BEUDAMED
    FDA Enforcement Class II Ongoing

    BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.

    Recall: Z-0231-2024 · Reported November 15, 2023

    Enforcement

    Recall Number
    Z-0231-2024
    Event ID
    93114
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Breg Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 15, 2023
    Initiation Date
    September 13, 2023
    Classification Date
    November 3, 2023
    Address
    2382 Faraday Ave, Carlsbad, CA, 92008-7218, United States

    Description

    BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.

    Reason

    Due to walkers not meeting product specifications. Walkers were manufactured with misaligned wheels.

    Code Info

    Model/Product Number - 100519-000 UDI-DI Code: 00672736130834 Lot Numbers: CM82293623, CM82293923, CM82293823, CM82442923, CM82457323, CM82457423, CM82442823, CM82457523, CM82531023, CM82531223

    Distribution

    U.S.: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WY. O.U.S.: N/A

    Quantity

    11,193 units