ACS Lap Chole Pack Recall: Higher EO Concentration Risk

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Recalling firmAmerican Contract Systems, Inc.2610 Ne Industrial Dr Ste 220, N/A · Kansas City, MO 64117-2648

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✎ GovInfoNow plain-language explainer

What happened, in plain English

American Contract Systems is recalling ACS Lap Chole Packs that may have been sterilized with a higher than specified EO concentration. This could pose a risk to users if the product is not properly handled after sterilization.

Why it’s dangerous

The product was sterilized using a higher concentration of ethylene oxide (EO) than specified. This could lead to improper sterilization if the product is not handled correctly after the process, potentially causing contamination or other issues.

Who’s affected

Users of ACS Lap Chole Packs with Model BLLC42M and Lot 643211 are affected. Those handling the product without proper sterilization procedures may be at higher risk.

How to tell if you have this one

Check for Model BLLC42M and Lot 643211 on the product. The product may have a Unique Device Identifier (UDI) of 00191072152473.

Brand
American Contract Systems
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the model (BLLC42M) and lot number (643211) to confirm if your product is affected.

✎ GovInfoNow

Questions people ask

What is the specific hazard with this product?

The product may have been sterilized with a higher than specified concentration of ethylene oxide (EO).

How can I tell if my product is affected?

Check for Model BLLC42M and Lot 643211 on the product. The product may have a Unique Device Identifier (UDI) of 00191072152473.

What should I do if I have this product?

The recall record does not specify a remedy, so no action is required beyond checking if your product matches the affected model and lot numbers.

Take action

Contact American Contract Systems

We’ve drafted a message you can send American Contract Systems to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1039-2022 — American Contract Systems American Contract Systems

Hello,

I own a American Contract Systems that is covered by recall Z-1039-2022 from American Contract Systems.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1039-2022 (March 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1039-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

American Contract Systems, Inc. recalls ACS Lap Chole Pack

Recall notice