Medical Device Safety and Recalls: Fresenius NaturaLyte Liquid Bicarbonate Concentrate (Part Number: 08-4000-LB)

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Title: Medical Device Safety and Recalls: Fresenius NaturaLyte Liquid Bicarbonate Concentrate (Part Number: 08-4000-LB)

The U.S. Food and Drug Administration has issued a recall for the NaturaLyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle (Part Number: 08-4000-LB).  The product may develop higher than expected bacteria levels during its shelf life.  Lab testing identified the bacteria as Halomonas (species 1, 2, 3), a gram negative bacteria typically found in water with high salt concentration.  The FDA has received one report of death and two reports of injury that may be related to use of this product.  The use of affected product may cause serious adverse health consequences, including sepsis, bacteremia, and death.  For more information, please see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm399124.htm


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