BEUDAMED
    FDA Recall Terminated

    Alaris PC units, Model No. 8015. Infusion pump.

    Recall: Z-1311-2015 · Initiated March 12, 2015

    Recall

    Recall Number
    Z-1311-2015
    Event Number
    70608
    Firm
    CareFusion 303, Inc.
    FEI Number
    2016493
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 12, 2015
    Posted
    March 23, 2015
    Terminated
    September 25, 2017
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

    Description

    Alaris PC units, Model No. 8015. Infusion pump.

    Reason

    CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur upon power on during the "Power-On Self Test" due to a keypad issue.

    Action

    CareFusion sent an Urgent: Medical Device Recall Notification letter dated March 12, 2015, to all affected customers. The letter informs the customers that CareFusion has received service reports of a system error on the Alaris PC unit 8015. The letter informs customers of the problems identified and the actions to be taken. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018, [email protected]. Customers with adverse event reports are instructed to contact customer advocacy at (888) 812-3266, [email protected]. Customers with technical questions regarding the Alaris system are instructed to contact technical support at (888) 812-3229, [email protected].

    Distribution

    Worldwide Distribution - USA (nationwide), Canada, European Union, Singapore and Australia.

    Quantity

    56,015 units