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Fresenius Medical Care Holdings, Inc. recalls Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.
Recalled March 5, 2014 · FDA recall Z-1098-2014 · Fresenius Medical Care Holdings
Hazard
Dialysate Port Leak During Priming of the Dialyzers · FDA Class II
Units
3,460,672 units
Sold at
Worldwide distribution: USA (nationwide) and the country of: Mexico.
Description
Dialysate Port Leak During Priming of the Dialyzers
Product
Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.
Manufacturer(s)
Fresenius Medical Care Holdings, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →