Shiley Reusable Cannula cuffed tracheostomy tubes

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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
    HPRA

4 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Product Classification
  • Product Description
    Medical Device Safety Alert: Covidien Shiley Reusable Cannula Cuffed Tracheostomy Tubes
  • Manufacturer
  • Model / Serial
    8FEN, 8LPC, 8FENJ, 8FEN-S, 8FENJ-S, 8LPC-S | See FSN
  • Product Classification
  • Product Description
    MD: Basic tracheostomy tube, single-use
  • Manufacturer
  • Model / Serial
    Shiley Reusable Cannula Cuffed Tracheostomy Tubes, Product codes: 8FEN, 8LPC, 8LPC-SFenestrated, Cuffed TT, size 8Product code: 8FEN Lot Numbers: 0910000342 - 1101001558; 110201893X - 120600700XLow Pressure Cuffed TT, size 8Product Code: 8LPC Lot Numbers:0910000346 - 1101001823, 110200327X - 120600351XEVAC Low Pressure Cuffed TT, size 8Product Code: 8LPC-S Lot Numbers: 0910001002 - 1103002052, 111000400X - 120600014XARTG Numbers: 181271 & 100137
  • Product Classification
  • Manufacturer