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Recalled Naturalyte Linked to One Death, Two Injuries

June 4, 2014 — On May 28, the U.S. Food and Drug Administration (FDA) updated a recall for Naturalyte after finding that two injuries and one death may have been caused by the products.

Naturalyte, a liquid bicarbonate concentrate used in hemodialysis, was recalled on April 10 over concern about bacterial contamination. The FDA expanded the recall of 49 lots to include an additional 9 lots on May 1. On May 28, the recall was classified as Class I, meaning the FDA believes there is a reasonable probability of the products causing serious injury or death.

Naturalyte was pulled because it can develop higher-than-expected levels of bacterial contamination during its shelf-life. The bacteria was identified as Halomonas (species 1, 2, 3), which is a gram-negative bacteria that thrives in water with high salinity (salt).

Patients who are treated with Naturalyte are at risk of developing complications like fever, hypotension (low blood pressure), chills, and/or breathing problems. If there is a large amount of bacteria in the product, they could also develop life-threatening bacterial complications like systemic infection, sepsis, blood poisoning, or bacteremia.

In 2012, the FDA recalled Naturalyte after learning that it was associated with hundreds of deaths at Fresenius dialysis clinics in 2010. The problem was that doctors were failing to administer proper doses, which resulted in bicarbonate overdoses. This causes metabolic alkalosis, a condition that increases a patient’s risk of heart attack, stroke, and death.

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