Dialysis Drug Recall in Tennessee

A Fresenius product used in dialysis was recalled after one death by bacterial infection and other cases of sickness after certain lots of the drug were administered.

The U.S. Food and Drug Administration (FDA) issued the class 1 recall related to the use of Fresenius NaturaLyte Liquid Bicarbonate Concentrate. The FDA reported that laboratory tests identified Halmonas species, a bacterial strain typically found in water with a high salt concentration, in the product during its shelf life.

Fresenius noted in its recall announcement that according to the medical literature, bacterial contamination of the dialysate may lead to bacteremia or systemic infection, although “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.”

The Tennessean newspaper wrote that 26 dialysis centers in Tennessee were among those receiving the product.

“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,” a Fresenius representative said. The affected lots were produced in the Fresenius facility in Montreal, Canada.