Device Recall Transonic ADT 1018 Flow QC Clear Advantage Tubing

  • Modèle / numéro de série
    Lots B151130E2 and B161115E0
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution and to the states of : NJ, NY, OH, PA, and TX., and to the countries of : Canada, South Korea, Thailand, Australia and Taiwan.
  • Description du dispositif
    Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 || The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hemodialysis treatment.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Transonic Systems Inc, 34 Dutch Mill Rd, Ithaca NY 14850-9785
  • Société-mère du fabricant (2017)
  • Source
    USFDA