Retiro De Equipo (Recall) de ORAL/NASAL MURPHY - UNCUFFED

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SMITHS MEDICAL CANADA LTD. (SIMS).

¿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
    53385
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2009-09-14
  • País del evento
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Smiths medical international ltd. has become aware that certain portex uncuffed paediatric tracheal tubes were manufactured with an internal diameter slightly smaller than specifications. there is a remote potential for a suction catheter to become lodged in a tracheal tube which may require extubation.

Device

  • Modelo / Serial
    Model Catalog: 100/127/035 (Lot serial: ALL LOTS PRIOR SEPT 2009); Model Catalog: 100/127/030 (Lot serial: ALL LOTS PRIOR SEPT 2009); Model Catalog: 100/127/025 (Lot serial: ALL LOTS PRIOR SEPT 2009); Model Catalog: 100-134-030 (Lot serial: ALL LOTS PRIOR SEPT 2009); Model Catalog: 100/112/035 (Lot serial: ALL LOTS PRIOR SEPT 2009); Model Catalog: 100/112/030 (Lot serial: ALL LOTS PRIOR SEPT 2009); Model Catalog: 100-134-035 (Lot serial: ALL LOTS PRIOR SEPT 2009); Model Catalog: 100-141-035 (Lot serial: ALL LOTS MAY 2007-NOV 2008); Model Catalog: 100-141-025 (Lot serial: ALL LOTS MAY 2007-NOV 2008); Model Catalog: 100-141-030 (Lot serial: ALL LOTS MAY 2007-NOV 2008); Model Catalog: 100-105-030 (Lot serial: ALL LOTS PRIOR SEPT 2009); Model Catalog: 100-105-035 (Lot serial: ALL LOTS PRIOR SEPT 2009); Model Catalog: 100-105-025 (Lot serial: ALL LOTS PRIOR SEPT 2009); Model Catalog: 100-111-035 (Lot serial: ALL LOTS PRIOR SEPT 2009); Model Catalog: 100-111-030 (Lot serial: ALL LOTS PRIOR SEPT 2009); Model Catalo
  • Clasificación del producto
  • Descripción del producto
    PORTEX TRACH TUBEMURPHY EYECLEAR
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
  • Source
    HC