Events

Retiro De Equipo (Recall) de Nv Guider Catheter 90cm NV GUIDER CATHETER 90CM 40° 7F; NV GUIDER CATHETER 90CM ST 7F; NV GUIDER CATHETER 90CM ST 8F

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-2017-RN-01517-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-12-18
  • 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-01517-1
  • 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
    Stryker has initiated a lot specific product recall on certain lots of guider 7f and 8f product which may be at risk of degrading within their shelf-life period. the root cause of the issue is exposure of components to uv light while in storage between 2014 and october 2017.There have been no reports of injuries associated with this issue.
  • Acción
    Stryker is advising users to inspect stock an quarantine any remaining units of the affected product. Affected stock can be returned to Stryker and replaced with unaffected product.

Device

Nv Guider Catheter 90cm NV GUIDER CATHETER 90CM 40° 7F; NV GUIDER CATHETER 90CM ST 7F; NV GUIDER ...
  • Modelo / Serial
    Nv Guider Catheter 90cm NV GUIDER CATHETER 90CM 40° 7FItem Number: 10043 Lot Numbers: 19948645, 18836128, 19545073, 19793264, 19809517, 20024281 NV GUIDER CATHETER 90CM ST 7FItem Number: 10051 Lot Numbers: 18898135, 18898416NV GUIDER CATHETER 90CM ST 8F Item Number: 10052 Lot Numbers: 18643117ARTG Number: 146034
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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