BEUDAMED
    FDA Enforcement Class III Terminated

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

    Recall: Z-1162-2013 · Reported May 1, 2013

    Enforcement

    Recall Number
    Z-1162-2013
    Event ID
    64508
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sirtex Medical Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 1, 2013
    Initiation Date
    February 27, 2013
    Classification Date
    April 23, 2013
    Termination Date
    March 30, 2015
    Address
    Centrecourt Business Park,, Unit D4, 25-27, Paul Street North, North Ryde, New South Wales, N/A, Australia

    Description

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

    Reason

    Incorrect expiration date

    Code Info

    Batch HB024V02 to HB024V14; Batch HB025V02 to HB024V10

    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