Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36501 |
| Brand Name: | Haemofilter |
| Model: | Prismaflex ST100 and Prismaflex ST150 - Product code 107636, 107640 |
| Affected: | Prismaflex ST100 - All lots including and manufactured after 24F0069. Prismaflex ST150 - All lots including and manufactured after 24E0059 |
| Software version: | |
| Recalling Organisation: | Vantive Limited 7-9 Niall Burgess Road Mt Wellington Auckland 1060 |
| Contact Information: | |
| Manufacturer: | Gambro Industries SA |
| Brand Name: | Meyzieu TPE sets |
| Model: | Prismaflex TPE2000 - Product code 107144 |
| Affected: | All lots including and manufactured after 24E0067CB |
| Software version: | |
| Recalling Organisation: | Vantive Limited 7-9 Niall Burgess Road Mt Wellington Auckland 1060 |
| Contact Information: | |
| Manufacturer: | Gambro Industries SA |
| Brand Name: | oXiris Set - EU MDR |
| Model: | Oxiri - Product code 97003 |
| Affected: | All lots including and manufactured after 24F0087 |
| Software version: | |
| Recalling Organisation: | Vantive Limited 7-9 Niall Burgess Road Mt Wellington Auckland 1060 |
| Contact Information: | |
| Manufacturer: | Baxter Healthcare SA (Switzerland) |
| Brand Name: | oXiris Set - EUMDR - Vantive |
| Model: | (Oxiris) |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Vantive Limited 7-9 Niall Burgess Road Mt Wellington Auckland 1060 |
| Contact Information: | |
| Manufacturer: | Vantive Health GmbH |
| Issue: | The manufacturer is notifying Prismaflex Control Unit users of a potential risk of the Prismaflex Set deaeration chamber becoming dislodged during use. This issue does not affect PrisMax Control Units and may only occur when Prismaflex Sets are used with the Prismaflex Control Unit, as the two systems have different deaeration chamber holder designs. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 26/1/2026 |
