FDAFDA · Food and drugs·Recall number Z-2437-2025
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
Published September 3, 2025 · Recall initiated: July 28, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- VANTIVE US HEALTHCARE LLC
- Distributor
- Worldwide
- Lot
- UDI 00085412639499, All Serial Numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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