Recall Z-2439-2025— VANTIVE US HEALTHCARE LLC

Name: FDA recall Z-2439-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-28

Class II · Ongoing

Class II FDA medical device recall by VANTIVE US HEALTHCARE LLC, initiated 2025-07-28. It names 2 FDA 510(k) clearances: K193482, K190910. Product: TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631. 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.

Recalling firm: VANTIVE US HEALTHCARE LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-07-28
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

2 on FDA's record

K193482 — PrisMax System Version 3Baxter Healthcare Corporation·cleared 2020-03-13
K190910 — PrisMax System Version 2Baxter Healthcare Corp·cleared 2019-07-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.