Medline Industries, LP — Class II recall: Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) LV…

Summary

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)… Status: Ongoing.

Entities

• Medline Industries, LP