Devices

Device Recall Fresenius Optiflux F160NR High Flux Dialyzers

Model / Serial
Lot Numbers: 13NU01014 13SU01001 13SU01002
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) and the country of: Mexico.
Product Description
Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. || Single Use acute or chronic hemanalysis treatment.
Manufacturer
Fresenius Medical Care Holdings, Inc.
1 Event
- Recall of Device Recall Fresenius Optiflux F160NR High Flux Dialyzers

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

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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