Events

Retiro De Equipo (Recall) de WECK Visistat 35W Skin Stapler

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Teleflex Medical 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-2016-RN-01545-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-25
  • 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-01545-1
  • 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
    Teleflex is recalling this product due to potential for an incomplete seal on the sterile package. the sterility of the product cannot be guaranteed. if a non-sterile product is used, there is potential for infection to occur. a broken sterile seal on a sterile package is typically easily seen before use. no patient injuries have been reported related to this issue.
  • Acción
    Teleflex is advising customers to immediately quarantine affected stock. Affected stock is not to be distributed. Teleflex will arrange for the collection of affected stock and will issue credit for returned stock.

Device

WECK Visistat 35W Skin Stapler
  • Modelo / Serial
    WECK Visistat 35W Skin StaplerCatalogue Number: 528235Batch Numbers: 73H1500255, 73K1500618ARTG Number: 126367
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd