Events

Retiro De Equipo (Recall) de Cook Hemospray Endoscopic Hemostat

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 Wilson-Cook Medical 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
    16747
  • Fecha de inicio del evento
    2014-05-27
  • 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
    Cook medical has received a small number of reports related to the inability to spray the powder for the hemospray endoscopic hemostat. these reports involve difficulty spraying the hemospray powder from the delivery system. adverse events that may occur due to spraying difficulties include inadequate treatment.
  • Acción
    Product to be returned to supplier

Device

Cook Hemospray Endoscopic Hemostat
  • Modelo / Serial
    Model: Models: HEMO-7-EU, HEMO-10-EU, Affected: W3320783 (HEMO-7), and W3344464 (HEMO-10)
  • Manufacturer
    Wilson-Cook Medical Inc

Manufacturer

Wilson-Cook Medical Inc