FDA DevicesClass II
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) LV...
Published: May 13, 2026Recall ID: Z-2125-2026Category: devicesCountry: US
Reason for Recall / 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 assurance level (SAL) of the Recalled Products.
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98642 |
| Address 1 | 3 Lakes Dr |
| 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 |
| Postal code | 60093-2753 |
| Report date | 20260513 |
| Product type | Devices |
| Product quantity | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260107 |
| Initial firm notification | Letter |
| Center classification date | 20260507 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - US Nationwide distribution.