VANTIVE US HEALTHCARE LLC: Device Recall

Recall #Z-2437-2025 · 07/28/2025

Class II: Risk

Recall Details

Recall Number: Z-2437-2025
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: 4772 units

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

Product Description

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

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.