FDA DevicesClass II
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KI...
Published: February 25, 2026Recall ID: Z-1402-2026Category: 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) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43
Affected Products
Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98329 |
| Address 1 | 3 Lakes Dr |
| Code info | 1) DM1035, UDI-DI: 10193489442755(each), 40193489442756(case), Lot Number: 21BBN221; 2) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 22GBN333; 3) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 22GBF510; 4) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 22EBL039; 5) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 22CBU342; 6) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21JBJ253; 7) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21IBJ337; 8) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21DBD662; 9) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21ABO838; 10) DYKMBNDL43, UDI-DI: 10193489478891(each), 40193489478892(case), Lot Number: 21ABJ003 |
| Postal code | 60093-2753 |
| Report date | 20260225 |
| Product type | Devices |
| Product quantity | 684 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 | 20260217 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide.