American Contract Systems recalls medical convenience kits that may have been re-gassed more than once during sterilization, risking product safety and effectiveness. Affected kits include specific item numbers and serial numbers.
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 convenience kits that were re-gassed (sterilized) more than once during manufacturing. This process hasn't been validated, so the kits' safety and effectiveness can't be confirmed. Using these kits could lead to potential harm during medical procedures.
The kits were re-gassed more than once during the sterilization process. This re-gassing wasn't validated, meaning the products' safety and effectiveness aren't guaranteed. Using these kits could lead to potential harm during medical procedures.
Healthcare providers and medical facilities using the recalled medical convenience kits are most at risk. Patients using these kits during procedures may face potential safety issues.
Check for specific item numbers: RCGY52D, UIGN82M, UIHY16AE, LMGY39U, OWGY11Q, FHGY09S. Look for bag serial numbers listed in the recall notice or lot numbers like 8532011, 8490211, etc.
Verify the item number and bag serial number against the list provided in the recall notice.
The kits were re-gassed more than once during sterilization, which hasn't been validated for safety and effectiveness.
The recall notice doesn't specify a remedy, so check the item numbers and serial numbers to see if your kit is affected.
The recall notice states that product safety and effectiveness can't be confirmed, which could lead to potential harm 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-0179-2026 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0179-2026 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.
