Events

Recall of LUTONIX 014 and 035 OTW Drug Coated PTA Dilatation Catheter

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Bard 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-2014-RN-00153-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-02-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00153-1
  • 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
    Lutonix has confirmed that some devices from specific lots may have been packaged in foil pouches with a defective chevron seal. this is the seal used to open the package containing the sterile balloon catheter. the potential hazard associated with a package having a defective chevron seal is loss of sterility.
  • Action
    Customers are asked to not use or further distribute any of the affected product. Bard is advising that no special follow-up treatment or clinical care is recommended for patients who have already undergone treatment with the devices affected by this recall.

Device

LUTONIX 014 and 035 OTW Drug Coated PTA Dilatation Catheter
  • Model / Serial
    LUTONIX 014 and 035 OTW Drug Coated PTA Dilatation CatheterProduct Codes: 9020413500150 and 9020515250040Lot Numbers: GFXJ2800 and GFXK2769Supplied under the Special Access Scheme
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd