American Contract Systems recalls Vaginal Delivery ASDV25B kits due to potential sterilization failure from humidity issues. Affected units have specific lot and expiration dates.
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 vaginal delivery kits because humidity problems may mean they weren't properly sterilized. This could lead to infection risks for patients during medical procedures.
The kits have a chart recorder that doesn't work properly, causing humidity readings to be inaccurate. This means the sterilization process might not have been completed correctly, potentially leading to infection risks.
Healthcare providers using the Vaginal Delivery ASDV25B kits with specific lot numbers and expiration dates are affected. Patients undergoing delivery procedures using these kits face the highest risk.
Check for the model name 'Vaginal Delivery ASDV25B' and lot number 2405102 with expiration date 05/10/2025. The product is sold under the manufacturer's name American Contract Systems.
Verify the lot number (2405102) and expiration date (05/10/2025) on the kit's label.
The recall is due to humidity readings being out-of-specification, which means sterilization assurance requirements may not have been met.
Check the lot number and expiration date; if it matches the recalled units, contact American Contract Systems for further instructions.
The recall indicates potential sterilization failure, which could lead to infection risks during medical procedures.
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-3238-2024 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-3238-2024 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.
