BEUDAMED
    FDA Enforcement Class II Terminated

    Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding.

    Recall: Z-1847-2014 · Reported July 2, 2014

    Enforcement

    Recall Number
    Z-1847-2014
    Event ID
    68256
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Corporation Englewood
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 2, 2014
    Initiation Date
    May 28, 2014
    Classification Date
    June 21, 2014
    Termination Date
    August 8, 2016
    Address
    14445 Grasslands Dr, N/A, Englewood, CO, 80112-7062, United States

    Description

    Abacus 3.1, Pharmacy Calculator Product Usage: Provide pharmacy calculations for automated compounding.

    Reason

    Baxter Corporation is initiating a field correction following an upgrade to ABACUS Software v3.1, when Clinimix 4.25110 is used in an order, the Nutritional Summary and any labels containing energy information may display 1,000 times less protein than is actually present in the solution.

    Code Info

    Product Code: 8300-0167, 8300-0168, 8300-0169

    Distribution

    US Nationwide Distribution and the state of VA.

    Quantity

    42