Events

Recall of Arrow International 4Fg Seldinger Conversion Set with Long Sheath(Peripherally inserted central venous catheter)

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-00729-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00729-1
  • 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
    The reason for this action is due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. the component tabs extend past the opening to the sheath, so even if both tabs break, there will be some length of the sheath that would protrude from the skin. therefore, embolus of the sheath should not occur. the defect is easy to recognise and the clinician would have the choice of either continuing with the split sheath or using a new one. although the issue does not pose a significant risk to the patient, it may cause a delay of treatment when placing the catheter.
  • Action
    Customers are advised not to use or distribute any affected stock and immediately quarantine them. Teleflex Medical will arrange collection of any affected stock from affected facilities. This action has been closed-out on 18/08/2016.

Device

Arrow International 4Fg Seldinger Conversion Set with Long Sheath(Peripherally inserted central v...
  • Model / Serial
    Arrow International 4Fg Seldinger Conversion Set with Long Sheath(Peripherally inserted central venous catheter)Catalogue number: PI-01451-LSBatch Numbers: 23F14J0437, 23F14K0406, 23F14B0935, 23F14H1535, 23F15A0278, 23F15D0907ARTG Number: 148783
  • Manufacturer
    Teleflex Medical Australia Pty Ltd

Manufacturer

Teleflex Medical Australia Pty Ltd