BEUDAMED
    FDA Recall Terminated

    Smiths Medical HOTLINE Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions

    Recall: Z-1444-2014 · Initiated March 17, 2014

    Recall

    Recall Number
    Z-1444-2014
    Event Number
    67714
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    1221261
    Product Code
    LGZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 17, 2014
    Posted
    April 9, 2014
    Terminated
    June 9, 2015
    Address
    160 Weymouth St, Rockland, MA, 02370-1136

    Description

    Smiths Medical HOTLINE Fluid Warming Set L-80. Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity conditions

    Reason

    Injection port of the Set may leak blood/ IV fluids from the septum of the injection port or the septum may become dislodged

    Action

    Smiths Medical issued Urgent Field Safety Notice Recall on 3/17/14 via mail service. Distributors will be instructed to notify their customers. The Field Safety Notice will also include an Urgent Recall Notice Confirmation Form (Confirmation Form) that consignees will be instructed to send back to Smiths Medical for carrying out the action and tracking effectiveness.Accounts are to inspect inventory and return recalled product. If you should have any questions regarding this information, please contact Shirley Duggan, Quality System Engineer at 1-781-763-9335 or by E-Mail [email protected].

    Distribution

    Worldwide Distribution - USA Nationwide in the states of: AU, CA, CL, CN, CZ, GT, ID, IN, IT, JP, LY, NZ, QA, SG, SK, TR, TW.

    Quantity

    870 units