Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Optiflux F180NR High Flux Dialyzers Recalled by Fresenius Medical Care Holdings, Inc. Due to Dialysate Port Leak During Priming of the Dialyzers
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 Holdings, Inc. directly.
Affected Products
Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use acute or chronic hemanalysis treatment.
Quantity: 52,752 units
Why Was This Recalled?
Dialysate Port Leak During Priming of the Dialyzers
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fresenius Medical Care Holdings, Inc.
Fresenius Medical Care Holdings, Inc. has 161 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report