BEUDAMED
    FDA Enforcement Class II Terminated

    Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830

    Recall: Z-1858-2020 · Reported May 13, 2020

    Enforcement

    Recall Number
    Z-1858-2020
    Event ID
    85210
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    R82 A/S
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 13, 2020
    Initiation Date
    March 6, 2020
    Classification Date
    May 4, 2020
    Termination Date
    September 5, 2023
    Address
    Parallelvej 3, N/A, Gedved, N/A, N/A, Denmark

    Description

    Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830

    Reason

    The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use of a tool.

    Code Info

    All units distributed from 04/01/2017 to 02/10/2020

    Distribution

    NC

    Quantity

    2230 units