Events

Retiro De Equipo (Recall) de Vascutek Unsealed PTFE (Maxiflo)

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 Vascutek 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
    22345
  • Fecha de inicio del evento
    2017-12-08
  • 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 manufacturer has reviewed the ifu contents to ensure consistency across all product families and to ensure that the instructions for use provide state of the art instruction and content to users. as a result of these updates, further clarity will be provided to clinicians regarding immersion of grafts in saline solution, and to enhance knowledge on the use of formaldehyde in the manufacturing process.
  • Acción
    Instructions for use to be updated

Device

Vascutek Unsealed PTFE (Maxiflo)
  • Modelo / Serial
    Model: , Affected: All Lots
  • Manufacturer
    Vascutek Ltd

Manufacturer

Vascutek Ltd