Events

Recall of BodyGuard Pump IV Administration Set

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by REM Systems 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-00446-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00446-1
  • 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
    The manufacturer caesarea medical electronics (cme) has identified that the sr segment in the sets from two batches have slight variations in dimensions, in some places being at borderline specification. these random variations along the tubing, when used in intermittent mode that includes long intervals of zero or near zero rate, may yield under- infusion results.
  • Action
    REM Systems is advising users to review their stock and quarantine the affected batches. Replacement stock will be provided by REM Systems.

Device

BodyGuard Pump IV Administration Set
  • Model / Serial
    BodyGuard Pump IV Administration SetCatalogue Number: CE-GEN00014Batch Numbers: 12387350 & 1483529ARTG Number: 119624
  • Manufacturer
    REM Systems Pty Ltd

Manufacturer

REM Systems Pty Ltd