Events

Recall of SAM XT Extremity Tourniquets (SAM XT) - Military (SAM-XT M) and Civilian (SAM-XT-C) Products

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ferno 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-2018-RN-00434-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-05-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00434-1
  • 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
    Based on internal testing, ferno have identified a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. an affected tourniquet will not have the “box x stitch” icon on the upper right of the folded instructions for use (ifu) insert. tourniquets not affected will display the “box x stitch” icon on the upper right of the folded ifu.To date, no reports of adverse health consequences have been received.
  • Action
    Ferno is advising customers to inspect inventory and quarantine affected units to prevent further use. Users should contact their Ferno Australia representative for return and replacement details.

Device

SAM XT Extremity Tourniquets (SAM XT) - Military (SAM-XT M) and Civilian (SAM-XT-C) Products
  • Model / Serial
    SAM XT Extremity Tourniquets (SAM XT) - Military (SAM-XT M) and Civilian (SAM-XT-C) Products Batch Numbers: XT1748 and XT1802 Impacted stock distributed between March 2017 - April 2018ARTG Number: 293915(Ferno Australia - Tourniquet strap)
  • Manufacturer
    Ferno Australia Pty Ltd

Manufacturer

Ferno Australia Pty Ltd