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One Death Associated with NaturaLyte Liquid Bicarbonate Concentrate

Filed June 3rd, 2014 Eric

The U.S. Food and Drug Administration (FDA) has given Class I status to Fresenius Medical Care Holdings, Inc.’s recall of NaturaLyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle – Part Number: 08-4000-LB.

On April 10, 49 lots of NaturaLyte liquid were recalled and nine additional lots were added on May 1. According to the recall notice, the affected products were manufactured August 2013 to April 2014 and distributed August 15, 2013 to April 7, 2014.

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.

The recall was issued because 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 said it has received one report of death and two reports of injury that may be related to use of this product. The agency warned that use of affected product may cause serious adverse health consequences, including sepsis, bacteremia, and death.

Jon Stone, spokesperson for Fresenius Medical Care, told Nephrology News & Issues the company is looking into these reports. Stone said the company initiated the voluntary recall when testing revealed that certain lots of the product had increased bacteria levels. Fresenius identified the bacteria as Halomonas Nephrology News & Issues reported.

“According to a few case reports in the medical literature, bacterial contamination of the dialysate may lead to bacteremia or systemic infection,” Fresenius said in a May 21 news release. “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.”

Customers who may have the affected lots are urged to contact Fresenius Medical Care Customer Service at 800-323-5188, 7:00 a.m. – 6:00 p.m., Central Time.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

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