FDA recalls Fresenius 2008 Series dialysis machines

Update: Fresenius clarifies recall of hemodialysis machines

The U.S. Food and Drug Administration has issued a class II recall of the following models of the Fresenius 2008 Serieshemodialysis machines: 2008H, 2008K, 2008K2, 2008k@Home, 2008T.

Fresenius Medical Care is recalling 111,504 dialysis machines sold across the United States, and 3,638 units sold in Canada, and Mexico, because of complaints of saline bags inappropriately filling during recirculation and setup. The recall affects all serial numbers of the listed models.

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