FDAHealthJuly 28, 2025
VANTIVE US HEALTHCARE LLC — PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
⚠️ 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
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- July 28, 2025
Worldwide
What's affected?
- Product
- PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
- Lot code
- UDI 00085412639499, All Serial Numbers
Additional details
UDI 00085412639499, All Serial Numbers
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 4772 units.
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