BEUDAMED
    FDA Enforcement Class II Terminated

    One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.

    Recall: Z-0402-2016 · Reported December 16, 2015

    Enforcement

    Recall Number
    Z-0402-2016
    Event ID
    72364
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 16, 2015
    Initiation Date
    September 11, 2015
    Classification Date
    December 10, 2015
    Termination Date
    May 17, 2016
    Address
    780 Brookside Dr, N/A, Spencer, IN, 47460-1080, United States

    Description

    One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.

    Reason

    Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button, including the Decompression Tube and Low Profile Replacement Button devices because they may contain decompression tube adapters with a protrusion that could impede its ability to be introduced or removed from the PEG Button.

    Code Info

    Material Number (UPN) M00563020, Lot # 18184947, Exp. April 30, 2017; Material Number M00563080, Lot # 18179867, Exp. April 30, 2017; & Lot # 18212410 , Exp. May 31, 2017; Material Number M00568510, Lot # 18296155, Exp. May 31, 2018.

    Distribution

    US Distribution to the states of : IN, NV, CA, PA, CT, TN, NY, WI, and WA, and Internationally to Ireland.

    Quantity

    22 units