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-2017-RN-00736-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-06-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00736-1
  • 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
    Intersurgical has identified the possibility that the valve of the bvm manual resuscitation system may become stuck during storage. this could result in theintended tidal volume not being delivered through the valve, which may cause a delay in treatment.The instructions for use (ifu) provided with these products includes the requirement to ensure that the bag, valve and oxygen delivery are functioning correctly prior to use.
  • Action
    Users are asked to inspect their stocks and quarantine all units from the above lot numbers, then complete the attached Reply Form and email or fax it to us so that we may arrange collection and issue credit. Please complete the Reply Form even if you have no stock which is subject to recall, as we require this information to reconcile this process.

Device

BVM (Bag-Valve-Mask) Manual Resuscitation Systems
  • Model / Serial
    BVM (Bag-Valve-Mask) Manual Resuscitation SystemsMultiple Reference and Lot NumbersARTG Number: 225855
  • Manufacturer
    Intersurgical Australia Pty Ltd

Manufacturer

Intersurgical Australia Pty Ltd