Medline Recalls Triple Lumen Insertion Kits Over Sterilization Equipment Calibration Issues

What Happened

Medline Industries, LP has voluntarily initiated a recall of specific Triple Lumen Insertion Kits. The recall was issued after the company identified calibration issues with the equipment used to sterilize and package the devices. While the products were exposed to validated sterilization cycles, the calibration errors have the potential to impact the Sterility Assurance Level (SAL) of the kits.

Which Products Are Affected

The recall affects 15 units of the following product:

• Product Name: Medline Convenience Kits: KIT TRIPLE LUMEN INSERTION
• Model Number: DYNDM1031A
• Lot Number: 23EBM150
• UDI-DI: 10884389555897 (individual unit); 40884389555898 (case)
• Recall Number: Z-1407-2026

The affected products were distributed worldwide, including nationwide across the United States.

What You Should Do

Healthcare providers and distributors should immediately check their inventory for the affected lot number (23EBM150). Medline Industries, LP notified customers of the issue via a formal letter. If you possess any of the recalled units, follow the instructions provided in the firm’s notification regarding the return or quarantine of the devices. For further inquiries, contact Medline Industries, LP at their headquarters in Northfield, Illinois.

Why This Matters

Maintaining the sterility of medical insertion kits is critical for patient safety. A compromised Sterility Assurance Level increases the risk of infection or sepsis during clinical procedures involving triple lumen insertion.

Source

Information provided by the FDA under recall event ID 98329.