PrisMax V3 control Unit-US recall
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
Why was PrisMax V3 control Unit-US 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI 07332414126018, All serial numbers
- Product
- PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
- Recalling firm
- VANTIVE US HEALTHCARE LLC
- Quantity
- 2449 units
- Distribution
- Worldwide
- Recall date
- September 3, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)