BEUDAMED
    FDA Enforcement Class II Terminated

    Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520

    Recall: Z-1370-2018 · Reported April 18, 2018

    Enforcement

    Recall Number
    Z-1370-2018
    Event ID
    79579
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical Europe Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 18, 2018
    Initiation Date
    March 15, 2018
    Classification Date
    July 5, 2018
    Termination Date
    October 5, 2020
    Address
    Ida Business Park, Athlone, N/A, Ireland

    Description

    Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520

    Reason

    These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.

    Code Info

    (a) 655300160 655316 Batch Numbers 13EG28 13HG23 (b) 655500200 655520 Batch Numbers: 13EG28

    Distribution

    US Nationwide Distribution

    Quantity

    200 units