Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Optiflux 200NRe Dialyzer Finished Assy. Recalled by Fresenius Medical Care Holdings, Inc. Due to Dialyzers were distributed after being exposed to cold...
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 200NRe Dialyzer Finished Assy., Model no. 0500320E
Quantity: 19 cases
Why Was This Recalled?
Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.
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