Global Dialysis - Fresenius changes its labeling on its Naturalyte and Granuflo dialysate concentrates to reflect total base content.

Fresenius changes its labeling on its Naturalyte and Granuflo dialysate concentrates to reflect total base content.

FMC: Fresenius Medical Care North America (FMCNA) announced today that the Food and Drug Administration (FDA) has classified FMCNA’s voluntary action to change the labeling on its dialysate products as a Class 1 recall. In conjunction with this classification, and to further reinforce the importance of correct dialysate dosing, FMCNA will continue its process to place updated labels on its NaturaLyte and GranuFlo Acid Concentrate products, and to update its hemodialysis machine operator’s manuals. To date, FMCNA has notified more than 90 percent of its customers of these two labeling updates, and will continue with that effort until it is complete. The FDA’s action does not involve the removal of any FMCNA products from the marketplace.

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