American Contract Systems recalls medical convenience kits that were re-gassed more than once during sterilization. Products may not be safe or effective due to unvalidated 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 convenience kits that were re-gassed (sterilized) more than once. This could mean the products are unsafe or ineffective because they weren't properly validated after multiple sterilization cycles.
These kits were sterilized more than once using ethylene oxide gas. The process wasn't validated to ensure safety after multiple cycles, so the products might not work or be safe for medical use.
Healthcare professionals and patients using these medical kits may be affected. Those with specific medical procedures requiring these kits are at higher risk.
Check for item numbers like HSLM53AB, MILM82A, or RCNA47B on the kit. Look for lot numbers 8192111, 8024911, or 8061111 and bag serial numbers listed in the recall notice.
Identify the item number, lot number, and bag serial number on the medical kit to confirm if it's affected.
These kits were re-gassed (sterilized) more than once during manufacturing, which wasn't validated for safety or effectiveness.
Check for item numbers like HSLM53AB, MILM82A, or RCNA47B with specific lot numbers and bag serial numbers listed in the recall notice.
The recall doesn't require immediate stop use; check product details to see if it's affected.
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-0183-2026 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0183-2026 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.
