BEUDAMED
    FDA Enforcement Class II Terminated

    Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL.

    Recall: Z-0326-2017 · Reported November 9, 2016

    Enforcement

    Recall Number
    Z-0326-2017
    Event ID
    75197
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hill-Rom, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 9, 2016
    Initiation Date
    August 9, 2016
    Classification Date
    October 31, 2016
    Termination Date
    March 24, 2017
    Address
    1069 State Road 46 E, Batesville, IN, 47006-7520, United States

    Description

    Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL.

    Reason

    Ceiling Bracket 71 was shipped with a larger center hole. A potentially hazardous situation exists that if the Ceiling Bracket 71 with a larger center hole is used for a concrete ceiling Ultra System installation with the M8 screw and the safe working load is exceeded, the system could fall.

    Code Info

    manufacturing date between Dec 01, 2015- Apr 14, 2016

    Distribution

    WA NC OH PA MI Australia Sweden

    Quantity

    188