BEUDAMED
    FDA Recall 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 · Initiated April 23, 2012

    Recall

    Recall Number
    Z-2030-2012
    Event Number
    61691
    Firm
    Sigma
    FEI Number
    1314492
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 23, 2012
    Posted
    July 18, 2012
    Terminated
    July 5, 2018
    Address
    711 Park Ave, Medina, NY, 14103-1036

    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.

    Action

    Sigma sent an Urgent: Customer Safety Alert dated April 23, 2012 via UPS delivery to all consignees requesting both acknowledgement of notification and confirmation that recommended actions have been taken. Customers are asked to follow the instructions contained in the recall letter. Customers with questions may contact the firm at 800-356-3454 ext 300.

    Distribution

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

    Quantity

    2,048 CD's