BEUDAMED
    FDA Enforcement Class II Terminated

    K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provide flexible knee support.

    Recall: Z-1447-2014 · Reported April 16, 2014

    Enforcement

    Recall Number
    Z-1447-2014
    Event ID
    67821
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Breg Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 16, 2014
    Initiation Date
    March 14, 2014
    Classification Date
    April 10, 2014
    Termination Date
    April 14, 2014
    Address
    2885 Loker Ave E, N/A, Carlsbad, CA, 92010-6626, United States

    Description

    K-Lite Knee 2 Stays with Visco, Model No. 122015. Product Usage: The product is intended to provide flexible knee support.

    Reason

    Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because they contain latex but were not labeled with the required caution label.

    Code Info

    Lot No. 705593

    Distribution

    USA Nationwide Worldwide in the states of: TX, KY, IN, and FL.

    Quantity

    2 units