BEUDAMED
    FDA Recall Terminated

    Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.

    Recall: Z-1162-2013 · Initiated February 27, 2013

    Recall

    Recall Number
    Z-1162-2013
    Event Number
    64508
    FEI Number
    3003428886
    Product Code
    NAW
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    February 27, 2013
    Posted
    April 23, 2013
    Terminated
    March 30, 2015
    Address
    25-27 Paul Street North, Sirtex Medical Limited Centrecourt Business Park Unit D4, North Ryde, New South Wales Australia

    Description

    Sirtex SIR-yttrium 90 microspheres (Radionuclide); SIR-Y001. Indicated for the treatment of unresectable metastatic liver tumors.

    Reason

    Incorrect expiration date

    Action

    Sirtex notified medical end users on 2/27/13 via email correspondence with a copy of the recall letter attached. This was done to ensure advice was received at the same time that the goods were arriving. Hard copies of the recall letter, which were stamped "copy", were also sent to the individual facilities via UPS, processed for delivery Thursday, 28 February, 2013. Medical end users were advised in the recall letter to contact the US Customer Service staff at (888) 474-7839 x 702 to arrange for the pick-up if they decide to return the unused product.

    Distribution

    Nationwide Distribution-USA (nationwide) including DC and the states of AZ, CA, CT, GA, ID, IL,KY, LA, MD, ME, MO, MT, NJ, NV, WA, and WV.

    Quantity

    21 doses