Fresenius Medical Care North America (FMCNA) announced today that its voluntary recall of 56 lots of NaturaLyte® Liquid Bicarbonate Concentrate, 6.4 liters (intended for use in hemodialysis machines) from distribution has been classified as a Class 1 Recall.
The affected lots were produced in its Montreal, Canada facility and are being recalled because they may develop higher bacteria levels than is allowed by the company’s internal specification during their shelf life.
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). According to a few case reports in the medical literature, 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.
Customer notifications were published on April 10th and May 1st, 2014. The customer notifications (available at www.fmcna.com) include a list of the product lot numbers which should be permanently removed from use and returned. For more infectious disease news and information, visit and “like” the Infectious Disease News Facebook page.
As part of its voluntary recall, the company informed the U.S. Food and Drug Administration (FDA) and Health Canada, as well as its customers – on April 10th and May 1st, 2014 – about these findings and promptly took steps to remove all of the affected lots from distribution, and discontinue their use.
According to the website, MicrobiologyBytes:
All the organisms in the genus Halomonas are Gram-negative rods. They are extremophiles in that they are able to tolerate (and in some cases require) medium or high concentrations of salt for growth (at least 0.2M NaCl). Members of this genus vary from moderate halophiles such as Halomonas elongata to extreme halophiles such as Halobacterium salinarum. The word “halophile” means “salt-loving” in Greek. Halophiles are common in aquatic environments such as the Dead Sea, where halophillic bacteria tint the sediments bright colors. Many other salt lakes and inland seas, usually found in arid regions, have similarly high salt concentrations and are inhabited by halophiles. Halomonas species are also found in hypersaline Antarctic lakes beneath the ice-sheets