BEUDAMED
    FDA Enforcement Class III Terminated

    NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC.

    Recall: Z-0599-2016 · Reported January 13, 2016

    Enforcement

    Recall Number
    Z-0599-2016
    Event ID
    72707
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nipro Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    January 13, 2016
    Initiation Date
    April 1, 2014
    Classification Date
    January 6, 2016
    Termination Date
    December 14, 2016
    Address
    3150 Nw 107th Ave, N/A, Miami, FL, 33172, United States

    Description

    NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ¿ inch. Item code FS+173230BC.

    Reason

    Device has the potential to have torn wings.

    Code Info

    Model No.: FS+173230BC, Lot #14A22 and Lot #14A26.

    Distribution

    US distribution including TN.

    Quantity

    160,000 pieces.