Device product

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

Z-2439-2025

July 28, 2025

Class II

Product summary

Firm: VANTIVE US HEALTHCARE LLC
Event: Event 97233
Status: Ongoing
Classification: Class II
Quantity: 7432 units
Official record key: device-enforcement:Z-2439-2025

Official wording

Reason: 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

Code information: UDI 07332414124731, All serial numbers

Distribution pattern: Worldwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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