BEUDAMED
    FDA Enforcement Class II Terminated

    Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.

    Recall: Z-1520-2017 · Reported March 29, 2017

    Enforcement

    Recall Number
    Z-1520-2017
    Event ID
    75353
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 29, 2017
    Initiation Date
    November 1, 2016
    Classification Date
    March 21, 2017
    Termination Date
    April 24, 2020
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386, United States

    Description

    Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.

    Reason

    Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped.

    Code Info

    all units

    Distribution

    Worldwide distribution. US nationwide, Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, and Canada.

    Quantity

    613,800 total units (575,221 units in US)