According to the FDA recall notice (5/21/14), 56 lots of NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liters, were subject to a Class 1 recall. The products, produced in Montreal, Canada, were recalled due to a higher level of bacteria than allowed by the company’s internal specification. Affected lots were manufactured from August 2013 to April 2014.
“According to a few case reports in the medical literature, bacterial contamination of the dialysate may lead to bacteremia or systemic infection,” the FDA notes.
The FDA noted in a separate announcement that use of the recalled product could result in sepsis, bacteremia and death. “The FDA has received one report of death and two reports of injury that may be related to the use of this product,” the agency wrote.
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That memo, however, was only sent to outside medical care centers after the FDA received it, four months after it was sent to Fresenius centers.
Lawsuits have been filed against Fresenius Medical Care, alleging patients suffered serious side effects, including cardiac arrest, or died after having dialysis treatment using NaturaLyte or GranuFlo. Some lawsuits have been consolidated for multidistrict litigation (MDL 2428, In Re: Fresenius Granuflo/Naturalyte Dialysate Products Liability Litigation). The lawsuits involve factual questions regarding whether GranuFlo and NaturaLyte were defectively designed or defectively manufactured, and whether Fresenius knew or should have known of the potential risks associated with the products.