Events

Recall of Clements Suction Regulators

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by BMDi TUTA Healthcare Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00105-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-01-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00105-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / 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