BEUDAMED
    FDA Enforcement Class I Terminated

    Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia) pump is one of the modules offer under the Alaris System. The Auto ID is a barcode scanner.

    Recall: Z-0534-2014 · Reported January 1, 2014

    Enforcement

    Recall Number
    Z-0534-2014
    Event ID
    66865
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 1, 2014
    Initiation Date
    December 5, 2013
    Classification Date
    December 20, 2013
    Termination Date
    June 2, 2016
    Address
    10020 Pacific Mesa Blvd, N/A, San Diego, CA, 92121-4386, United States

    Description

    Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia) pump is one of the modules offer under the Alaris System. The Auto ID is a barcode scanner.

    Reason

    CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message.

    Code Info

    not available

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Netherlands, and Australia.

    Quantity

    4824 total units (4242 units in US)