Events

Retiro De Equipo (Recall) de ISOMed Arterial Embolectomy Catheters – Single Lumen (2F & 3F)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medical Specialties 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-00091-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-01-18
  • 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-00091-1
  • 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 (isomed) has advised that for procedures requiring embolectomy/thrombectomy of arteriovenous (av) fistulas, the catheter used should have the tensile strength to withstand at least 9n of resistance. after extensive testing, it was determined that the maximum resistances of the isomed 2f, 3f & 4f single lumen arterial embolectomy catheters are: 3n, 5n & 9n respectively. to minimise the risk of vessel damage, balloon rupture or tip detachment in av fistula procedures, it is recommended that single lumen arterial embolectomy catheters of less than 4f (i.E. 2f & 3f) should not be used for these procedures. the “warnings” section of the ifu has been updated to include this information.
  • Acción
    Medical Specialties Australia is advising users to immediately inspect their stock for affected products. IFUs in the affected stock are to be discarded and replaced with a copy of the updated IFU. This action has been closed-out on 26/05/2017.

Device

ISOMed Arterial Embolectomy Catheters – Single Lumen (2F & 3F)
  • Modelo / Serial
    ISOMed Arterial Embolectomy Catheters – Single Lumen (2F & 3F)Product/Catalogue Numbers (2F): 300240, 300260, 300280, 300240T, 300260T, 300280TProduct/Catalogue Numbers (3F): 300340, 300360, 300380, 300340T, 300360T, 300380TAll Lots/Batches affectedARTG Number: 168959
  • Manufacturer
    Medical Specialties Australia Pty Ltd

Manufacturer

Medical Specialties Australia Pty Ltd
  • Source
    DHTGA