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FDANovember 5, 2018device

Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Potential for external blood leaks from the dialyzer header

What to do

FDA enforcement status: Terminated

Brands named

fresenius medical care renal therapiesfreseniusfresenius medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E — Recall Details · AllClear