| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01545-1 |
| Product Name/Description |
WECK Visistat 35W Skin Stapler
Catalogue Number: 528235
Batch Numbers: 73H1500255, 73K1500618
ARTG Number: 126367 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
Teleflex is recalling this product due to potential for an incomplete seal on the sterile package. The sterility of the product cannot be guaranteed. If a non-sterile product is used, there is potential for infection to occur. A broken sterile seal on a sterile package is typically easily seen before use. No patient injuries have been reported related to this issue |
| Recall Action |
Recall |
| Recall Action Instructions |
Teleflex is advising customers to immediately quarantine affected stock. Affected stock is not to be distributed. Teleflex will arrange for the collection of affected stock and will issue credit for returned stock.
This action has been closed out on the 09/10/2018. |
| Contact Information |
1300 360 226 - Teleflex Medical Australia Customer Service |