Fresenius Medical Care, the world’s largest distributor of dialysis products and services, is issuing an urgent medical device recall on 49 lots of NaturaLyte Liquid Bicarbonate Concentrate due to high levels of bacterial contamination found in the product. The company says it is currently conducting an investigation to identify the organism(s) in its dialysis concentrate and, when testing is complete, will announce the identity of those bacteria.
NaturaLyte is used to regulate electrolytes in patients undergoing dialysis treatment. The company says no pyrogenic reactions, bacterial infections or related adverse events have been reported to date in connection with the recall.
A pyrogenic reaction may occur when a patient is exposed to a significant amount endotoxins present in the bacterial cell wall of gram negative bacteria, resulting in fever, hypotension, flushing, chills, and/or breathing difficulties. The effects of endotoxins are only temporary but patients may develop long-range health consequences secondary to the severity of the reaction. In addition, a high bioburden in the dialysis concentrate may lead to transient bacteremia.
A list of lot numbers can be found in the Fresenius announcement.
NaturaLyte, along with a similar Fresenius dialysis concentrate, GranuFlo, were recalled in 2012 after company officials determined that the products were labeled in a confusing way that could cause dosing errors that could result in an overdose of bicarbonate. Elevated bicarbonate can cause serious cardiovascular risks including sudden cardiac arrest.
The company currently faces numerous personal injury and wrongful death lawsuits related to improper labeling on containers of GranuFlo and NaturaLyte.
Source: Fresenius Medical Care