BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1847-2014 · Initiated May 28, 2014

    Recall

    Recall Number
    Z-1847-2014
    Event Number
    68256
    Firm
    Baxter Corporation Englewood
    FEI Number
    1419106
    Product Code
    NEP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 28, 2014
    Posted
    June 22, 2014
    Terminated
    August 8, 2016
    Address
    14445 Grasslands Dr, Englewood, CO, 80112-7062

    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.

    Action

    Baxter sent an Urgent Device Correction letter dated May 27, 2014 via certified mail to affected customers. The letter identified the affected product, problem and actios to be taken. Customers were instructed to: 1. Review and distribute this communication to pharmacy staff and compounding staff that use ABACUS software. This notice is intended only for customers that have upgraded to version 3.1 of the software. 2. Please acknowledge receipt of this notification by completing the enclosed customer reply form and return it to Baxter by either faxing it to 1-224-270-5457 or scanning and e-mailing it to [email protected]. 3. If you have distributed ABACUS to other facilities, please notify the end users in accordance with your customary procedures. For questions call Baxter Techenical Support line at 1-800-678-2292.

    Distribution

    US Nationwide Distribution and the state of VA.

    Quantity

    42