American Contract Systems recalls medical convenience kits that were re-gassed (sterilized more than once) after initial Ethylene Oxide process. Product quality, safety, and effectiveness cannot be confirmed 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 sterilization process. This means the products' quality, safety, and effectiveness cannot be confirmed because they haven't been validated for multiple sterilization cycles.
The kits were re-gassed (sterilized more than once) after an initial Ethylene Oxide sterilization process had a nonconformance. These products have not been validated for exposure to multiple sterilization cycles, so their quality, safety, and effectiveness cannot be confirmed.
Healthcare professionals using these medical convenience kits for cardiac procedures are most at risk. The specific kits are used in catheterization labs and cardiac procedures.
Check for the item numbers: EVLH67F (LEFT HEART CATH PACK), FDCL22R (CATH LAB ANGIO), IHCC03X (CATH CARDIAC PACK), TNCC02AD (CARDIAC CATH TRINITY), UICC27AG (CARDIAC CATH ANGIO PACK), or UIRD89AH (RADIAL PACK). Look for specific lot numbers and bag serial numbers listed in the recall notice.
Identify the item number and lot number from the recall notice to confirm if your kit is affected.
The kits were re-gassed (sterilized more than once) after a nonconformance during the initial Ethylene Oxide sterilization process, and have not been validated for multiple sterilization cycles.
The affected kits include EVLH67F (LEFT HEART CATH PACK), FDCL22R (CATH LAB ANGIO), IHCC03X (CATH CARDIAC PACK), TNCC02AD (CARDIAC CATH TRINITY), UICC27AG (CARDIAC CATH ANGIO PACK), and UIRD89AH (RADIAL PACK).
Check the item number and lot number against the list provided in the recall notice, which includes specific bag serial numbers and lot numbers for each kit type.
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-0175-2026 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0175-2026 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.
