FDA recall Z-2439-2025

VANTIVE US HEALTHCARE LLC · Class II · device

Product

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

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

Key facts

Status: Ongoing
Initiation date: 2025-07-28
Report date: 2025-09-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2439-2025