BEUDAMED
    FDA Recall Terminated

    Therakos Cellex Procedural Kits. Designed to interface with the Cellex Photopheresis System to perform cell separation and photoactivation in a single, closed and sterile circuit.

    Recall: Z-2839-2011 · Initiated December 2, 2010

    Recall

    Recall Number
    Z-2839-2011
    Event Number
    57518
    Firm
    Therakos Inc
    FEI Number
    2523595
    Product Code
    LNR
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 2, 2010
    Posted
    July 19, 2011
    Terminated
    February 19, 2015
    Address
    1001 Us Highway 202, Raritan, NJ, 08869

    Description

    Therakos Cellex Procedural Kits. Designed to interface with the Cellex Photopheresis System to perform cell separation and photoactivation in a single, closed and sterile circuit.

    Reason

    Cellex Procedural kits may have minor tears in their Tyvek covers.

    Action

    Therakos, Inc. sent an "Important Product Notification" dated December 2, 2010 to all affected customers. The letter included description of problem, affected lot and recommendations. Customers were asked to dispose any product with affected lot and to contact them for for replacement, and to complete and return the attached Fax reply form. For additional information contact Therakos Customer Technical Services at 877-865-6850.

    Distribution

    Nationwide (USA) distribution including the state of MI, MO, WI, CA, OH, NH, MA, and OR.

    Quantity

    110 units