American Contract Systems recalls medical convenience kits that may have been re-gassed more than once during sterilization, risking product safety and effectiveness.
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. This could mean the products are unsafe and might not work properly.
The kits were re-gassed after a problem occurred during the first sterilization process. This means they may not be safe or effective because they were exposed to multiple sterilization cycles without proper validation.
Healthcare professionals using these medical kits are likely affected. Those who have the specific kit models listed in the recall are at risk.
Check for the item numbers: HSAN63N, IHAN02W, MHCA98AK, RCAN45C, or UDCO10F. Look for the lot numbers and bag serial numbers listed in the recall notice.
Identify the item number and lot number from the recall list to confirm if your kit is affected.
The kits were re-gassed more than once during sterilization, which may affect their safety and effectiveness.
Check the item number (HSAN63N, IHAN02W, MHCA98AK, RCAN45C, or UDCO10F) and lot number against the list provided in the recall notice.
The recall notice does not specify a remedy, so contact American Contract Systems 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-0180-2026 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0180-2026 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.
