Events

Retiro De Equipo (Recall) de ARROW OnControl System Trays ARROW OnControl Bone Lesion Biopsy System Tray ARROW OnControl Bone Marrow Biopsy System Tray ARROW OnControl System Sterile Procedure Tray

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Teleflex 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-2016-RN-01494-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-14
  • 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-01494-1
  • 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
    Teleflex has identified an issue where there is the potential for an incomplete seal on the outer sterile package. because of the compromised packaging, the sterility of the inside drape, which is used in preparation for bone marrow aspiration with the oncontrol system, cannot be guaranteed. if sterility of the drape is compromised, there is the potential for infection to occur.
  • Acción
    Customers are advised not to use or further distribute any affected stock. Teleflex Medical will arrange collection of the stock under quarantine and a credit to be applied to the customer's account.

Device

ARROW OnControl System Trays ARROW OnControl Bone Lesion Biopsy System Tray ARROW OnControl Bone ...
  • Modelo / Serial
    ARROW OnControl System TraysARROW OnControl Bone Lesion Biopsy System TrayARROW OnControl Bone Marrow Biopsy System TrayARROW OnControl System Sterile Procedure TrayCatalogue Numbers: 9403-EU-006, 9408-EU-006, 9411-EU-006, 9462-EU-001, 9463-EU-001, 9464-EU-001, 9466-EU-001Multiple Batch NumbersARTG Number: 264374
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd