Events

Retiro De Equipo (Recall) de AQUAPAK BRITISH and INTL 340 SW, 340 ML W/040B Humidifier Adaptors

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-2015-RN-00138-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-03
  • 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-2015-RN-00138-1
  • 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 medical is recalling the products listed due to a possibility that the packages may contain foreign material, (predominantly synthetically derived pvc). this foreign matter has only been found in the package and not in the gas flow path of the humidifier product. if the foreign matter particles migrate into the sterile water reservoir, or enter the connecting tubing between the reservoir and the patient, the particle could potentially enter the patient airway at very high gas flows and could cause the hazard of mild lung discomfort, which is usually temporary and reversible.
  • Acción
    A Teleflex representative will contact hospitals and medical centres to arrange for the affected devices to be inspected. Any units with foreign material will be recalled. If there is no visible foreign matter the product is safe to use. Unaffected batches are not expected to be available until May 2015. This action has been closed-out on 31/05/2016.

Device

AQUAPAK BRITISH and INTL 340 SW, 340 ML W/040B Humidifier Adaptors
  • Modelo / Serial
    AQUAPAK BRITISH and INTL 340 SW, 340 ML W/040B Humidifier AdaptorsCatalogue number: 400340 Batch Numbers: 149137, 307137, 362137, 385137Catalogue number: 003-40B Batch Numbers: 312137, 394137, 396137, 429137Catalogue Number: 400360 Batch Number: 91136ARTG Number: 215829
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd