Events

Retiro De Equipo (Recall) de COSEAL Surgical Sealant 2ml and 4ml

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Baxter Healthcare Pty 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
    RC-2014-RN-00827-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-24
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00827-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Out of specification results were 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 a serious risk for the patient's life. all other stability requirements were met. the investigation into this issue is ongoing, and appropriate actions will be taken.
  • Acción
    Baxter is requesting their customers to discontinue use of the affected lots. Baxter Customer Service can be contacted to arrange for the return of affected inventory. This action has been closed-out on 04/08/2016.

Device

COSEAL Surgical Sealant 2ml and 4ml
  • Modelo / Serial
    COSEAL Surgical Sealant 2ml and 4mlCOSEAL 2mlProduct Code: 934073COSEAL 4mlProduct Code: 934074Multiple lot numbers affectedARTG Number: 181132
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd