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.
Reason for recall: 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. Distribution: US Nationwide distribution in the states of SD, IA, MN, WA, IL. Quantity: 32,433 total Lot/code info: UDPG88W UDI-DI 191072216359 lot 7935611 bag serial number N/A * If bag serial number is listed as "N/A", then whole lot is affected
191072216359
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.