Events

Retiro De Equipo (Recall) de Bair Hugger® Blankets - Temperature Management System

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
    22550
  • Fecha de inicio del evento
    2018-02-01
  • 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 through customer feedback that a design change to 3mtm bair hugger full access underbody warming blanket, model 63500 can make these blankets more susceptible to unintended occlusion of airflow resulting in limited or partial inflation during use.
  • Acción
    Product to be returned to supplier

Device

Bair Hugger® Blankets - Temperature Management System
  • Modelo / Serial
    Model: , Affected: Lots numbers R10359, R10360, R10361, R10362, R10363, R10364, R10365, R 10366;
  • Manufacturer
    3M Health Care Group

Manufacturer

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