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Medical Device Recalls
FDA Investigating Role of Baxter's Recalled Dialyzers in Kidney Dialysis Patient Deaths

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November 7, 2001

The FDA is investigating reports of over 50 patient deaths worldwide, including four in the United States, that may have been caused by certain dialyzers made by Baxter Healthcare Corporation, Deerfield, Ill.

Baxter voluntarily recalled the dialyzers in mid-October after reports of deaths associated with its product in kidney dialysis patients in Spain, Croatia, Italy, Germany, Taiwan, Colombia and the U.S. The U.S. deaths occurred at dialysis facilities in Austin, Tex., and Kearney, Neb. Most of the dialysis patients who died experienced shortness of breath, chest tightness, cardiac arrest or stroke symptoms within hours of being dialyzed.

FDA has worked closely with Baxter and with regulatory agencies abroad to identify the problems quickly, and protect public health by recalling the dialyzers.

Preliminary tests have led Baxter to conclude that a perfluorohydrocarbon-based performance fluid used in a manufacturing step may have played a role in the deaths of these patients. Confirmatory tests are underway. Baxter reports that it has permanently ceased manufacturing these dialyzers. No dialyzer shortage is anticipated as a result of Baxter's decision.

The following dialyzers--labeled either Althane or Baxter--were recalled:

The products were distributed from January 1998 to October 15, 2001, to dialysis facilities in more than 50 countries. The first reported deaths occurred in Spain in mid-August.

In mid-October, Baxter notified all of its customers to stop using these dialyzers immediately and return any inventory. FDA is continuing to work with Baxter to ensure the recall is effective.

If you would like to contact Baxter you can either call the Center For One Baxter at 1-800-422-9837 or 847-948-4770 (Monday through Friday, 8:00 a.m. to 5:00 p.m. CST)

Updated November 7, 2001

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