PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
Reported: September 3, 2025 Initiated: July 28, 2025 #Z-2437-2025
Product Description
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
Reason for Recall
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
Details
- Recalling Firm
- VANTIVE US HEALTHCARE LLC
- Units Affected
- 4772 units
- Distribution
- Worldwide
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701. Recalled by VANTIVE US HEALTHCARE LLC. Units affected: 4772 units.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 3, 2025. Severity: Moderate. Recall number: Z-2437-2025.
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