BEUDAMED
    FDA Recall Terminated

    CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY

    Recall: Z-0307-2018 · Initiated November 22, 2017

    Recall

    Recall Number
    Z-0307-2018
    Event Number
    78673
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    November 22, 2017
    Posted
    January 2, 2018
    Terminated
    September 25, 2020
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY

    Reason

    Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. The label attached to the back of the pump may list a serial number that does not match the correct serial number programmed into the software of the pump.

    Action

    The recall notices were disseminated via FedEx to US consignees on November 22, 2017. The recall notices were disseminated via email to Australian consignees on November 27, 2017. The consignee was directed to turn on the pump and check the serial against the serial number on the label. If they did not match, then they were directed to return the unit.

    Distribution

    US, Australia

    Quantity

    58 units