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Devices
Device Recall Optiflux 180NR
Model / Serial
Lot # 7LU416
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide including the states of AZ, CA, HI, IA, ID, IL, IN, KS, KY, MI, MN, MO, NE, NV, NY, OH, OR, PA, WA, and WI.
Product Description
Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North America, Waltham, MA 02451. (Hemodialyzer)
Manufacturer
Fresenius Medical Care North America
1 Event
Recall of Device Recall Optiflux 180NR
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Manufacturer
Fresenius Medical Care North America
Manufacturer Address
Fresenius Medical Care North America, 920 Winter St, Waltham MA 02451-1521
Manufacturer Parent Company (2017)
Fresenius SE & Co KGaA
Source
USFDA
Language
English
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