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 serial numbers for affected units.
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 products are unsafe or ineffective for medical use.
The kits were re-gassed after a sterilization issue, which means they may not be safe or effective. Repeated sterilization cycles can compromise product quality and safety without proper validation.
Medical professionals and patients using these kits for healthcare purposes. Those who have the specific item numbers and serial numbers listed in the recall are most at risk.
Check the item number and serial number on the kit. Affected items include FHCP08Y (bag serial 68258296), HICS50I (bag serial 68273637), and HSCB90B (bag serials 47506618 or 47508489). If the bag serial number is listed as 'N/A', the entire lot is affected.
Look for the item number and bag serial number on the medical convenience kit to determine if it is affected.
The kits were re-gassed more than once during sterilization, which may compromise their safety and effectiveness.
Check the item number and bag serial number. Affected kits include FHCP08Y (bag serial 68258296), HICS50I (bag serial 68273637), and HSCB90B (bag serials 47506618 or 47508489). 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-0181-2026 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0181-2026 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.
