| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00295-1 |
| Product Name/Description |
Syntel Silicone Thrombectomy Catheter
Reference number: A4558
Lot number: SST1056
Expiry date: 2027-08
ARTG 147757
(Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Catheter, embolectomy) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
It has been reported that during the use of the Syntel Silicone Thrombectomy Catheter, the guide tip (not the balloon or catheter) can become damaged and result in the tip detaching.
To date no injuries have occurred as a result of this problem. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are to check their inventory to determine if they have any of these devices and if so, quarantine affected devices immediately. Upon return of the completed Customer Response Form, customers will be sent instructions for sending the product back to the company at no cost.
This action has been closed out on 20/05/2024 |
| Contact Information |
02 9006 1662 - Emergo Australia |