Reported Sep 14, 2022 · Ongoing
Various ob/gyn 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 ob/gyn packs
- Lot codes and dates
15 of 15 products
Products covered by this recall # Product as published 1 LSROBDELIVC, 2104091, 904211, 14531604 2 LSRVAGDELIVC, 2106011, 863211, 44252284 3 LSRVAGDELIVC, 2106011, 863211, 44135283 4 LSRCFHVAGDC, 2108042, 791211, 64123598 5 LSRCFHVAGDC, 2108042, 791211, 64123599 6 LSRCFHVAGDC, 2108042, 791211, 64123597 7 LSRVAGDELIVC, 2108181, 776211, 44139780 8 LSROBDELIVC, 2109231, 743211, 64319309 9 UPVD01G, 2109211, 741211, 15187693 10 MEVG08P, 2105132, 873211, 14874335-004 11 SLOB77F, 2108101, 779211, 15093748-004 12 MEVG08Q, 2108192, 770211, 15103947-004 13 BHVG89C, 2104291, 887211, 14962314-004 14 BHVG89C, 2106303, 827211, 14956518-004 15 AGOB35D, 2107221, 799211, 64183198-006 - Amount recalled
- 15 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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