Class II

Medical Device Recall: TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631

VANTIVE US HEALTHCARE LLC · July 28, 2025

Reason for Recall

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

Distribution

Worldwide

Quantity Affected

7432 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2439-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

VANTIVE US HEALTHCARE LLC Medical Device Recall: TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631 | SafeCheck