Devices

Device Recall 2008K Home Blood lines Combiset True Flow Series

Model / Serial
All lot codes
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-USA (nationwide) and the country of Canada.
Product Description
2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use || Catalog Number: 03-2962-3. || Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
Manufacturer
Fresenius Medical Care Holdings, Inc.
1 Event
- Recall of Device Recall 2008K Home Blood lines Combiset True Flow Series

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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