| 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 |
|
| 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 |