Medline Convenience Kits: 1) Lvad Driveline Tray, Model Number: Dm1035; 2) Kit Surg Onc Insert Cent.venou, Model Number: Dykmbndl43

Recall Summary Medline is recalling two convenience kits—an LVAD Driveline Tray (Model DM1035) and a Surgical Oncology Central Venous Catheter Insertion Kit (Model DYKMBNDL43)—due to calibration problems with the sterilization equipment used to prepare them. Although the products went through sterilization processes, the equipment calibration issues may have affected whether the devices met required sterility standards. This recall affects all units of these two products that were processed with the affected equipment.

Product

Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KIT SURG ONC INSERT CENT.VENOU, Model Number: DYKMBNDL43

Reason

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.

Classification

Class II

Category

consumer product recall

Country

United States

Agency

FDA-DEVICES

Recall date

2026-01-07

Status

Open, Classified

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/4b916c15-f94b-4e57-9b5e-8a666abf8a90