| TGA Action ID |
RC-2025-RN-00694-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
SKULL TRACTION TONG LARGE
Product Code: FF870R |
| ARTG Number |
352690 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
It was identified that the Instructions for Use (IFU) did not include essential information regarding contraindications and application details. As a result, this critical information was not made available to the end user.
Within the past five years no complaints due to this problem were registered |
| Instructions for Customers/Users |
Customers should be aware that the Instruction for Use (IFU) TA009782 has been updated in the following content:
2.1.2 Intended use
2.1.4 Absolute contraindications
2.1.5 Relative contraindications
Additional details about the changes are provided in the customer letter, and the latest IFU updates can be downloaded using the link included in that letter: Electronic Instructions for Use (eIFU) | B. Braun
This action has been closed out on 25/08/2026 |
| Action Commencement Date |
7/08/2025 |
| Responsible Entity |
|
| Contact Information |
1800 251 705 - B Braun Recall Coordinator |