Events

Retiro De Equipo (Recall) de Disposable StrykeFlow Tip(electrosurgical suction tip)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker 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-2015-RN-00484-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-05
  • 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-2015-RN-00484-1
  • 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
    An internal review concluded that 6 lots of disposable strykeflow tips were shipped with a potentially deformed blister pouch, which could potentially impact the sterility of the product. although to date there have been no reported events of infection to stryker as a result of using potentially affected product, there is a remote possibility for infection due to usage of a non-sterile product.
  • Acción
    Customers are asked to check any affected items in their possession and quarantine any affected units immediately. A Stryker Representative will coordinate an inspection of the affected items in quarantine. Any affected items will be removed by the Stryker Representative. This action has been closed-out on 2/06/2016.

Device

Disposable StrykeFlow Tip(electrosurgical suction tip)
  • Modelo / Serial
    Disposable StrykeFlow Tip(electrosurgical suction tip)Item Number: 250-070-505Affected Lots: 14021FG2, 13337FG2, 13343FG2, 13347FG2, 14007FG2, 14016FG2ARTG Number: 142786
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA