German company Fresenius has had multiple runs with the FDA in recent years, with the agency hitting its plants in the U.S., Puerto Rico and India with warning letters. Fresenius' Montreal, Canada, plant has caused it fewer problems, but it too has now encountered quality-control failings.
The misstep led to Fresenius Medical Care North America--the dialysis wing of the business--recalling 56 lots of NaturaLyte liquid bicarbonate concentrate, a product used in hemodialysis machines. Fresenius pulled the products after discovering they could harbor higher levels of bacteria than is allowed by its internal specifications. Lab testing found Halomonas, a type of bacteria that thrives when salt concentrations are between 5% and 25%.
While dialysis machines use filters to stop bacteria or endotoxins reaching patients, case reports suggest this precautionary measure can fail. Writing in the journal Medicine in 2009, staff at a renal care center reported they found bacteria in the blood of two of their patients within days of each other. An investigation led the team to conclude that Halomonas bacteria have pathogenic potential.
Fresenius made reference to the case reports in its recall notice, which followed two warnings to customers on April 10 and May 1. Steps were also taken to pull the affected lots from distribution. Fresenius' role as both a manufacturer and consumer of NaturaLyte--it provides hemodialysis at its 2,150 North American dialysis facilities--may have simplified this process.
- read the recall notice