BEUDAMED
    FDA Enforcement Class III Terminated

    SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.

    Recall: Z-2030-2012 · Reported July 25, 2012

    Enforcement

    Recall Number
    Z-2030-2012
    Event ID
    61691
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sigma
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 25, 2012
    Initiation Date
    April 23, 2012
    Classification Date
    July 18, 2012
    Termination Date
    July 5, 2018
    Address
    711 Park Ave, Medina, NY, 14103-1036, United States

    Description

    SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.

    Reason

    Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum Infusion Pump System because it may result in a facility drug library that does not represent common clinical practices.

    Code Info

    All versions

    Distribution

    Worldwide Distribution - US (nationwide) including Puerto Rico, and Canada.

    Quantity

    2,048 CD's