Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) LVAD DRIVELINE TRAY, Model Number: DM1035A

Summary

The FDA issued a Class II for Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) LV by Medline Industries, LP. Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the vali.

Details

Product Description

Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) LVAD DRIVELINE TRAY, Model Number: DM1035A; 3) CENTRAL LINE DRESSING CHANGE TRAY, Model Number: DT8670A

Lot/Code Info: 1) DM1035, UDI-DI: 10653160327752(each), 653160327755(case), Lot Number: 2020042290; 2) DM1035, UDI-DI: 10653160327752(each), 653160327755(case), Lot Number: 2020052290; 3) DM1035, UDI-DI: 10653160327752(each), 653160327755(case), Lot Number: 2020072290; 4) DM1035, UDI-DI: 10653160327752(each), 653160327755(case), Lot Number: 2020082690; 5) DM1035A, UDI-DI: 10653160345251(each), 653160345254(case), Lot Number: 2022030390; 6) DM1035A, UDI-DI: 10653160345251(each), 653160345254(case), Lot Number: 2022072590; 7) DM1035A, UDI-DI: 10653160345251(each), 653160345254(case), Lot Number: 2023062390; 8) DM1035A, UDI-DI: 10653160345251(each), 653160345254(case), Lot Number: 2023101290; 9) DM1035A, UDI-DI: 10653160345251(each), 653160345254(case), Lot Number: 2025031190; 10) DM1035A, UDI-DI: 10653160345251(each), 653160345254(case), Lot Number: 2025051290; 11) DT8670A, UDI-DI: 653160177473(each), 10653160177470(case), Lot Number: 2020051390

Quantity Affected: 9720 units

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-01-07

Company