Fresenius Medical Care North America
Country not established
- Devices
- 50
- FDA recalls
- 12
At a glance
Market reach
- United States
- FDA recalls
What Fresenius Medical Care North America makes
The company manufactures hemodialysis and peritoneal dialysis components, including acid concentrate solutions for dialysis fluid, dialyzers like the Optiflux series, and blood chamber clips for vascular access. It also produces hemoadsorption systems for toxin removal, automated cell separators with disposable platelet sets, and sterile administration sets with infection-control connectors. Additional products include priming sets for dialysis circuits, viral-blocking transducer protectors, and online clearance monitors for real-time hemodialysis performance tracking.
These devices are regulated under FDA Class II and unclassified (U) classifications, with most cleared via the 510(k) pathway. The portfolio is listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Search and filter all 50 devicesFDA recalls
FDA recall records list 12 recalls initiated by Fresenius Medical Care North America, the earliest on 2004-09-20 and the most recent on 2010-05-14. By recorded status: 12 terminated. The reasons filed fall into these groups: labeling or instructions for use, electrical or power and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2010
- 14 May 2010 Z-1951-2010 Unclassified (pre-2012) Terminated Hemodialyzer may leak at the header/end cap
2009
- 20 Nov 2009 Z-2224-2010 Unclassified (pre-2012) Terminated Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy.
- 20 Nov 2009 Z-2225-2010 Unclassified (pre-2012) Terminated Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy.
- 20 Nov 2009 Z-2226-2010 Unclassified (pre-2012) Terminated Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy.
- 20 Nov 2009 Z-2227-2010 Unclassified (pre-2012) Terminated Power cords may fail if the prongs crack or fail at the plug, and may become a fire/burn/shock hazard or delay/interrupt therapy.
2008
- 25 Nov 2008 Z-0859-2009 Unclassified (pre-2012) Terminated Port may crack and separate resulting in potential blood exposure/blood loss for the patient
- 25 Nov 2008 Z-0860-2009 Unclassified (pre-2012) Terminated Port may crack and separate resulting in potential blood exposure/blood loss for the patient
2007
- 3 Dec 2007 Z-0738-2008 Unclassified (pre-2012) Terminated Leaking: the Dialyzer may leak at the header resulting in small amounts of blood loss.
2006
- 22 Mar 2006 Z-0834-06 Unclassified (pre-2012) Terminated Stay safe trigger body may not connect to the extension set and result in associated peritonitis
2005
- 28 Nov 2005 Z-0333-06 Unclassified (pre-2012) Terminated Mislabeled: Inner product mislabeled as F180NR (Catalog Number 0500318N) instead of F160NR
Show all 12 recalls
2005
- 28 Nov 2005 Z-0334-06 Unclassified (pre-2012) Terminated Mislabeled: Inner product mislabeled as 180NR (Catalog Number 0500318N) instead of 160NR
2004
- 20 Sep 2004 Z-0017-05 Unclassified (pre-2012) Terminated Peritoneal Dialysis Transfer Set may have occluded pathway
Frequently asked questions
How many devices does Fresenius Medical Care North America have in the registry?
The registry currently lists 50 devices for Fresenius Medical Care North America. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fresenius Medical Care North America's devices?
Among its 50 most recently registered devices, Fresenius Medical Care North America has devices listed in FDA 510(k) (50 devices).
What risk classes do Fresenius Medical Care North America's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Fresenius Medical Care North America's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Fresenius Medical Care North America?
FDA recall records list 12 recalls initiated by Fresenius Medical Care North America, the most recent initiated on 14 May 2010. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Fresenius Medical Care North America in the registry?
The most recently registered devices listed for Fresenius Medical Care North America include FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIES, CRIT-LINE CLIP (CLIC) BLOOD CHAMBER, Optiflux dialyzer and FRESENIUS ART HEMOADSORPTION SYSTEM.