Events

Retiro De Equipo (Recall) de Teleflex Hudson RCI Lifesaver Single Patient Use Manual Resuscitator

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 Galemed Corporation.

¿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
    18809
  • Fecha de inicio del evento
    2015-07-08
  • 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: Ebos Group Ltd, 14-18 Lovell Court, Rosedale, Auckland 0632
  • Causa
    The oxygen intake port may be blocked which can prevent the bag from filling. this may prevent the device from delivering breathing support to the patient. a delay in treatment may potentially lead to patient injury or death. to date, teleflex has not received any reports of patient injury or death related to this issue.
  • Acción
    Product to be returned to supplier

Device

Teleflex Hudson RCI Lifesaver Single Patient Use Manual Resuscitator

Manufacturer

Galemed Corporation