| TGA Action ID |
RC-2026-RN-00715-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Safsite Valve VV/O Extra Cap RV1000NC
Primary Catalogue Number: 415068
Lot Numbers: 0061968348, 0061966913
Expiry Dates: 31/10/2029, 30/09/2026 |
| ARTG Number |
136029 |
| Unique Device Identifier (UDI) |
04045928016067 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
B Braun has identified a potential problem with certain lots of the Safsite Valves, following customer complaints of leakage and backflow. There is the potential that the valves may remain in the open position after disconnecting from the port.
To date, there have been 15 reports of injuries to patients associated with leakage/backflow, which could have caused a minor delay in treatment while replacing the device. If the valve contains hazardous medication, there is the potential that leakage could result in exposure causing injury to the patient, clinician or other. If the leakage is not evident, the valve may result in blood loss or be contaminated, potentially resulting in bloodstream infection. No serious injuries or deaths have been reported related to this problem. |
| Instructions for Customers/Users |
Customers are to:
- Identify, cease use, and quarantine the above lots subject to recall. Do not destroy any affected product.
- Complete and return the response form. Upon receipt of a completed response form, B Braun will contact customers and provide a Returned Authorisation (RA) for any impacted cases, including partial cases. Collection of the product will also be arranged.
Credit and/or replacement of the products will be based on customer's individual needs. |
| Action Commencement Date |
18/09/2026 |
| Responsible Entity |
|
| Contact Information |
02 9629 0282 - B Braun Australia Quality Department |