Medline Convenience Kits: 1) Lvad Driveline Tray, Model Number: Dm1035a; 2) Lvad Driveline Tray, Model Number: Dm1035; 3) Central Line Dressing Change Tray, Model Number: Dt8670a

Recall Summary Medline is recalling three types of medical convenience kits (LVAD Driveline Trays models DM1035A and DM1035, and Central Line Dressing Change Tray model DT8670A) because equipment used to sterilize and package them had calibration problems. While the products went through sterilization processes, the calibration issues may have affected whether the products are properly sterile. This recall affects anyone who received these specific kit models.

Product

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

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 I

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/f6562a69-94da-4b85-8e42-bc4b5b8c1f49