Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PRIMSAFLEX M100 SET Recalled by VANTIVE US HEALTHCARE LLC Due to There is a potential dislodgement of the Prismaflex...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact VANTIVE US HEALTHCARE LLC directly.
Affected Products
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Quantity: 230,596 units
Why Was This Recalled?
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About VANTIVE US HEALTHCARE LLC
VANTIVE US HEALTHCARE LLC has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report