Baxter Urgent Product Recall

Return to BQA memo 01-048

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

October 18, 2001

Subject: A15, A18 and A22 Dialyzers (237015, 237018, 237022).
 AF150, AF180, AF220 (238015, 238018, 238022) Dialyzers.
 All lots of the above product codes.

Dear Hemodialysis Physician:

Baxter is initiating a voluntary recall of the products specified above that are labeled either Althane or Baxter. This action is being taken due to reports of serious adverse events that have resulted in patient deaths. There is no evidence to date to link these incidents to the dialyzers. This action is being initiated solely as a precautionary measure in the interest of patient safety while the investigations continue. Patient safety is our highest priority.

Among other actions under way, Baxter has established an independent panel of recognized experts in nephrology to understand the potential cause(s) of these unfortunate events.

Our records show that you have received these specific product codes. Please discontinue use of these product codes immediately. Contact Hospital Order Support at 1-800-284-4060, extension 2684 (between 7:30 am – 5:00 pm CST) for return of product to Baxter for credit. Limited support is available after hours for emergency situations.

If you have distributed these dialyzers to other facilities, please forward this information immediately.

If you have further questions, you may contact the Renal Helpline (between 7:30 am – 4:30 pm CST) at 1-888-736-2543 (Opt. 2). Please complete and return, via fax, the enclosed reply form to confirm the receipt of this information. Your prompt attention to this matter is greatly appreciated.

Sincerely,

/s/ Marge Brown, Director Quality Systems, Baxter Healthcare Corporation

XC: Hemodialysis Center Administrator