VANTIVE US HEALTHCARE LLC
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for VANTIVE US HEALTHCARE LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-09-03FDA-DeviceClass IITherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted
- 2025-09-03FDA-DeviceClass IIPrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724
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
- 2025-09-03FDA-DeviceClass IIPrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
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
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