BEUDAMED
    FDA Enforcement Class II Terminated

    Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092

    Recall: Z-1239-2016 · Reported March 30, 2016

    Enforcement

    Recall Number
    Z-1239-2016
    Event ID
    73315
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CareFusion 303, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 30, 2016
    Initiation Date
    February 12, 2016
    Classification Date
    March 24, 2016
    Termination Date
    June 23, 2017
    Address
    10020 Pacific Mesa Blvd, N/A, San Diego, CA, 92121-4386, United States

    Description

    Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092

    Reason

    CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a "System Error" or "Missing Battery" error code (120.4630).

    Code Info

    Serial No. 4044845 9950535 4064411 12475162 4045659 9899143 3606478 4021398 4093501 4043745 4063430 4094994 9907675 9945292 9922622 4043375 12409069 4020663 12498854 4044531 4058193 12351849 4064030 9925068 12426138 4063830 4063911 9945269

    Distribution

    Nationwide in US: AR, AZ, CA, FL, GA, IN, KY, MD, MI, MN, MO, NJ, NM, NY, OH, OR, PA, SC, TN, TX, VA, WI.

    Quantity

    170 units