Devices

Device Recall Fresenius 2008K, 2008K2 and 2008K2home Hemodialysis Machines

  • Modèle / numéro de série
    Catalog numbers: 2008K: 190300, 190303, 190305, 190336, 190371, 190372, 190373, 190517, R190305 (Refurbished), R190371 (Refurbished), RTL190371, RTL190373, RTLR190305 (Refurbished), RTLR190371 (Refurbished), RTLR190373 (Refurbished)
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product distributed to 5404 customers throughout the US and the world.
  • Description du dispositif
    Fresenius 2008K, 2008K2 and 2008 K2@home Hemodialysis Machines, Manufactured by Fresenius USA Inc., Walnut Creek, CA
  • Manufacturer
    Fresenius Medical Care North America
  • 1 Event

Fabricant

Fresenius Medical Care North America
  • Adresse du fabricant
    Fresenius Medical Care North America, 920 Winter St, Waltham MA 02451-1521
  • Société-mère du fabricant (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA