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VANTIVE US HEALTHCARE LLC recalls PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
Recalled September 3, 2025 · FDA recall Z-2438-2025 · VANTIVE US HEALTHCARE
Hazard
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 · FDA Class II
Units
2449 units
Sold at
Worldwide
Description
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
Product
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
Manufacturer(s)
VANTIVE US HEALTHCARE LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →