Events

Rappel de Clements Suction Regulators

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par BMDi TUTA Healthcare Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-00105-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-01-24
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00105-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    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