BEUDAMED
    FDA Recall 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 · Initiated September 21, 2015

    Recall

    Recall Number
    Z-0078-2017
    Event Number
    75350
    Firm
    Biocompatibles U.K., Ltd. Bortoli House Weydon Lane; Old Farnham Lane Farnham United Kingdom
    FEI Number
    3002124543
    Product Code
    NAW
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    September 21, 2015
    Terminated
    October 17, 2016

    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.

    Action

    Biocompatibles UK Ltd sent an Urgent Field Safety Notice dated September 21, 2015, to all affected customers. The firm did not request return or destruction of the product. Customers with questions were instructed to call 613-410-1870. For questions regarding this recall call 613-801-1848.

    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