American Contract Systems recalls UDPG88W PICC G-TUBE PACK 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 medical convenience kits that were re-gassed more than once during sterilization. This could mean the kits are unsafe or ineffective for medical use.
The kits were re-gassed (sterilized) more than once after a problem occurred during the first sterilization process. This means the kits haven't been tested to ensure they're safe or effective after multiple sterilizations.
Healthcare providers using these kits for patient care are most at risk. Patients receiving treatments with these kits may face safety issues.
Check for the model UDPG88W and lot number 7935611 on the kit packaging. If the bag serial number says 'N/A', the entire lot is affected.
Look for the model UDPG88W and lot number 7935611 on the kit packaging. If the bag serial number is listed as 'N/A', the entire lot is affected.
The kits were re-gassed (sterilized) more than once after a problem occurred during the initial sterilization process, meaning they haven't been validated for safety and effectiveness after multiple sterilizations.
Check for the model UDPG88W and lot number 7935611 on the kit packaging. If the bag serial number says 'N/A', the entire lot is affected.
The recall record does not specify a remedy, so no action is required beyond checking if you have the product.
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-0186-2026 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-0186-2026 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.
