| TGA Action ID |
RC-2025-RN-00387-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Haines Reusable Tourniquet with Silicone Strap
Haines Reusable Silicone Tourniquet - Pack 5 Inner Pack
Product code: RT-SIL-5
Lot number: 50962
Haines Reusable Silicone Tourniquet - Pack 25 Inner Pack
Product code: RT-SIL-25
Lot number: 50962
Haines Reusable Silicone Tourniquet - Pack 250 Outer Pack
Product code: RT-SIL-250
Lot number: 50962 |
| ARTG Number |
282685 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
Haines has received several reports of difficulty in achieving a secure grip when applying the tourniquet to a patient's arm. In some cases, the strap may slip during application, compromising the effectiveness of the device.
The problem might cause a delay in application for the healthcare professional. The failure is easily recognised during application and does not pose a direct clinical risk to patients. |
| Instructions for Customers/Users |
Customers can continue to use stock that performs as intended.
If stock exhibits the slipping problem customers are to contact the sponsor to arrange for replacement devices.
This action has been finalised on 8/7/2025. |
| Action Commencement Date |
10/04/2025 |
| Responsible Entity |
|
| Contact Information |
1300 424 637 - Business Support team |