Fresenius Medical Naturalyte and Granuflo Acid Concentrate Class 1 Recall Issued
- Ennis & Ennis
06/27/2012 - Fresenius Medical heas issued a class 1 recall of NaturaLyte and GranuFlo Acid Concentrates. 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.
Fresenius is warning clinicians to be aware of the concentration of acetate or sodium diacetate contained in Fresenius' Naturalyte Liquid and Granuflo Dry Acid Concentrate.
Inappropriate prescription of these products can lead to a high serum bicarbonate levels 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 FDA has issued a general safety communication related to inappropriate prescription and resultant alkali dosing errors in the dialysate concentrates used in hemodialysis.
On March 29, 2012, the firm sent an Urgent Product Notification to their clinics and customers. This notification provided clinicians with prescribing information regarding the Naturalyte Liquid and Granuflo Acid Concentrate.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
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Free Nationwide GranuFLo - NaturaLyte Lawsuit Case Evaluations:
If you or a loved one have suffered serious GranuFlo or NaturaLyte side effects, suffered a loss due to GranuFlo Side Effects or have been injured as a result of a metabolic alkalosis you may be entitled to compensation. Contact the GranuFlo Dialysis Injury Lawyers of Ennis & Ennis today for a free confidential case evaluation by filling out the form on this page or call toll-free: 1-800-856-6405.