Events

Retiro De Equipo (Recall) de TISSUE-GUARD Family of Products - VASCU-GUARD, DURA-GUARD, PERI-GUARD and SUPPLE PERI GUARD (Xenograft)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Baxter Healthcare 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-2013-RN-01036-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-10-14
  • 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-2013-RN-01036-1
  • 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
    There is a possibility of packaging leakage for the tissue-guard family of products- vascu-guard, dura-guard, peri-guard, and supple peri-guard. these products are packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. the contents of the unopened, undamaged container are sterile. leakage can occur as a result of damage during shipment and can be identified by an unsealed container or by highly visible evidence of water damage to the packaging, instructions for use, box, label, and/or - surrounding products in the shipping container.
  • Acción
    Baxter is requesting their customers to locate all affected product and return for credit.

Device

TISSUE-GUARD Family of Products - VASCU-GUARD, DURA-GUARD, PERI-GUARD and SUPPLE PERI GUARD (Xeno...
  • Modelo / Serial
    TISSUE-GUARD Family of Products - VASCU-GUARD, DURA-GUARD, PERI-GUARD and SUPPLE PERI GUARD (Xenograft)
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd