Device Recall Prismaflex

Fabricante

  • Dirección del fabricante
    Gambro Renal Products, Incorporated, 14143 Denver West Pkwy, Lakewood CO 80401-3266
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

Dispositivo con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Product code: 6023014700, 107493, 113081, 115269; Serial Number: All;   Affected Software Versions: SW 4.1x, 5.10, 6.10, 7.xx, 8.00
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Algeria, Armenia, Australia, Bahrain, Belarus, Belgium, Canada, China, Cyprus, Denmark, Egypt, France, Germany, Great Britain, Greece, Ireland, Italy, Albania, Bulgaria, Croatia, Czech Republic, Estonia, Hong Kong, Hungary, Iceland, India, Iran, Israel, Ivory Coast, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Montenegro, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Ukraine, Vietnam, Yemen, Argentina, Brazil, Chile, and Dominican Republic
  • Descripción del producto
    Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system. || Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload. *Therapeutic Plasma Exchange (TPE) therapy for patients weighing 20 kilograms or more with diseases where removal of plasma components is indicated.
  • Manufacturer