BEUDAMED
    FDA Enforcement Class II Ongoing

    Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight Spring Arm part numbers 42A-43L, 42A-43M, 42A-43H, and 42A-43S. Ceiling mounted utilities and equipment dispensing system.

    Recall: Z-0452-2024 · Reported December 13, 2023

    Enforcement

    Recall Number
    Z-0452-2024
    Event ID
    93351
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    IHB OPERATIONS B.V.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 13, 2023
    Initiation Date
    July 19, 2023
    Classification Date
    December 1, 2023
    Address
    Floresstraat 52, Zwolle, N/A, Netherlands

    Description

    Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight Spring Arm part numbers 42A-43L, 42A-43M, 42A-43H, and 42A-43S. Ceiling mounted utilities and equipment dispensing system.

    Reason

    Weakened connection point on the adjustable suspension arm, potentially causing damage or a break.

    Code Info

    UDI-DI: 10841736115951 (F110 SERIES), UDI-DI: 10841736115968 (F120 SERIES), UDI-DI: 10841736115975 (F130 SERIES), UDI-DI: 10841736116491 (F320 SERIES), UDI-DI: 10841736116545 (F330 SERIES), UDI-DI: 10841736116576 (F350 SERIES), UDI-DI: 10841736116590 (F410 SERIES), UDI-DI: 10841736116651 (F420 SERIES).

    Distribution

    US: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MB, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, VT, WA, WI, WV.

    Quantity

    1,497