PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dial...
FDA Recall #Z-1227-2026 — Class II — January 6, 2026
Product Description
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for Recall
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Recalling Firm
VANTIVE US HEALTHCARE LLC — Deerfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
230,596 units
Distribution
US Nationwide distribution.
Code Information
UDI/DI 07332414064556, All lots including and manufactured after 24F0077CA
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated