Health Canada, Canada’s federal health agency, has announced that Fresenius Medical Care is voluntarily recalling specific lots of NaturaLyte Sodium Bicarbonate Liquid Concentrate in 6.4L and 8L sizes due to bacterial contamination.
This product is used in kidney dialysis (hemodialysis) to remove waste products from the blood by passing them out of the body through a filtering system. The affected product (lots 13JMLB004, 13JMLB006, 13JMLB007 and 13JMLB008) was distributed to hospital and home settings between August 8, 2013 and October 28, 2013, with expiration dates that run from June through December 2014. Fresenius advises users to check lot numbers before administering the product and immediately discontinue use of affected lots. Recalled products should be stored in a secured area, away from other products, until they can be returned to Fresenius.
For information on return of the product, contact Fresenius Customer Service toll free at 1.888.709.4411.
The company indicates that it has not received any reports of adverse events associated with the possible bacterial contamination. Health Canada is monitoring the recall and working with the company to help ensure patients and healthcare professionals are informed of the problem. Dialysis patients and health professionals can visit MedEffect Canada’s Adverse Reaction Reporting web page for information on how to report adverse events online, by mail or by fax.