Fresenius Medical Care’s NaturaLyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle was subject to a Class I recall. 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 received one report of death and two reports of injury that may be related to use of this product. Use of the recalled product may cause serious adverse health consequences, including sepsis, bacteremia, and death.
NaturaLyte Liquid Bicarbonate Concentrate is used in the treatment of acute and chronic renal failure during hemodialysis. The concentrate is formulated for use with a three-stream hemodialysis machine, which is calibrated for acid and bicarbonate concentrates.
In addition to discontinuing the use of the recalled products, hemodialysis providers should perform a heat disinfection program of any machines that came in contact with the product. The affected products were manufactured August 2013 to April 2014 and distributed August 15, 2013, to April 7, 2014. The affected part number is 08-4000-LB. The recall affects 58 lots.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication