American Contract Systems recalls medical delivery kits that were re-gassed after initial sterilization, risking product safety and effectiveness. Affected kits may not be safe for use due to multiple sterilization cycles.
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
American Contract Systems is recalling medical delivery kits that were re-gassed (sterilized more than once) after a problem occurred during the first sterilization process. This could mean the kits are unsafe for use because they haven't been properly validated after multiple sterilization cycles.
The kits were re-gassed after an initial sterilization issue, meaning they underwent multiple sterilization cycles without proper validation. This could compromise the product's safety, effectiveness, and quality, potentially leading to unsafe medical procedures.
Healthcare providers using these kits during labor and delivery are most at risk. The recall affects specific medical delivery kits sold to hospitals and clinics.
Check for item numbers AHLD15X, AKDV96B, EVBH28D, or UPVD01K on the kits. The kits were sold with specific lot numbers and bag serial numbers listed in the recall notice.
Identify the item number and lot number on the kit to confirm if it's affected.
The kits were re-gassed after a problem occurred during the initial sterilization process, which means they were sterilized more than once without proper validation.
No, the kits have not been validated for exposure to multiple sterilization cycles, so their safety and effectiveness cannot be confirmed.
The recall notice does not specify a remedy, so you should check the product details to see if it's affected and contact the manufacturer for further instructions.
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-0173-2026 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0173-2026 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.
