Reported Sep 14, 2022 · Ongoing
Various Angiography/Cath Lab packs/trays
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 Angiography/Cath Lab packs/trays
- Lot codes and dates
61 of 61 products
Products covered by this recall # Product as published 1 LSRCUSTCATHG,2104091, 911211, 44064504 2 LSRCARDCATHG,2105191, 874211, 14884701 3 LSRCARDCATHG,2106031, 861211, 14887382 4 LSRCFHCATHD,2106151, 839211, 14887387 5 LSRCARDCATHG,2106172, 842211, 14882944 6 LSRCARDCATHG,2106172, 842211, 14887386 7 LSRCUSTCATHG,2106181, 840211, 44251069 8 LSRCFHCATHD,2107102, 810211, 15020227 9 LSRCFHCATHD,2107102, 810211, 15020826 10 LSRCFHCATHD,2107262, 807211, 15020266 11 LSRSPECPROCF,2107262, 803211, 64117654 12 LSRCARDCATHG,2108171, 783211, 44139783 13 LSRCFHCATHD,2109071, 765211, 44376128 14 LSRCFHCATHD,2109071, 765211, 44376127 15 LSRCFHCATHD,2109071, 765211, 44376129 16 LSRCFHCATHD,2109071, 765211, 44376130 17 LSRCUSTCATHG,2109201, 754211, 44373704 18 LSRCFHCATHD,2109271, 740211, 15142078 19 MMCC14D,2104143, 898211, 64033893 20 IHCC03R,2107061, 819211, 44183402 - Amount recalled
- 61 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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