FDA-Device2022-07-06Class II
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Fresenius Medical Care Holdings, Inc.
Hazard
Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.
Sold states
US Nationwide distribution in the state of Pennsylvania.
Affected count
19 cases
Manufactured in
920 Winter St Bld 950, Waltham, MA, United States
Products
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1303-2022Don't want to check this manually?
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