Device Recall Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube

  • Modelo / Serial
    Lot Numbers: 0806000266, 0806000858, 0806000859, 0806001328, 0807000555, 0807001444, 0807002502, 0808000387, 0808000431, 0808002285, 0810000288, 0810000289, 0810000864, 0810000865, 0810001201, 0811000228, 0811000522, 0811000523, 0811000546, 0811000547 and 0811001875.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution, including Puerto Rico.
  • Descripción del producto
    Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube, REF 3.0 PED, Sterile. Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled in Mexico. The product is provided as one each shipped in an inner carton to end customers. || The intended use of the device is to bypass upper airway obstructions, provide long term ventilation, and support and/or manage tracheal/bronchial secretions.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Covidien Limited, 6135 Gunbarrel Ave, Boulder CO 80301-3214
  • 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