Baxter Corporation Letter to Customers concerning Dialyzer Recall

Return to BQA memo 01-048

Baxter Healthcare Corporation
Route 120 & Wilson Road
Round Lake, Illinois  60073-0490

November 5, 2001

Dear Baxter Customer,

Baxter is deeply saddened by the recent reports of hemodialysis patient deaths and we extend our sympathy to family members of those patients. Since first learning of a potential problem with our A and AF series dialyzers, we encouraged a thorough investigation by international health authorities and independent medical experts, in addition to conducting our own in-depth analysis.

Given our utmost concern for patient safety, we continued our intensive investigation, even after exhausting all standard internationally recognized safety and toxicity tests. We diligently pursued every potential lead based on the facts available to us and even began pursuing other less obvious courses of investigation in search of what could be the cause of the unexplained deaths.

Over this past weekend, we believe we have uncovered the probable cause and felt a responsibility to make public our findings immediately, even though confirmatory studies remain under way. Our preliminary tests indicate that a fluid used in the manufacturing of a small number of these dialyzers is the likely cause of the tragic events. Still, we believe there remain substantive gaps in information about the facts associated with many of the patient deaths that will result in ongoing uncertainty. As such and given our overriding priority of patient safety, we’ve decided the most prudent course of action is to permanently cease manufacturing these dialyzers. We will be working with medical professionals, regulatory bodies, testing authorities, nephrology experts and families of the deceased to address all issues.

It is important that I clarify that our actions only impact the A, AF and AX dialyzers. All other Baxter products remain unaffected by the findings of our investigation and our subsequent decision to cease manufacturing. This includes other Baxter dialyzers, hemodialysis instruments and ancillaries, peritoneal dialysis products and all other Baxter supplied products and services.

Most of you will have been working with your local Baxter representative to determine an alternative dialyzer(s) and we continue to work to ensure continuity of patient care. 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) or select this link to obtain contact information (exit DHS) for your region.

Again, thank you for your ongoing support and confidence in Baxter during our investigations. We are committed to maintaining your confidence, as well as that of your patients, and helping you make the best possible arrangements for your patients. We will continue to keep you informed of any further developments and hope you will contact us with any comments or questions.

Sincerely, [end of text]