| TGA Action ID |
RC-2026-RN-00060-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Prismaflex Sets
Prismaflex ST100 Set
Product Code: 107636
All lots including and manufactured after 24F0069
Prismaflex ST150 Set
Product Code:107640
All lots including and manufactured after 24E0059
Prismaflex TPE2000
Product Code: 107144
All lots including and manufactured after 24E0067CB
Oxiris Set Row
Product Code: 973003
All lots including and manufactured after 24F0087 |
| ARTG Number |
160473, 354699, 403937, 498166 |
| Unique Device Identifier (UDI) |
07332414075613, 07332414075651, 07332414069339, 07332414201241 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
There is a potential for dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. A dislodged deaeration chamber may lead to an “Air in Blood” alarm on the Prismaflex Control Unit. The alarm may result in a delay/interruption of therapy, and in some cases blood loss due to clotting/failure to return blood manually.
Vantive Australia has received 3 (439 globally) reports related to this problem. |
| Instructions for Customers/Users |
- Customers may continue to use the Prismaflex sets by instituting the workaround steps outlined in the Customer Letter.
- Vantive is actively working on a correction for this problem and will advise when available.
Update 05/05/2026: Users are to be aware of the updates to the ARTG Certificates for the oXiris Set. It is now supplied under two ARTG references: 403937 and 498166. Therapy may continue to be performed using the Prismaflex Sets. Vantive is still working on a correction to this problem, and further updates will be provided when it is available. |
| Action Commencement Date |
3/02/2026 |
| Responsible Entity |
|
| Contact Information |
1800 920 133 - Vantive Customer Service |