medical Class II Updated 2022-07-06

Fresenius Medical Care Holdings, Inc. recalls Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E

Recalled Product

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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI (GTIN): (01)00840861100163 Lot 22AU04017
View official government recall

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