Device Recall Guardian II Hemostasis Valve

  • Modelo / Serial
    Lot numbers: 41776, 41777, 41874, 42108, 42525, 581766, 581767, 583285, and 583286.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution in the states of AL, AR, CA, CO, DE, FL, GA, ID, IL IN, IA,KY, LA, MD, MA, MI, MO, NE,NV, NH, NY, NC, OH, PA, SD, TN, TX, UT, VA, WA, and WV. OUS: Ireland
  • Descripción del producto
    Guardian II Hemostasis Valve, models 8210 and 8211. The following models are only available Outside the US: FH101, FH101-T, FH101-25, and FH101-50. || Product Usage: The Guardian hemostasis valves are designed to be used as conduits when interventional devices with diameters up to 8 F are inserted into the human vascular system. The devices have two seals: the low-pressure seal, and the high-pressure seal. Closure of the high-pressure seal, which is achieved when the nut can no longer rotate, secures the diagnostic/interventional device in position within the vasculature and allows for pressure injections up to 600 psi.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Vascular Solutions, Inc., 6464 Sycamore Ct N, Maple Grove MN 55369-6032
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA