Medical device recalls Moderate risk

VANTIVE US HEALTHCARE LLC recalls PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701

Recall date
July 28, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2437-2025
FDA classification
Class II
Brand / firm
VANTIVE US HEALTHCARE LLC
Sold / distributed
Worldwide

Why it was 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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