A Fresenius solution used in hemodialysis machines has been recalled because of concerns over bacteria contamination following a patient death.
The U.S. Food and Drug Administration issued a notice this week of the recall, saying it had received one report of death and two reports of injury that may be related to use of Fresenius NaturaLyte Liquid Bicarbonarte Concentrate. Lab testing identified Halmonas, a bacteria typically found in water with high salt concentration, in the product during its shelf life, the FDA said.
Twenty-six dialysis centers in Tennessee were among those that received the product, said Jon Stone, a spokesman for Fresenius Medical Care North America. He did not identify the centers.
“We have notified all of our affected customers that the recalled product should be removed and are continuing to work with them to carry out the recall,” Stone said.
Forty-nine lots of the solution were recalled on April 10, followed by another nine lots on May 1. The last of the recalled product was distributed April 7.