Vantive US Healthcare Recalls Oxiris Set Dialyzers Due to Chamber Dislodgement Risk

What Happened

Vantive US Healthcare LLC has initiated a voluntary recall of the Oxiris Set dialyzer system. The recall was prompted by the discovery of a potential defect where the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit during use.

Which Products Are Affected

The recall involves the following medical device:

• Product Name: OXIRIS SET (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
• Product Code: 112016
• Recall Number: Z-1226-2026
• UDI/DI: 07332414102234
• Lot Information: All lots including and manufactured after 24G0041Z
• Quantity: 2,724 units
• Distribution: Distributed nationwide across the United States.

What You Should Do

The recalling firm, Vantive US Healthcare LLC, initiated the recall process on January 6, 2026, via a notification letter to affected customers. Healthcare facilities and providers in possession of these units should follow the specific instructions provided in the firm’s notification letter regarding the inspection or return of the affected sets. For further inquiries, contact Vantive US Healthcare LLC at their Deerfield, Illinois location.

Why This Matters

This Class II recall indicates that the use of the affected product may cause temporary or medically reversible adverse health consequences. A dislodged deaeration chamber could lead to treatment interruptions or other complications during critical dialysis procedures.

Source

Information provided by the FDA.