BEUDAMED
    FDA Recall Terminated

    M-19 (Iridium 192): Source Production and Equipment Company, St. Rose, LA. Brachytherapy source.

    Recall: Z-1717-2009 · Initiated March 3, 2008

    Recall

    Recall Number
    Z-1717-2009
    Event Number
    52428
    Firm
    Source Production & Equipment Inc
    FEI Number
    1000437833
    Product Code
    KXK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 3, 2008
    Terminated
    August 19, 2009
    Address
    113 Teal St, St Rose, LA, 70087-4022

    Description

    M-19 (Iridium 192): Source Production and Equipment Company, St. Rose, LA. Brachytherapy source.

    Reason

    Radioactive source broke during use.

    Action

    Source Production and Equipment, Inc. notified the Distributor by phone and letter March 2008 and requested the return of all affected units.

    Distribution

    Nationwide Distribution -- GA, NV and NY.

    Quantity

    3 units