UPDATE 1-FDA issues warning letter to Fresenius on dialysis device

* FDA says co made unauthorized changes to device

* FDA says devices were misbranded

* Co sees no financial impact from FDA move

(Updates alerts)

April 12 (Reuters) – U.S. health regulators have issued a
warning letter to German healthcare conglomerate Fresenius SE
for unauthorized design changes in its dialysis
device, CombiSet, before its sale in the United States.

According to the U.S. Food and Drug Administration (FDA),
the company’s Fresenius Medical Care unit made some
design changes to the device, including a change in the tubing
segment from thick wall to thin wall.

The FDA said the company initiated a recall of the modified
CombiSet on Nov. 19, 2010, due to device failure related to the
design change.

The FDA said the modifications were not cleared under U.S.
regulations and the devices were “adulterated” because there was
no pre-market approval or an approved application for an
investigational device exemption.

“These devices are also misbranded … because you did not
notify the agency of your intent to introduce these devices into
commercial distribution,” FDA told Fresenius in the warning

A Fresenius Medical Care spokesman said the FDA warning
letter on the device will have no financial impact on the

The company made the changes after it had voluntarily
recalled the initial version of the CombiSet Tue Flow device in
January, the spokesman said.

FDA has given 15 working days to respond and notify of the
steps taken to correct the noted violations.

The FDA letter is available at:

(Reporting by Shravya Jain in Bangalore, additional reporting
by Ludwig Burger in Frankfurt; Editing by Gopakumar Warrier)

UPDATE 1-FDA issues warning letter to Fresenius on dialysis device