American Contract Systems recalls adult central line insertion supply kits that were re-gassed after initial 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 adult central line insertion supply kits that were re-gassed (sterilized more than once) after a nonconformance during initial sterilization. This could mean the kits are unsafe and ineffective for medical use.
The kits were re-gassed after a problem occurred during the first sterilization process. This means they may not be safe or effective for medical use because they were exposed to multiple sterilization cycles without proper validation.
Healthcare professionals using these kits for central line insertions are most at risk. Patients receiving these kits could face safety issues.
Check for item numbers UICL44P or UICL44R on the kit. Lot 8003911 for UICL44P and Lot 83177:711 for UICL44R are affected. If the bag serial number is listed as 'n/a', the entire lot is affected.
Look for item numbers UICL44P or UICL44R on the kit, and check the lot numbers and serial numbers as listed in the recall notice.
The kits were re-gassed after a nonconformance during initial sterilization, which means they may not be safe or effective for medical use.
The recall notice does not specify a remedy, so check the official recall information for next steps.
Yes, Lot 8003911 for UICL44P and Lot 8317711 for UICL44R are affected. If the bag serial number is 'n/a', the entire lot is affected.
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-0177-2026 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0177-2026 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.
