Device Recall Fresenius 2008 Series Hemodialysis Delivery Systems

  • Model / Serial
    Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with bibag System 2008T Hemodialysis Machine
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: || Models: || Fresenius 2008K and 2008K2 Dialysate Delivery System || Fresenius 2008K@home Hemodialysis Machine with bibag System || 2008T Hemodialysis Machine || The Fresenius 2008¿ Series Machines are indicated for acute and chronic dialysis therapy
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Fresenius Medical Care Renal Therapies Group, LLC, 920 Winter St, Waltham MA 02451-1521
  • Manufacturer Parent Company (2017)
  • Source
    USFDA