Events

Retiro De Equipo (Recall) de FAKWP (Fineline 6100258) and FAKSITE (Fineline 5820595) First Aid Kits

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Scott Health and Safety.

¿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-2014-RN-01234-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-11-27
  • 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-2014-RN-01234-1
  • 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
    Scott safety has been advised by the supplier, pacsource, of the ‘10 ml normal saline for irrigation’ with batch number 1t2324002 included in the kits may not be sterile after failing the test for sterility undertaken by the tga.
  • Acción
    Scott Safety is recalling all affected First Aid Kits and requesting that these kits should be returned to them immediately. Scott Safety will inspect and replace ‘10 ml Normal Saline for Irrigation’ with alternate component that has already been secured. All new stock will be clearly marked with a QC sticker next to the barcode. This action has been closed-out on 18/03/2016.

Device

FAKWP (Fineline 6100258) and FAKSITE (Fineline 5820595) First Aid Kits
  • Modelo / Serial
    FAKWP (Fineline 6100258) and FAKSITE (Fineline 5820595) First Aid Kits All lot NumbersARTG Number: 170275
  • Manufacturer
    Scott Health and Safety

Manufacturer

Scott Health and Safety
  • Source
    DHTGA