BEUDAMED
    FDA Recall Terminated

    SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.

    Recall: Z-2285-2013 · Initiated August 30, 2013

    Recall

    Recall Number
    Z-2285-2013
    Event Number
    66151
    Firm
    CareFusion 303, Inc.
    FEI Number
    2016493
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    August 30, 2013
    Posted
    September 26, 2013
    Terminated
    April 16, 2014
    Address
    10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

    Description

    SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.

    Reason

    CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber.

    Action

    A customer letter dated August 30, 2013 will be sent to customers to inform them that CareFusion is recalling the SmartSite Low Sorbing Infusion Set Models 10015048, Lot Numbers 130153883 and 13025342 as a result of a potential for separation at the tubing sleeve below the drip chamber.The letter informs the customers of the problem identified, issues, potential risk, and the immediate actions to be taken. Customers are instructed to complete the customer response form and return the form to CareFusion. Customers are instructed to return recalled products directly to distributors. A distributor letter will also be sent to distributors on 8/30/13 to inform them of the problems identified and the actions to be taken. Distributors are instructed to contact the Customer Support Team, return customer response form, and they are instructed to contact the CareFusion Support Center at 1-800-562-6018 with any questions. .

    Distribution

    Nationwide in US: PA, OK, TX, FL, NC, CA, IN, WI

    Quantity

    15860 units