Events

Retiro De Equipo (Recall) de Kimguard Container Filters 23cm x 23cm (square)

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 Kimberly-Clark Corp.

¿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
    14359
  • Fecha de inicio del evento
    2013-03-25
  • 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: Kimberly-Clark New Zealand, Level 1, 86 Plunket Ave, Manukau City, Auckland
  • Causa
    Investigation has identified that some individual container filter units from product lots as listed might contain thin layers that may potentially compromise the ability of the filter to maintain a sterile barrier. the risk associated with this potential failure mode is that use of an affcetd filter could result in possible contaimination of surgical instruments and supplier within the container.
  • Acción
    Product to be returned to supplier

Device

Kimguard Container Filters 23cm x 23cm (square)
  • Modelo / Serial
    Model: 68509, Affected: MF1279xxx. MF1287xxx, MF1288xxx
  • Manufacturer
    Kimberly-Clark Corp

Manufacturer

Kimberly-Clark Corp