Reported Sep 14, 2022 · Ongoing
Various hysterectomy, vaginal 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 hysterectomy, vaginal packs
- Lot codes and dates
29 of 29 products
Products covered by this recall # Product as published 1 LSRGYOSCOPYG, 2104281, 888211, 63995389 2 LSRLMGLAPF, 2105282, 856211, 44252282 3 LSRHPGYND, 2106092, 847211, 14887375 4 LSRHPGYND, 2106092, 847211, 14887374 5 LSRHPGYND, 2106092, 847211, 14887373 6 AMJL22Z, 2106112, 840211, 64176443 7 FDMN88N, 2107013, 821211, 64168939 8 MMJL16C, 2108023, 791211, 44180974 9 UIGY37AA, 2108033, 789211, 64104498 10 FHGG12V, 2109131, 748211, 64223133 11 BHOB33G, 2104191, 894211, 14870011-004 12 AHHY33M, 2105131, 867211, 14874336-004 13 MEHY02M, 2106152, 834211, 15003746-004 14 MEHY02M, 2106152, 834211, 15003740-004 15 MEHY02M, 2106152, 834211, 15003713-004 16 MEHY02M, 2106152, 834211, 15003709-004 17 MEHY02M, 2106152, 834211, 15003704-004 18 MEHY02M, 2106152, 834211, 15001377-004 19 MEHY02M, 2106152, 834211, 15003712-004 20 CXVG89X, 2106171, 833211, 43996010-005 - Amount recalled
- 29 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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