Events

Recall of 4FR Single Lumen Pressure Injectable Peripherally Inserted Central Catheter (PICC)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Teleflex Medical Australia 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-00915-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-09-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00915-1
  • 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 labelling inaccuracy in the instructions for use (ifu) and injection card. the ifu and the injection card contained within the product states that picc testing included 10 pressure injection cycles. this is not correct, it should state that catheter testing included only 5 pressure injection cycles.If it were to be used for more than five (5) pressure injections, it cannot be ruled out that there is a potential risk that the catheter could rupture during injections 6-10. catheter rupture can cause catheter or air embolism, bleeding or ineffective treatment and may require the need for radiologic or surgical intervention. no customer complaints have been received for this issue.
  • Action
    Customers are notified not to use the device for more than five pressure injections. Future stock will have the IFU and injection card amended to reflect this change. This action has been closed-out on 26/08/2016.

Device

4FR Single Lumen Pressure Injectable Peripherally Inserted Central Catheter (PICC)

Manufacturer

Teleflex Medical Australia Pty Ltd