Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Optiflux F160NR Capillary High Flux Dialyzer Single Use Only Recalled by Fresenius Medical Care Renal Therapies Group, LLC Due to Potential for external blood leaks from the dialyzer...
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 Fresenius Medical Care Renal Therapies Group, LLC directly.
Affected Products
Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Quantity: 9,097 cs x 12 units each
Why Was This Recalled?
Potential for external blood leaks from the dialyzer header
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fresenius Medical Care Renal Therapies Group, LLC
Fresenius Medical Care Renal Therapies Group, LLC has 27 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report