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Naturalyte Liquid and Granuflo Dry Acid Concentrate for Chronic Renal Failure Hemodialysis Recalled Due to Potential for Cardiopulmonary Arrest


The manufacturer of Fresenius' Naturalyte Liquid and Granuflo Dry Acid Concentrate is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) in the product. Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. This may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. This product may cause serious adverse health consequences, including death.

 

The Naturalyte and Granuflo Dry Acid Concentrate are used in the treatment of acute and chronic renal failure during hemodialysis. The concentrate is formulated to be used with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates.

 

This concentrate was manufactured and distributed from January 2008 through June 2012.

 

The FDA has issued a general safety communication related to inappropriate prescription and resultant alkali dosing errors in the dialysate concentrates used in hemodialysis.

 

See the Recall

 

 

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