Events

Recall of CADD Legacy 1, Model 6400 Ambulatory Infusion Pump

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smiths Medical Australasia 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-01440-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-11-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01440-1
  • 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
    Smiths medical became aware that a number of cadd legacy 1, model 6400 ambulatory infusion pumps, may contain non-matching serial numbers. specifically, the label attached to the back of the pump may list a serial number that does not match the correct serial number programmed into the software of the pump. the non-matching serial number issue does not impact the functionality of the infusion pumps. the risk to patient health as a result of this issue is negligible.
  • Action
    Smiths Medical is advising users to determine if the serial number on the back of the pump matches the electronic serial number programmed into the pump. If the serial numbers do not match, the pumps are to be returned to Smiths Medical.

Device

CADD Legacy 1, Model 6400 Ambulatory Infusion Pump
  • Model / Serial
    CADD Legacy 1, Model 6400 Ambulatory Infusion Pump Product Number: 21-6400-51Serial Numbers: 410006, 410007, 410008, 410009, 410010, 410011, 410012 ARTG Number: 109467
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd