Device Recall Catheter, Introducer

  • Model / Serial
    Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide in the states of: NY, NH, IN, MI, FL and NJ and in the countries of: Europe and Latin America.
  • Product Description
    Brand Name: AFX" Introducer System, Model Number S17-45. || Lot Numbers: 1079840, 1079843, 1079844, 1079845. || Product Usage: || The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Endologix Inc, 11 Studebaker, Irvine CA 92618-2013
  • Source
    USFDA