BEUDAMED
    FDA Recall Terminated

    Amigo Insulin Infusion Pump

    Recall: Z-1335-04 · Initiated May 7, 2004

    Recall

    Recall Number
    Z-1335-04
    Event Number
    29436
    Firm
    Nipro Diabetes Systems, Inc.
    FEI Number
    3003352163
    Product Code
    LZG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 7, 2004
    Posted
    September 14, 2004
    Terminated
    May 3, 2012
    Address
    3801 Commerce Pkwy, Miramar, FL, 33027

    Description

    Amigo Insulin Infusion Pump

    Reason

    A FDA inspection of the firm revealed deficiencies in the company's quality system. Problems exhibited may include motor failure or unintended operation.

    Action

    The firm will notify each distributor and user by letter and/or telephone of the recall.

    Distribution

    Distributed to New York, New Jersey, Florida,Indiana, Utah, Colorado and Wyoming.

    Quantity

    8 Pumps