BEUDAMED
    FDA Recall Terminated

    Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4037, Smiths Medical ASD, Inc, Dublin, Ohio 43016

    Recall: Z-0695-2008 · Initiated November 21, 2007

    Recall

    Recall Number
    Z-0695-2008
    Event Number
    45889
    Firm
    Smiths Medical Asd Inc
    FEI Number
    1526863
    Product Code
    CBT
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    November 21, 2007
    Posted
    January 31, 2008
    Terminated
    September 30, 2010
    Address
    6250 Shier Rings Rd, Dublin, OH, 43016-1270

    Description

    Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4037, Smiths Medical ASD, Inc, Dublin, Ohio 43016

    Reason

    Misbranded; The product codes are labeled incorrectly with a green promotional label for "New split septum sampling site. Only use needle-free access devices .......", however this product code contains a sampling site which is accessed with a shrouded needle, NOT with a needle-free access device

    Action

    Smiths Medical mailed certified letters (Urgent Product Advisory Notifications) dated November 19, 2007, to all customers that received the affected lot. Firms are instructed to make the field correction (extra label removal) or mail the product back to Smiths for the correction.

    Distribution

    Nationwide including the states of CA, DC, IL, IN, MD, MN, NC, NE, SC, and TN and Puerto Rico.

    Quantity

    1440 units