Reported Sep 3, 2025 · Ongoing
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
Vantive US Healthcare LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: VANTIVE US HEALTHCARE LLC · 510 Lake Cook Rd · Deerfield, IL · 60015-4964
Is this the product you have?
PrisMax V3 control Unit-USHemodialysis Delivery SystemProduct Code 955724
- Lot codes and dates
- UDI 07332414126018, All serial numbers
- Amount recalled
- 2449 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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