Events

Retiro De Equipo (Recall) de Medline procedure packs containing Unomedical Suction Tubing (Sterile and Non-sterile)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medline International Two Australia 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-00606-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-07-03
  • 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-00606-1
  • 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
    An internal assessment of convatec’s product complaints has confirmed that these devices are not meeting their expectations or those of our customers. specifically, the connector part for application to the suction devices in these lots, has failed to meet its required reliability. suction tubes are intended to connect a suction device, such as a suction catheter or suction handle, to a vacuum unit. suction tubes are equipped with multi-purpose connectors that are designed to fit many suction devices and outlets. the connector parts of the specified lots have a higher probability to crack once applied to suction devices outlets.
  • Acción
    Medline is requesting end users to remove and discard the Unomedical Suction Tubing from the procedure pack at the time the scrub nurse prepares for the surgery. This action has been closed-out on 15/08/2016.

Device

Medline procedure packs containing Unomedical Suction Tubing (Sterile and Non-sterile)
  • Modelo / Serial
    Medline procedure packs containing Unomedical Suction Tubing (Sterile and Non-sterile) Sterile Codes: 530.25.200, 530.25.300, 530.25.450, 530.25.600, 530.25.800, 530.30.200, 530.30.300, 530.30.450, 530.30.600, 533.30.300Non-sterile Codes: 533.25.050, 533.25.100, 533.25.150, 533.25.200, 533.25.300, 533.25.450, 533.25.600Multiple BatchesARTG Numbers: 137961 (Sterile) & 204281 (Non-sterile)
  • Manufacturer
    Medline International Two Australia Pty Ltd

Manufacturer

Medline International Two Australia Pty Ltd