Vantive US Healthcare Recalls Prismaflex ST100 Sets Due to Chamber Dislodgement Risk

What Happened

Vantive US Healthcare LLC has initiated a voluntary recall of the Prismaflex ST100 Set. The recall was issued due to a potential issue where the deaeration chamber of the set may dislodge from the Prismaflex Control Unit during operation.

Which Products Are Affected

The recall affects the following medical device:

• Product Name: PRISMAFLEX ST100 SET US (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
• Product Code: 107636US
• UDI/DI: 00085412954073
• Lot Information: All lots including and manufactured after 24G0072
• Quantity: 87,436 units
• Recall Number: Z-1224-2026

These products were distributed nationwide across the United States.

What You Should Do

The firm initiated the recall process on January 6, 2026, via a notification letter to affected customers. Healthcare facilities and providers should identify any affected stock from the specified lots. For instructions regarding the management of affected units or to report issues, contact Vantive US Healthcare LLC at their headquarters located at 510 Lake Cook Rd, Deerfield, IL 60015-4964.

Why This Matters

A dislodged deaeration chamber can lead to interruptions in dialysis therapy. The FDA has classified this as a Class II recall, indicating that the use of the product may cause temporary or medically reversible adverse health consequences.

Source

Information provided by the FDA.