Marilyn McGoldrick on May 23, 2014 10:39:00 AM
Fresenius Medical Care North America (FMCNA), a Massachusetts based company, will voluntarily recall 56 lots of NaturaLyte® Liquid Bicarbonate Concentrate, 6.4 liters (intended for use in hemodialysis machines). The products were recalled because they could develop harmful levels of bacteria during their shelf life. The bacteria in the solution has been identified as Halomonas (species 1, 2, 3), a Gram Negative bacteria.
The recall is classified as a Class 1. Class 1 recalls are issued when there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death. The bacterial contamination in NaturaLyte Liquid Bicarbonate Concentrate could lead to bacteremia or systemic infection, and potentially death. The FDA encourages consumers who have had adverse reactions to submit online reports to the agency.
Fresenius previously issued a Class 1 recall for Naturalyte Liquid Acid Concentrate. That product used as formulated could cause cardiac arrest and death.
The Thornton Law Firm drugs and medical device team is investigating claims against Fresenius. If you believe you have been injured by a defective Fresenius Naturalyte dialysis product, please contact us here, or call Attorney Marilyn McGoldrick, at 1-888-431-1395 for a free and confidential evaluation of your legal rights.