Retiro De Equipo (Recall) de KimVent Microcuff Subglottic Suctioning Endotracheal Tube, 7.0 mm, 7.5 mm, 8.0 mm, 8.5 mm & 9.0 mm

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Kimberly Clark Aust Pty 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Halyard australia pty ltd on behalf of kimberly-clark australia pty ltd, is recalling certain kimvent* microcuff* subglottic suctioning endotracheal tubes following advice that the referenced product codes and lot numbers may have the inflation line detach from the endotracheal tube during use (i.E. if pulled, tugged or excess tube/patient movement occurs). the potential harms associated with the pilot balloon inflation line disconnecting from the ett lumen include the need to re-intubate the patient to re-establish an adequate cuff seal and maintain appropriate ventilation of the patient. if the inflation line detachment and resulting cuff deflation are not detected and connected in time the patient may initially lose positive end expiratory pressure and get a reduction in tidal volumes.
  • Acción
    Kimberly-Clark is requesting their customers to inspect their stocks and quarantine all units of the above lot numbers. Customer Service Team Leader Halyard Australia can be contacted to arrange for a return goods authorisation and credit note to be issued. This action has been closed-out on 01/03/2016.


  • Modelo / Serial
    KimVent Microcuff Subglottic Suctioning Endotracheal Tube, 7.0 mm, 7.5 mm, 8.0 mm, 8.5 mm & 9.0 mmProduct Codes: 13220, 13221, 13222, 13223 & 13224Multiple Lot NumbersARTG number: 215983
  • Clasificación del producto
  • Manufacturer