BEUDAMED
    FDA Recall Terminated

    Therakos CellEx Photopheresis System; Photopheresis Procedural Kits, for use with the THERAKOS CellEx Instrument;

    Recall: Z-1654-2010 · Initiated March 29, 2010

    Recall

    Recall Number
    Z-1654-2010
    Event Number
    55300
    Firm
    Therakos Inc
    FEI Number
    2523595
    Product Code
    LNR
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 29, 2010
    Posted
    May 26, 2010
    Terminated
    July 18, 2013
    Address
    1001 Us Highway 202, Raritan, NJ, 08869

    Description

    Therakos CellEx Photopheresis System; Photopheresis Procedural Kits, for use with the THERAKOS CellEx Instrument;

    Reason

    Higher than normal blood leaks on THERAKOS CELLEX Procedural Kits that are intended for use with the THERAKOS CELLEX Photopheresis System

    Action

    On March 29, 2010, Therakos Photopheresis sent Important Product Correction Notification letters by FedEx to all direct end use and distributor customers who received lot X120 in addition to phone contact. On March 31, 2010 those who received lot X123 were sent letters by Fed Ex as well as phone contact.. The one Canadian customer was notified by phone on March 31, 2010 followed by a Fed Ex letter. On April 12, consignees who were shipped Lot X119 were contacted by phone, followed by a hard copy letter. On May 7, 2010 all direct end use and distributor consignees were notified of the additional lot being added to the recall. Questions may be directed to Therakos Customer Technical Services at 1-877-865-6850.

    Distribution

    Nationwide Distribution, and Canada and Germany

    Quantity

    280 units in US (1 sales unit contains 3 kits each)