BEUDAMED
    FDA Enforcement Class II Terminated

    Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood.

    Recall: Z-0161-2016 · Reported November 4, 2015

    Enforcement

    Recall Number
    Z-0161-2016
    Event ID
    72365
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nipro Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 4, 2015
    Initiation Date
    August 13, 2015
    Classification Date
    October 23, 2015
    Termination Date
    October 13, 2017
    Address
    3150 Nw 107th Ave, N/A, Miami, FL, 33172, United States

    Description

    Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood.

    Reason

    Some 1 1/4" needles were packaged and labeled in the 1" blister package.

    Code Info

    Lot # 15C03

    Distribution

    Indiana

    Quantity

    50,000 pieces