| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00737-1 |
| Product Name/Description |
Safil Sutures
Safil Violet 1 (4) 70cm HR26
Safil Violet 4/0 (1,5) 70cm HR22
Safil Violet Undyed 4/0 (1,5) 70cm, DS24
Safil Violet Undyed 2/0 (3) 70cm HR26
Safil Violet 3/0 (2) 70cm, HR22
Safil Violet 2 (5) 70cm HR 37S
Safil Violet 2 (5) 70cm HR37S
Multiple Item Codes and Batch Numbers
ARTG Number: 222738 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
20/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
B. Braun has been identified that some of the items in specific batches have damaged packaging which may affect the sterility of the products. No specific monitoring of patients is recommended at this time.
To date, there have been no reports of any adverse patient outcome which could be associated with this potential sterility issue. |
| Recall Action |
Recall |
| Recall Action Instructions |
B. Braun is requesting customers:
1. Identify, quarantine and return affected devices;
2. Do not use affected devices anymore;
3. Patients with affected devices in use should be monitored carefully;
4. Inform the responsible personnel in the relevant facilities; and
5. Confirm receipt of the correspondence as per the instructions given in the Customer Letter.
This action has been closed out on 13/09/2019 |
| Contact Information |
1800 251 705 - B Braun |