Events

Retiro De Equipo (Recall) de Renasys Transparent Film and Renasys Gauze Dressing Kits (used to dress, protect and seal wounds undergoing Negative Pressure Wound Therapy (NPWT))

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smith & Nephew 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-2016-RN-01065-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-08-10
  • 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-2016-RN-01065-1
  • 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
    Smith & nephew have identified seal integrity failures on the folded sterile renasys transparent film pouches during transit testing. all the seal integrity failures identified during the testing occurred at the point where the sterile renasys transparent film pouches were folded during the packaging process.The loss of sterility has the potential to contribute to a local infection. to date, smith & nephew is not aware of any complaints reported in relation to this issue that has led to a local infection.
  • Acción
    Smith & Nephew are advising users to inspect stock and quarantine all affected units. In the event that a Transparent Film is required for NPWT therapy, the responsible Health Care Professional should be consulted to determine an alternative Transparent Film or alternative treatment. Affected stock can be returned and replaced with unaffected product.

Device

Renasys Transparent Film and Renasys Gauze Dressing Kits (used to dress, protect and seal wounds ...
  • Modelo / Serial
    Renasys Transparent Film and Renasys Gauze Dressing Kits (used to dress, protect and seal wounds undergoing Negative Pressure Wound Therapy (NPWT))Part Numbers: 66800394, 66800932, 66800933, 66800934, 66800935, 66800936, 66801255, 66801256, 66801257, 66801258Multiple Products and Lot Numbers affectedARTG Number: 149671
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd