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Device Recall Fresenius Optiflux F200NRe High Flux Dialyzers
Model / Serial
Lot Numbers: 13LU04022 13LU04021 13NU04003 13NU04005 13NU04018 13SU04002
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) and the country of: Mexico.
Product Description
Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. || Single Use acute or chronic hemanalysis treatment.
Manufacturer
Fresenius Medical Care Holdings, Inc.
1 Event
Recall of Device Recall Fresenius Optiflux F200NRe High Flux Dialyzers
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Manufacturer
Fresenius Medical Care Holdings, Inc.
Manufacturer Address
Fresenius Medical Care Holdings, Inc., 920 Winter St, Waltham MA 02451-1521
Manufacturer Parent Company (2017)
Fresenius SE & Co KGaA
Source
USFDA
Language
English
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