Device Recall Spectra Optia Apheresis System

  • Modèle / numéro de série
    Serial Numbers: 1P00100 thru 1P00719
  • Classification du dispositif
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and countries of Australia, Belgium, Canada, China, Hong Kong, Japan, Malaysia, Mexico, Pakistan, Saudi Arabia, Singapore, South Korea, Taiwan, Thailand, and Vietnam.
  • Description du dispositif
    Spectra Optia Apheresis System, REF: 61000, CaridianBCT, Lakewood, CO 80215. || The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis applications. The system may be used to perform Therapeutic Plasma Exchange, Mononuclear Cell Collection, and Red Blood Cell Exchange.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Caridian BCT, Incorporated, 10811 W Collins Ave, Lakewood CO 80215-4440
  • Société-mère du fabricant (2017)
  • Source
    USFDA