Events

Retiro De Equipo (Recall) de Stryker NV Excelsior (used to assist in the delivery of diagnostic agents) SL-10 90deg 2-Tip, NV Neuroform 3EZ-3.0x15mm and 3EZ-3.5x15mm Microcatheters (used with occlusive devices in the treatment of intracranial aneurysms)

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-2013-RN-01156-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-11-11
  • 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-2013-RN-01156-1
  • 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 become aware that certain lots of the affected neurovascular products have incorrect product expiry dates printed on the packaging. all products are currently still within their validated expiry date, the earliest expiry date being april 2015.
  • Acción
    Stryker is requesting users inspect stock and return affected stock to Stryker for replacement.

Device

Stryker NV Excelsior (used to assist in the delivery of diagnostic agents) SL-10 90deg 2-Tip, NV ...
  • Modelo / Serial
    Stryker NV Excelsior (used to assist in the delivery of diagnostic agents) SL-10 90deg 2-Tip, NV Neuroform 3EZ-3.0x15mm and 3EZ-3.5x15mm Microcatheters (used with occlusive devices in the treatment of intracranial aneurysms) NV Excelsior SL-10 90deg 2-Tip Neurovascular MicrocatheterCatalogue No: 168191Lot No: 17045959ARTG Number: 177031NV Neuroform 3EZ-3.0x15mm, 3EZ-3.5x15mm Stent SystemCatalogue Nos: EN3E3015, EN3E3515Lot Nos: 17032024, 17032027ARTG Number: 172281
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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