Fresenius Medical Care North America has announced the voluntary recall in the United States and Canada of a total of 56 lots of its 6.4-liter Fresenius NaturaLyte Liquid Bicarbonate Concentrate, which is used in dialysis machines, for potential bacterial contamination. The voluntary recall was reported to FDA, which has given the recall its the most serious Class I designation. FDA says it has received one report of death and two reports of injury that may be related to use of this product. Further, use of the affected product “may cause serious adverse health consequences, including sepsis, bacteremia, and death.” An initial recall of 49 lots was announced on April 10, followed by an expanded recall on May 1. A link to a list of the recalled lot numbers is provided here.
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