Reported Sep 14, 2022 · Ongoing

Various C-section 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 C-section packs
Lot codes and dates

24 of 24 products

Products covered by this recall
#Product as published
1LSRHPCSECTB, 2106301, 826211, 64124711
2FHCP08U, 2107143, 807211, 64166455
3LMSE38N, 2108202, 770211, 64231900
4CFCS39G, 2108243, 768211, 64232041
5IHCS29AA, 2109272, 733211, 64214921
6CXCS92U, 2106191, 830211, 64071586-006
7BHCS88D, 2104163, 897211, 64072275-006
8BHCS88D, 2104163, 897211, 64072274-006
9BHCS88D, 2104163, 897211, 64072275-006
10BHCS88D, 2105151, 869211, 64067191-006
11BHCS88D, 2106091, 848211, 64045555-006
12BHCS88D, 2106232, 835211, 64091025-006
13BHCS88D, 2106232, 835211, 64091024-006
14BHCS88D, 2107061, 835211, 64090343-006
15BHCS88D, 2107132, 811211, 64089826-006
16BHCS88D, 2107132, 811211, 64089827-006
17BHCS88D, 2107132, 811211, 64089828-006
18BHCS88D, 2107161, 806211, 64088821-006
19BHCS88D, 2107161, 806211, 64088822-006
20BHCS88D, 2108171, 777211, 64092742-006
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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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:55 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.