| TGA Action ID |
RC-2026-RN-00592-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
GYNECARE TVT EXACT Continence System
Reference Code: TVTRL
LOT Numbers: 5000013, 5000023, 5000025, 5000027, 5000032, 5000036, 5000037, 5000039
Expiry Dates: 31/07/2026, 31/08/2026 |
| ARTG Number |
351636 |
| Unique Device Identifier (UDI) |
10705031062375 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
The manufacturer, Ethicon SARL, has identified a problem whereby white particulates were observed within the sterile barrier of certain LOTs. The manufacturer has determined that the white particulates originated from the adhesive layer applied to the Tyvek lid on the product packaging.
The white particulates are visible to the naked eye during package inspection and opening in the operating room by trained personnel. The particulates are mainly located within the package blister and come from packaging materials. These materials are not cytotoxic, not genotoxic, and not expected to sensitise or irritate or be systematically toxic. While there is a potential for particulates to transfer to the TVT EXACT tape, it is unlikely to affect device functionality. Surgical delay may occur if a surgeon opts not to use the product, but there is no expected direct harm associated with this problem. |
| Instructions for Customers/Users |
Customers are to:
- Inspect stock and quarantine any affected product on hand to prevent further use.
- Return any affected stock on hand to Endotherapeutics.
- Contact Customer Service to arrange replacement stock. |
| Action Commencement Date |
7/08/2026 |
| Responsible Entity |
|
| Contact Information |
(02) 9869 2868 - Endotherapeutics Customer Service |