American Contract Systems recalled 32,433 UDPG88W PICC G-TUBE PACK medical kits nationwide after a nonconformance in Ethylene Oxide sterilization led to re-gassing. The devices have not been validated for multiple sterilization cycles. Healthcare providers and patients should stop using the kit immediately and follow recall instructions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact American Contract Systems Inc. or your healthcare provider for instructions. Notification method: Letter
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Medical convenience kits used in procedures involving PICC lines and G tubes. These kits are intended to streamline preparation and care in clinical settings.
Re-gassing after EO sterilization means the product may have undergone more than one sterilization cycle without validation. This creates uncertainty about sterility, quality, and effectiveness.
This recall is not identified as part of a broader industry pattern.
Hospitals and clinics may need to halt use of affected lots. The recall affects 32,433 units and spans several states, potentially impacting patient procedures and sterilization workflows.
Recall notice and product identifiers are available via the FDA enforcement recall page linked in the notice.
Remedy processing generally occurs within weeks to months, depending on logistics and replacement availability.
Keep the recall notice, packaging, lot codes, and any correspondence with the manufacturer for records.
Model: UDPG88W UDI-DI 191072216359 lot 7935611 bag serial number N/A. Sold across the United States in SD, IA, MN, WA, IL. Recall date: 2025-09-04. Report date: 2025-10-22. Price: Unknown.
No injuries or incidents have been reported.
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