Product News and Recalls

FDA investigates dialysis company Fresenius

Fox News reports that the U.S. Food and Drug Administration has issued a warning to Fresenius Medical Care, a German company that manufactures kidney dialysis equipment and operates dialysis centers.

The agency’s warning letter alleges that Fresenius failed to adequately test artificial kidneys — called “dialyzers” – manufactured in Utah, to make sure they adequately meet design specifications.

The FDA stopped short of issuing a recall in this case. But the agency has raised other concerns about Fresenius recently.

The FDA is investigating whether Fresenius sat on information suggesting that one of its products carries a potentially lethal risk.

In November, 2011, Fresenius sent out an internal memo to its own doctors stating that 941 patients suffered cardiac arrest in the company’s clinics in 2010, and the incidents may be associated with a product called GranuFlo.

Yet Fresenius did not inform other clinics of this concern until March, 2012, and only did so after an anonymous tipster gave the U.S. Food and Drug Administration a copy of the in-house warning.

Fresenius is the leading supplier of dialysis machines and disposable products in the United States, at both its own clinics and those maintained by other companies. Fresenius also treats more than a third of the estimated 400,000 Americans who receive kidney dialysis.

You should consult with a doctor before making any change in your medical care. If you or a loved one have suffered injury or death after kidney dialysis, contact Lopez McHugh for a free consultation; we can help determine if GranuFlo was used.

See the story here:

http://www.foxbusiness.com/news/2013/03/14/fresenius-medical-care-gets-fda-warning-letter-on-dialyzer-validation/