Recall Z-2437-2025— VANTIVE US HEALTHCARE LLC

Name: FDA recall Z-2437-2025
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 one FDA 510(k) clearance: K190910. Product: PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701. Reason: Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles.

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

1 on FDA's record

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

PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701

Reason for recall

Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles

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