BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1858-2020 · Initiated March 6, 2020

    Recall

    Recall Number
    Z-1858-2020
    Event Number
    85210
    FEI Number
    3001657382
    Product Code
    ITJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 6, 2020
    Terminated
    September 5, 2023
    Address
    R82 A/S Parallelvej 3 Gedved 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.

    Action

    R82, Inc. notified their sole consignee on 02/09/2020 by email. The notice identified the choking hazard and requested that the consignee notify their customers of the hazard. The consignee will be sending letters beginning the week of 03/16/2020 to their customers.

    Distribution

    NC

    Quantity

    2230 units