BEUDAMED
    FDA Recall Terminated

    Alaris PC Unit, Model 8015

    Recall: Z-2671-2017 · Initiated June 12, 2017

    Recall

    Recall Number
    Z-2671-2017
    Event Number
    77077
    Firm
    CareFusion 303, Inc.
    FEI Number
    2016493
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 12, 2017
    Posted
    June 19, 2017
    Terminated
    October 26, 2018
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

    Description

    Alaris PC Unit, Model 8015

    Reason

    BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrupted infusions.

    Action

    BD sent an Medical Device Safety Notification Letter dated June 12, 2017 , to customers to inform them that BD is issuing this Safety Notification letter to inform you of reports of customers experiencing a System Error (error code: 255-16-275) with Alaris System PC unit model 8015 that can result in interruption of infusions. Customers are informed of the issue, potential risk, and required actions to be taken by users and by BD. Customers with questions with the safety notification are instructed to call (888) 562-6018 or email [email protected]. Customers with adverse event reports are instructed to call (888) 812-3266 or email [email protected]. Customers with technical questions are instructed to call (888) 812-3229 or email [email protected]. For further questions, please call (858) 617-5925.

    Distribution

    Worldwide Distribution - USA (nationwide) and to the countries of : Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, and Canada.

    Quantity

    568,283 units