ACS Cath Lab Pack Recall: Higher EO Sterilization 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 Cath Lab Pack model FTCL83K with lot 982:221 due to potential equipment failure from higher than specified EO sterilization concentration. This could lead to malfunction during medical procedures.

Why it’s dangerous

The catheter lab pack was sterilized with a higher than specified concentration of ethylene oxide (EO). This could cause the equipment to malfunction during medical procedures, potentially leading to equipment failure.

Who’s affected

Medical facilities using ACS Cath Lab Pack model FTCL83K with lot 982221 are affected. Staff handling the equipment are at risk if it malfunctions during procedures.

How to tell if you have this one

Check for model FTCL83K and lot number 982221 on the catheter lab pack. The unique device identifier (UDI) is 00191072151360.

Brand
American Contract Systems
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify model FTCL83K and lot number 982221 on the catheter lab pack.

✎ GovInfoNow

Questions people ask

What is the specific model and lot number of the recalled product?

The recalled product is ACS Cath Lab Pack model FTCL83K with lot number 982221.

Is there a remedy for this recall?

The recall record does not specify a remedy.

What could happen if the product is used?

The product may malfunction during medical procedures due to higher than specified EO sterilization concentration.

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-1040-2022 — American Contract Systems American Contract Systems

Hello,

I own a American Contract Systems that is covered by recall Z-1040-2022 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-1040-2022 (March 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1040-2022 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 Cath Lab Pack

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