Fresenius Medical Care Holdings, Inc. recalls Dialyzer Optiflux 160NRe
- Recall date
- December 5, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0801-2025
- FDA classification
- Class II
- Brand / firm
- Fresenius Medical Care Holdings, Inc.
- Sold / distributed
- Nationwide Distribution.
Why it was recalled
Potential for internal blood leaks due to cracked polyurethane
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Dialyzer Optiflux 160NRe
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