Events

Retiro De Equipo (Recall) de Medline Custom Procedure Kits

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Medline Assembly 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
    18514
  • Fecha de inicio del evento
    2015-05-14
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: REM Systems Limited, 69 Elizabeth Knox Place, Glen Innes, AUCKLAND
  • Causa
    Medline is recalling certain lots of procedure packs which contain covidien devon light gloves. 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, micro-organisms from the light handle could be transferred to the clinician and thus patient, resulting in risk of surgical site infection. medline is recommending that a light cover is discarded at the time of the surgical procedure.
  • Acción
    Manufacturer to issue advice regarding use

Device

Medline Custom Procedure Kits

Manufacturer

Medline Assembly Australia Pty Ltd