Events

Retiro De Equipo (Recall) de Kii Abdominal Troacar5x55mm Kii Optical Z-Thread Dual Pack

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Applied Medical 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-01102-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-23
  • 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-01102-1
  • 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
    Applied medical has been advised that during shipment, the packaging of specific lots of kii abdominal troacars have the potential to become punctured with small holes, which would compromise the sterile barrier.
  • Acción
    1. Users are to complete the Customer Recall Notification Confirmation Form supplied with the customer letter to acknowledge the recall and indicate if they are returning or have already used the affected lots. 2. If no product is being returned, indicate this on the supplied Customer Recall Notification Confirmation Form 3. Return the supplied Recall Notification Confirmation Form to Applied Medical Australia 4. Return affected product and a copy of the supplied Recall Notification Confirmation Form to Applied Medical.

Device

Kii Abdominal Troacar5x55mm Kii Optical Z-Thread Dual Pack
  • Modelo / Serial
    Kii Abdominal Troacar5x55mm Kii Optical Z-Thread Dual PackModel Number: CTR14Lot Numbers: 1269694, 1275188, 1279039, 1283226, and 1287785ARTG Number: 224148
  • Manufacturer
    Applied Medical Australia Pty Ltd

Manufacturer

Applied Medical Australia Pty Ltd