Events

Retiro De Equipo (Recall) de OM040R - Doyen-Collin Mouth Gag 120mm Produced between Feb 2016 and Oct 2017 inclusive

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por B Braun Australia 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
    Recall
  • ID del evento
    RC-2018-RN-00124-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-03-14
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00124-1
  • 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
    Braun has been notified by the manufacturer that an error in the initial manufacture of these items has been identified resulting in a potential for the protective sleeves to become “sticky” after reprocessing.It has been determined that the used plastic sleeves of the instrument do not meet the valid specification. instead of the specified material silicone, the material pvc was used for the manufacturing of the sleeves. this could render affected instruments unusable after reprocessing.
  • Acción
    B Braun is advising users to ensure that the affected products are no longer used and to complete and fax the Facsimile Reply Form provided with the Customer Letter to them so that they may arrange for devices to be collected and repaired.

Device

OM040R - Doyen-Collin Mouth Gag 120mm Produced between Feb 2016 and Oct 2017 inclusive
  • Modelo / Serial
    OM040R - Doyen-Collin Mouth Gag 120mmProduced between Feb 2016 and Oct 2017 inclusiveARTG Number: 99164
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd