Best Practices kits containing certain production lots of Clearify Visualization System

  • Modelo / Serial
    Kit Parent Codes: 00Z2224 00Z2232 00Z2298 00Z2363  00Z2364  00Z2365 00Z2366  00Z2421  00Z2425 00Z2430  00Z2431  00Z2460 00Z2493  00Z2534  00Z2535  000Z2544  00Z5000B  00Z5001B  GYNKIT2
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - US (Nationwide) Foreign: Austria Belgium Bulgaria Brazil Chile Cyprus Denmark Egypt Finland France France Germany Greece Hungary Iran Ireland Israel Italy Japan Kenya Kuwait Latvia Luxembourg Mexico Namibia Netherlands Nigeria Norway Poland Portugal Romania Saudi Arabia Serbia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom
  • Descripción del producto
    Best Practices kits containing certain production lots of Clearify Visualization System || Item Code: 21-345 || Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Medtronic, 60 Middletown Ave, North Haven CT 06473-3908
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source