American Contract Systems recalls medical cysto packs 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 cysto packs that were re-gassed (sterilized more than once) after a manufacturing issue. This could compromise product safety and effectiveness, potentially leading to health risks during medical use.
The cysto packs were re-gassed more than once during the sterilization process. This re-gassing was done after a nonconformance occurred in the initial sterilization cycle. As a result, the products have not been validated for multiple sterilization cycles, which could affect their safety and effectiveness.
Healthcare providers and patients using these medical cysto packs. Those with the specific item numbers and serial numbers listed in the recall are most at risk.
Check for item numbers: BUCY78E, CMCP10X, IHCY10Y, MHCY35AE, PLBY52E, UDCY31Z, UICY28L. Look for specific lot numbers and bag serial numbers listed in the recall notice.
Identify the item number, lot number, and bag serial number to confirm if your cysto pack is affected.
The cysto packs were re-gassed more than once after a manufacturing issue during the initial sterilization process, which could affect their safety and effectiveness.
Check for the specific item numbers (BUCY78E, CMCP10X, IHCY10Y, MHCY35AE, PLBY52E, UDCY31Z, UICY28L) and corresponding lot numbers and bag serial numbers listed in the recall notice.
The recall does not specify a stop-use action; affected products should be checked for the specific identifiers to determine if they are part of the recall.
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-0174-2026 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0174-2026 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.
