Events

Retiro De Equipo (Recall) de Rusch Bronchopart Tube Set Left

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 Rusch 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
    17809
  • Fecha de inicio del evento
    2015-01-12
  • 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
    Teleflex are recalling specific products following receipt of customer complaints reporting that the cobb connector detached from the main connector prior to use. this cobb connector detachment should be readily identified by the user during set-up and prior to use of the device. if during use, cobb connector separation occurs and presents as a leak in the breathing circuit and if it is unnoticed, then there is a remote probability that the patient may need to be re-intubated due to the risk of respiratory distress and hypoxia.
  • Acción
    Product to be returned to supplier

Device

Rusch Bronchopart Tube Set Left
  • Modelo / Serial
    Model: Product Code: 116100-000260, Affected: 29 lots
  • Manufacturer
    Rusch Inc

Manufacturer

Rusch Inc