BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0150C

    Recall: Z-2116-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-2116-2026
    Event ID
    98642
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 13, 2026
    Initiation Date
    January 7, 2026
    Classification Date
    May 7, 2026
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number:PAIN0150C

    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.

    Code Info

    1) PAIN0150C, UDI-DI: 10193489819571(each), 40193489819572(case), Lot Number: 21JBV886

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    448 units