Events

Retiro De Equipo (Recall) de CENTRAL VENOUS CATHETERIZATION KIT

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
    16155
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-11-01
  • 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
    Some of the outer trays used in the packaging of the products were found to have cracks. therefore the packaging may have been compromised and sterility of the product cannot be guaranted.

Device

CENTRAL VENOUS CATHETERIZATION KIT
  • Modelo / Serial
    Model Catalog: AK-04650-E (Lot serial: >10 lots Contact manufacturer); Model Catalog: AK-04660 (Lot serial: >10 lots Contact manufacturer); Model Catalog: AK-03000 (Lot serial: >10 Lots Contact manufacturer); Model Catalog: NH-05501 (Lot serial: RL9029591); Model Catalog: NH-05501 (Lot serial: RL9019412); Model Catalog: NH-05501 (Lot serial: RL8118743); Model Catalog: NH-05501 (Lot serial: RF9057542); Model Catalog: NH-05501 (Lot serial: RF9044688); Model Catalog: AK-04050 (Lot serial: >10 lots Contact manufacturer); Model Catalog: NS-04100 (Lot serial: >10 lots Contact manufacturer); Model Catalog: AK-04150-E (Lot serial: >10 lots Contact manufacturer); Model Catalog: ASK-03000-CHUQ (Lot serial: >10 lots Contact manufacturer); Model Catalog: ASK-03000-CHUQ1 (Lot serial: >10 lots Contact manufacturer)
  • Descripción del producto
    CENTRAL VENOUS CATHERIZATION KIT
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.