Events

Retiro De Equipo (Recall) de VASCU-GUARD Peripheral Vascular Patch, 0.8 x 8cm

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-2016-RN-00879-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-07-01
  • 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-00879-1
  • 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
    Baxter healthcare is issuing a recall notice in response to post-marketing reports overseas received for the vascu-guard peripheral vascular patch. to date, baxter has received four post-marketing reports for the vascu-guard product for intraoperative or post-operative bleeding episodes, which required additional clinical intervention. at this point, it is unknown whether there is any causal relationship between vascu-guard and the reported events. in the interim, baxter is requesting that customers immediately discontinue the use of the identified product lots until the investigation has concluded.
  • Acción
    Baxter is advising users to discontinue use, and return all affected stock.

Device

VASCU-GUARD Peripheral Vascular Patch, 0.8 x 8cm
  • Modelo / Serial
    VASCU-GUARD Peripheral Vascular Patch, 0.8 x 8cmProduct Code: VG0108NLot Number: SP16B05-1119217Supplied under the Special Access Scheme (SAS)
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd