Events

Retiro De Equipo (Recall) de Hsiner_Manual Resuscitator (Disposable)

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 Hsiner Co 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
    Recall
  • ID del evento
    20998
  • Fecha de inicio del evento
    2017-01-10
  • 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: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
  • Causa
    The manufacturer has identified the possibility of a functional failure on the pop-off valve assembled on the disposable manual resuscitator. the valve may have a dimension issue, resulting in the valve being unable to fully close off when the patient needs higher pressure (40cm h2o and above).
  • Acción
    Product to be returned to supplier

Device

Hsiner_Manual Resuscitator (Disposable)
  • Modelo / Serial
    Model: , Affected: Product Code: HS-60122 and HS-60123. Batch/Lot/Serial numbers: 20160926019, 20160926020, 20161108023 and 20161108066
  • Manufacturer
    Hsiner Co Ltd

Manufacturer

Hsiner Co Ltd