BEUDAMED
    FDA Recall Terminated

    EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5

    Recall: Z-0126-2011 · Initiated July 26, 2010

    Recall

    Recall Number
    Z-0126-2011
    Event Number
    56730
    Firm
    Hospira, Inc.
    FEI Number
    3013319212
    Product Code
    DNN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 26, 2010
    Posted
    October 22, 2010
    Terminated
    February 25, 2014
    Address
    600 N Field Dr, Bldg J45, Lake Forest, IL, 60045

    Description

    EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5

    Reason

    The EndoTool software did not always provide an audible alert when a blood glucose measurement was due. This could result in a patient not receiving an appropriate dose of insulin.

    Action

    Hospira issued an Urgent Device Field Correction letter dated July 23, 2010 to consignees, providing details of the potential issue and the associated patient risk. Hospira is finalizing software enhancements which will resolve this situation within the next 90 days ,and will contact each consignee when it is available to be downloaded from the Hospira website. The notification letter also included a clinical bulletin, outlining mitigation instructions for clinicians to use until the software enhancement is available. Consignees were requested to complete and return an attached Reply Form by fax. Customers can contact the Hospira EndoTool support line at 1-877-349-4582 for clinical inquiries about this recall.

    Distribution

    Nationwide Distribution in states of CA, FL, IL, IN, KY, KS, MI, MO, MT, NC, NJ, NM, NV, OH, SC, SD, TN, TX, VA, WA, and WY.

    Quantity

    97 units total (96 version 7.2.1800.3 and 1 version 7.2.1825.5)