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Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00434-1
Product Name/Description 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 2018

ARTG Number: 293915
(Ferno Australia - Tourniquet strap)
Recall Action Level Retail
Recall Action Classification Class II
Recall Action Commencement Date 17/05/2018
Responsible Entity Ferno Australia Pty Ltd
Reason/Issue 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.
Recall Action Recall
Recall Action Instructions 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.

This action has been closed out on 22/05/2020
Contact Information 07 3881 4999 - Ferno Australia