Events

Retiro De Equipo (Recall) de NON-STERILE STEP DOWN CONNECTOR

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

¿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
    121020
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-12-05
  • 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
    Integra lifesciences corporation (integra) has recently become aware that the current packaging configuration for the non-sterile step down connector may lead to a potentially conflicting message regarding product sterility. this individually sold non-sterile stepdown connector is packaged with a label that correctly states the product is non-sterile and also with instructions for use (ifu) from the sterile kit with which it is designed to be used as a reference to the customers. although the accessories are marked on the external label as non-sterile the ifu which is visible through the packaging states that the related shunt kit is sterile. this may lead to confusion as to whether these non-sterile products are sterile.

Device

NON-STERILE STEP DOWN CONNECTOR
  • Modelo / Serial
    Model Catalog: NL8600401 (Lot serial: )
  • Descripción del producto
    NON-STERILE STEP DOWN CONNECTOR
  • Manufacturer
    INTEGRA CANADA ULC.

Manufacturer

INTEGRA CANADA ULC.