Class 2 Device Recall Baxter Prismaflex

• Date Initiated by Firm: January 06, 2026
• Date Posted: February 02, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1225-2026
• Recall Event ID: 98180
• 510(K)Number: K212216
• Product Classification: Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
• Product: PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
• Code Information: UDI/DI 00085412917696, All lots including and manufactured after 24F0085
• Recalling Firm/ Manufacturer: VANTIVE US HEALTHCARE LLC; 510 Lake Cook Rd; Deerfield IL 60015-4964
• For Additional Information Contact: Vantive customer service; 800-284-4060
• Manufacturer Reason for Recall: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
• FDA Determined Cause: Component design/selection
• Action: Vantive issued an Urgent Medical Device Correction notice to its consignees on 01/06/2026 via USPS first class mail. The notice explained the issue, hazard involved, and requested the following: 1. You may continue to perform therapy using the Prismaflex sets listed above. Please monitor the deaeration chamber during therapy to ensure it remains in an upright position within the holder. 2. Vantive is aware of customers who have experienced this issue and attempted to further secure the deaeration chamber in an upright position. If attempting to secure the deaeration chamber in an upright position, please consider the following: . Ensure there are no kinks in the tubing and that the deaeration chamber remains visible. . If the Prismaflex Control Unit issues an Air in Blood alarm, check if air is present. If there is no air present, check if the deaeration chamber is dislodged from the holder and ensure there are no clots present. 1. If no dislodgement, please follow the operator s manual instructions for Air in Blood alarm. 2. In case of dislodgement with clotting, follow the associated instructions within the Prismaflex Control Unit operator s manual to stop the therapy and replace the set. 3. Only in case of dislodgement without clotting or any other alarms, if the chamber is secured in an upright position, follow the associated instructions within the Prismaflex Control Unit operator s manual to proceed with treatment. Facilities who further distributed the products were directed to notify those departments or facilities. Dealers, wholesalers, distributor/resellers, or original equipment manufacturers (OEM) who further distributed the products were directed to notify their customers. For general questions regarding this communication, please contact Vantive Customer Care at 833-542-CRRT (2778). Vantive Customer Care is available 24 hours a day, seven days a week.
• Quantity in Commerce: 264,040 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KDI