Events

Retiro De Equipo (Recall) de RPK-01 Luer Connector

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Tekmed 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-2018-RN-00251-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-03-28
  • 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-2018-RN-00251-1
  • 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
    It has been identified that there is a difficulty connecting the female luer to haemodialysis blood tubing lines, end caps and syringes which may result in blood or air leakage at the connection site. to date, there have been no reports of injury in australia as a result of this issue.
  • Acción
    TekMed is requesting customers immediately review their stock on hand for affected units and to discontinue their use and distribution. Affected product should be returned to TekMed who will issue a suitable account credit. New unaffected product is currently being manufactured.

Device

RPK-01 Luer Connector
  • Modelo / Serial
    RPK-01 Luer Connector Lot Number: MCCC310Expiry Date:13-10-2021ARTG Number:145174 (Tekmed - Medcomp Long-term Implantable Haemodialysis Catheter Packs - Catheter, haemodialysis, implantable)
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Manufacturer
    Tekmed Pty Ltd

Manufacturer

Tekmed Pty Ltd