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U.S. Department of Health and Human Services

Safety

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Baxter Healthcare Dialyzers

Audience: Dialysis healthcare professionals, Risk Managers, Hospital Administrators

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. In mid-October, Baxter notified all of its customers to stop using these dialyzers immediately and return any inventory. 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.

[Nov 07, 2001 - Letter - FDA]