FDA-Device2025-09-03Class II
TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
VANTIVE US HEALTHCARE LLC
Hazard
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
Sold states
Worldwide
Affected count
7432 units
Manufactured in
510 Lake Cook Rd, Deerfield, IL, United States
Products
TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2439-2025Don't want to check this manually?
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