Events

Retiro De Equipo (Recall) de Stryker Neurovascular Excelsior SL-10/Excelsior 1018 Microcatheters

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-00485-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-09
  • 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-00485-1
  • 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 above excelsior sl-10/excelsior 1018 microcatheters have incorrect product expiry dates printed on the packaging. the earliest expiration date of the affected products is may 2016. in the event these products remain in the market after the labelled expiry date, there is a potential hazard that patients exposed to this product may experience severe health consequences.
  • Acción
    Stryker is requesting their customers to quarantine any affected lots on hand. Any affected items will be removed by the Stryker Representative and customers will be provided with unaffected replacement stock. This action has been closed-out on 18/08/2016.

Device

Stryker Neurovascular Excelsior SL-10/Excelsior 1018 Microcatheters
  • Modelo / Serial
    Stryker Neurovascular Excelsior SL-10/Excelsior 1018 MicrocathetersExcelsior SL-10 150CM 2 TIPExcelsior 1018 Pre-shaped 45 150CMExcelsior SL-10 Pre-shaped 45 150CMExcelsior SL-10 Pre-shaped 90 150CMExcelsior SL-10 Pre-shaped J 150CMCatalogue Numbers: 168189, 144190, 168190, 168191, 168192Lot Numbers: 17026669, 17013156, 17013021,17026849, 17030892, 17045869, 17045959, 17046094, 17046274, 17046229ARTG Numbers: 177031, 149440, 147430
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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