FDAnews Device Daily Bulletin

FDA ISSUES CLASS I CERTIFICATION TO BAXTER'S MERIDIAN RECALL

Dec. 14, 2005
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FDA ISSUES CLASS I CERTIFICATION TO BAXTER'S MERIDIAN RECALL

The FDA has designated Baxter Healthcare's September recall of its Meridian hemodialysis instrument a Class I recall, the agency's most serious certification given to products that may cause serious injury or death.

In its Sept. 28 urgent product recall letter, Baxter directed 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 kinks in the blood tubing.

There have been reports of hemolysis (broken blood cells) related to kinks in the blood tubing sets used with the Meridian, the firm said. One death and at least one serious injury have been associated with kinking of blood tubing sets routed through both channels of the clips mounted on the front of the Meridian, it added.

In the September letter, Baxter provided labels that clearly display the proper routing of the blood tubing sets. The firm also asked that all healthcare 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. In addition, Baxter said it would provide modified tubing clips to eliminate related safety issues as soon as possible.

Baxter said the Class I designation does not require the return of Meridian instruments currently on the market. Baxter stopped making the Meridian in 2002. Roughly 2,100 Meridian instruments are currently in use, including 1,700 in the U.S.

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