BEUDAMED
    FDA Enforcement Class II Terminated

    Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.

    Recall: Z-2251-2016 · Reported August 3, 2016

    Enforcement

    Recall Number
    Z-2251-2016
    Event ID
    74637
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BEST THERATRONICS LTD.
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    August 3, 2016
    Initiation Date
    May 6, 2016
    Classification Date
    July 22, 2016
    Termination Date
    August 1, 2017
    Address
    413 MARCH ROAD, N/A, KANATA, N/A, N/A, Canada

    Description

    Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.

    Reason

    It was discovered that both the new device and the predicate device failed to comply with performance standard.

    Code Info

    All Raycell units with serial #'s 5000 and higher.

    Distribution

    Nationwide

    Quantity

    128