VANTIVE US HEALTHCARE LLC recalls TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631

Recall date

July 28, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2439-2025

FDA classification

Class II

Brand / firm

VANTIVE US HEALTHCARE LLC

Sold / distributed

Worldwide

Why it was recalled

Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted

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

What was recalled

TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631