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MEDICAL DEVICE RECALLMODERATE
Prismaflex M100 Set
Vantive is recalling the Prismaflex M100 Set due to a potential deaeration chamber dislodgement from the control unit.
What to do
Healthcare facilities should immediately inspect all affected units and contact the manufacturer for further instructions regarding the use of these sets.
Why it was recalled
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
How to identify it
UPC 07332414064556
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Where it was sold
Distributed nationwide.
Official source
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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification