Events

Retiro De Equipo (Recall) de SAM XT Extremity Tourniquets (SAM XT) - Military (SAM-XT M) and Civilian (SAM-XT-C) Products

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Ferno 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-2018-RN-00434-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-05-17
  • 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-00434-1
  • 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
    Based on internal testing, ferno have identified a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. an affected tourniquet will not have the “box x stitch” icon on the upper right of the folded instructions for use (ifu) insert. tourniquets not affected will display the “box x stitch” icon on the upper right of the folded ifu.To date, no reports of adverse health consequences have been received.
  • Acción
    Ferno is advising customers to inspect inventory and quarantine affected units to prevent further use. Users should contact their Ferno Australia representative for return and replacement details.

Device

SAM XT Extremity Tourniquets (SAM XT) - Military (SAM-XT M) and Civilian (SAM-XT-C) Products
  • Modelo / Serial
    SAM XT Extremity Tourniquets (SAM XT) - Military (SAM-XT M) and Civilian (SAM-XT-C) Products Batch Numbers: XT1748 and XT1802 Impacted stock distributed between March 2017 - April 2018ARTG Number: 293915(Ferno Australia - Tourniquet strap)
  • Manufacturer
    Ferno Australia Pty Ltd

Manufacturer

Ferno Australia Pty Ltd