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 Medical Developments International Limited.

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-00838-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-07-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00838-1
  • 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
    Medical developments international has identified the possibility that the valve of the bvm manual resuscitation system may become stuck during storage. this could result in the intended tidal volume not being delivered through the valve, which may cause a delay in treatment.The instructions for use (ifu) provided with these products include the requirement to ensure the bag, valve and oxygen delivery is functioning correctly prior to use.
  • Action
    Medical Developments International is requesting users inspect their stocks and quarantine all units from the affected batch numbers, then complete the supplied Reply Form and email or fax it back 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 the process.

Device

BVM (Bag-Valve-Mask) Manual Resuscitation Systems
  • Model / Serial
    BVM (Bag-Valve-Mask) Manual Resuscitation SystemsCatalogue Number: RS-7595-BVMDAWBatch Numbers: up to 1170328006Catalogue Number: RS-7595-BVMDABatch Numbers: up to 1160629050Catalogue Numbers: RS-7595-BVMDC, RS-7595-BVMDC3Batch Numbers: up to 1160728029Catalogue Number: RS-7595-BVMDC3Batch Numbers: up to 11600922002ARTG Number: 147543
  • Manufacturer
    Medical Developments International Limited

Manufacturer

Medical Developments International Limited