCY45M, 2104231, 890211, 44175283-005 - Amount recalled
- 21 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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