American Contract Systems recalls IR Procedure Pack CEAT19W due to humidity readings out of spec, risking unconfirmed sterilization. Affected units sold from 2024-05-10.
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 its IR Procedure Pack (CEAT19W) because humidity readings in one area were out of specification. This means they can't confirm the product meets sterilization requirements, which is critical for medical use.
The chart recorder in the kit malfunctioned, causing humidity readings to be outside acceptable limits. This makes it impossible for the manufacturer to verify that the product is properly sterilized, which is essential for medical safety.
Healthcare facilities using this medical convenience kit are likely affected. Medical staff handling the kit are at risk if sterilization isn't confirmed.
Check for the model CEAT19W on the kit. Units with lot number 2405102 and expiration date 05/10/2024 are affected.
Verify the model number CEAT19W, lot number 2405102, and expiration date 05/10/2024.
The manufacturer cannot confirm sterilization due to humidity issues, so it may not be safe for medical use.
Look for model CEAT19W, lot number 2405102, and expiration date 05/10/2024.
The recall record does not specify a remedy, so contact the manufacturer for guidance.
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-3235-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-3235-2024 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.
