Events

Recall of Non-Flow-Stop CADD Medication Cassette Reservoirs 50 and 100mL

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-01299-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-10-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01299-1
  • 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 become aware that certain non-flow-stop cadd medication cassette reservoirs may have been manufactured with an incorrect pressure plate. this product is designed without an arch, but the defective product has a plate with an arch.There is a risk that under delivery of medication may result from the tubing becoming partially or completely occluded when the cassette is attached to the pump. the clinician is not aware of the issue because the pump will continue to operate as if it is infusing medication without alarming for an occlusion.
  • Action
    Smiths Medical is advising users to quarantine remaining stock of the affected product for return for credit. It is recommended that users transition to an equivalent flow stop version of the CADD Medication cassettes.

Device

Non-Flow-Stop CADD Medication Cassette Reservoirs 50 and 100mL
  • Model / Serial
    Non-Flow-Stop CADD Medication Cassette Reservoirs 50 and 100mL50mL CADD Medication CassetteItem Code: 21-7001-24100mL CADD Medication CassetteItem Code: 21-7002-24 100mL CADD Medication Cassette, YellowItem Code: 21-7100-24Multiple Lot Numbers ARTG Number: 145297
  • Product Classification
    General Hospital and Personal Use Devices
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd