American Contract Systems recalls Cath Lab Pack CECL02P due to humidity readings out of spec, risking unconfirmed sterilization. Affected units sold from 2024-05-10 to 2025-05-10.
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
American Contract Systems is recalling a medical convenience kit called Cath Lab Pack CECL02P because humidity readings in one area were out of specification. This means they can't confirm the kit was properly sterilized, which could lead to infection risks during medical procedures.
The kit's humidity readings were out of specification in one controlled environment area. This prevents American Contract Systems from confirming that the product met sterilization requirements, which is critical for medical safety.
Healthcare facilities using this medical convenience kit are most at risk, particularly those in controlled environments where humidity levels must be precise. Patients and staff could face infection risks if the kit wasn't properly sterilized.
Check for the model CECL02P on the kit. Units were manufactured with lot number 2405102 and expire May 10, 2025. This kit was sold from May 10, 2024, to May 10, 2025.
Look for the model CECL02P, lot number 2405102, and expiration date of May 10, 2025 on the kit.
The manufacturer cannot confirm sterilization was achieved due to humidity issues, so it may not be safe for medical use.
The recall record does not specify a remedy, so no action is required beyond checking if you have the affected model.
Check for model CECL02P, lot number 2405102, and expiration date of May 10, 2025 on the kit.
We’ve drafted a message you can send American Contract Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-3239-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-3239-2024 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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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.
