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: LKRA40G UDI-DI 191072189691 Lot 8025211 Bag serial number 68154347 * If bag serial number is listed as "N/A", then whole lot is affected
191072189691
Official record: FDA (Device enforcement) ↗
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