FDA recall Z-2438-2025

VANTIVE US HEALTHCARE LLC · Class II · device

Product

PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724

Reason for recall

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

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-2438-2025