American Contract Systems recalls medical convenience kits that were re-gassed (sterilized more than once) after a nonconformance during initial 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) after a nonconformance during the initial Ethylene Oxide gas injection process. These products have not been validated for exposure to multiple sterilization cycles, so their safety and effectiveness cannot be confirmed.
The products were re-gassed (sterilized) more than once after a nonconformance occurred during the initial Ethylene Oxide gas injection process. These products have not been validated for exposure to multiple sterilization cycles, meaning their safety, quality, and effectiveness cannot be confirmed.
Healthcare professionals and medical facilities that own or use the recalled medical convenience kits are most at risk. The specific products affected are listed in the recall notice with unique identifiers.
Check the product's item number and description, such as AKGN82E GENERAL, AMCB08Y CHEST BREAST PACK, or ANBP10AC BASIC PACK. Look for the UDI-DI number and lot number listed in the recall notice.
Identify the product by its item number (e.g., AKGN82E, AMCB08Y) and UDI-DI number from the recall list.
The products were re-gassed (sterilized) more than once after a nonconformance during the initial Ethylene Oxide gas injection process. These products have not been validated for exposure to multiple sterilization cycles, so their safety and effectiveness cannot be confirmed.
Check the product's item number and description, such as AKGN82E GENERAL, AMCB08Y CHEST BREAST PACK, or ANBP10AC BASIC PACK. Look for the UDI-DI number and lot number listed in the recall notice.
The recall notice does not specify a remedy or action steps for affected products.
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-0172-2026 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0172-2026 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.
