Device Recall McGrath MAC2 Video Laryngoscope Blades

  • Modelo / Serial
    Product Code: 350-017-000.   Lot Numbers and Expiration Dates: Lot 13121202, Expires 2016/12/11; Lot 13122301, Expires 2016/12/25; Lot 13042401, Expires 2017/5/5; Lot 14030501, Expires 2017/3/16; Lot 14031814, Expires 2017/3/26; Lot 14061616, Expires 2017/6/25.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - US Nationwide in the state of GA and the countries of Austria, China, Denmark, Finland, France, Hong Kong, Israel, Italy, Netherlands, Poland, Saudi Arabia, Singapore, South Korea, Taiwan, and Turkey.
  • Descripción del producto
    McGrath MAC2 Video Laryngoscope Blades || Product supplied in box of 50 items, each individually peel-pouched and EtO sterilized. || Product Usage: Single Use, sterile video laryngoscope blade for use with McGRATH MAC Video Laryngoscopes
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Aircraft Medical Limited, 9-10 SAINT ANDREW SQUARE, EDINBURGH United Kingdom
  • 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