Device Recall Edwards Lifesciences Duraflo coated FemFlex II Femoral Arterial Cannula

  • Modèle / numéro de série
    Model DIIFEMII018A, Lot 59337174
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide Distribution including the states of: FL, MA, MI, NY, PA, TX.
  • Description du dispositif
    Edwards Lifesciences Duraflo coated Femoral Cannula. || Product Usage: || The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin-coated blood path is desired. || The femoral arterial cannulae are wire-reinforced, thin-wall cannulae.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Edwards Lifesciences, LLC, 12050 Lone Peak Pkwy, Draper UT 84020-9414
  • Société-mère du fabricant (2017)
  • Source
    USFDA