FDA issues warning letter to Fresenius SE over dialysis tubing set
April 15th, 2011 // 1:30 pm @ jmpickett
The U.S. Food and Drug Administration has issued a warning letter to Fresenius SE for unauthorized design changes to its CombiSet True Flow Series Hemodialysis Blood Tubing Set, marketed by Fresenius Medical Care North America.
May 11 Top Selling Webinar – FDA Expectations of Senior Management
Save 50% Now with Offer Code 1012199
According to the FDA letter, Fresenius implemented design changes to the dialysis tubing set, including a change in a tubing segment from thick wall to thin wall, before distributing the device in the United States. In November 2010, Fresenius issued a recall of the device due to failure caused by the design changes.
The FDA has asked Fresenius to notify the agency of the specific steps they have taken to correct the violations within 15 working days working from the time they receive the letter.
