Events

Retiro De Equipo (Recall) de Caliber Inflation Device

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Bard 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-2017-RN-00758-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-06-13
  • 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-2017-RN-00758-1
  • 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
    The manufacturer, perouse medical has identified that specific product code / lot number combinations of the caliber inflation device may be at risk of containing a crack in the primary packaging, resulting in a breach of the sterile barrier. for a cracked package, there is the risk of microbial contamination (infection) caused by the use of a product. sterility would not be preserved due to a primary packaging damage.
  • Acción
    Bard is advising users to immediately examine their inventory, and quarantine and remove product subject to this recall from their shelves. Do not use or further distribute any affected product. Product is to be returned by either handing to the user's Bard Territory Manager or by contacting Bard Australia Customer Service who will arrange for the return of any affected product.

Device

Caliber Inflation Device
  • Modelo / Serial
    Caliber Inflation DeviceProduct Code: CL3030Lot Numbers: 15045606, 15055430, 15065858, 15075121, 15075411, 15075821 and 15085378ARTG Number: 174371
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd