FDAJuly 28, 2025device
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
What to do
FDA enforcement status: Ongoing
Brands named
vantive us healthcarevantivevantive us
UPCs
00085412639499
Recall history
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