Events

Recall of Compounded Medications within CADD Medication Non-flow stop Cassette Reservoirs

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-2017-RN-01392-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01392-1
  • 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 been made aware of a recall initiated by smiths medical australasia of certain lots of 50 and 100ml cadd medication cassette reservoirs (non-flow stop) as they may have been manufactured with an incorrect pressure plate. baxter has identified some of the affected batches have been used to prepare compounded medications supplied to customers.
  • Action
    Baxter Healthcare is advising users to inspect stock and quarantine affected units. Baxter are re-issuing required cassettes, if required.

Device

Compounded Medications within CADD Medication Non-flow stop Cassette Reservoirs
  • Model / Serial
    Compounded Medications within CADD Medication Non-flow stop Cassette Reservoirs
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd