Events

Retiro De Equipo (Recall) de Skin Graft Knife Blades for use with Thackray Watson Cobbett and Braithwaite Skin Graft Knife (Pack of 10 blades)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Random Parts.

¿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-2014-RN-00654-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-06-24
  • 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-2014-RN-00654-1
  • 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 have two reports of product found during use where the terminally sterile packaging has not been fully sealed. the manufacturer is advising that the issue remains isolated to batch 6561302 and will be evident prior to use.
  • Acción
    Customers are advised to ensure that the affected batch is isolated. Random Parts will arrange for the affected stock to be collected and replaced.

Device

Skin Graft Knife Blades for use with Thackray Watson Cobbett and Braithwaite Skin Graft Knife (Pa...
  • Modelo / Serial
    Skin Graft Knife Blades for use with Thackray Watson Cobbett and Braithwaite Skin Graft Knife (Pack of 10 blades)Product Code: 667455Lot Number: 6561302ARTG Number: 122572
  • Manufacturer
    Random Parts

Manufacturer

Random Parts
  • Source
    DHTGA