BEUDAMED
    FDA Recall 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 · Initiated August 13, 2015

    Recall

    Recall Number
    Z-0161-2016
    Event Number
    72365
    Firm
    Nipro Medical Corporation
    FEI Number
    1000132332
    Product Code
    LLB
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    August 13, 2015
    Posted
    October 23, 2015
    Terminated
    October 13, 2017
    Address
    3150 Nw 107th Ave, Miami, FL, 33172

    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.

    Action

    Customers were issued a RMA 60001203 on August 18, 2015.

    Distribution

    Indiana

    Quantity

    50,000 pieces