PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Di...
FDA Recall #Z-1230-2026 — Class II — January 6, 2026
Product Description
PRISMAFLEX HF1000 SET, Product Code 107142; 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
115,112 units
Distribution
US Nationwide distribution.
Code Information
UDI/DI 07332414069315, All lots including and manufactured after 24F0094CA
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated