BEUDAMED
    FDA Enforcement Class II Terminated

    Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System

    Recall: Z-1112-2013 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1112-2013
    Event ID
    64653
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carefusion Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2013
    Initiation Date
    March 6, 2013
    Classification Date
    April 14, 2013
    Termination Date
    May 8, 2014
    Address
    3750 Torrey View Ct, N/A, San Diego, CA, 92130-2622, United States

    Description

    Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System

    Reason

    The recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software version 9.12. Automating infusion pump parameter input from either the electronic medical record (EMR) or the Alaris Auto-ID module for a continuous infusion with a bolus dose option may result in a loss of information from the Guardrails Data s

    Code Info

    not available

    Distribution

    Worldwide Distribution USA Nationwide and the countries of Australia and Canada.

    Quantity

    4,090 total units