Device Recall NIOA / NIOP is an instant IO access device

  • Model / Serial
    1620005
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    WI, TX, CA, LA and the following countries: UK, Spain, Poland, Israel, Czech Republic, France, Belgium, Denmark, Italy, Cyprus, Austria, Greece, Slovenia, Australia, Germany, Estonia, New Zealand, Switzerland, Costa Rica, Guatemala, Canada, Malaysia, Poland, Singapore, Lithuania, Romania
  • Product Description
    NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle into the bone marrow of a patient and allows connection of syringe or IV administration set. || The NIO-A is intended for adults above 12 years old and the NIO-P is intended for pediatric patients 3 - 12 years of age.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Waismed Ltd, 10, Amal St, Rosh Haayin Israel
  • Manufacturer Parent Company (2017)
  • Source
    USFDA