Devices

Device Recall Fresenius 2008K, 2008K2 and 2008K2home Hemodialysis Machines

Model / Serial
Catalog numbers: 2008K: 190300, 190303, 190305, 190336, 190371, 190372, 190373, 190517, R190305 (Refurbished), R190371 (Refurbished), RTL190371, RTL190373, RTLR190305 (Refurbished), RTLR190371 (Refurbished), RTLR190373 (Refurbished)
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Product distributed to 5404 customers throughout the US and the world.
Product Description
Fresenius 2008K, 2008K2 and 2008 K2@home Hemodialysis Machines, Manufactured by Fresenius USA Inc., Walnut Creek, CA
Manufacturer
Fresenius Medical Care North America
1 Event
- Recall of Device Recall Fresenius 2008K, 2008K2 and 2008K2home Hemodialysis Machines

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

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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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