American Contract Systems recalls Bilateral Tubal Ligation Pack FHBT3T due to potential failure in sterilization assurance. Affected units have UDI-DI 00191072178107 and lot 2405102.
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 specific medical device because they can't confirm it was properly sterilized. This could mean the device might not be safe for use in procedures.
The device's chart recorder malfunctioned, causing humidity readings to be inaccurate. This led to uncertainty about whether the device met sterilization standards, which is critical for medical safety.
Patients who received this specific Bilateral Tubal Ligation Pack model for medical procedures are affected. Healthcare providers using this device for sterilization checks are at higher risk.
Check for the model number FHBT3T on the device. Affected units have UDI-DI 00191072178107 and lot number 2405102. The expiration date is May 10, 2025.
Look for the model number FHBT3T, UDI-DI 00191072178107, and lot number 2405102 on the device.
American Contract Systems identified that the chart recorder malfunctioned, causing humidity readings to be out-of-specification in one controlled environment. This means they can't confirm the device was properly sterilized.
The recall record does not specify a remedy. You should check the device details to see if it matches the affected model and lot numbers.
The recall record does not mention a deadline for action.
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-3233-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-3233-2024 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.
