Recall Z-2438-2025 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
VANTIVE US HEALTHCARE LLC
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
| Date | Aug 26, 2025 (initiated Jul 28, 2025) |
| Status | Open, Classified |
| Reason | Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed, or T1205: BLD Self-Test Failure |
| Root cause | Under Investigation by firm |
| Action | Vantive issued an Urgent Medical Device Correction notice to it consignees on 0728/2025 via USPS first class mail. The notice explained the issues with the devices, hazard involved, and requested the following: Actions to be Taken by Customers 1. Operators may continue to safely use the PrisMax Systems and TherMax Blood Warmer Units per the associated Operator s Manuals and on-screen instructions. If further assistance is required, please contact your local Vantive account representative. Please ensure that all operators of these devices are made aware of this Urgent Medical Device Correc |
| Quantity | 2449 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193482 | PrisMax System Version 3 Baxter Healthcare Corporation, Mar 13, 2020 |