Devices

Device Recall Fresenius FDS08 Dialysate Delivery Machine

  • Modèle / numéro de série
    Catalog Numbers 190011 (60 Hz main power supply), 190092 (50 Hz main power supply), 150425 (AC power cord assembly -hemodialysis machine) and 160089 (AC power cord assembly, Granuflo 1 mixers)
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product distributed to 5404 customers throughout the US and the world.
  • Description du dispositif
    Main Power Supply Assembly (50 and 60 Hz) and AC Power cord assembly for hemodialysis machines and Granuflo 1 mixers, Distributed by Fresenius USA Inc., Walnut Creek, CA
  • Manufacturer
    Fresenius Medical Care North America
  • 1 Event

Fabricant

Fresenius Medical Care North America
  • Adresse du fabricant
    Fresenius Medical Care North America, 920 Winter St, Waltham MA 02451-1521
  • Société-mère du fabricant (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA

2 dispositifs médicaux avec un nom similaire

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Device Recall Fresenius FDS08 Dialysate Delivery Machine
  • Modèle / numéro de série
    Catalog numbers 501228, R190188 (Refurbished), R501228, RTLR501228 (Refurbished)
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product distributed to 5404 customers throughout the US and the world.
  • Description du dispositif
    Fresenius 2008H Dialysate Delivery Machine, Manufactured by Fresenius USA Inc., Walnut Creek, CA
  • Manufacturer
    Fresenius Medical Care North America
Device Recall Fresenius FDS08 Dialysate Delivery Machine
  • Modèle / numéro de série
    Catalog Numbers G047-80101 and RTLG047-80101
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product distributed to 5404 customers throughout the US and the world.
  • Description du dispositif
    Fresenius Granuflo 1 Mixer Dissolution Unit - Tested, and Granuflo Dissolution Tank, Model Numbers G047-80101 and RTLG047-80101, Manufactured by Fresenius USA Inc., Walnut Creek, CA
  • Manufacturer
    Fresenius Medical Care North America