Class 1 Recall: Baxter Healthcare Corp. Meridian® Hemodialyis (HD) Instrument

FDA has classified Baxter Health Corp’s recall of its Meridian Hemodialyis Instruments as a Class I recall. Baxter had initiated the recall in September 28th, 2005 after reports of hemolysis (broken blood cells) related to kinks in the blood tubing sets used with the Meridian. Till now, there have been reports of one death and one serious injury associated with this problem.

This recall doesn’t affect Meridian instruments currently on the market. According to the new labeling that Baxter released, only one of the two channels of the two channel clips should be used.

Baxter’s letter to Meridian’s customers can be found at http://www.baxter.com

For more details on this update, please refer to: http://www.fda.gov/cdrh/recalls/recall-092805.html

If you have any comments regarding this update, please email at: info@mdiconsultants.com

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