Device Recall HomeChoice PRO

  • Modelo / Serial
    All HomeChoice PRO Systems with software versions 8.51 and 8.52.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, Guatemala, Chile, Brazil, Turkey, Singapore, Taiwan, Canada, Belgium, Czech Republic, Israel, Italy, Jordan, Lebanon, Malta, Spain, Sweden, Turkey and the United Kingdom.
  • Descripción del producto
    HomeChoice PRO Automated 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
  • 1 Event

Fabricante

  • Dirección del fabricante
    Baxter Healthcare Corp., Rt 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA

6 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    All HomeChoice Systems with software versions 8.5 and higher.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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
  • Modelo / Serial
    All units that do not bear the CE marking.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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
  • Modelo / Serial
    Units with software version 8.7 used with Physioneal Clear-Flex PD products
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Those HomeChoice units in Denmark and Sweden only, where the Physioneal Clear-Flex products are approved for use.
  • Descripción del producto
    HomeChoice PRO Automated 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
  • Manufacturer
  • Modelo / Serial
    all serial numbers
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, including Puerto Rico, and internationally to Argentina, Austria, Australia, Belgium, Canada, Chile, China, Colombia, Denmark, Ecuador, France, Germany, Guatemala, Hong Kong, Ireland, India, Italy, Korea, Mexico, Malaysia, Nicaragua, the Netherlands, New Zealand, Peru, the Philippines, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, the United Kingdom, Uruguay and Venezuela.
  • Descripción del producto
    HomeChoice PRO Automated 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
  • Modelo / Serial
    All serial numbers released prior to 08/23/07
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide; USA, Australia, New Zealand, China, Hong Kong, the Philippines, Thailand, Asia, Canada, Algeria, Austria, Bahrain, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Iraq, Ireland, Israel, Italy, Jordan, Kuwait, Latvia, Lebanon, Lithuania, Malta, Morocco, The Netherlands, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Senegal, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Ukraine, Latin America and Japan.
  • Descripción del producto
    HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, and T5C8300R, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A
  • Manufacturer
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