Fresenius Medical Care has identified the bacteria behind last month’s NaturaLyte recall, and has expanded the action due to the potential for affected lots of the dialysis concentrate to cause serious adverse events. The U.S. Food & Drug Administration (FDA) has also granted Class I recall status to the new NaturaLyte recall, which is the agency’s most serious recall category.
According to a notice posted on the FDA’s website last week, the affected lots of NaturaLyte may become contaminated with Halomonas during its shelf-life. Exposure to this bacterium can lead to bacteremia or systemic infection. However, Fresenius maintains that the dialysis filter (dialyzer) and the use of the Diasafe filter or equivalent create an effective bacteria and endotoxin barrier that makes this event unlikely.
A total of 56 lots of NaturaLyte Bicarbonate Concentrate sold in 6.4 liter bottles are now being recalled. All of the affected lots were distributed between August 15, 2013 and April 7, 2014. The affected lots contain a product code of 08-4000-LB, with expiration dates of 6/30/2014, 7/31/2014, 8/31/2014, and 12/31/2014.
According to the notice, customers have been advised to remove all affected NaturaLyte lots and return them to Fresenius.
Meanwhile, Fresenius continues to face hundreds of lawsuit over an earlier recall of NaturaLyte, which also affected its GranuFlo dialysis concentrate. Both of these products were subject to a Class I recall in 2012 after they were linked to hundreds of instances of cardiac arrest – some of them fatal – among patients treated at Fresenius clinics in 2012.
As of May 15th, more than 1,700 NaturaLyte and GranuFlo lawsuit claims had been filed in Massachusetts federal court on behalf of individuals who allegedly experienced heart attacks, strokes, cardiac arrest, and sudden cardiac death following treatment with one of the two concentrates. The cases allege that the products’ instructions for use and label warnings were inadequate to prevent a dangerous spike in the amount of bicarbonate present in the blood of dialysis patients. As such, plaintiffs are alleged to have suffered a disorder known as metabolic alkalosis, which put them at risk for serious and catastrophic health problems.