Home / Recalls / VANTIVE US HEALTHCARE LLC / Z-2437-2025

Z-2437-2025 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
4772 units

Product Description

PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701

Reason for Recall

Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles

Distribution Pattern

Worldwide

Code Information

UDI 00085412639499, 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)