BEUDAMED
    FDA Recall Terminated

    Therakos Cellex Photopheresis System CellexUSA & Cellex. The photopheresis system is indicated for use in the ultraviolet-A (UVA) irradiation in the presence of the photoactive drug 8-methoxypsoralen (8-MOP) of extracorporeally circulating leukocyte-enriched blood in the palliative treatment of the skin manifestation of cutaneous T-cell lymphoma (CTCL) in person who have not been responsive to other forms of treatment. The Cellex procedural kits are designed to interface with the Cellex Photopheresis System to perform cell separation and photo activation in a single closed and sterile circuit. This is accomplished by use of an integrated centrifuge bowl and associated tubing for separation of whole blood into red blood cells, plasma, and buffy coat (leukocyte-enriched blood). All blood components are returned to the patient. The procedural kits are fully assembled as received by the customer and the customer is only required to place the components in the Cellex System to enable the system for use.

    Recall: Z-0595-2012 · Initiated September 1, 2011

    Recall

    Recall Number
    Z-0595-2012
    Event Number
    60628
    Firm
    Therakos, Inc.
    FEI Number
    2523595
    Product Code
    LNR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 1, 2011
    Posted
    January 11, 2012
    Terminated
    March 27, 2014
    Address
    1001 Us Highway 202, Raritan, NJ, 08869-1424

    Description

    Therakos Cellex Photopheresis System CellexUSA & Cellex. The photopheresis system is indicated for use in the ultraviolet-A (UVA) irradiation in the presence of the photoactive drug 8-methoxypsoralen (8-MOP) of extracorporeally circulating leukocyte-enriched blood in the palliative treatment of the skin manifestation of cutaneous T-cell lymphoma (CTCL) in person who have not been responsive to other forms of treatment. The Cellex procedural kits are designed to interface with the Cellex Photopheresis System to perform cell separation and photo activation in a single closed and sterile circuit. This is accomplished by use of an integrated centrifuge bowl and associated tubing for separation of whole blood into red blood cells, plasma, and buffy coat (leukocyte-enriched blood). All blood components are returned to the patient. The procedural kits are fully assembled as received by the customer and the customer is only required to place the components in the Cellex System to enable the system for use.

    Reason

    There have been three confirmed reports of post reinfusion hemolysis or hemoglobinuria in patients treated on the Therakos Cellex Photopheresis System.

    Action

    Therakos sent an "URGENT PRODUCT CORRECTION NOTIFICATION" dated September 1, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. Additionally, a Confirmation of Receipt was attached to the letter for customers to complete and return. Contact Therakos Technical Support at 1-877-865-6850 for questions regarding this notice.

    Distribution

    Worldwide Distribution.

    Quantity

    49 USA, 65 Foreign