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-0801-2025

More Fresenius Medical Care Holdings, Inc. recalls

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