BEUDAMED
    FDA Enforcement Class II Terminated

    Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist at the point of care within the operating room.

    Recall: Z-1015-2013 · Reported April 3, 2013

    Enforcement

    Recall Number
    Z-1015-2013
    Event ID
    53991
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CareFusion Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 3, 2013
    Initiation Date
    November 20, 2009
    Classification Date
    March 28, 2013
    Termination Date
    March 28, 2013
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121, United States

    Description

    Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist at the point of care within the operating room.

    Reason

    The recall was initiated because Carefusion has confirmed that when the PAS 2000 drawers due to inaccessability of drawers caused by system down time or lock-up.

    Code Info

    All Pyxis Anesthesia System Model 2000

    Distribution

    Worldwide Distribution - USA (Nationwide) including CANADA.

    Quantity

    2637