VANTIVE US HEALTHCARE LLC recalls PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
- Recall date
- July 28, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2438-2025
- FDA classification
- Class II
- Brand / firm
- VANTIVE US HEALTHCARE LLC
- Sold / distributed
- Worldwide
Why it was recalled
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
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 V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
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