How Voluntary Was the Fresenius Medical Care Recall?

August 15, 2012, 8:00AM. By Gordon Gibb

Waltham, MAWhile it may lay claim as the strongest and most serious recall notice in the basket of tools available to the US Food and Drug Administration (FDA), a Class 1 recall is not a recall at all, per se. In other words, according to ENP Newswire (6/28/12) an FDA Class 1 recall does not require the removal of the recalled products from the market. In truth, a Class 1 recall is an alert (albeit serious) to physicians and clinicians. Such is the case with the Fresenius Medical Care recall involving Naturalyte Liquid Acid Concentrate and GranuFlo.

The Naturalyte and GranuFlo Dry Acid Concentrate are used in the treatment of acute and chronic renal failure during hemodialysis, according to the official FDA notice related to the recall, a notice that was first posted in late March but updated in July. "The concentrate is formulated to be used with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates," the notice states.

The manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in Naturalyte Liquid and GranuFlo Dry Acid Concentrate, the FDA continues. "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 FDA references the potential for Alkali dosing errors and to that end has issued a general safety communication.

The concern appears to be warranted. According to various sources there have been hundreds of cases involving cardiac arrest in association with the use of these products, with numerous reports of problems forwarded to the manufacturer of Naturalyte and GranuFlo, Fresenius Medical Care North America, of Waltham. However, while Fresenius is said to have notified its own clinics of this concern in 2011, it has been alleged that Fresenius failed to notify other clients that used Naturalyte and GranuFlo. It has also been alleged the FDA was kept in the dark until a leaked internal memo found its way to the agency.

The FDA investigated Dialysate Concentrates Hemodialysis, and their findings reportedly led to the 'voluntary' recall by Fresenius in March of this year. The manufacturer issued its initial statement on March 29th.

The FDA is said to be continuing its investigation of the Fresenius products and their relationship to cardiac events and other health-related issues amidst the Naturalyte Liquid Acid Concentrate recall, and Naturalyte GranuFlo recall. The agency is also said to be investigating the actions of Fresenius with regard to the alleged failure to notify the greater medical community beyond its own boundaries.