BEUDAMED
    FDA Enforcement Class II Ongoing

    Quick Release Gait Belt, 60

    Recall: Z-0055-2021 · Reported October 14, 2020

    Enforcement

    Recall Number
    Z-0055-2021
    Event ID
    86448
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 14, 2020
    Initiation Date
    September 15, 2020
    Classification Date
    October 5, 2020
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    Quick Release Gait Belt, 60

    Reason

    The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma radiation.

    Code Info

    Model: MDT821208NATM /503689 Lots: 33019040001, 33019090001 and 33019100001 Used in kits with model number: DYKF1045 Lots: 20EBB832 and 20EBM643.

    Distribution

    Domestic Distribution Only: IL, MI

    Quantity

    13,500 units