After receiving two reports of injury and one report of death, the U.S. Food and Drug Administration issued a Class 1 Recall of NaturaLyte Liquid Bicarbonate Concentrate, which is used in hemodialysis machines.
The FDA’s Class 1 Recall classification is considered the most serious type of recall. This type of recall is only used when the use of or exposure to the affected product has a reasonable probability of causing serious adverse health consequences or death.
The company that owns and produces NaturaLyte, Fresenius Medical Care North America, discovered through their own testing that unacceptable levels of bacteria may develop within the NaturaLyte concentrate. “According to a few case reports in the medical literature, bacterial contamination of the dialysate may lead to bacteremia or systemic infection,” FMCNA stated in their May 21 press release.
According to a report online by The Tennessean, the product was distributed to 26 dialysis centers in Tennessee.
If you or someone close to you receives dialysis and seriously harmed by this product, please contact us immediately for free legal advice at (423) 396-0720.
Gary Massey, Jr., is a well-known courtroom advocate practicing law in Chattanooga, Tennessee. Gary is a native of Tennessee who began practicing law in 1998. He graduated from Cumberland School of Law where he was ranked in the top 3% of his class and was an editor of the Cumberland Law Review.
