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Medium risk Electronics & LightingClass II

VANTIVE US HEALTHCARE LLC Recall

PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Updated January 6, 2026

VANTIVE US HEALTHCARE LLC is recalling PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System. Hazard: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Is the VANTIVE US HEALTHCARE LLC recalled? Yes. This product was recalled by FDA on January 6, 2026. Details below.

What is recalled

PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Am I affected

You may be affected if you own this product. Check the brand, model, and lot/date codes listed in the recall against your item.

What to do right now

Voluntary: Firm initiated

The hazard

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

Brands affected

VANTIVE US HEALTHCARE LLC
Source
FDA
Category
Electronics & Lighting
Recall ID
fda-Z-1228-2026
Classification
Class II
Recalled
January 6, 2026
Read the official notice

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