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Fresenius Medical Care expands recall of Sodium Bicarbonate Liquid Concentrate

Issued April 9, 2014
Issue
Further to a public communication issued April 5, 2014, Fresenius Medical Care is expanding its voluntary recall (see list below) to include additional lots of "NaturaLyte Sodium Bicarbonate Liquid Concentrate" in 6.4L and 8L volumes. The recall of this product is due to bacterial contamination. Health Canada will continue monitoring the recall and working with the company to help ensure patients and healthcare professionals are informed. Health Canada will also continue to provide updates to Canadians, as necessary. Fresenius Medical Care has indicated to Health Canada that they are making every effort to expedite shipment of replacement product to customers and their patients. Health Canada has posted advice for patients, hospitals and home patient programs . Complete List of Lots of NaturaLyte Liquid Bicarbonate Concentrate Products Code Lot Expiration 08-4000-LB6.4 14AMLB013 December 31, 2014 14AMLB014 December 31, 2014 14AMLB015 December 31, 2014 14AMLB016 December 31, 2014 14AMLB017 December 31, 2014 14BMLB001 January 31, 2015 13JMLB004 June 30, 2014 13JMLB006 June 30, 2014 13JMLB008 June 30, 2014 13JMLB005 June 30, 2014 13KMLB001 July 31, 2014 13KMLB002 July 31, 2014 13KMLB003 July 31, 2014 13KMLB004 July 31, 2014 13KMLB005 July 31, 2014 13KMLB007 July 31, 2014 13KMLB008 July 31, 2014 13KMLB009 July 31, 2014 13KMLB010 July 31, 2014 13KMLB011 July 31, 2014 13KMLB012 July 31, 2014 13KMLB013 July 31, 2014 13KMLB014 July 31, 2014 13KMLB015 July 31, 2014 13KMLB016 July 31, 2014 13LMLB001 August 31, 2014 13LMLB002 August 31, 2014 13LMLB003 August 31, 2014 13LMLB004 August 31, 2014 13LMLB005 August 31, 2014 13LMLB006 August 31, 2014 13LMLB007 August 31, 2014 13LMLB008 August 31, 2014 13LMLB009 August 31, 2014 13LMLB010 August 31, 2014 13LMLB011 August 31, 2014 13LMLB012 August 31, 2014 13LMLB014 August 31, 2014 13LMLB015 August 31, 2014 13LMLB016 August 31, 2014 14AMLB002 December 31, 2014 14AMLB003 December 31, 2014 14AMLB004 December 31, 2014 14AMLB005 December 31, 2014 14AMLB007 December 31, 2014 14AMLB008 December 31, 2014 14AMLB010 December 31, 2014 14AMLB012 December 31, 2014 08-4000-LB6.4T 13LMLB013 August 31, 2014 13KMLB006 July 31, 2014 08-4000-LB8 13JMLB007 June 30, 2014 13KMLB017 July 31, 2014 14AMLB011 December 31, 2014
Hazard description
Contamination