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U.S. Department of Health and Human Services

Safety

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Baxter Meridian Hemodialyis (HD) Instrument

Audience: Hemodialysis administrators, nephrologists and other healthcare professionals

[Posted 12/14/2005] The FDA has classified Baxter Healthcare Corporation's Meridian Hemodialyis (HD) Instrument (Product Codes 5M5576 and 5M5576R) as a Class I recall. There have been reports of hemolysis 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.

This classification does not require the return of Meridian instruments currently in the market. In the September 28, 2005 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.

Baxter also 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 on this procedure. In addition, Baxter will be providing modified tubing clips to eliminate related safety issues as soon as possible.

[December 13, 2005 - Press Release - Baxter Healthcare]
[December 19, 2005 - Recall Notice - FDA]
[September 28, 2005 - Firm Recall Notice - Baxter Healthcare]