Information Update - Fresenius Medical Care expands recall of Sodium Bicarbonate Liquid Concentrate

OTTAWA, April 9, 2014 /CNW/ - 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 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

 

 

SOURCE Health Canada

For further information:

Media Inquiries: 
Health Canada
(613) 957-2983

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1-866 225-0709

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