Devices

Device Recall HomeChoice & Yume

  • Model / Serial
    All units that do not bear the CE marking.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including Puerto Rico, and internationally to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, Guatemala, Honduras, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, New Zealand, Peru, Philippines, Saudi Arabia, Singapore, South Africa, Taiwan, Turkey, Uruguay and Venezuela.
  • Product Description
    HomeChoice and Yume Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, T5C4441, T5C4441R
  • Manufacturer
    Baxter Healthcare Renal Div
  • 1 Event

Manufacturer

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

One device with a similar name

Learn more about the data here

Device Recall HomeChoice & Yume
  • Model / Serial
    All HomeChoice Systems with software versions 8.5 and higher.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Argentina, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Denmark, Ecuador, France, Germany, Guatemala, Hong Kong, India, Ireland, Italy, Korea, Malaysia, Mexico, Nicaragua, the Netherlands, Peru, the Philippines, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela and the United Kingdom.
  • Product Description
    HomeChoice and Yume Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R
  • Manufacturer
    Baxter Healthcare Renal Div