Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

PrisMax V2-US Recalled by VANTIVE US HEALTHCARE LLC Due to Low deaeration chamber level at post priming tests...

Date: July 28, 2025
Company: VANTIVE US HEALTHCARE LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact VANTIVE US HEALTHCARE LLC directly.

Affected Products

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

Quantity: 4772 units

Why Was This Recalled?

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

Where Was This Sold?

Worldwide

About VANTIVE US HEALTHCARE LLC

VANTIVE US HEALTHCARE LLC has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report