Class II

Medical Device Recall: PRIMSAFLEX M100 SET, Product Code 106697; 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

230,596 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1227-2026

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.