Vantive US Healthcare Recalls Prismaflex HF1000 Sets Due to Component Dislodgement Risk

What Happened

Vantive US Healthcare LLC has initiated a voluntary recall of the Prismaflex HF1000 Set. The recall was prompted by the discovery of a potential issue where the deaeration chamber of the set may dislodge from the Prismaflex Control Unit during medical procedures.

Which Products Are Affected

The recall involves the following medical device:

• Product Name: PRISMAFLEX HF1000 SET (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
• Product Code: 107140
• Recall Number: Z-1229-2026
• UDI/DI: 07332414069254
• Lot Information: All lots including and manufactured after 24G0034CA
• Quantity: 93,576 units
• Distribution: Nationwide across the United States

What You Should Do

The firm began notifying customers of the issue via a letter sent on January 6, 2026. Healthcare facilities and providers in possession of the affected lots should follow the specific guidance provided in the manufacturer’s notification letter. For additional inquiries, contact Vantive US Healthcare LLC, located at 510 Lake Cook Rd, Deerfield, IL 60015.

Why This Matters

This recall is classified as Class II by the FDA. The potential dislodgement of the deaeration chamber from the control unit during dialysis could lead to treatment interruptions or other safety risks for patients undergoing care.

Source

Information sourced from the FDA (Event ID: 98180).