NaturaLyte Recall Announced in Canada, As GranuFlo Lawsuits Mount in U.S.

Published on April 15, 2014 by Sandy Liebhard

Fresenius Medical Care has announced a new NaturaLyte recall in Canada, amid concerns that certain lots of the dialysis concentrate could be contaminated with bacteria. Fortunately, no adverse events have been linked to the products involved in the recall.

According to the HealthCanada notice, the NaturaLyte Sodium Bicarbonate Liquid Concentrate products involved in the recall were distributed to hospital and home settings in Canada between August 8, 2013 and October 28, 2013. Prior to using any NaturaLyte product, home healthcare nurses and others should check the packaging for the following lot numbers: 13JMLB004, 13JMLB006, 13JMLB007 and 13JMLB008 in 6.4L and 8L volumes.

If a user discovers one of the above lot numbers, they should contact the Fresenius Customer Service Team at 1-888-709-4411 for instructions on how to return the recalled product.

GranuFlo Lawsuits Surpass 1,500 in U.S. Litigation

The Canadian announcement comes just two years after Fresenius Medical Care recalled NaturaLyte, as well as another dialysis concentrate product called GranuFlo, in the U.S. The products were named in the Class I recall after a dosage issue was linked to hundreds of cases of cardiac arrest, some that were fatal, among dialysis patients treated at Fresenius Medical Care dialysis clinics.

Though the problems that prompted the GranuFlo recall were detailed in a November 2011 memo Fresenius issued to its clinics, facilities outside of the company’s network received no such information at that time. In fact, they would receive no information until March 2012, when Fresenius issued a nationwide advisory that advised doctors to adjust dosage of GranuFlo and NaturaLyte in order to avoid a dangerous elevation of bicarbonate in patients’ blood.  Such an occurrence – known as metabolic alkalosis – can lead to sudden and dangerous cardiac problems, including heart attacks, strokes, and sudden cardiac death.

In June of that year, the U.S. Food & Drug Administration (FDA) announced that it had designated the March 2012 notice a Class I recall, its most serious type of product recall.

Since the announcement of the 2012 GranuFlo and NaturaLyte recall, at least 1,570 product liability lawsuits have been filed in the U.S. District Court, District of Massachusetts on behalf of individuals who allegedly suffered heart attacks, strokes and other life-threatening heart problems due to the administration of the medications. The GranuFlo lawsuits claim Fresenius concealed the dangers associated with the two products, and failed to provide dialysis clinics with adequate warnings or instructions for their use.