Device Recall Cellex Photopheresis System

  • 모델명 / 제조번호(시리얼번호)
    Mfr lot #D342
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    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

제조사

  • 제조사 주소
    Therakos Inc, 10 N High St, West Chester PA 19380-3003
  • 제조사 모회사 (2017)
  • Source
    USFDA