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Fresenius Medical Care Holdings, Inc. recalls Dialyzer Optiflux 160NRe
Recalled January 15, 2025 · FDA recall Z-0801-2025 · Fresenius Medical Care Holdings
Hazard
Potential for internal blood leaks due to cracked polyurethane · FDA Class II
Units
5,351 cases (64,212 dialyzers)
Sold at
Nationwide Distribution.
Description
Potential for internal blood leaks due to cracked polyurethane
Product
Dialyzer Optiflux 160NRe
Manufacturer(s)
Fresenius Medical Care Holdings, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →