Device Recall SK6000 PAQ drape pouch

  • Model / Serial
    Lot # 16047 and 16046
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    US Distribution in states of: FL, MI, and VA.
  • Product Description
    Sterile Drape, SK6000 PAQ drape pouch (for use with the SPY Fluorescent System (SPY 2000/2001)) || The SPY Fluorescent Imaging System is intended to provide fluorescent images for the visual assessment of blood flow in vessels and related tissue perfusion during cardiovascular surgical procedures. For use in intraoperative visual assessment of the coronary vasculature and bypass grafts during coronary artery bypass (BABG) surgery.
  • Manufacturer
  • 1 Event


  • Manufacturer Address
    NOVADAQ TECHNOLOGIES INC., 8329 Eastlake Dr Unit 101, Burnaby Canada
  • Manufacturer Parent Company (2017)
  • Source