Recall archive / FDA device enforcement
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724 — FDA record Z-2438-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 28, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
- 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
- Classification
- Class II
- Recalling firm
- VANTIVE US HEALTHCARE LLC
- Quantity
- 2449 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2438-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI 07332414126018, All serial numbers |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Sep 3, 2025
- Recall initiation date
- Jul 28, 2025
- Center classification date
- Aug 26, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.