VANTIVE US HEALTHCARE LLC recalls PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Recall date
- January 6, 2026
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1228-2026
- FDA classification
- Class II
- Brand / firm
- VANTIVE US HEALTHCARE LLC
- Sold / distributed
- US Nationwide distribution.
Why it was recalled
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
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