American Contract Systems recalls medical convenience kits that were re-gassed more than once during sterilization, risking product safety and effectiveness. Affected kits may not be safe for use.
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 could mean the kits are unsafe and might not work properly after repeated sterilization cycles.
The kits were sterilized more than once using ethylene oxide gas, which the manufacturer did not properly validate. This repeated sterilization could compromise the product's safety, quality, and effectiveness.
Healthcare professionals and patients using these medical convenience kits are affected. Those using kits with the specific item numbers and lots listed in the recall are most at risk.
Check for item numbers RCEN25B or RCHN27D with specific lot numbers and bag serial numbers listed in the recall notice. If the bag serial number is 'n/a', the entire lot is affected.
Identify the item number, lot number, and bag serial number to confirm if your kit is affected.
The kits were re-gassed (sterilized more than once) after a nonconformance occurred during the initial ethylene oxide gas injection process.
Check for item numbers RCEN25B or RCHN27D with specific lot numbers and bag serial numbers listed in the recall notice. If the bag serial number is 'n/a', the entire lot is affected.
The recall 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-0178-2026 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0178-2026 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.
