Device Recall HomeChoice PRO & Yume Plus

  • Modèle / numéro de série
    All units that do not bear the CE marking.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    HomeChoice PRO and Yume Plus Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, T5C8300, T5C8300R
  • Manufacturer
  • 1 Event

Fabricant

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

Un dispositif médical avec un nom similaire

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  • Modèle / numéro de série
    All HomeChoice Systems with software versions 8.5 and higher.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    HomeChoice PRO and Yume PlusAutomated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R
  • Manufacturer