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FDAMay 4, 2022device

Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.

What to do

FDA enforcement status: Terminated

Brands named

fresenius medical carefreseniusfresenius medical

UPCs

00840861100163

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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