Reported Sep 14, 2022 · Ongoing
Various Laparoscopy 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 Laparoscopy Packs
- Lot codes and dates
39 of 39 products
Products covered by this recall # Product as published 1 LSRENDOSCOPH, 2104281, 890211, 14887854 2 LSRENDOSCOPH, 2108251, 784211, 44375070 3 LSRENDOSCOPH, 2110011, 740211, 15140201 4 PLLA88I, 2104162, 895211, 14779054 5 AMGL09X, 2104281, 887211, 64029666 6 IHGB89AB, 2107293, 791211, 64104353 7 UIUA68AG, 2108202, 771211, 64233083 8 FRLC65S, 2104301, 882211, 44123696-005 9 MHLC19AH, 2105181, 863211, 63956744-006 10 CXRO12W, 2107082, 811211, 64110751-006 11 SLLP38F, 2107132, 807211, 64100877-006 12 SLLP38F, 2107132, 807211, 64100879-006 13 SLLP38F, 2107132, 807211, 64100878-006 14 CXLP87AJ, 2107162, 803211, 15011547-004 15 BHLC43J, 2108042, 784211, 44294507-005 16 BHLC43J, 2108042, 784211, 44234508-005 17 MERS50Q, 2108193, 769211, 64206337-006 18 BHRP78C, 2104131, 903211, 64073208-006 19 BHRP78C, 2104131, 903211, 64073209-006 20 BHRP78C, 2106221, 831211, 64091105-006 - Amount recalled
- 39 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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