Reported Sep 14, 2022 · Ongoing
Various Pacemaker Packs, Cardio Thoracic 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 Pacemaker Packs, Cardio Thoracic Packs
- Lot codes and dates
24 of 24 products
Products covered by this recall # Product as published 1 LSREPCUSTOML, 2106181, 835211, 44251067 2 LSRCVBASING, 2107102, 817211, 64116041 3 LSRSMVEINB, 2107221, 810211, 64119459 4 LSRCFHENDAE, 2107171, 807211, 64116602 5 UICT16E, 2108183, 771211, 15066268 6 BHOH94I, 2104141, 897211, 63987116-006 7 BHOH95, 2104301, 902211, 44123693-005 8 ANCV60AI, 2105201, 860211, 63956881-006 9 UDIP97AD, 2105201, 860211, 14858003-004 10 CEFS17I, 2105262, 855211, 44132805-005 11 FHPM10P, 2106092, 840211, 44129541-005 12 SLCV01E, 2107081, 812211, 64110741-006 13 SLEP03F, 2108271, 761211, 44314505-005 14 SLEP03F, 2108271, 761211, 44314504-005 15 CXCV91X, 2108311, 757211, 44315778-005 16 MECV98V, 2108312, 757211, 44313827-005 17 SAPA90X, 2108311, 758211, 64204754-006 18 SLCV01E, 2109161, 742211, 64208360-006 19 MEEP10F, 2109202, 740211, 64220361-006 20 UMOH42C, 2105072, 876211, 64061399-006 - Amount recalled
- 24 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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