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# NaturaLyte Liquid Bicarbonate Concentrate: Recall - Potential Health Risk
- URL: https://www.foodconsumer.org/naturalyte_liquid_bicarbonate_0522140334/
- Published: 2014-05-22T16:34:00.000Z
- Updated: 2026-09-22T18:12:13.000Z
- Description: Fresenius Medical Care North America recalled 56 lots of NaturaLyte Liquid Bicarbonate Concentrate for hemodialysis machines that may exceed its internal bacteria limits. Testing identified Halomonas; the FDA notice says infection from the lots is unlikely.
- Author: Food Consumer
- Tags: Alerts, Shopping, #vivvo-import

# NaturaLyte Liquid Bicarbonate Concentrate: Recall - Potential Health Risk

**AUDIENCE**: Nephrology, Nursing

**ISSUE**: Fresenius Medical Care North America issued a recall notice for NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liters (intended for use in hemodialysis machines). Bacterial contamination of the dialysate may lead to bacteremia or systemic infection. The dialysis filter (dialyzer) and the use of the Diasafe filter or equivalent create an effective bacteria and endotoxin barrier that makes this event unlikely.

The affected lots are being recalled because they may develop higher bacteria levels than is allowed by the company’s internal specification during their shelf life.

**BACKGROUND**: Laboratory testing has identified the bacteria as Halomonas (species 1, 2, 3), a Gram Negative bacteria, typically found in water with high salinity (salt concentration).

**RECOMMENDATION**: A list of the 56 lot numbers of product which should be permanently removed from use and returned is available at [www.fmcna.com](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTQwNTIyLjMyNDM2MzQxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE0MDUyMi4zMjQzNjM0MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE2ODM2MTEyJmVtYWlsaWQ9Zm9vZGNvbnN1bWVyLm9yZ0BnbWFpbC5jb20mdXNlcmlkPWZvb2Rjb25zdW1lci5vcmdAZ21haWwuY29tJmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&100&&&http://www.fmcna.com/?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) [](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTQwNTIyLjMyNDM2MzQxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE0MDUyMi4zMjQzNjM0MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE2ODM2MTEyJmVtYWlsaWQ9Zm9vZGNvbnN1bWVyLm9yZ0BnbWFpbC5jb20mdXNlcmlkPWZvb2Rjb25zdW1lci5vcmdAZ21haWwuY29tJmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&101&&&http://www.fda.gov/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery "Disclaimer Icon"). Customer notifications were published on April 10th and May 1st, 2014.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

- Complete and submit the report Online:[www.fda.gov/MedWatch/report.htm](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTQwNTIyLjMyNDM2MzQxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE0MDUyMi4zMjQzNjM0MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE2ODM2MTEyJmVtYWlsaWQ9Zm9vZGNvbnN1bWVyLm9yZ0BnbWFpbC5jb20mdXNlcmlkPWZvb2Rjb25zdW1lci5vcmdAZ21haWwuY29tJmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&102&&&http://www.fda.gov/MedWatch/report.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)
- [Download form](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTQwNTIyLjMyNDM2MzQxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE0MDUyMi4zMjQzNjM0MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE2ODM2MTEyJmVtYWlsaWQ9Zm9vZGNvbnN1bWVyLm9yZ0BnbWFpbC5jb20mdXNlcmlkPWZvb2Rjb25zdW1lci5vcmdAZ21haWwuY29tJmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&103&&&http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) or call [1-800-332-1088](tel:1-800-332-1088) to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the press release, at:

[http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm398553.htm](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTQwNTIyLjMyNDM2MzQxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE0MDUyMi4zMjQzNjM0MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE2ODM2MTEyJmVtYWlsaWQ9Zm9vZGNvbnN1bWVyLm9yZ0BnbWFpbC5jb20mdXNlcmlkPWZvb2Rjb25zdW1lci5vcmdAZ21haWwuY29tJmZsPSZleHRyYT1NdWx0aXZhcmlhdGVJZD0mJiY=&&&104&&&http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm398553.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)