PlainRecalls
FDA Devices Moderate Class II Ongoing

PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Reported: February 11, 2026 Initiated: January 6, 2026 #Z-1225-2026

Product Description

PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Reason for Recall

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Details

Recalling Firm
VANTIVE US HEALTHCARE LLC
Units Affected
264,040 units
Distribution
US Nationwide distribution.
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System. Recalled by VANTIVE US HEALTHCARE LLC. Units affected: 264,040 units.
Why was this product recalled?
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 11, 2026. Severity: Moderate. Recall number: Z-1225-2026.