FDA-Device2025-01-15Class II
Dialyzer Optiflux 160NRe
Fresenius Medical Care Holdings, Inc.
Hazard
Potential for internal blood leaks due to cracked polyurethane
Sold states
Nationwide Distribution.
Affected count
5,351 cases (64,212 dialyzers)
Manufactured in
920 Winter St Bld 920, Waltham, MA, United States
Products
Dialyzer Optiflux 160NRe
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0801-2025Don't want to check this manually?
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