Z-2438-2025 Class II Ongoing
FDA device recall Z-2438-2025 was initiated by VANTIVE US HEALTHCARE LLC on July 28, 2025 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 2449 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 3, 2025
- Initiation Date
- July 28, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2449 units
Product Description
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
Reason for Recall
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
Distribution Pattern
Worldwide
Code Information
UDI 07332414126018, All serial numbers