NaturaLyte Hemodialysis Concentrate Recall
On April 4th, 2014, the U.S. Food and Drug Administration (FDA) announced that a medical device recall had been initiated for NaturaLyte Liquid Bicarbonate Concentrate 6.4 liter bottle, part number 08-4000-LB.
About NaturaLyte Liquid Bicarbonate Concentrate
NaturaLyte Liquid Bicarbonate Concentrate is medical device manufactured by Fresenius Medical Care and is used during hemodialysis. The FDA has announced two recalls, the first on April 10, 2014 and the second recall on May 1, 2014, covering a total 58 lots of NaturaLyte Liquid Bicarbonate Concentrate due to a bacterial contamination.
On May 21, 2014, the FDA classified the recall as a Class I recall. The FDA explains that Class I recalls are issued when death or serious adverse effects are reasonably probable with use of the medical device.
FDA Received Report of One Death
The FDA has received reports of two injuries and one death that may be related to the use of the recalled NaturaLyte Liquid Bicarbonate Concentrate. Halomonas bacteria, levels of which increase as NaturaLyte Liquid Bicarbonate Concentrate is being stored before use, was determined to be the cause of the contamination.
The FDA warns that using the contaminated NaturaLyte Liquid Bicarbonate Concentrate could potentially lead to:
NaturaLyte Liquid Bicarbonate Concentrate Recall Lot Numbers
The recalled lots were manufactured between August 2013 and April 2014 and shipped between August 15, 2013 and April 7, 2014.
Lots Recalled 04/10/2014 (49 Lots):
Lots recalled May 1, 2014 (9 Lots):