Events

Retiro De Equipo (Recall) de Cardioxyl Sutures

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Reid 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-00670-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-06-23
  • 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-00670-1
  • 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
    A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified. the treatment substance which is used during the manufacture for easing the crimping process of the needles is only applied on the area where the thread is in contact with the needle ie, approximately one (1) cm from the end of the thread. the treated ends are clearly out of the implanted section of the thread.
  • Acción
    Customers are advised to inspect their stock and quarantine all affected units. Reid Healthcare Pty Ltd will arrange for affected stock to be recovered and issued with replacement stock or a credit note.

Device

Cardioxyl Sutures
  • Modelo / Serial
    Cardioxyl SuturesProduct Numbers: : 73130AN, 73130T, 73P30A, 73P30AM, 73P30AN, 73P30BS, 73P30O, 73P30P, 73P30R, 73P30U, 73P30V, 73S30AE, 73S30AG, 73S30AT, 73S30AX, 73S30P and 73S30VMultiple batch numbersARTG Number: 166050
  • Manufacturer
    Reid Healthcare Pty Ltd

Manufacturer

Reid Healthcare Pty Ltd