Vantive US Healthcare Recalls Prismaflex TPE2000 Sets Due to Component Dislodgement Risk

What Happened

Vantive US Healthcare LLC has initiated a voluntary recall of the Prismaflex TPE2000 Set. The recall was prompted by the discovery of a potential defect where the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit. This issue was officially classified by the FDA as a Class II recall on February 2, 2026.

Which Products Are Affected

The recall involves medical devices distributed nationwide across the United States. The following specific product is affected:

• Product Name: PRISMAFLEX TPE2000 SET (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
• Product Code: 114093
• UDI/DI: 07332414111038
• Affected Lots: All lots including and manufactured after 24J0106
• Quantity: 13,760 units
• Recall Number: Z-1231-2026

What You Should Do

Vantive US Healthcare LLC notified affected customers via a formal letter initiated on January 6, 2026. Healthcare providers and facilities in possession of these sets should review their inventory for the affected lot numbers. For further instructions regarding the return or management of these units, contact Vantive US Healthcare LLC at their Deerfield, Illinois headquarters.

Why This Matters

The dislodgement of the deaeration chamber from the control unit can disrupt the dialysis process. While classified as a Class II recall, the defect represents a potential risk to patient safety and the integrity of the medical procedure.

Source

Information provided by the FDA.