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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