BEUDAMED
    FDA Enforcement Class I Terminated

    Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural

    Recall: Z-0950-2017 · Reported January 25, 2017

    Enforcement

    Recall Number
    Z-0950-2017
    Event ID
    75466
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 25, 2017
    Initiation Date
    December 2, 2016
    Classification Date
    January 18, 2017
    Termination Date
    July 24, 2018
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386, United States

    Description

    Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural

    Reason

    During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.

    Code Info

    All products manufactured or serviced in the time period October 2011 through June 2015.

    Distribution

    Nationwide Distribution

    Quantity

    382,635 units