Events

Retiro De Equipo (Recall) de Multigate Custom Procedure Packs containing Convatec’s Unomedical brand Suction Tube

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Multigate Medical Products 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-00601-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-07-02
  • 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-00601-1
  • 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
    Convatec is conducting a recall (tga ref no: rc-2015-rn-00514-1) of various sized unomedical branded suction tubes. the tubes are being recalled as the connector on the tubes has a probability of cracking once it is applied to suction device ports.Multigate is issuing this notice to your hospital as you have received the above custom procedure packs (cpp) where you have specified the inclusion of the unomedical suction tube that is now subject to this recall.
  • Acción
    Multigate requesting end users to stop using the affected CPP. Multigate will supply replacement sterile tubing as for all the affected stock. Once replacement tubing is received end users are required to replace the defective tube with the sterile replacement product.

Device

Multigate Custom Procedure Packs containing Convatec’s Unomedical brand Suction Tube

Manufacturer

Multigate Medical Products Pty Ltd