VANTIVE US HEALTHCARE LLC: Device Recall

Recall #Z-2438-2025 · 07/28/2025

Class II: Risk

Recall Details

Recall Number: Z-2438-2025
Classification: Class II
Product Type: Device
Recalling Firm: VANTIVE US HEALTHCARE LLC
Status: Ongoing
Date Initiated: 07/28/2025
Location: Deerfield, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2449 units

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

Product Description

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

Distribution Pattern

Worldwide

Other Recalls by VANTIVE US HEALTHCARE LLC

Class II: Risk 01/06/2026

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Class II: Risk 01/06/2026

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Class II: Risk 01/06/2026

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Class II: Risk 01/06/2026

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Class II: Risk 01/06/2026

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

View all recalls by VANTIVE US HEALTHCARE LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.