Devices

Shiley Reusable Cannula Low-Pressure Cuffed Tracheostomy Tubes

  • Modèle / numéro de série
    (1)8FEN Starting Lot Number: 0910000342 Ending Lot Number: 1101001558 Starting Lot Number: 110201893X Ending Lot Number: 120600700X (2)8LPC Starting Lot Number: 0910000346 Ending Lot Number: 1101001823 Starting Lot Number: 110200327X Ending Lot Number: 120600351X (for more code see attached)
  • Classification du dispositif
    Anesthesiology Devices
  • Description du dispositif
    Tracheostomy Tubes,mechanical ventilation
  • Manufacturer
    Covidien
  • 1 Event

Fabricant

Covidien
  • Société-mère du fabricant (2017)
    Medtronic plc
  • 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.
  • Représentant du fabricant
    Al-Faisaliah Medical System, Riyadh (01) 2119999
  • Source
    SFDA