Events

Retiro De Equipo (Recall) de Fusion Pushing Catheter

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por William A Cook 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-00852-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-07-11
  • 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-2017-RN-00852-1
  • 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
    Cook medical has identified a labelling issue with the fusion pushing catheter. the graphic on the product label on the fs-pc-7 device shows the outer diameter (od) of the pushing catheter is 7fr. however, the od of the pushing catheter for the fs-pc-7 device is 6fr; therefore the od has been incorrectly represented on the label. this issue impacts the product label only.The device has always been manufactured to the correct specification (6fr) and has been shown in design verification and validation during simulated use testing that it can be effectively used with a 7fr stent (as indicated on the label that it can be used with a 7fr stent).To date, there have been no complaints or reports of injury/illness due to this issue.
  • Acción
    Cook Medical is requesting customers: 1. Examine inventory immediately to identify and quarantine affected products; 2. Return the required Acknowledgement and Receipt Form indicating quantities, part numbers, and lot numbers of affected products within 30 days; 3. Return any affected products as per the instructions in the acknowledgement and receipt Form; 4. Even if you do not have affected products, you must still complete the Acknowledgement and Receipt Form and send it via fax (07 3841 3905) or email to cau.custserv@cookmedical.com 5. Report adverse events to Cook Medical Customer Relations at cau.custserv@cookmedical.com , or call toll free -1800 777 222 Monday through Friday between 7:30 am and 5:00 pm (Eastern Time), or by email to: cau.custserv@cookmedical.com.

Device

Fusion Pushing Catheter

Manufacturer

William A Cook Australia Pty Ltd