Device Recall System 1000, TINA, AURORA and ARENA Hemodialysis Instruments

  • Model / Serial
    product codes S1000L3, S1000L3P, S1000LC2, S1000L3T, S1000L3TD, S1000L3PR, ARENASP, ARENASPP, ARENASPX, ARENADPX; all serial numbers
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and internationally to Canada, Korea, Hong Kong, Shanghai, Jamaica, Philippines, United Kingdom, Denmark, India, Belgium, Mexico, Italy, Austria, Sweden, Ecuador, Argentina, Brazil, Chile, Colombia, Peru, Turkey and Australia.
  • Product Description
    System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and ARENA; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Baxter Healthcare Renal Div, 1620 Waukegan Rd Bldg R, Mc Gaw Park IL 60085-6730
  • Source
    USFDA