Reported Sep 14, 2022 · Ongoing
Various Angiography 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 packs/trays
- Lot codes and dates
57 of 57 products
Products covered by this recall # Product as published 1 LSRARTDATANGA,2105051, 884211, 44136929 2 LSRANGIRM21G,2105111, 874211, 63991913 3 LSRCFHANGD,2106031, 854211, 14887381 4 LSRARTDATANGA,2107102, 821211, 44256256 5 LSRARTDATANGA,2107102, 821211, 44256255 6 LSRARTDATANGA,2110011, 742211, 44373255 7 LSRARTDATANGA,2110011, 742211, 44373260 8 LMAN19U,2106292, 824211, 64169682 9 IHAN02S,2108111, 782211, 64190032 10 ANCA80AG,2109161, 743211, 64222813 11 SLPC34,2104022, 908211, 44127417-005 12 MHHY51F,2104151, 895211, 63978560-006 13 CXAN39N,2105072, 873211, 14875221-004 14 FHAG11X,2105072, 873211, 44111418-005 15 MHIR99AF,2105132, 868211, 63958625-006 16 BHAN91L,2105211, 860211, 44107976-005 17 ANCA80AG,2105212, 860211, 63956879-006 18 UDIN23AB,2105253, 855211, 63955146-006 19 SLPC34H,2106011, 853211, 44130251-005 20 SLPC34H,2106232, 827211, 43995487-005 - Amount recalled
- 57 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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