FDA-Device2014-03-05Class II
Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use acute or chronic hemanalysis treatment.
Fresenius Medical Care Holdings, Inc.
Hazard
Dialysate Port Leak During Priming of the Dialyzers
Sold states
Worldwide distribution: USA (nationwide) and the country of: Mexico.
Affected count
52,752 units
Manufactured in
920 Winter St, Waltham, MA, United States
Products
Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use acute or chronic hemanalysis treatment.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1101-2014Don't want to check this manually?
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