ALERT - Dialyzer Recall by Baxter

PDF Version of BQA 01-048 (PDF, 24 KB)
includes some attachments

Date: November 30, 2001 -- DSL-BQA-01-048

To: Hospitals HOSP 22, End-Stage Renal Disease ESRD 09

From: Janet Eakins, Chief, Provider Regulation and Quality Improvement Section

cc: Susan Schroeder, Director, Bureau of Quality Assurance

On October 18, 2001, following the deaths of 53 patients, four in the United States, Baxter voluntarily issued a recall of the following dialyzers:

A15, A18, and A22 Dialyzers (237015, 237018, 23722)

AF150, AF180, AF 220, Dialyzers (238015, 238018, 238022)

All lots of the above product codes

On November 14, 2001 CMS issued a memo outlining the recall of Baxter dialyzers, labeled either Baxter or Althane. Two additional recalls were included in this memo, and they are:

Ax 1500, Ax2200

The FDA has issued a Medalert, ESRD networks have been asked to communicate this information to all dialysis providers, and CMS has asked state departments to communicate to all hospital providers.

The Wisconsin Health and Hospital Association (WHA) sent out an e-mail Alert to their membership on November 21, 2001.

Attached please find the CMS letter [NO LONGER AVAILABLE], the Baxter recall notice and customer letter, and a copy of the New York Times article. For additional information you may contact:

CMS - Judith Kari at jkari@cms.hhs.gov

Baxter - Center for One Baxter (exit DHS) at 1-800-422-9837 or 847-948-4770 (Monday through Friday 8:00 – 5:00pm CST)

Wisconsin BQA - Lydia Reitman at reitmla@DHS.state.wi.us

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