Events

Recall of ProTrack Microcatheter

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Pacing Importers 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-01417-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-11-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01417-1
  • 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
    There is a chance that the affected catheters may have circumferential cracks along its length.If the cracks are present on the device, they are likely to be detected by a physician upon removal of the catheter from the packaging. the cracks may result in leakage of fluids along the catheter. there have been no adverse event reports related to this discovery.
  • Action
    Baylis Medical is advising users to inspect stock and quarantine any unused units for return.

Device

ProTrack Microcatheter
  • Model / Serial
    ProTrack MicrocatheterPart number: CIC35-145Lot Numbers: CIFA131113, CIFA100614, CIFA100714, CIFA241014Part number: CIC38-145Lot Numbers: CIFA161013, CIFA240614, CIFA.271113, CIFA100714, CIFA311213, CIFA180814, CIFA210214, CIFA080914, CIFA070314, CIFA.221014, CIFA270314, CIFA050115, CIFA070514, CIFA210115, CIFA210514, CIFA060215ARTG Number: 185946
  • Manufacturer
    Pacing Importers Pty Ltd

Manufacturer

Pacing Importers Pty Ltd
  • Source
    DHTGA