Home / Recalls / VANTIVE US HEALTHCARE LLC / Z-2438-2025

Z-2438-2025 Class II Ongoing

Recalled by VANTIVE US HEALTHCARE LLC — Deerfield, IL

Recall Details

Product Type
Devices
Report Date
September 3, 2025
Initiation Date
July 28, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2449 units

Product Description

PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724

Reason for Recall

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

Distribution Pattern

Worldwide

Code Information

UDI 07332414126018, All serial numbers

Other recalls by VANTIVE US HEALTHCARE LLC

  • Z-1231-2026 Class II — PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or (January 6, 2026)
  • Z-1225-2026 Class II — PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With (January 6, 2026)
  • Z-1224-2026 Class II — PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With (January 6, 2026)
  • Z-1227-2026 Class II — PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Wi (January 6, 2026)
  • Z-1229-2026 Class II — PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or (January 6, 2026)
  • Z-1226-2026 Class II — OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sea (January 6, 2026)
  • Z-1230-2026 Class II — PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or (January 6, 2026)
  • Z-1228-2026 Class II — PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Wi (January 6, 2026)
  • Z-0409-2026 Class II — Sharesource Connectivity Platform for Use with Homechoice Claria Product Code (August 28, 2025)
  • Z-2439-2025 Class II — TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, (July 28, 2025)