BEUDAMED
    FDA Enforcement Class II Terminated

    The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA. Manufacturing lot D342 UDI: 20705030200003 The system designed to separate the patient's blood into various fractions and collect the white blood cell (WBC) fraction. The WBC fraction is treated with a photoactive drug UVADEX¿ (methoxsalen) Sterile Solution. The UVADEX is photo-activated by UVA light and results in the WBCs undergoing apoptosis

    Recall: Z-1322-2016 · Reported April 13, 2016

    Enforcement

    Recall Number
    Z-1322-2016
    Event ID
    73012
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Therakos Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 13, 2016
    Initiation Date
    December 21, 2015
    Classification Date
    April 5, 2016
    Termination Date
    October 14, 2016
    Address
    10 N High St, N/A, West Chester, PA, 19380-3003, United States

    Description

    The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA. Manufacturing lot D342 UDI: 20705030200003 The system designed to separate the patient's blood into various fractions and collect the white blood cell (WBC) fraction. The WBC fraction is treated with a photoactive drug UVADEX¿ (methoxsalen) Sterile Solution. The UVADEX is photo-activated by UVA light and results in the WBCs undergoing apoptosis

    Reason

    The Mallinckrodt (Therakos) post-market monitoring process detected an increased trend in tubing leaks within the pump tubing organizer, associated with a portion of Kits from Lot D 342.

    Code Info

    Mfr lot #D342

    Distribution

    Nationwide Distribution to AL, AZ, CA, CO, DC, FL, ID, IL, IN, MA, ME, MN, MO, NC, NJ, NY, OH, PA, SC, TN, TX, UT, VT, AND WI.

    Quantity

    729 units