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FDA: NaturaLyte Be Responsible for Patient Death, Injuries

Jun 3, 2014

The U.S. Food and Drug Administration (FDA) just announced that it received one report of a death and two reports of injury that may be associated with use of recalled lots of Fresenius Medical Care North America's (FMCNA) NaturaLyte liquid bicarbonate concentrate, according to Nephrology News & Issues.

"This week, subsequent to the recall, the FDA updated its website with information that it received," Jon Stone, spokesperson for Fresenius Medical Care, told Nephrology News & Issues. "We are looking into these reports."

According to Stone, FMCNA implemented the voluntary recall when it was discovered through testing that some NaturaLyte lots, which fell within acceptable bacteria levels for release to market, were later found to have increased bacteria levels. FMCNA identified that bacterium as Halmonas,a Gram Negative bacteria, which is normally detected in water with high salinity (salt concentration), according to Nephrology News & Issues.

"According to a few case reports in the medical literature, bacterial contamination of the dialysate may lead to bacteremia or systemic infection," FMCNA indicated in a May 21, 2014 news release.

The recall was initiated by FMCNA on April 4, 2014 and included 49 lots. The recall was expanded to include nine more lots on May 1. Effective May 21, the FDA classified the recall as a Class I, the agency’s most serious designation. A Class I indicates that a reasonable probability exists that use of the recalled product will cause serious adverse health consequences or death.

Those who may be in possession of the recalled NaturaLyte products are advised to discontinue the product’s use immediately and place the recalled NaturaLyte in a secure, segregated area. If the recalled NaturaLyte product was on the dialysis machine prior to patient treatment, a heat disinfect program should be conducted. In all cases, contact FMCNA, toll-free, at 1.800.323.5188 for instructions on how to return the recalled product.

A complete list of lot numbers associated with the recalled NaturaLyte may be accessed at the FDA website

Recent lawsuits accuse Fresenius Medical Care of deliberately concealing potentially fatal problems with its recalled GranuFlo and NaturaLyte products. The products are approved to lower the acidity of patients’ blood during dialysis treatments. Lawsuits allege that patients’ treated with these products tested with a high concentration of acetone, which led to abnormally high levels of bicarbonate in their blood, which, in turn, led to fatal heart problems and strokes, according to prior court documents. A judicial panel recently decided that the lawsuits would be consolidated into a federal court hearing. Fresenius Medical Care now faces hundreds of claims; many more are expected. Massachusetts is the chosen venue.

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