Events

Retiro De Equipo (Recall) de Askina Gel 15g

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-00364-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-05-17
  • 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-00364-1
  • 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
    B.Braun's manufacturing site it has determined that the irradiation dose qualified for sterilisation of specific products was too low. in consequence, the germ reduction through gamma irradiation may not have reached the requested sterility assurance level of 0.000001.To date, there have been no reports of any adverse patient outcome as a result of this issue.
  • Acción
    B.Braun is advising customers to identify quarantine and return affected stock as per the instructions given in the Customer letter.

Device

Askina Gel 15g
  • Modelo / Serial
    Askina Gel 15g Item Code: 001419NAll BatchesARTG Number: 177492(B Braun Australia Pty Ltd - Dressing, hydrogel)Irradiation Dose Qualified for Sterilisation
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd