Events

Retiro De Equipo (Recall) de Covidien Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, cuffless

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Covidien LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    18521
  • Fecha de inicio del evento
    2015-05-19
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Covidien NZ Ltd, Level 3, Building 5, Central Park Corporate Centre, 666 Great South Road, Penrose, AUCKLAND 1051
  • Causa
    Covidien has recalled these devices following reports from customers, where patients who recently switched from the current shiley™ neonatal and pediatric products to the affected products, experienced discomfort immediately after the switch in a limited number of situations. in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels, were also observed immediately after the switch.
  • Acción
    Product to be returned to supplier

Device

Covidien Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, cuffless
  • Modelo / Serial
    Model: Product Numbers: 2.5NEF, 3.0NEF, 3.5NEF, 4.0NEF, 4.5NEF, 2.5PEF, 3.0PEF, 3.5PEF, 4.0PEF, 4.5PEF, 5.0PEF, 5.5PEF, 5.0PELF, 5.5PELF, 6.0PELF, 6.5PELF, Affected: All lot numbers beginning with 12, 13, and 14
  • Clasificación del producto
    Anesthesiology Devices
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • 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
    NZMMDSA