Events

Retiro De Equipo (Recall) de Medisafe SureSafe Wraps and Drapes

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 Medisafe Industries 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
    13741
  • Fecha de inicio del evento
    2012-11-02
  • 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: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • Causa
    Identified that the machinery used during the manufacturing of these particular products may have caused metal shaving, a residue of the grinding process, to be present in the finished product.To prevent recurrence of this issue the manufacturer is putting in place additional quality checks and quality control processes.
  • Acción
    Product to be returned to supplier

Device

Medisafe SureSafe Wraps and Drapes
  • Modelo / Serial
    Model: SU-J6102, SU-J6105, SUJ6106, SU-j6108, SU-J6122, SU-J6123, SU-J6126, SU-J6130, Affected: GA120807NS, GA120808NS, GA120802NS, GA12072ONS, GA120725NS,
  • Manufacturer
    Medisafe Industries Ltd

Manufacturer

Medisafe Industries Ltd
  • Source
    NZMMDSA