BEUDAMED
    FDA Recall Terminated

    SmartSite Add-On Bag Access Device, Model No. 10013365

    Recall: Z-1883-2017 · Initiated November 17, 2016

    Recall

    Recall Number
    Z-1883-2017
    Event Number
    75013
    Firm
    CareFusion 303, Inc.
    FEI Number
    2016493
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 17, 2016
    Terminated
    October 29, 2018
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

    Description

    SmartSite Add-On Bag Access Device, Model No. 10013365

    Reason

    CareFusion is recalling the SmartSite Add-On Bag Device due to reports of separation and/or leakages between the spike port and the drip chamber spike. A separation or leak can cause a delay of infusion, an interruption of infusion, exposure to medication or hazardous infusates, or underinfusion.

    Action

    CareFusion sent an Urgent Medical Device Recall Notification letter dated November 2016, to inform their customers that CareFusion is recalling the SmartSite Add-On Bag Access Device Model 10013365 because of reports of leakages between the spike port and the drip chamber spike. The letter informs the customers of the lot numbers, potential risk and immediate actions to be taken. Customers with questions are instructed to contact CareFusion Support Center at (888) 562-6018 for recall related questions. Customers with adverse event report questions are instructed to contact Customer Advocacy at (888) 812-3266 or by email at [email protected]. Customers are instructed to complete and return the enclosed mandatory customer response card.

    Distribution

    US Distribution

    Quantity

    384,923 units