The U.S. Food and Drug Administration said last month it received one report of death and two reports of injury that may be related to use of 58 recalled lots of Fresenius Medical Care North America's NaturaLyte liquid bicarbonate concentrate.
FMCNA initiated the voluntary recall when it discovered that testing of certain lots of NaturaLyte showed high levels of Halmonas, gram-negative bacteria typically found in water with high salinity (salt concentration).
“According to a few case reports in the medical literature, bacterial contamination of the dialysate may lead to bacteremia or systemic infection,” FMCNA said in a May 21 news release. “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.”
FMCNA initiated the recall, which included 49 lots, on April 4. The company expanded it to include nine additional lots on May 1. On May 21, the recall was classified by the FDA as Class 1, considered the most serious type.