American Contract Systems recalled 32,433 medical convenience kits on September 4, 2025. The recall follows issues with multiple sterilization cycles that compromise product safety. Patients and healthcare providers should stop using these devices immediately.
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
The recalled product is the UDPG88W PICC G-TUBE PACK, affected by a sterilization issue. It was distributed nationwide in states including South Dakota, Iowa, Minnesota, Washington, and Illinois.
The identified products were re-gassed after a nonconformance during the initial Ethylene Oxide gas injection. These products have not been validated for exposure to multiple sterilization cycles, impacting their quality and safety.
No specific incidents or injuries have been reported related to this recall, but the potential for severe safety risks exists due to compromised sterilization.
Stop using the recalled medical kits immediately. Follow the recall instructions provided by American Contract Systems or consult your healthcare provider.
For further instructions, contact American Contract Systems Inc. at their official website or via the recall notification letter.
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