BEUDAMED
    FDA Recall Terminated

    SmartSite Extension Set, Model No. 20029E, intravascular administration set.

    Recall: Z-1459-2014 · Initiated March 19, 2014

    Recall

    Recall Number
    Z-1459-2014
    Event Number
    67774
    Firm
    CareFusion 303, Inc.
    FEI Number
    2016493
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 19, 2014
    Posted
    April 16, 2014
    Terminated
    June 6, 2015
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

    Description

    SmartSite Extension Set, Model No. 20029E, intravascular administration set.

    Reason

    Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.

    Action

    CareFusion sent an Urgent Medical Device Recall Notification letter dated March 2014 to all customers. The letter informs the customers of the problems identified, potential risk and the actions to be taken. Customers are instructed to complete and return to CareFusion the enclosed recall response card. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact Customer Advocacy at (888) 812-3266 or email [email protected]. Customers with technical questions regarding the Alaris System are instructed to contact Technical Support at (888) 812-3299.

    Distribution

    USA Nationwide Distribution in the states of: AR, AZ, CA, CO, FL, ID, MD, MI, NC, NV, OK, OR, PA, TX, VA, WI

    Quantity

    7,700 units