| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01092-1 |
| Product Name/Description |
FemoSeal Vascular Closure System
All non-expired product
Product Code: C11202
Multiple Lot Numbers
ARTG Number: 263892 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Terumo Medical Corporation has received an increase in device related malfunction complaints for FemoSeal Vascular Closure Systems. Specifically, after the deployment of the inner locking disc, the complaints state that the button will not spring back as intended, preventing the outer locking disc from deploying and completing the procedure.
An investigation by Terumo has identified that the internal suture becomes entrapped as a result of operator miss-assembly during device manufacture and that this issue then only becoming visible midway through device deployment. |
| Recall Action |
Recall |
| Recall Action Instructions |
1. Review the urgent medical device recall notification and distribute to all staff working with this equipment.
2. Inform any facilities that may have received this product of the recall action.
3. Quarantine all product in the affected population, record the lot number and quantity on the Customer Response Form supplied with the Customer Letter
4. Place quarantined product in a secure location for return to Terumo Australia Regulatory Affairs Department.
5. Package and return all affected product via courier
This action has been closed out on the 26/09/2018. |
| Contact Information |
1800 837 866 - Terumo Customer Service |