Class II

Medical Device Recall: PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701

VANTIVE US HEALTHCARE LLC · July 28, 2025

Reason for Recall

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

Distribution

Worldwide

Quantity Affected

4772 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2437-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.