Events

Retiro De Equipo (Recall) de Cryolife Bioglue Surgical Adhesive

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 Cryolife Inc.

¿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
    16856
  • Fecha de inicio del evento
    2014-06-19
  • 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
    At the request of the fda the manufacturer has changed the expiration dating for bioglue surgical adhesive from 24 months to 18 months due to the fact that the serum albumin component monomer failed to meet internally established end of shelf-life specification. the specification limit was set based on manufacturing capability at the time the process was first established.
  • Acción
    Instructions for use to be updated

Device

Cryolife Bioglue Surgical Adhesive
  • Modelo / Serial
    Model: CRY-BG3515-5, Affected: Lot No: all lot numbers pre 14MGV024
  • Manufacturer
    Cryolife Inc

Manufacturer

Cryolife Inc