Retiro De Equipo (Recall) de Disposable Reuter Tip-Deflecting Wire Guide

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por William A Cook Australia Pty Ltd.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Cook medical has identified that the labels of specific lots of disposable reuter tip-deflecting wire guides do not explicitly state that they are heparin coated. the products are labelled with the correct catalogue identifier, which includes the suffix “bh” that indicates the product is heparin coated. however, users who are not familiar with the “bh” nomenclature may not be aware that the product contains heparin.To date, no adverse events have been reported due to this issue. under rare circumstances, these products could unknowingly be used in a patient with a heparin allergy or a patient with a history of heparin induced thrombocytopenia (hit). either of these situations could potentially result in serious injury or death.
  • Acción
    Cook Medical is advising users to inspect stock and quarantine remaining units for replacement with unaffected stock.


  • Modelo / Serial
    Disposable Reuter Tip-Deflecting Wire GuideCatalogue Identifier (Prefix/Suffix): DTDW-/-BHLot Numbers: F4791428, F4791430, NS5562947 and F4791427Supplied under Special Access Scheme (SAS)
  • Manufacturer