More than 1.8 million bottles of NaturaLyte dialysate concentrate manufactured by Fresenius Medical Care may be contaminated with bacteria, according to federal drug regulators.
A NaturaLyte Liquid Bicarbonate Concentrate recall was announced by the FDA in its enforcement report for the week of July 1, warning that the bottles may have bacterial contamination.
According to the FDA, Fresenius Medical Care first sent out an Urgent Medical Device Recall to its customers regarding the issue in May, and that the solution was shipped to dialysis centers nationwide.
Fresenius issued the recall after determining that some lots of NaturaLyte contained higher levels of bacteria, known as the bioburden, than was acceptable. The bacteria was not identified in the recall notices, but reportedly poses a risk of bloodstream infections.
NaturaLyte is a dialysate concentrate used for hemodialysis at Fresenius dialysis centers, as well as other medical facilities that purchase the product from Fresenius. The recall forced some centers around the world to close due to the resulting shortage.
The recall affects 1,856,619 6.4 liter bottles of NaturaLyte Liquid Bicarbonate Concentrate in liquid form, with a catalog number of 08-4000-LB, and lot numbers beginning with 14DMLB, 14EMLB, 14HMLB, 14JMLB, 14KMLB, 14LMBL, 14NMLB, 14PMLB, and 14SMLB. The recalled bottles were formulated for use with a three steam hemodialysis machine, calibrated for acid and bicarbonate concentrates.
Fresenius warned its customers to discontinue use of the recalled bottles immediately and to place all affected units in a secure, segregated area. The company also recommended that a [Heat Disinfect] program be run on any machine on which the recalled products were used.
Customers with questions can call the FMCNA Customer Service Team at 1-800-323-5188 for instructions on returning affected products.
This latest recall comes a little more than a year after at least one patient died and two more were likely injured due to contaminated NaturaLyte bottles that were also recalled. In that case, Fresenius reported that Halomonas, a gram negative bacteria, had potentially contaminated 56 lots of NaturaLyte 6.4 liter bottles.
Fresenius Medical Care currently faces several thousand product liability lawsuits over problems with Naturalyte and Granuflo, a similar dry acid concentrate. The cases stem from a 2012 recall, which was issued after the manufacturer acknowledged that many users were experiencing cardiac arrest or sudden death during or shortly after dialysis treatment involving Granuflo or NaturaLyte.
The dialysis solutions convert to bicarbonate at a much higher rate than doctors originally recognizing, resulting in an FDA recall in March 2012 to ensure the manufacturer adequately informed medical providers about the importance of monitoring bicarbonate levels.
According to allegations raised in the Fresenius dialysis lawsuits filed on behalf of individuals nationwide, the manufacturer knew or should have known about this risk of cardiac arrest for years, yet withheld information from physicians and consumers.
In November 2011, the company sent an internal memo to their own clinics warning about the importance of monitoring bicarbonate levels, after more than 900 people died at Fresenius clinics during 2010 after receiving Granuflo or NaturaLyte. However, this information was not provided to other clinics that purchased the dialysis solutions from Fresenius.
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.
In the federal court system, the Fresenius litigation over NaturaLyte and Granuflo 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.