| TGA Action ID |
RC-2025-RN-00509-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Various Texium Components
Product Names: BD Texium 3 mL, 5ml, 10ml, 20ml, 60ml & BD Texium closed-male luer with female cap
Product Codes:MY8003-0006, MY8005-0006, MY8010-0006, MY8020-0006, MY8060-0006, 10012241
Multiple lot numbers
ARTG's: 177502, 307702 |
| ARTG Number |
177502, 307702 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
BD has identified that specific lots of standalone Texium components, and IV infusion sets and syringes containing the Texium closed-male Luer component (as listed above) have the potential to leak during use at the connection interface between the Texium component and the SmartSite Needle-free Connector. |
| Instructions for Customers/Users |
Customers should;
1. Replace affected products in use.
2. If already in use, and you are unable to determine if the product is within scope, continue to monitor for leakage or replace product.
3. BD will provide replacement/credit for all discarded inventory
This action has been finalised on 22/9/2025. |
| Action Commencement Date |
3/06/2025 |
| Responsible Entity |
|
| Contact Information |
1800 656 100 - Customer Service Team |