Events

Retiro De Equipo (Recall) de Ultradent Absorbent Point

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 Ultradent Products Inc.

¿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
    21842
  • Fecha de inicio del evento
    2017-08-21
  • 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: Ultradent Products Australia Pty Ltd, 61 Reid Road, Glenbrook, RD1, Waiuku 2681
  • Causa
    The sterile packaging on the products was removed in order to place the product barcode underneath on the product container. this process created a non-sterile product when distributed. although no complaints have been received, it is recommended that these lots of absorbent paper points be discarded.
  • Acción
    Product to be returned to supplier

Device

Ultradent Absorbent Point
  • Modelo / Serial
    Model: , Affected: Part No. 1560, 1554, 1555, 1558, 1559
  • Manufacturer
    Ultradent Products Inc

Manufacturer

Ultradent Products Inc