Law360, New York (April 12, 2011, 2:04 PM ET) -- The U.S. Food and Drug Administration on Tuesday unveiled a warning letter to Fresenius SE reprimanding the German medical supplier for making unauthorized modifications to a dialysis device following a November recall.
The FDA said in the April 6 letter that Fresenius’ medical care unit made changes to the structure of a tubing segment in the CombiSet True Flow Series Hemodialysis Blood Tubing Set and distributed it in the U.S. without FDA clearance.
According to the agency, the change in the hardness of the materials affected...
Fresenius Dialysis Device Faces FDA Scrutiny
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