Vantive US Healthcare Recalls PRISMAFLEX M150 Sets Due to Deaeration Chamber Issues

What Happened

Vantive US Healthcare LLC has initiated a voluntary recall of the PRISMAFLEX M150 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. The FDA has classified this as a Class II recall.

Which Products Are Affected

The recall involves approximately 137,576 units distributed nationwide across the United States. Affected products include:

• Product Name: PRISMAFLEX M150 SET (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
• Product Code: 109990
• UDI/DI: 07332414090005
• Lot Information: All lots including and manufactured after 24F0100CA
• Recall Number: Z-1228-2026

What You Should Do

Vantive US Healthcare LLC began notifying affected customers via a formal letter on January 6, 2026. Healthcare facilities and providers should immediately check their inventory for the specified lot numbers. For additional information or instructions regarding the return of affected units, contact Vantive US Healthcare LLC at their Deerfield, Illinois office located at 510 Lake Cook Rd.

Why This Matters

The dislodgement of the deaeration chamber during medical procedures could lead to therapy interruptions or other clinical complications. A Class II classification indicates that while the probability of serious adverse health consequences is remote, the product may cause temporary or medically reversible health issues.

Source

Information provided by the FDA under event ID 98180.