Recall Z-2438-2025— VANTIVE US HEALTHCARE LLC
Class II · Ongoing
Class II FDA medical device recall by VANTIVE US HEALTHCARE LLC, initiated 2025-07-28. It names one FDA 510(k) clearance: K193482. Product: PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724. Reason: 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.
- Recalling firm
- VANTIVE US HEALTHCARE LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-07-28
- Firm location
- Deerfield, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.