Medline Industries Recalls Basic Nerve Block Trays Due to Sterilization Calibration Issues

What Happened

Medline Industries, LP has initiated a voluntary recall of specific medical convenience kits due to calibration issues identified in the equipment used for sterilization and packaging. While the products were processed through validated sterilization cycles, the calibration discrepancies have the potential to impact the Sterility Assurance Level (SAL) of the devices, meaning the products may not meet required sterility standards.

Which Products Are Affected

The recall specifically involves the following product:

• Product Name: Medline Convenience Kits: BASIC NERVE BLOCK TRAY W/LINEN
• Model Number: PAIN0150C
• Lot Number: 21JBV886
• UDI-DI: 10193489819571 (individual units), 21JBV886 (case)
• Recall Number: Z-1387-2026
• Quantity: 448 units

The affected kits were distributed nationwide across the United States and to international locations.

What You Should Do

Healthcare facilities and distributors should immediately check their inventory for the affected lot number (21JBV886). Medline has initiated notification to customers via a formal letter. Any units from the recalled lot should be quarantined and not used for patient care. For further instructions on returns or to report issues, contact Medline Industries, LP at their headquarters in Northfield, Illinois.

Why This Matters

Sterility is critical for medical devices used in invasive procedures like nerve blocks. A failure to maintain the proper Sterility Assurance Level increases the risk of patient infection and related medical complications.

Source

Information provided by the FDA.