Devices

Device Recall NaturaLyte Sodium Bicarbonate Liquid Concentrate

  • Modèle / numéro de série
    Lot Number: 11 BMLB005 (Incorrect Lot Number: 11 BLMB005)
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution--AL, CA, CT, FL, GA, NJ, NV, NY, OR, PA, and WA
  • Description du dispositif
    Naturalyte@ Sodium Bicarbonate Liquid Concentrate, Dialysate Concentrate for Hemodialysis Liquid || Part number: 08-4000-LB || Formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates
  • Manufacturer
    Fresenius Medical Care Holdings, Inc.
  • 1 Event

Fabricant

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