International Medical Devices Database

Manufacturer Address
Fresenius Medical Care North America, 95 Hayden Avenue, Lexington MA 02421-7942
Source
USFDA
3 Events

2 devices in the database

Device Recall Fresenius Medical Care

Model / Serial
Lot Numbers: 5SR119; 52R124; 5SR125; 5SR149; 5SR150; 5SR173; 6AR014; 6AR015; 6AR032; 6AR044; 6AR045; 6AR055; 6AR069; 6AR085; 06AR086; 6AR267; 6AR280;6AR298; 6BR013;6BR031; 6BR040; 6BR043; 6BR064; 6BR075; 6BR091; 6BR092; 6BR110; 6BR127; 6BR141; 6BR281
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Canada
Product Description
Newton IQ 4 Lead Cycler Set with stay-safe patient connectors, used for acute and chronic peritoneal dialysis. || Catalog Number: 050-87028

Device Recall Fresenius Medical Care

Model / Serial
Lot Number: 5LU319
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide
Product Description
Optiflux Series Fresenius Polysulfone F180NR dialyzer High Flux || Catalog Number: 0500318N

3 manufacturers with a similar name

Learn more about the data here

Fresenius Medical Care North America

Manufacturer Parent Company (2017)
Fresenius SE & Co KGaA
Source
DH

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

Fresenius Medical Care North America

Manufacturer Address
Fresenius Medical Care North America, 95 Hayden Ave, Lexington MA 02421-7942
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.

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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.

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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.

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