The U.S. Food and Drug Administration (FDA) is investigating reports of over 50 patient deaths worldwide, including four in the United States, that may have been caused by dialyzers made by Baxter Healthcare Corporation, Deerfield, Ill.

Baxter voluntarily recalled the dialyzers (Baxter recall notice) after reports of deaths associated with its product in kidney dialysis patients. 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.

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 (Baxter news release). Baxter reports that it has permanently ceased manufacturing these dialyzers.

Dangerous Dialyzers

The following dialyzers — labeled either Althane or Baxter — were recalled:
• Series A11, A15, A18 and A22
• Series AF150, AF180 and AF220
• Series AX1500 and AX2200

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.

If you would like to contact Baxter, 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)

Baxter Dialyzers Links

FIVE KIDNEY DIALYSIS DEATHS PROMPT BAXTER/FDA Action

FDA Investigating Role of Baxter's Recalled Dialyzers in Kidney ...

USATODAY.com — Baxter recalls kidney filters after deaths

CNN.com — Dialysis product may be behind patient deaths ...

NY Times Article: Baxter Dialyzer Recall

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