Device Recall Cuvette / Tubing Pack

  • Modèle / numéro de série
    6912 , 6913 6914, 6932, 6933 6934, 6922, 6923 6924, CV-6912, CV-6913, CV-6914 Cardiovascular Procedure Kits- Various
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution.
  • Description du dispositif
    CDI¿ H/S Cuvette || The intended use for the CDI¿ H IS Cuvette is as follows: The CDI¿ H/S Cuvettes are intended for use with a CDI monitor during cardiopulmonary bypass procedures when continuous monitoring of blood hematocrit and oxygen saturation is desired.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Terumo Cardiovascular Systems Corporation, 125 Blue Ball Rd, Elkton MD 21921-5315
  • Société-mère du fabricant (2017)
  • Source
    USFDA