Covidien Shiley Tracheostomy Tube, Cuffed with Inner Cannula

Fabricant

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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
    NZMMDSA

Un dispositif médical avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Model: 8FEN, Affected: Lots between 0910000342 and 1101001558; and 110201893x and 120600700x
  • Classification du dispositif
  • Manufacturer