Events

Retiro De Equipo (Recall) de Baxter CoSeal Surgical Hemostatic Sealant, 2ml and 4ml

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 Baxter Healthcare Corporation SA.

¿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
    17037
  • Fecha de inicio del evento
    2014-07-25
  • 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: Baxter Healthcare Ltd, 33 Vestey Drive, Mt Wellington, AUCKLAND
  • Causa
    The recall is being conducted as a precautionary measure due to out of specification results observed at the 18-month time point (out of 18-month licensed shelf life to expiration) during a coseal stability study. the parameter that is out of specification is an indicator of possible failure for the product to gel appropriately. coseal's failure to gel does not represent risk for the patient's life. all other stability requirements were met.
  • Acción
    Product to be returned to supplier

Device

Baxter CoSeal Surgical Hemostatic Sealant, 2ml and 4ml

Manufacturer

Baxter Healthcare Corporation SA