The FDA warned dialysis products maker Fresenius Medical Care Holdings Inc. (NYSE:FMS) about unauthorized design changes to its CombiSet True Flow Series blood tubing set.
The April 6 warning letter resulted from information the German dialysis maker provided to the agency in response to a Nov. 2010 recall of the tubing set. The company said the recall resulted from reports of arterial line kinks and that no deaths or serious injuries were reported in association with the malfunctions, but the Food & Drug Administration classified the action as a Class I recall, the agency’s most serious.
FDA officials said that in their query of the recall they found that Fresenius had made changes to the device, including altering the thickness of one of its tubing sets, that were not cleared under an original 510(k) clearance.
“While you claim that design validations did not raise any new issues or unexpected results surrounding product performance, safety, and effectiveness, the change in material hardness affected the device performance characteristics, demonstrated by the device failures and the November 19, 2010, recall of the modified CombiSet,” according to the warning letter.
The federal watchdog agency gave Fresenius 15 days from the date of the letter to “correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again.”