FDA-Device2018-12-26Class II
Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Fresenius Medical Care Renal Therapies Group, LLC
Hazard
Potential for external blood leaks from the dialyzer header
Sold states
US Nationwide
Affected count
9,097 cs x 12 units each
Manufactured in
920 Winter St, Waltham, MA, United States
Products
Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0658-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief