Device Recall Cellex Photopheresis System

  • Model / Serial
    Mfr lot #D342
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • 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.
  • Product 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
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Therakos Inc, 10 N High St, West Chester PA 19380-3003
  • Manufacturer Parent Company (2017)
  • Source
    USFDA