Events

Retiro De Equipo (Recall) de PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT

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
    33305
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2005-05-24
  • País del evento
    Canada
  • 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
    Guiding catheters which have been discovered to have weakened sidewalls in the area around the black over molded "stop" which may compromise the devices resistance to breakage. the "stop" may become detached.

Device

PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT
  • Modelo / Serial
    Model Catalog: 538090E (Lot serial: K510893); Model Catalog: 538070E (Lot serial: K518075 K520177 K548751); Model Catalog: 538080E (Lot serial: K510893); Model Catalog: 538070E (Lot serial: K510893); Model Catalog: 538090E (Lot serial: K510891 K510892 K565595); Model Catalog: 538080E (Lot serial: K510891 K510892 K565595); Model Catalog: 538070E (Lot serial: K510891 K510892 K565595); Model Catalog: 538090E (Lot serial: K586109 K614402 K629274); Model Catalog: 538080E (Lot serial: K586109 K614402 K629274); Model Catalog: 538070E (Lot serial: K586109 K614402 K629274); Model Catalog: 538090E (Lot serial: K515076 K518078 K558496); Model Catalog: 538080E (Lot serial: K515076 K518078 K558496); Model Catalog: 538070E (Lot serial: K515076 K518078 K558496); Model Catalog: 538090E (Lot serial: K559483 K614996 K630177); Model Catalog: 538080E (Lot serial: K559483 K614996 K630177); Model Catalog: 538070E (Lot serial: K559483 K614996 K630177); Model Catalog: 538090E (Lot serial: K523556 K527903 K548745); Model Catalog: 53
  • Descripción del producto
    portex perfit percutaneous dilational
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

SMITHS MEDICAL CANADA LTD. (SIMS)
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Smiths Group Plc
  • Source
    HC