FDA Medical devices recall ·
PrisMax V3 control Unit-US, Hemodialysis Delivery System… recall
- Recall number
- Z-2438-2025
- 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
- 2449 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
Why was it recalled?
Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed, or T1205: BLD Self-Test Failure
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 07332414126018, 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-2438-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.