Class II
Medical Device Recall: PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
VANTIVE US HEALTHCARE LLC · January 6, 2026
Reason for Recall
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
87,436 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1224-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.