| TGA Action ID |
RC-2026-RN-00786-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
TraumaFix Professional Pelvic Splint
Lot Number: 3629
Reference:11007 |
| ARTG Number |
516494 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
The hook and loop strap of the splint have been assembled incorrectly. The fault occurs in the entire lot 3629.
The problem would cause a delay to treatment while the user identifies a solution to secure the strap correctly. If the user is unable to identify a solution to fix the strap, their treatment will have reduced efficacy. Inadequate tightening may fail to fully immobilise the pelvis and may fail to control internal haemorrhage. |
| Instructions for Customers/Users |
Customers are to:
- Inspect their stock immediately and quarantine any stock of lot number 3629 on hand to prevent further use or distribution.
- Return affected stock on hand with the completed Response Form to Reliance Medical Australia. |
| Action Commencement Date |
9/10/2026 |
| Responsible Entity |
|
| Contact Information |
02 5944 5588 - Reliance Medical Australia |