| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-01186-1 |
| Product Name/Description |
Gynecare Thermachoice III Thermal Balloon Ablation Silicone Catheter
Product Code: TC033
All Lots from 31st November 2013 are affected
ARTG Number: 97100 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/12/2015 |
| Responsible Entity |
|
| Reason/Issue |
This product is being removed from the market as stability data does not substantiate the labelled two-year shelf life of affected product.
The affected units may fail prematurely before the labelled two-year shelf life. The failure may be manifested by pinhole leak, Hexcap crack leak and Tri-Y manifold crack leak. These types of leakage may potentially result in the abortion of the procedure, temporary thermal injury to the cervix and/or vagina and in some cases additional surgical procedures. |
| Recall Action |
Recall |
| Recall Action Instructions |
The sponsor is advising users to inspect stock and quarantine the affected units prior to their return to the sponsor. This action has been closed-out on 07/09/2018. |
| Contact Information |
1800 252 194 - Customer Service |