BEUDAMED
    FDA Enforcement Class I Terminated

    ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition), 8300-0156 ABACUS 3.0 CE, 8300-0157 ABACUS 3.0 SE, 8300-0158 ABACUS 3.0 ME, 8300-0166 ABACUS 3.1 DE, 8300-0167 ABACUS 3.1 CE, 8300-0168 ABACUS 3.1 SE, 8300-0169 ABACUS 3.1 ME. ABACUS is a Windows - based order entry TPN software application for comprehensive calculations and label printing. The primary use of Abacus is for Total Parenteral Nutrition (TPN) order calculations.

    Recall: Z-1566-2014 · Reported May 21, 2014

    Enforcement

    Recall Number
    Z-1566-2014
    Event ID
    67884
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Corporation Englewood
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 21, 2014
    Initiation Date
    April 2, 2014
    Classification Date
    May 12, 2014
    Termination Date
    January 20, 2016
    Address
    14445 Grasslands Dr, Englewood, CO, 80112-7062, United States

    Description

    ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition), 8300-0156 ABACUS 3.0 CE, 8300-0157 ABACUS 3.0 SE, 8300-0158 ABACUS 3.0 ME, 8300-0166 ABACUS 3.1 DE, 8300-0167 ABACUS 3.1 CE, 8300-0168 ABACUS 3.1 SE, 8300-0169 ABACUS 3.1 ME. ABACUS is a Windows - based order entry TPN software application for comprehensive calculations and label printing. The primary use of Abacus is for Total Parenteral Nutrition (TPN) order calculations.

    Reason

    1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values during the creation of TPN orders. 2. ABACUS v3.1 may automatically add additional sterile water to a formula equal to the volume of a premix resulting in an over dilution. 3. All software versions of ABACUS software display the calcium phosphate curve points for Premasol incorrectly. 4. All software v

    Code Info

    Product Code 8300-0045, 8300-0046, 8300-0047, 8300-0156, 8300-0157, 8300-0158, 8300-0166, 8300-0167, 8300-0168, 8300-0169

    Distribution

    Worldwide Distribution - USA nationwide, Canada, Colombia, Dominican Republic, Panama, Austria, Bosnia Herzegovina, Bulgaria, Bahrain, Estonia, France, Germany, Georgia, Hungary, Ireland, Israel, Jordan, Kuwait, Latvia, Morocco, Oman, Qatar, Saudi Arabia, Slovenia, Slovakia, South Africa, Switzerland, United Arab Emirates, United Kingdom, Hong Kong, and Taiwan.

    Quantity

    2034