Reported Sep 3, 2025 · Ongoing
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
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 V2-US, Hemodialysis Delivery System
- Product Codes
955626955558955627955701
- Lot codes and dates
- UDI 00085412639499, All Serial Numbers
- Amount recalled
- 4772 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
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
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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