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Important Safety Information on Recall of Additional Lots of NaturaLyte® Sodium Bicarbonate Liquid Concentrate due to Potential Bacterial Contamination

Issued July 20, 2015
Issue
Further to the voluntary recall conducted by Fresenius Medical Care on May 14, 2015 , additional lots of NaturaLyte® Sodium Bicarbonate Liquid Concentrate in 6.4L volumes are being recalled due to possible bacterial contamination. Alternative Sodium Bicarbonate Liquid Concentrate has been sourced by Fresenius from other vendors and is available to replace your existing inventory and ensure an uninterrupted supply for your clinic and patients. This product is used in haemodialysis, which removes waste products from the blood by passing the blood out of the body through a filtering system and returning the cleaned blood to the body when the kidneys are not functioning properly. The affected product subject to the current recall was distributed to hospitals and home settings between February 23, 2015 and July 15, 2015. Users should check lots (see “Products Affected” section below) prior to administering or using this product.