Device Recall SwanGanz CCOombo CCO/SvO2/VIP Thermodilution Catheter

  • Modèle / numéro de série
    Lot 58617326
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- AL, AR, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Hawaii, and Puerto Rico and countries of Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, UK, Greece, Ireland, Israel, Italy, Kuwait, Netherlands, Norway, Portugal, Sweden, Colombia, Australia, and Singapore.
  • Description du dispositif
    Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter For use with Vigilance Monitor. This package contains: One catheter and one volume-limited syringe. REF: 746F8 || For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Edwards Lifesciences, Llc, 1 Edwards Way, Irvine CA 92614-5688
  • Source
    USFDA