Retiro De Equipo (Recall) de STOPCOCK WITH EXTENSION

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ARROW INTERNATIONAL INC. (SUBSIDIARY OF TELEFLEX INCORPORATED).

¿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
    74221
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-03-08
  • 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
    Some of the pouches in which these sterile products are packaged have been found to have pin holes. therefore the sterility of the product cannot be guaranteed.

Device

  • Modelo / Serial
    Model Catalog: W19945 (Lot serial: >10 contact manufacturer); Model Catalog: W20471 (Lot serial: >10 contact manufacturer); Model Catalog: W20570 (Lot serial: >10 contact manufacturer); Model Catalog: W01272 (Lot serial: >10 contact manufacturer); Model Catalog: W01244 (Lot serial: >10 contact manufacturer); Model Catalog: W21491 (Lot serial: >10 contact manufacturer); Model Catalog: W21887 (Lot serial: >10 contact manufacturer); Model Catalog: W20171 (Lot serial: >10 contact manufacturer); Model Catalog: W20044 (Lot serial: >10 contact manufacturer); Model Catalog: W21370 (Lot serial: >10 contact manufacturer); Model Catalog: W21357 (Lot serial: >10 contact manufacturer); Model Catalog: W21122 (Lot serial: >10 contact manufacturer); Model Catalog: W20979 (Lot serial: >10 contact manufacturer); Model Catalog: W19922 (Lot serial: >10 contact manufacturer); Model Catalog: W15549 (Lot serial: >10 contact manufacturer); Model Catalog: W20027 (Lot serial: >10 contact manufacturer); Model Catalog: W21774 (Lot seri
  • Descripción del producto
    Stopcock with Extension
  • Manufacturer

Manufacturer