Events

Retiro De Equipo (Recall) de Ambu Laryngeal Mask, single-use

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 Ambu AS.

¿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
    19585
  • Fecha de inicio del evento
    2015-12-18
  • 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: Medxus Ltd, Unit 4, 100 Fitgerald Avenue, Christchurch 8011
  • Causa
    Potential sterility breach., a failure has been discovered during routine quality control at the manufacturing site., this failure may cause a small hole, (approximately 0.5mm) in the pouch of the device leading to a potential compromised sterile barrier., after identification of failure, comprehensive investigation has shown a low prevalence of up to 3% for the affected lots., manufacturer has not received any complaints or other market feedback on the matter, dating from when the products were marketed in 2014., .

Device

Ambu Laryngeal Mask, single-use
  • Modelo / Serial
    Model: AMB408-300-000, Affected: 1794260, 1745425, 1724948, 1794260, 1729556, 1724950, 1732622
  • Manufacturer
    Ambu AS

Manufacturer

Ambu AS
  • Empresa matriz del fabricante (2017)
    Ambu A/S
  • Source
    NZMMDSA