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Fresenius Medical Care Holdings, Inc. recalls Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Recalled July 6, 2022 · FDA recall Z-1303-2022 · Fresenius Medical Care Holdings
Hazard
Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure. · FDA Class II
Units
19 cases
Sold at
US Nationwide distribution in the state of Pennsylvania.
Description
Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.
Product
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Manufacturer(s)
Fresenius Medical Care Holdings, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →