Events

Retiro De Equipo (Recall) de Hudson RCI Sheridan Sher-I-Bronch Endobronial Tubes

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 Teleflex 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
    18618
  • Fecha de inicio del evento
    2015-06-05
  • 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
    Teleflex is recalling the products referenced above following receipt of customer complaints reporting that the double swivel connector may crack or separate on the endobronchial tube. should this occur,the device may leak, causing a risk of respiratory distress or hypoxia that can, in some cases, lead to the need to re-intubate the patient.
  • Acción
    Product to be returned to supplier

Device

Hudson RCI Sheridan Sher-I-Bronch Endobronial Tubes
  • Modelo / Serial
    Model: 5-15401, 5-16028, 5-16035, 5-16037, 5-16039, 5-16041, 5-16128, 5-16135, 5-16137, 5-16139, 5-16141, 5-16142, Affected: Selected batches
  • Clasificación del producto
    Anesthesiology Devices
  • Manufacturer
    Teleflex Medical Inc

Manufacturer

Teleflex Medical Inc