FDA Class I Classification Given to Baxter's Sept. 2005 Urgent Product Recall for Meridian Hemodialysis Instrument

The Food and Drug Administration (FDA) released the following information:

Contact:
Cindy Resman, (847) 948-2815
Deborah Spak, (847) 948-2349

 Baxter Healthcare Corporation announced that the U.S. Food and Drug Administration (FDA) has classified a September 28, 2005 Urgent Product Recall letter from Baxter to customers regarding the company's Meridian Hemodialyis (HD) Instrument (Product Codes 5M5576 and 5M5576R) as a Class I recall. This classification does not require the return of Meridian instruments currently in the market. In the September letter, Baxter directs customers to route blood tubing through only one channel of the two channel clips mounted on the front of the Meridian to reduce the risk of blood tubing kinks.

Specifically, there have been reports of hemolysis (broken blood cells) related to kinks in the blood tubing sets used with the Meridian. To date, there have been reports of one death and at least one serious injury, associated with kinking of blood tubing sets routed through both channels of the clips mounted on the front of the Meridian. The clinical implication of returning hemolyzed blood to a patient can range from no adverse health consequences up to and including death. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the affected product may cause serious injury or death if the problem is not corrected.

To help customers address this issue, Baxter provided labels with the September 28, 2005 customer letter, to be affixed to Meridian instruments. The labels clearly display the proper routing of the blood tubing sets. Further, Baxter asks that all care providers be trained and that they follow the proper set up and use only one of the two retainers in each of the double-tubing clips during treatment. Continuous verification through visual inspection of the tubing will reduce the chances of kinking. In addition, Baxter will be providing modified tubing clips to eliminate related safety issues as soon as possible. Baxter's letter to customers is available on its web site at www.baxter.com.

The last Meridian was manufactured in 2002. Approximately 2,100 Meridian instruments are currently in use, including 1,700 in the United States. Baxter announced in July 2005 that it would no longer manufacture any hemodialysis instruments and the company has been working to transition customers to alternate hemodialysis instruments through a distribution arrangement with Gambro Renal Products. Specific to the Meridian, Baxter has already initiated a transition of Meridian instruments in the field to Gambro instruments. The costs associated with this transition plan have been included in a previously announced charge estimated to be approximately $50 million, which has been partially recorded in the third quarter of 2005 and the remaining charge will be recorded in subsequent quarters.

Customers requesting copies or with questions regarding the September 28, 2005 letter, or the FDA's classification of this action, or who need technical assistance, may contact the company at 1-800-4BAXTER (1-800-422-9837).

If you are a physician or a patient who has experienced a problem with the Meridian device, please send a report to FDA's MedWatch program. Information regarding FDA's MedWatch program is available at http://www.fda.gov/medwatch or call 1-800-332-1088.

Type of Recall:
Class I - This is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.