| TGA Action ID |
RC-2025-RN-00872-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
SD-400U-10 and SD-400U-15 Single Use Electrosurgical Snares
Descriptions: SnareMaster Plus 10mm, SnareMaster Plus 15mm
Models: SD-400U-10, SD-400U-15
Material Codes: N5998230, N5998330
Lot Numbers: 2YV to 57V, 2YV to 54V |
| ARTG Number |
145853 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Olympus discovered holes in a small number of device pouches during an internal review of the SD-400 Snares sterile packaging process. The investigation determined that small holes may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
The probability of device contamination resulting from these holes is low. However, any SD-400 Snare package with a hole cannot be considered sterile.
If the device with affected packaging is used on a patient, there is a potential risk of it being non- sterile and contaminated, which could lead to infection. If the problem is identified prior to use, it may result in procedural delays while a replacement device is obtained.
Olympus has not received any complaints related to this problem to date. |
| Instructions for Customers/Users |
Customers are to:
- Examine their inventory and quarantine any affected lot numbers of SD-400 Snares.
- Cease use of the affected product immediately.
Olympus will contact customer who return the response form to coordinate the return process and provide the corresponding credit.
No replacement stock is currently available, but it will start to become available at the end of 2025 and will be steadily increasing in early 2026. |
| Action Commencement Date |
13/10/2025 |
| Responsible Entity |
|
| Contact Information |
1300 132 992 - Olympus Customer Operations |