Vantive US Healthcare Recalls Prismaflex ST150 Sets Due to Chamber Dislodgement Risk

What Happened

Vantive US Healthcare LLC has initiated a voluntary recall of the Prismaflex ST150 Set. The recall was prompted by the discovery of a potential mechanical issue where the deaeration chamber of the set may dislodge from the Prismaflex Control Unit during operation.

Which Products Are Affected

The recall involves the following medical device:

• Product Name: PRISMAFLEX ST150 SET US (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
• Product Code: 107640US
• UDI/DI: 00085412917696
• Lot Information: All lots including and manufactured after 24F0085
• Quantity: 264,040 units
• Distribution: Nationwide across the United States

What You Should Do

Vantive US Healthcare LLC initiated the recall process on January 6, 2026, via a notification letter to affected customers. Healthcare facilities and providers currently using these sets should review their inventory for the affected lot numbers. For specific instructions regarding the continued use or return of these devices, contact Vantive US Healthcare LLC at their headquarters in Deerfield, Illinois.

Why This Matters

This recall is classified as a Class II event by the FDA. The dislodgement of the deaeration chamber from the control unit could lead to interruptions in dialysis treatment or other procedural complications, though the probability of serious adverse health consequences is considered remote.

Source

Information provided by the FDA under Recall Number Z-1225-2026.