The U.S. Food and Drug Administration (FDA) received reports of one death and two injuries that may be related to use of recalled lots of Fresenius Medical Care North America’s NaturaLyte liquid bicarbonate concentrate.
Jon Stone, a spokesperson for Fresenius Medical Care, said, “the FDA updated its website with information that it received,” according to Nephrology News & Issues. Stone said Fresenius initiated the voluntary recall of NaturaLyte when testing revealed that certain lots of the product had increased bacteria levels. The bacteria is Halomonas, a gram-negative bacteria, typically found in water with high salinity (salt concentration). The FDA warns that use of the affected product may cause serious adverse health consequences, including sepsis, bacteremia, and death.
In a May 21 news release, Fresenius said that in a few reported cases “bacterial contamination of the dialysate may lead to bacteremia or systemic infection,” according to Nephrology News, though the use of the “Diasafe filter or equivalent” creates a bacteria and endotoxin barrier that makes this event unlikely, according to the company.
Fresenius initiated the recall on April 4, with 49 lots of NaturaLyte, and on May 1 expanded the recall to nine additional lots. On May 21, the recall was classified as Class 1, which is the FDA’s most serious recall class, and is reserved for situations in which there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death.
Fresenius advises customers to immediately discontinue use of the recalled lots and store them in a secure area until they can be returned. For instructions on how to return recalled NaturaLyte, customers should call Customer Service at 1.800.323.5188.