Events

Retiro De Equipo (Recall) de Vascutek Gelweave Grafts

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
    17011
  • Fecha de inicio del evento
    2014-07-16
  • 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
    Manufacturer provides a high temperature cautery with each gelweave and thoraflex hybrid product and a low temperature cautery with each biovalsalva stentless biplex , stented biovalsalva biplex and rvot elan biplex conduit. these cauteries are used to cut and trim the graft. manufacturer has decided to stop supplying the cautery with these product packs due to the cautery battery having a shorter shelf life than the vascutek graft product. manufacturer will update the ifu, removing the reference to the inclusion of a catery with thes products., manufacturer will not be recalling any product as there is negligible rsk to users and patients.
  • Acción
    Instructions for use to be updated

Device

Vascutek Gelweave Grafts
  • Modelo / Serial
    Model: , Affected: all lots
  • Manufacturer
    Vascutek Ltd

Manufacturer

Vascutek Ltd