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VANTIVE US HEALTHCARE LLC recalls PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
Recalled September 3, 2025 · FDA recall Z-2437-2025 · VANTIVE US HEALTHCARE
Hazard
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 · FDA Class II
Units
4772 units
Sold at
Worldwide
Description
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
Product
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
Manufacturer(s)
VANTIVE US HEALTHCARE LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →