BEUDAMED
    FDA Enforcement Class II Terminated

    AbbVie PEG Kit 20 FR

    Recall: Z-0786-2017 · Reported December 28, 2016

    Enforcement

    Recall Number
    Z-0786-2017
    Event ID
    75794
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AbbVie Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 28, 2016
    Initiation Date
    November 22, 2016
    Classification Date
    December 17, 2016
    Termination Date
    July 9, 2019
    Address
    1 N Waukegan Rd, N/A, North Chicago, IL, 60064-1802, United States

    Description

    AbbVie PEG Kit 20 FR

    Reason

    AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnections of the AbbVie 20FR PEG tube from the Y-connectors.

    Code Info

    AbbVie PEG Kit 20 Fr Product Code 62912-01-16 with lot numbers: 32025245, 32265215, 32335206, 32335336

    Distribution

    U.S. consignees located throughout the country and Puerto Rico. Foreign Consignees: Worldwide.

    Quantity

    541 units