Events

Recall of Vented Paclitaxel Set (infusion set used during the administration of medication of anaesthetic drugs)

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-2015-RN-01070-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-11-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01070-1
  • 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 healthcare has received reports of leaks at the spike's air vent subassembly.A leak in a paclitaxel set may result in a breach in sterility of the fluid path with subsequent contamination of the solution. if not detected during priming or initial set up, this may lead to serious adverse health consequences. this leak may also result in potential skin contact which would result in potential skin irritation.
  • Action
    Baxter Healthcare is advising users to inspect and quarantine any affected stock for return to Baxter. This action has been closed-out on 31/08/2016.

Device

Vented Paclitaxel Set (infusion set used during the administration of medication of anaesthetic d...
  • Model / Serial
    Vented Paclitaxel Set (infusion set used during the administration of medication of anaesthetic drugs)Product Code: MMC9627SLot Number: 14H13V434ARTG Number: 108526
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd