Fresenius Medical Care Renal Therapies Group, LLC recalls Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
- Recall date
- November 5, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0658-2019
- FDA classification
- Class II
- Brand / firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Sold / distributed
- US Nationwide
Why it was recalled
Potential for external blood leaks from the dialyzer header
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Get recall alerts
Free email alert whenever Fresenius Medical Care Renal Therapies Group, LLC has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Fresenius Medical Care Renal Therapies Group, LLC