Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Reason for recall: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products. Distribution: Worldwide distribution - US Nationwide. Quantity: 15 units Lot/code info: 1) DYNDM1031A, UDI-DI: 10884389555897(each), 40884389555898(case), Lot Number: 23EBM150
10884389555897, 40884389555898
Official record: FDA (Device enforcement) ↗
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