Baxter Dialyzers
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In mid-October, 2001, Baxter International announced that it was voluntarily
recalling certain dialyzers after reports of deaths associated with its product
in kidney dialysis patients in Spain, Croatia, Italy, Germany, Taiwan, Colombia
and the U.S. The first reported deaths occurred in Spain in mid-August. Most
of the dialysis patients who died experienced shortness of breath, chest tightness,
cardiac arrest or stroke symptoms within hours of being dialyzed.
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
According to a Baxter press release issued on November 5, 2001, 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. Additional tests are currently underway.
- Baxter
Dialyzer Recall Information Baxter International
- FDA
Investigating Role of Baxter's Recalled Dialyzers in Kidney Dialysis Patient
Deaths US Food and Drug Administration, Center for Drug Evaluation and
Research, November 7, 2001
- Baxter
Finds Possible Link in 53 Deaths The New York Times, November 6, 2001
-
Baxter: Fluid in Filters May Be Link to Deaths MSNBC.com (Daily Herald),
November 6, 2001
- Following
Extensive Investigation, Baxter Identifies Probable Cause of Recent Hemodialysis
Patient Deaths Baxter International, Novermber 5, 2001
- Product
Recall Letter (US customers only) (MS Word) Baxter Interrnational, October
18, 2001
-
Baxter Urges Comprehensive Scientific Analysis of Hemodialysis Treatment Safety
Baxter International, October 15, 2001
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