FDA Issues Recall for NaturaLyte Dialysis Concentrate
The FDA has issued a recall notice for NaturaLyte liquid bicarbonate concentrate manufactured by Fresenius Medical Care, NA. NaturaLyte is used in dialysis treatment for patients suffering from kidney failure. The recall was issued after laboratory testing identified the presence of bacteria in several samples. Fifty six lots of the product are being recalled and should be returned to the manufacturer.
In 2012, the FDA issued a Class I recall of Fresenius dialysis products GranuFlo and NaturaLyte after it learned of an internal study and memo issued by Fresenius about the use of these products in its own clinics. The memo reported 941 patients across 667 Fresenius Medical Care facilities suffered cardiac arrest during and soon after treatment. The study found that patients being treated with GranuFlo and NaturaLyte had a six to eight times increased risk for heart attack or sudden cardiac death within 48 hours of treatment.
Injured patients have filed lawsuits against Fresenius for failing to warn healthcare professionals and patients of the increased risk for cardiac events. Our product liability attorneys have talked with hundreds of dialysis patients who have used GranuFlo and NaturaLyte and have suffered serious personal injury. If you or someone you care about has used these dialysis products and suffered a serious cardiac event, contact us for a free case evaluation.