ACS IR - Angio 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 IR Angio Pack devices with model JEIR37H and lot 657: they were sterilized using a higher than specified EO concentration. This could pose safety risks during use.

Why it’s dangerous

The product was sterilized with a higher than specified EO concentration. This could lead to potential safety issues during use, though the exact risk is not clearly described in the recall.

Who’s affected

Users of ACS IR Angio Pack devices with model JEIR37H and lot 657211 are affected. Medical professionals using these devices are most at risk.

How to tell if you have this one

Check for model JEIR37H and lot number 657211 on the device. The unique device identifier (UDI) is 00191072151612.

Brand
American Contract Systems
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Identify the model number (JEIR37H) and lot number (657211) on the device.

✎ GovInfoNow

Questions people ask

What is the specific hazard with this product?

The product was sterilized with a higher than specified EO concentration, which could pose safety risks during use.

How can I tell if my device is affected?

Check for model JEIR37H and lot number 657211 on the device. The unique device identifier (UDI) is 00191072151612.

What should I do if I have this device?

The recall does not specify a remedy, so check with American Contract Systems for further instructions.

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-1038-2022 — American Contract Systems American Contract Systems

Hello,

I own a American Contract Systems that is covered by recall Z-1038-2022 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-1038-2022 (March 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1038-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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 IR - Angio Pack

Recall notice