Events

Retiro De Equipo (Recall) de Medtronic Xomed Instrument Trays

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtronic 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-2013-RN-00781-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-08-01
  • 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-2013-RN-00781-1
  • 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
    During the validation of a new instrument, testing revealed that use of a gravity steam cycle with one of the listed instrument trays did not produce the sterility assurance level (sal) of 10-6 required by industry standard (ansi/aami st77:2006). a subsequent investigation of all medtronic xomed instrument trays identified additional trays as having certain locations within the tray that would not meet the recommended sterilization level of sal 10-6 during gravity steam sterilization cycles.
  • Acción
    Hospitals that use GRAVITY steam sterilisation cycles are requested to quarantine all stock immediately. Hospitals that use PREVACUUM steam sterilisation are advised that they can continue to use the trays once they have attached a label stating 'PREVACUUM ONLY' provided by Medtronic. A Medtronic representative will be in contact with customers to arrange for replacement with a new tray with updated labelling.

Device

Medtronic Xomed Instrument Trays
  • Modelo / Serial
    Medtronic Xomed Instrument Trays Lot Numbers: All lots distributed prior to July 2013Multiple Product Numbers
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA