Fresenius is recalling 49 lots of NaturaLyte Biocarbonate Concentrate, which is used during hemodialysis procedures, due to a potential risk of bacterial contamination.
The NaturaLyte recall (PDF) was announced in a letter sent to healthcare providers on April 10. While no illnesses have been reported, Fresenius Medical Care North America warned that the affected products may contain “higher levels of bacterial contamination than allowed by our internal specification.”
Fresenius indicates that it is currently testing the recalled NaturaLyte Bicarbonate Concentrate to identify the type of bacteria present, promising to provide additional information on the bacteria once testing is complete.
The recall affects 49 lots of NaturaLyte Bicarbonate Concentrate sold in 6.4 liter bottles, which were distributed between August 15, 2013 and April 7, 2014. The affected lots contain a product code of 08-4000-LB, with expiration dates of 6/30/2014, 7/31/2014, 8/31/2014, and 12/31/2014.
Fresenius warns that bacterial contamination could cause pyrogenic reactions from endotoxins present in bacteria, which can lead to fever, hypotension, flushing, chills, and potentially trouble breathing. While most of these symptoms are short-term, contamination could also lead to long-term health consequences.
The manufacturer has requested that dialysis clinics with bottles of NaturaLyte affected by the recall discontinue use immediately, place the recalled bicarbonate concentrate in a secure, segregated area, perform a [Heat Disinfect] program on any machine on which affected product was used, and contact a Fresenius service team by calling (800) 323-5188 for instructions on how to return the recalled NaturaLyte. The letters included a reply form the company wanted customers to fill out and return as well.
The recall comes a little more than two years after it was discovered that Fresenius withheld important safety information about the use of NaturaLyte and Granuflo, a dry acid concentrate.
Fresenius Medical Care not only makes many of the products used during dialysis treatment, but also operates many of the clinics in the U.S.
In November 2011, the company sent an internal memo to their own clinics warning about the importance of doctors monitoring bicarbonate levels during treatments, since side effects of Naturlyte and Granuflo may cause higher than expected bicarbonate levels and cause dialysis patients to suffer a sudden cardiac arrest or death.
While Fresenius provided these warnings to their own clinics, the information was withheld from other dialysis clinics using the products. After the internal memo was leaked to the FDA, Fresenius finally provided warnings to the entire medical community in March 2012, which the FDA classified as a NaturaLyte and GranuFlo recall.
More than 1,500 Fresenius dialysis treatment lawsuits are now being pursued by individuals throughout the United States who allege that sudden cardiac arrest or death following hemodialysis was caused by use of NaturaLyte or Granuflo. In the federal court system, the litigation has been centralized before U.S. District Judge Douglas P. Woodlock in the District of Massachusetts for coordinated handling during pretrial proceedings and a series of bellwether trials designed to gauge how juries are likely to respond to certain evidence and testimony that will be similar to what is offered in hundreds of other cases.