Events

Retiro De Equipo (Recall) de Medline Procedure Packs containing Covidien Devon Light Gloves

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medline International Two 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-2015-RN-00395-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-05-08
  • 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-2015-RN-00395-1
  • 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
    This recall has been initiated from the advice of medline’s supplier medtronic, involving lot numbers 508xxxx and below. these light gloves may contain splits and pin holes. if a clinician touches the handle unaware that the light glove is split and or contains pin holes, microorganisms from the light handle could be transferred to the clinician and thus patient, resulting in risk of surgical site infection.
  • Acción
    Medline is advising end users to remove the Light Glove from the procedure pack and discard at the point of surgery. This action has been closed-out on 16/02/2016.

Device

Medline Procedure Packs containing Covidien Devon Light Gloves

Manufacturer

Medline International Two Australia Pty Ltd