Devices

Device Recall Fresenius Optiflux B200 Flux Dialyzers

Model / Serial
Lot Numbers: 13LU02011 13LU02013 13NU02016 13NU02017
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA (nationwide) and the country of: Mexico.
Product Description
Optiflux B200 Flux Dialyzers; Product Number: 0500325E. || Single Use acute or chronic hemanalysis treatment.
Manufacturer
Fresenius Medical Care Holdings, Inc.
1 Event
- Recall of Device Recall Fresenius Optiflux B200 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

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

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.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)