Events

Recall of Vented Spike with Clearlink (fluid transfer set)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Baxter 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-2014-RN-00033-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-01-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00033-1
  • 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
    Baxter has determined that the vented spike with clearlink, product code emc3481 does not have sufficient stability data to support its labelling claims. as such, the sterile barrier cannot be assured for the duration of the claimed shelf life. deterioration in the integrity of the device packaging has the potential to result in a breach of the sterile barrier which could lead to complications due to infection.
  • Action
    Baxter is requesting users to locate and quarantine affected product. Affected product can be returned to Baxter for credit. Baxter has no alternative products to propose at this stage.

Device

Vented Spike with Clearlink (fluid transfer set)
  • Model / Serial
    Vented Spike with Clearlink (fluid transfer set)Product Code: EMC3481All lot numbers affectedARTG Number: 149588
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd