Vantive US Healthcare Recalls Primsaflex M100 Set Due to Deaeration Chamber Dislodgement Risk

What Happened

Vantive US Healthcare LLC has initiated a voluntary recall of the Primsaflex M100 Set. The recall was issued following reports of a potential safety issue where the deaeration chamber of the Prismaflex Set may dislodge from the Prismaflex Control Unit during use.

Which Products Are Affected

The recall involves the following medical device:

• Product Name: PRIMSAFLEX M100 SET (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
• Product Code: 106697
• UDI/DI: 07332414064556
• Lot Information: All lots including and manufactured after 24F0077CA
• Quantity: 230,596 units
• Distribution: Nationwide across the United States

What You Should Do

Healthcare providers and facilities using these sets should check their inventory for the affected product code and lot numbers. Vantive US Healthcare LLC initiated the notification process via letter on January 6, 2026. Facilities should follow the instructions provided in the firm’s notification regarding the handling and potential return of affected units. For further inquiries, contact Vantive US Healthcare LLC at their Deerfield, IL location.

Why This Matters

The dislodgement of the deaeration chamber from the control unit could lead to interruptions in treatment or mechanical issues during dialysis procedures. This Class II recall indicates that the product may cause temporary or medically reversible adverse health consequences.

Source

Information provided by the FDA under Recall Number Z-1227-2026.