Events

Retiro De Equipo (Recall) de Figulla Flex II ASD, Figulla Flex II PFO and Occlutech PDA Occluder Cardiac Occluders

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Getz Healthcare 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-00147-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-02-03
  • 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-00147-1
  • 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
    Occlutech has received a report whereby a customer inadvertently used an expired occlutech flex ii pusher cable and noticed doing so shortly after the implantation procedure. there was no impact on the patient, the procedure or the product performance. occlutech occluders and compatible pusher cables are packaged together into an occlutech product set which also contains the instructions for use and the patient information card. the outer label on the occlutech product set clearly shows the expiration dates of both the occluder and the pusher cable. as these dates can differ from each other, it is important to check both dates to not miss the shortest expiration date.
  • Acción
    Occlutech will in future be implementing a revised Occlutech product set label showing only the shortest expiry date. For current inventory, Getz Healthcare is advising customers to immediately check the expiration dates of the Occlutech Occluder and of the pusher cable as printed on the outer box-label of all products in their current inventory. If one of the expiration dates is exceeded, customers are to block and remove the Occlutech Occluder set containing the expired product from their inventory. Getz will replace all expired stock. End-users are also advised to carefully routinely review the Occutech Occluder set labels prior to use, in accordance the Instructions for Use. This action has been closed-out on 01/03/2018.

Device

Figulla Flex II ASD, Figulla Flex II PFO and Occlutech PDA Occluder Cardiac Occluders
  • Modelo / Serial
    Figulla Flex II ASD, Figulla Flex II PFO and Occlutech PDA Occluder Cardiac OccludersFigulla Flex II ASDProduct Code: 29ASDxx Figulla Flex II PFOProduct Code: 19PFOxxD Occlutech PDA OccluderProduct Codes: 42PDAxx, 42PDAxxL, 43PDAxxLMultiple Lot NumbersARTG Numbers: 201602, 201603, 219523
  • Manufacturer
    Getz Healthcare Pty Ltd

Manufacturer

Getz Healthcare Pty Ltd