Events

Retiro De Equipo (Recall) de Pine O Cleen DisinfectantHospital Grade 1.25 Plastic Bottles

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Reckitt Benckiser 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-00207-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-03-09
  • 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-00207-1
  • 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
    Pine o cleen disinfectant hospital grade (artg: 60110) in 1.25l plastic bottles may have a sub visible stress crack in the bottle neck which may cause the bottle to leak or the cap to break off at the neck and spillage may occur. in the event this happens it will typically occur when the bottle is opened for the first time or within the first few uses.The health risk associated with this issue is accidental exposure to skin and eyes potentially causing transient irritation that would likely be self limiting.If there is contact with the eyes or skin, wash the area with a large amount of water. if irritation persists see your doctor.This recall does not affect any other batches or sizes of pine o cleen disinfectant or any other rb products. this batch has been distributed to retail trade from january 16th 2018 until february 24th, 2018.All product received post february 24th, 2018 is not affected.
  • Acción
    Customers are asked to inspect their stock on hand and return affected product as per the instructions given in the Customer Letter

Device

Pine O Cleen DisinfectantHospital Grade 1.25 Plastic Bottles
  • Modelo / Serial
    Pine O Cleen DisinfectantHospital Grade 1.25 Plastic BottlesARTG Number: 60110(RECKITT BENCKISER NON-STERILE DISINFECTANTS, WITHOUT CLAIMS 'BENZALKONIUM CHLORIDE')
  • Manufacturer
    Reckitt Benckiser Pty Ltd

Manufacturer

Reckitt Benckiser Pty Ltd