FDA recall Z-2437-2025

VANTIVE US HEALTHCARE LLC · Class II · device

Product

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

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

Key facts

Status: Ongoing
Initiation date: 2025-07-28
Report date: 2025-09-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2437-2025