American Contract Systems recalls IHDC30R medical convenience kits that were 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) after a problem occurred during initial sterilization. This could mean the kits aren't safe or effective for medical use.
The kits were re-gassed more than once during sterilization. This process wasn't properly validated, so the kits might not be safe or effective for medical use.
Healthcare workers using these medical convenience kits are most at risk. The recall affects kits sold with specific lot numbers and serial numbers.
Check for the model IHDC30R D AND C PACK. The affected kits have lot number 8096511 and a bag serial number listed as 'N/A'.
Look for the lot number 8096511 and bag serial number 'N/A' on the kit packaging.
The kits were re-gassed more than once during sterilization, which wasn't properly validated, risking safety and effectiveness.
Check for lot number 8096511 and a bag serial number listed as 'N/A' on the kit packaging.
The official recall notice doesn't specify a remedy, so contact American Contract Systems for guidance.
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-0187-2026 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0187-2026 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.
