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05/22/2014 12:39 PM EDT
Fresenius Medical Care North America (FMCNA) announced today that its voluntary recall of 56 lots of NaturaLyte® Liquid Bicarbonate Concentrate, 6.4 liters (intended for use in hemodialysis machines) from distribution has been classified as a Class 1 Recall. The affected lots were produced in its Montreal, Canada facility and are being recalled because they may develop higher bacteria levels than is allowed by the company’s internal specification during their shelf life.