American Contract Systems recalls Endovascular AAA Pack ESED52B due to humidity readings out of spec, risking unconfirmed sterilization. Affected units have specific lot/expiry details.
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 Endovascular AAA Packs with model ESED52B because humidity readings in one area were out of specification. This means they can't confirm the packs were properly sterilized, which is critical for medical safety.
The device's chart recorder malfunctioned, causing humidity readings to be outside acceptable limits in a controlled environment. This prevents American Contract Systems from verifying that the packs were properly sterilized, which is essential for medical safety.
Healthcare facilities using the Endovascular AAA Pack ESED52B model with lot number 2405152 and expiration date 05/15/2025 are affected. Medical staff handling these packs face the highest risk due to potential sterilization issues.
Check for the model ESED52B, lot number 2405152, and expiration date 05/15/2025 on the medical convenience kit. The recall applies to specific units sold with these identifiers.
Identify the model ESED52B, lot number 2405152, and expiration date 05/15/2025 to confirm if your unit is affected.
American Contract Systems identified that humidity readings were out of specification in one controlled environment area due to an inoperable chart recorder, preventing confirmation of proper sterilization.
The recall record does not specify a remedy, so affected users should check product details to confirm if they have the recalled model and lot numbers.
The recall indicates potential sterilization issues, but no specific injury mechanism is described. The hazard level is low risk as the problem does not involve immediate danger like fire or injury.
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-3228-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-3228-2024 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.
