Device Recall TorFlex Transseptal Guiding Sheath

  • Modèle / numéro de série
    Lot Numbers: S21244, S21903, S21940, S22739 and S22739X1.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- United States, Canada, Chile, China, Colombia, Denmark, Egypt, France, Germany, Hong Kong, Italy, Mexico, Netherlands, New Zealand, Portugal, Qatar, Russia, Singapore, South Africa, Sweden, Switzerland, United Arab Emirates and the United Kingdom.
  • Description du dispositif
    Torflex Transseptal Guiding Sheath, Baylis Medical Company Inc., 5959 Trans-Canada Highway, Montreal, QC, Canada H4T1A1, (514) 488-9802; INCLUDES: One (1) Radiopaque Sheath, One (1) Radiopaque Dilator; And One (1) B* x 135 cm Guidewire. || Intended to allow left heart catheterization procedure to occur through the right atrium.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Baylis Medical Corp *, 5959 Trans-Canada Hwy, Montreal Canada
  • Source
    USFDA