medical Class II Updated 2026-02-11

VANTIVE US HEALTHCARE LLC recalls OXIRIS SET, Product Code 112016; Dialyzer, High Permeability

Recalled Product

OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System


Hazard / Issue

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI/DI 07332414102234, All lots including and manufactured after 24G0041Z
View official government recall

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