BEUDAMED
    FDA Recall Terminated

    Pharmacy compounding system . It is a twenty-four source compounder for multi-source fluid mixing of both macro and micro ingredient down to 0.2 ml quantities. Product Usage: Pharmacy compounding System for parenteral macro and micro ingredients

    Recall: Z-1389-2012 · Initiated March 23, 2009

    Recall

    Recall Number
    Z-1389-2012
    Event Number
    52024
    Firm
    Baxa Corporation
    FEI Number
    1419106
    Product Code
    NEP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 23, 2009
    Posted
    April 9, 2012
    Terminated
    April 10, 2012
    Address
    14445 Grasslands Dr, Englewood, CO, 80112

    Description

    Pharmacy compounding system . It is a twenty-four source compounder for multi-source fluid mixing of both macro and micro ingredient down to 0.2 ml quantities. Product Usage: Pharmacy compounding System for parenteral macro and micro ingredients

    Reason

    Software issue with compounding pump resulting in over delivery of component ingredients during routine operations.

    Action

    Baxa sent a Safety Alert letter dated March 23, 2009 to all affected consignees. The letter identified the affected product, problem and recommended actions with specific instructions related to the issue. Additionally, the firm will be providing a warning label for the affected product as soon as possible and is currently working on a product upgrade to correct the issue. For assistance contact Baxa Technical Support at 800-678-2292. The firm is also providing a 24 hour a day, 7 days a week Technical Support for the affected product.

    Distribution

    Worldwide Distribution - USA Nationwide including Canada.

    Quantity

    1322 units