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: 448 units Lot/code info: 1) PAIN0150C, UDI-DI: 10193489819571(each), 21JBV886(case), Lot Number: 21JBV886
10193489819571
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.