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
1LSRARTDATANGA,2105051, 884211, 44136929
2LSRANGIRM21G,2105111, 874211, 63991913
3LSRCFHANGD,2106031, 854211, 14887381
4LSRARTDATANGA,2107102, 821211, 44256256
5LSRARTDATANGA,2107102, 821211, 44256255
6LSRARTDATANGA,2110011, 742211, 44373255
7LSRARTDATANGA,2110011, 742211, 44373260
8LMAN19U,2106292, 824211, 64169682
9IHAN02S,2108111, 782211, 64190032
10ANCA80AG,2109161, 743211, 64222813
11SLPC34,2104022, 908211, 44127417-005
12MHHY51F,2104151, 895211, 63978560-006
13CXAN39N,2105072, 873211, 14875221-004
14FHAG11X,2105072, 873211, 44111418-005
15MHIR99AF,2105132, 868211, 63958625-006
16BHAN91L,2105211, 860211, 44107976-005
17ANCA80AG,2105212, 860211, 63956879-006
18UDIN23AB,2105253, 855211, 63955146-006
19SLPC34H,2106011, 853211, 44130251-005
20SLPC34H,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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:52 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.