Events

Retiro De Equipo (Recall) de CADD Medication Cassette Reservoir, 50ml

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smiths Medical Australasia 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-2015-RN-00081-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-01-30
  • 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-2015-RN-00081-1
  • 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
    Smiths medical has received a small number of complaints of leakage associated with the above-referenced cassettes. a small amount of leaking has been found to occur at the welding of the tube to the internal reservoir bag on some cassettes. if the leakage is noticed during cassette filling, it could result in a delay of therapy while an alternative cassette is obtained. if the leakage is noticed during fluid delivery with the patient, it could result in an interruption in therapy while the cassette is replaced.
  • Acción
    End users are requested to inspect their inventory and quarantine the affected Cassettes. A customer service representative will arrange for exchange of any unused affected Cassettes for credit or replacement. This action has been closed-out on 17/08/2016.

Device

CADD Medication Cassette Reservoir, 50ml
  • Modelo / Serial
    CADD Medication Cassette Reservoir, 50ml Order Code: 21-7001-24Batch Numbers: 14X297 and 14X323Order Code: 21-7301-24Batch Numbers: 14X324ARTG Number: 145297
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd