Medline Industries Recalls LVAD Driveline and Central Line Dressing Trays Over Sterility Concerns

What Happened

Medline Industries, LP has initiated a voluntary recall of several medical convenience kits due to identified issues with the calibration of equipment used during the sterilization and packaging process. While the products were exposed to validated sterilization cycles, the calibration discrepancies have the potential to impact the sterility assurance level (SAL) of the devices, meaning their sterility cannot be guaranteed.

Which Products Are Affected

A total of 9,720 units are included in this recall. The affected products were distributed nationwide in the United States and worldwide. The specific models and lot numbers are as follows:

• LVAD DRIVELINE TRAY (Model DM1035A)
  • UDI-DI: 10653160345251 (each), 00653160345254 (case)
  • Lot Numbers: 2025051290, 2025031190, 2023062390, 2023101290, 2022030390, 2022072590
• LVAD DRIVELINE TRAY (Model DM1035)
  • UDI-DI: 10653160327752 (each), 00653160327755 (case)
  • Lot Numbers: 2020042290, 2020052290, 2020072290, 2020082690
• CENTRAL LINE DRESSING CHANGE TRAY (Model DT8670A)
  • UDI-DI: 00653160177473 (each), 10653160177470 (case)
  • Lot Number: 2020051390

What You Should Do

Medline Industries notified affected customers via a formal recall letter. Healthcare facilities and distributors should immediately check their inventory for the model and lot numbers listed above. Any affected products should be quarantined and handled according to the instructions provided in the firm’s notification letter. For further information regarding returns or replacement, contact Medline Industries, LP directly at their Northfield, IL headquarters.

Why This Matters

This recall is significant because the affected trays are used in critical medical procedures involving Left Ventricular Assist Devices (LVAD) and central lines. If the sterility of these kits is compromised, it poses a serious risk of infection to patients undergoing these procedures.

Source

This information is based on official recall data provided by the FDA under recall number Z-1411-2026.