Device Recall SwanGanz Intellicath CCO/VIP Thermodilution Catheter with AMC Thromboshield

  • Model / Serial
    Lot 58619322 - expiration date between May 2010 and November 2010.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Edwards Lifesciences Swan-Ganz Intellicath CCO/VIP Thermodilution Catheter with AMC Thromboshield (an Antimicrobial *Heparin Coating) For use with Vigilance Monitor. REF: 139HF75 || 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

Manufacturer

  • Manufacturer Address
    Edwards Lifesciences, Llc, 1 Edwards Way, Irvine CA 92614-5688
  • Source
    USFDA