Events

Retiro De Equipo (Recall) de ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETER

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
    67770
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2009-05-12
  • 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 catheter have a deformity in the lumen at the catheter juncture hub which can cause difficulty in passing the spring wire guide through the hub of the catheter or removing the spring wire guide from the catheter.

Device

ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETER
  • Modelo / Serial
    Model Catalog: MC-15123 (Lot serial: >10 Lot numbers); Model Catalog: MC-12123 (Lot serial: >10 Lot numbers); Model Catalog: CS-12123-E (Lot serial: Contact manufacturer); Model Catalog: CS-15123-E (Lot serial: >10 Lot numbers); Model Catalog: CS-12123-E (Lot serial: >10 Lot numbers); Model Catalog: MC-12123 (Lot serial: Contact manufacturer); Model Catalog: MC-15123 (Lot serial: Contact manufacturer); Model Catalog: CS-15123-E (Lot serial: Contact manufacturer)
  • Descripción del producto
    Central Venous Catheter
  • Manufacturer
    ARROW INTERNATIONAL INC. (SUBSIDIARY OF TELEFLEX INCORPORATED)

Manufacturer

ARROW INTERNATIONAL INC. (SUBSIDIARY OF TELEFLEX INCORPORATED)