Events

Recall of BVM (Bag-Valve-Mask) Manual Resuscitation Systems

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Intersurgical Australia 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-2018-RN-00058-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-01-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00058-1
  • 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
    A manufacturing fault has been identified with the intersurgical bvm manual resuscitation system, which could result in the directional valves positioned on the back plate of the self inflating bag being orientated incorrectly. the incorrect orientation of the directional valves could result in the bvm manual system becoming over pressurised, which could result in patient barotrauma.
  • Action
    Intersurgical is advising users to inspect stock and quarantine affected units for return. In instances where an alternative product is not available, Intersurgical is advising users to inspect each device before use to determine if it is affected by the issue. If the device is not affected, it can be safely used.

Device

BVM (Bag-Valve-Mask) Manual Resuscitation Systems
  • Model / Serial
    BVM (Bag-Valve-Mask) Manual Resuscitation SystemsReference Number: 7150000, 7151000, 7152000, 7153000, 715400Lot Numbers: 7150000 – 372894, 7151000 – 372886, 7152000 – 372893, 7153000 – 372892, 7154000 – 370753 ARTG Number: 225855 (Intersurgical Australia Pty Ltd - Resuscitator, pulmonary, manual, single use)
  • Manufacturer
    Intersurgical Australia Pty Ltd

Manufacturer

Intersurgical Australia Pty Ltd