I am writing this to inform you of the following: A Baxter Healthcare facility in Michigan that received a recall letter from Baxter Healthcare yesterday stating that the recalled product was being used by the facility for end stage renal disease dialysis, including dialysis at a high pressure rate. The recall was initiated in June of last year when I learned the recall had begun. I was notified last week about the recall. The recalled Baxter Healthcare product does not meet current regulatory requirements at the FDA level. This product may not be dispensed or used by the public at Baxter Healthcare or by other healthcare facilities or practitioners. The Baxter Health Care products may be obtained at the FDA website () under Category IV, IVB, H, or IOC. I have directed Baxter Healthcare to immediately stop using this product. It is my understanding that they will begin distributing replacement products as soon as possible. A Baxter Healthcare employee at the Michigan facility provided me with some additional information, which I intend to share with the public. The recall letter sent to the Michigan facility said the recall affected dialysis equipment from 2004 and newer models. According to a Baxter Healthcare employee I spoke with today, that was not the case, as the recall letter only affected equipment manufactured from January 2010. No other types or models of Baxter Healthcare Dialysis Equipment are affected by this recall. It is my understanding that the Baxter Healthcare employee and the employee at the Michigan facility both said that the recall was initiated by Baxter Healthcare, without any involvement on the part of the local hospital. This recall will take some time to be resolved, as this recall letter was sent to only the one facility. A Baxter Healthcare employee at the hospital said hospital officials would be contacting the affected facility and would be contacting the public, as Baxter Healthcare did not notify them of this issue. One Baxter Healthcare employee at a hospital in Texas said it should take only a couple of days to resolve this recall. The Baxter Healthcare employee said the hospital was still working through this issue, and they would not be sure of a timeline for completing this process. For more information, please contact the FDA or my Office. Sincerely, John C. Calhoun, Jr.
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DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services 7500 Security Boulevard Baltimore, MD 21244-1850 Ref: S&C-02-05 DATE: FROM: November 14, 2001, Director, Survey and Certification
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