FDA Medical devices recall ·
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626… recall
- Recall number
- Z-2437-2025
- Date
- (initiated July 28, 2025)
- Company / brand
- Vantive Us Healthcare LLC
510 Lake Cook Rd, Deerfield, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4772 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
Why was it 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
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI 00085412639499, All Serial Numbers
Distribution
Worldwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2437-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.