Class II

Medical Device Recall: PRISMAFLEX M150 SET, Product Code 109990; 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

137,576 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1228-2026

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.

VANTIVE US HEALTHCARE LLC Medical Device Recall: PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System | SafeCheck