American Contract Systems recalls medical convenience kits that may have been re-gassed more than once during sterilization, risking product safety and effectiveness. Consumers should check item numbers and lot numbers for affected kits.
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 more than once during sterilization. This could mean the kits are unsafe or ineffective, especially for patients needing eye surgery.
The kits were re-gassed (sterilized) more than once after a problem occurred during the initial sterilization process. This means the products haven't been tested to ensure they're safe or effective after multiple sterilization cycles.
Patients using these kits for cataract or eye surgery procedures are most at risk. Healthcare providers who use the kits for medical procedures may also be affected.
Check for item numbers BFCT04X, CMEY17AI, PERP25AQ, or RFEY50AC with specific lot numbers and bag serial numbers listed in the recall notice. If a bag serial number is marked 'N/A', the entire lot is affected.
Identify the item number and lot number from the product packaging to see if it matches the recalled items listed in the notice.
The recall states these kits may not be safe or effective after being re-gassed more than once, so they should not be used until the manufacturer confirms they are safe.
Check the item number on the packaging (BFCT04X, CMEY17AI, PERP25AQ, or RFEY50AC) and the lot number and bag serial number as listed in the recall notice.
The recall does not specify a remedy, so contact American Contract Systems directly for guidance on next steps.
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-0185-2026 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0185-2026 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.
