Events

Retiro De Equipo (Recall) de PRELUDE SHORT SHEATH INTRODUCER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por INTER V MEDICAL 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
    118752
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-04-30
  • 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
    The sidearm tubing may detach from the sheath during use. if this failure occures it may result in excessive patient blood loss and/or risk of blood-borne pathogen exposure to those in the surrounding area.

Device

PRELUDE SHORT SHEATH INTRODUCER
  • Modelo / Serial
    Model Catalog: PSS-7F-4MT (Lot serial: PSS-6F-4-018MTF661571); Model Catalog: PSS-6F-4MT (Lot serial: PSS-6F-4-018MTF661571); Model Catalog: PSS-5F-4MT (Lot serial: PSS-6F-4-018MTF661571); Model Catalog: PSS-5F-4-038MT (Lot serial: PSS-6F-4-018MTF635079); Model Catalog: PSS-6F-4-018MT (Lot serial: PSS-6F-4-018MTF635079); Model Catalog: PSS-5F-4-018MT (Lot serial: PSS-6F-4-018MTF635079); Model Catalog: PSS-8F-4MT (Lot serial: PSS-6F-4-018MTF635079); Model Catalog: PSS-7F-4MT (Lot serial: PSS-6F-4-018MTF635079); Model Catalog: PSS-6F-4MT (Lot serial: PSS-6F-4-018MTF635079); Model Catalog: PSS-5F-4MT (Lot serial: PSS-6F-4-018MTF635079); Model Catalog: PSS-5F-4-038MT (Lot serial: PSS-5F-4MTF686781); Model Catalog: PSS-6F-4-018MT (Lot serial: PSS-5F-4MTF686781); Model Catalog: PSS-5F-4-018MT (Lot serial: PSS-5F-4MTF686781); Model Catalog: PSS-8F-4MT (Lot serial: PSS-5F-4MTF686781); Model Catalog: PSS-7F-4MT (Lot serial: PSS-5F-4MTF686781); Model Catalog: PSS-6F-4MT (Lot serial: PSS-5F-4MTF686781); Model Catalog:
  • Descripción del producto
    PRELUDE SHORT SHEATH INTRODUCER
  • Manufacturer
    INTER V MEDICAL INC.

Manufacturer

INTER V MEDICAL INC.
  • Dirección del fabricante
    MONTREAL
  • Source
    HC