BEUDAMED
    FDA Enforcement Class II Terminated

    TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.

    Recall: Z-0078-2017 · Reported October 19, 2016

    Enforcement

    Recall Number
    Z-0078-2017
    Event ID
    75350
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biocompatibles U.K., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    October 19, 2016
    Initiation Date
    September 21, 2015
    Classification Date
    October 13, 2016
    Termination Date
    October 17, 2016
    Address
    Bortoli House, Weydon Lane; Old Farnham Lane, Farnham, N/A, N/A, United Kingdom

    Description

    TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is indicated for radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC who can have placement of appropriately positioned hepatic arterial catheters.

    Reason

    One mislabeled dose of TheraSphere¿ Y-90 Glass Microspheres, which was shipped to Hong Kong (total radioactivity incorrect). The product ws labeled as 10 GBq and the actual does was 5 GBq.

    Code Info

    Lot 1599211, Expiry Date: 18SEP2015 (12 days after calibration)

    Distribution

    Worldwide Distribution - US to CA, FL, IL, WI, IN, OR, PA, MA, NY, KY, TX, MI, MD, NV, WA, OH, MN, and Internationally to Germany, Turkey, Hong Kong, Italy, Portugal

    Quantity

    64 doses