Events

Recall of CADD Medication Cassette Reservoir, 50ml

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-2015-RN-00081-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-01-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00081-1
  • 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 has received a small number of complaints of leakage associated with the above-referenced cassettes. a small amount of leaking has been found to occur at the welding of the tube to the internal reservoir bag on some cassettes. if the leakage is noticed during cassette filling, it could result in a delay of therapy while an alternative cassette is obtained. if the leakage is noticed during fluid delivery with the patient, it could result in an interruption in therapy while the cassette is replaced.
  • Action
    End users are requested to inspect their inventory and quarantine the affected Cassettes. A customer service representative will arrange for exchange of any unused affected Cassettes for credit or replacement. This action has been closed-out on 17/08/2016.

Device

CADD Medication Cassette Reservoir, 50ml
  • Model / Serial
    CADD Medication Cassette Reservoir, 50ml Order Code: 21-7001-24Batch Numbers: 14X297 and 14X323Order Code: 21-7301-24Batch Numbers: 14X324ARTG Number: 145297
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd