Events

Retiro De Equipo (Recall) de STATLOCK IAB Stabilisation Device (offers needle-free securement for intra-aortic balloon (IAB) catheters)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Maquet 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-2016-RN-00697-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-08
  • 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-2016-RN-00697-1
  • 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
    During post-quarantine packaging it was identified that the ifu for the statlock sheath stabilisation device for percutaneous sheath introducers was erroneously packaged with the mega and sensation plus iab catheter kits, instead of the ifu for the statlock catheter stabilisation device for iab catheters.
  • Acción
    Maquet is advising users to inspect and identify the affected stocks. The IFU from the affected units should be removed and disposed prior to the use of the device. Affected customers can obtain a copy of the correct IFU by visiting the Maquet website at www.Maquet.com/statlockIFU , by scanning the QR code in the customer letter or by contacting the customer's local Maquet representative. This action has been closed-out on 11/05/2017.

Device

STATLOCK IAB Stabilisation Device (offers needle-free securement for intra-aortic balloon (IAB) c...
  • Modelo / Serial
    STATLOCK IAB Stabilisation Device (offers needle-free securement for intra-aortic balloon (IAB) catheters)Macquet Part Number: 0065-00-0704Products affectedAll lot numbers from 3000001484 to 3000024495ARTG Number: 139645
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    DHTGA