Events

Retiro De Equipo (Recall) de Braces and Supports- Orthosis, leg, ankle/foot, unit

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 3M Health Care Group.

¿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
    22554
  • Fecha de inicio del evento
    2018-02-05
  • 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: 3M New Zealand Ltd, 250 Archers Road, Glenfield, AUCKLAND 0627
  • Causa
    The manufacturer recently became aware that there is natural rubber latex (1%) in the futuro™ quick strap ankle support. current packaging of this product does not have an explicit caution statement in relation to latex. individuals that are sensitive to latex may develop a reaction ranging from mild irritation to anaphylaxis when exposed to latex.
  • Acción
    Product to be returned to supplier

Device

Braces and Supports- Orthosis, leg, ankle/foot, unit
  • Modelo / Serial
    Model: , Affected: Quick Strap Ankle Support – 47736EN
  • Manufacturer
    3M Health Care Group

Manufacturer

3M Health Care Group
  • Empresa matriz del fabricante (2017)
    3m Company
  • Source
    NZMMDSA