Events

Retiro De Equipo (Recall) de Clements Suction Regulators

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por BMDi TUTA 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-2017-RN-00105-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-01-24
  • 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-2017-RN-00105-1
  • 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
    Recent customer feedback has alerted bmdi tuta healthcare to an issue with the sleeve index system (sis) on the handwheel coupling. this component is the interface between the regulator and the wall fitting. the groove in the handwheel has been manufactured with an incorrect dimension. due to this incorrect dimension it is possible to incorrectly connect the suction regulator to the air outlet for surgical tools.
  • Acción
    Users are advised to examine all affected suction regulators installed in their facility and ensure that they are connected to the correct source. This can be identified by the yellow suction label on both the regulator and the wall outlet. BMDi TUTA will arrange for the sleeves to be shipped to affected facilities for rework. Rework the handwheel component in accordance with the rework instructions provided in the customer letter.

Device

Clements Suction Regulators
  • Modelo / Serial
    Clements Suction RegulatorsModels:SUC89140 – High Vacuum High Flow RegulatorSUC89150 – Low Vacuum Low Flow RegulatorSUC89160 – Medium Vacuum Low Flow Baby Mucus RegulatorSUC89170 – Medium Vacuum High Flow Infant RegulatorSUC89180 – Low Vacuum Thoracic RegulatorARTG Number: 239973
  • Manufacturer
    BMDi TUTA Healthcare Pty Ltd

Manufacturer

BMDi TUTA Healthcare Pty Ltd