American Contract Systems recalls Endovascular AAA Pack ESED52B due to humidity readings out of spec, risking unconfirmed sterilization. Affected units have UDI-DI 00191072218339 and lot 2405153.
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 products were properly sterilized, which is critical for medical safety.
The device's chart recorder malfunctioned, causing humidity readings to be out of specification in a specific area. This prevents American Contract Systems from verifying that the product was sterilized correctly, which is essential for medical safety.
Medical professionals using the Endovascular AAA Pack ESED52B for procedures are likely affected. Those handling the product in controlled environments where humidity matters are at higher risk.
Check for the model ESED52B on the Endovascular AAA Pack. Affected units have UDI-DI number 00191072218339 and lot number 2405153.
Look for the model ESED52B, UDI-DI 00191072218339, and lot number 2405153 on the device.
The device's chart recorder malfunctioned, causing humidity readings to be out of specification in one area. This prevents American Contract Systems from confirming the product was properly sterilized.
The recall record does not specify a remedy, so no action is required beyond checking product details.
The manufacturer cannot confirm sterilization was met due to the humidity issue, so it may not be safe for medical use.
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-3227-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-3227-2024 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.
