Events

Retiro De Equipo (Recall) de WHISTLE TIP CATHETER

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

¿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
    47695
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-09-15
  • 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
    Although the product labeling identifies the catheters as "soft rubber" the natural rubber latex caution statement ("caution: this product contains natural rubber latex which may cause allergic reactions") was not printed on the product label. if a person with a latex sensitivity comes into contact with the latex component of the product an allergic reaction could occur.

Device

WHISTLE TIP CATHETER
  • Modelo / Serial
    Model Catalog: 403900120 (Lot serial: 13261); Model Catalog: 403900100 (Lot serial: 13451); Model Catalog: 403900120 (Lot serial: 13451); Model Catalog: 403900100 (Lot serial: 13511); Model Catalog: 403900120 (Lot serial: 13511); Model Catalog: 403900100 (Lot serial: 13261); Model Catalog: 403340140 (Lot serial: 14131); Model Catalog: 403300100 (Lot serial: 13311); Model Catalog: 403300100 (Lot serial: 14131); Model Catalog: 403340140 (Lot serial: 14091); Model Catalog: 403300140 (Lot serial: 14091); Model Catalog: 403300100 (Lot serial: 14091); Model Catalog: 403340140 (Lot serial: 14041); Model Catalog: 403300140 (Lot serial: 14041); Model Catalog: 403300100 (Lot serial: 14041); Model Catalog: 403340140 (Lot serial: 13481); Model Catalog: 403300140 (Lot serial: 13481); Model Catalog: 403300100 (Lot serial: 13481); Model Catalog: 403340140 (Lot serial: 13461); Model Catalog: 403300140 (Lot serial: 13461); Model Catalog: 403300100 (Lot serial: 13461); Model Catalog: 403340140 (Lot serial: 13311); Model Catal
  • Descripción del producto
    NELATON WHISTLE TIP CATHETER
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.