Events

Recall of PTFE GRAFTS – ADVANT VXT, FLIXENE, FLIXENE w/IFG, ADVANTA SST with expiration between April 2017 and May 2018

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Atrium Australia - Pacific Rim Pty Limited.

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-2013-RN-00737-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-07-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00737-1
  • 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
    Atrium medical has become aware that the label on the tab of the inner tyvek cover can adhere, to the inside wall of the outer tray. this may make it more difficult to employ the user's current technique which is to first pass the inner tray from the outer tray and then onto the sterile field. in some cases, because of the sticking of the inner tray to the outer tray, it has been reported that the inner tray must be lifted from the outer tray.
  • Action
    Atrium medical are advising users of work around instructions to follow to prevent the issue from occurring.

Device

PTFE GRAFTS – ADVANT VXT, FLIXENE, FLIXENE w/IFG, ADVANTA SST with expiration between April 2017 ...
  • Model / Serial
    PTFE GRAFTS – ADVANT VXT, FLIXENE, FLIXENE w/IFG, ADVANTA SST with expiration between April 2017 and May 2018Multiple catalogue and lot numbers affectedARTG Numbers: 154085, 155155, 155159, 155171, 154087, 155157, 155158, 155161, 155168, 155957, 176909, 155225, 182788
  • Manufacturer
    Atrium Australia - Pacific Rim Pty Limited

Manufacturer

Atrium Australia - Pacific Rim Pty Limited
  • Source
    DHTGA