Events

Retiro De Equipo (Recall) de Cook Inc - Guide Wire

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Cook 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
    22185
  • Fecha de inicio del evento
    2017-11-03
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Causa
    The manufacturer has identified that the label of heparin coated devices does not explicitly state that they are heparin coated. the products are labeled with the correct catalog 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.
  • Acción
    Manufacturer to issue advice regarding use

Device

Cook Inc - Guide Wire
  • Modelo / Serial
    Model: , Affected: Vascular guides and catheters multiple lots
  • Manufacturer
    Cook Incorporated

Manufacturer

Cook Incorporated