Events

Retiro De Equipo (Recall) de Surgical Tissue Pouches

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 Cook Incorporated.

¿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
    21481
  • Fecha de inicio del evento
    2017-06-01
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Causa
    The reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilisation of these products. preliminary investigation indicates that validation data related to the reprocessing of these devices do not meet the current guidance.
  • Acción
    Product to be returned to supplier

Device

Surgical Tissue Pouches
  • Modelo / Serial
    Model: , Affected: Lapsac Introducer, G16500 All Lots, G15771 All Lots
  • Manufacturer
    Cook Incorporated

Manufacturer

Cook Incorporated