FDA NEWS RELEASE

FDA Notifies Health Care Professionals of Problem with Baxter Healthcare's Meridian Hemodialysis Instrument
Kinks in Device Tubing Can Pose Serious Risk to Patients

The U.S. Food and Drug Administration (FDA) is announcing that Baxter Healthcare Corporation of Deerfield, Ill., has initiated a worldwide recall of its Meridian Hemodialysis Instrument because of reports of hemolysis (red blood cell destruction) that can result in kidney damage, anemia, and other serious health consequences. The hemolysis is caused by kinking in the blood tubing sets used with the Meridian. This has contributed to one death and one serious injury.

The affected devices are all Meridian Instruments with model numbers 5M5576 and 5M5576R. There are over 2,800 units currently in use, with approximately 2,100 devices in the United States. Users of the Meridian do not have to return the product to Baxter.

This week, Baxter notified its customers about the problem and today FDA is issuing this notification to ensure broad dissemination of the information to health care professionals. FDA also is notifying users that the results of the agency's own analysis and laboratory testing have confirmed the problem with blood line kinking and hemolysis.

Baxter is instructing users to route blood tubing through only one channel of the two channel clips mounted on the front of the Meridian to reduce the chances of kinking. This means that users should clamp the tubing in only one place, not two, to avoid causing hemolysis. (The original labeling for the device instructs users to route the blood tubing sets through both channels of the two-channel clips.) The firm also is instructing users to continuously verify by visual inspection that the tubing is not kinked.

The firm first notified its users about the problem in an "Urgent Product Recall" letter dated September 28, 2005. The notification included diagrams and labels to be placed on the Meridian instrument, displaying the correct use of the clips. The firm will be providing users with modified tubing clips to correct the problem. FDA is working with the company to ensure that the modified tubing clips are available as soon as possible.

Baxter's letters to customers are available on its website at www.Baxter.com. Consumers who have questions about the recall may contact Baxter Healthcare at 1-800-422-9837. Those who have technical questions may contact Baxter Healthcare at 1-800-553-6898.

Physicians or patients who have experienced problems with these devices should report to FDA's MedWatch program and to Baxter. See www.fda.gov/medwatch/ for filing information or call 1-800-FDA-1088 (1-800-332-1088).

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