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VANTIVE US HEALTHCARE LLC recalls PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Recalled February 11, 2026 · FDA recall Z-1227-2026 · VANTIVE US HEALTHCARE
Hazard
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. · FDA Class II
Units
230,596 units
Sold at
US Nationwide distribution.
Description
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Product
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Manufacturer(s)
VANTIVE US HEALTHCARE LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →