Events

Retiro De Equipo (Recall) de Spiggle & Theis ENT sinus single-use suction tubes (used for paranasal sinus suction)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por CoreMed 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-00184-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-19
  • 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-00184-1
  • 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
    There is a chance that the connection between the tube and the tip is faulty. this can lead to the tip loosening during use. the resulting risk for the patient, is that the tip could be left behind in the treated area or could be inhaled, which may lead to a severe health impairment for the patient. to date we are not aware of such a case.
  • Acción
    CoreMed is advising users to quarantine any remaining stocks of the affected product and return for replacement with unaffected stock.

Device

Spiggle & Theis ENT sinus single-use suction tubes (used for paranasal sinus suction)
  • Modelo / Serial
    Spiggle & Theis ENT sinus single-use suction tubes (used for paranasal sinus suction)Disposable suction tubes, 100mm length, sinus/nasal, 3.0mm dia, 45°angle, box of 50 (9fr)Product Code: REF 3010030Lot Number: 014443Disposable suction tubes, 100mm length, sinus/nasal, 4.0mm dia, 45°angle, box of 50 (12fr)Product Code: REF 3010040Lot Number: 014645, 014832ARTG Number: 205220
  • Manufacturer
    CoreMed Pty Ltd

Manufacturer

CoreMed Pty Ltd