Medline Convenience Kits: LVAD DRIVELINE TRAY, Model Number: DM1035 - 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

Source: FDA | Recall date: 05/13/2026

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Affected product: Medline Convenience Kits: LVAD DRIVELINE TRAY, Model Number: DM1035

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 as

Hazard: 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 as

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