BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1239-2016 · Initiated February 12, 2016

    Recall

    Recall Number
    Z-1239-2016
    Event Number
    73315
    Firm
    CareFusion 303, Inc.
    FEI Number
    2016493
    Product Code
    FRO
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 12, 2016
    Posted
    March 24, 2016
    Terminated
    June 23, 2017
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

    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).

    Action

    A customer notification letter dated 2/25/16 will be sent to all their customers who purchased the Alaris PC unit (Model 8000) to inform them that CareFusion is recalling it because a component on the PC unit power supply board may cause a "System Error" or "Missing Battery" error code (120.4630). The letter informs the customers of the potential risk involved and the actions to be taken. Customers with recall related questions are instructed to call CareFusion Support Center at (888) 562-6018, 7am-4pm PST, Mon-Fri or email at [email protected]. Customers with clinical inquires, product complaints or clinical troubleshooting are instructed to contact customer advocacy at (888) 812-3266, 24 hrs/day, 7 days/wk or email at [email protected]. Customers with technical questions regarding the Alaris system are instructed to contact technical support at (888) 812-3229, 6am-5pm PST, Mon-Fri or email at [email protected].

    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