10 Medtech Recalls that Shocked the Industry—NaturaLyte10 Medtech Recalls that Shocked the Industry—NaturaLyte
September 21, 2015
Fresenius' NaturaLyte Liquid Bicarbonate Concentrate was recalled in April 2014 because of its potential to "develop higher than expected bacteria levels during its shelf life," according to the FDA recall release.
NaturaLyte is a product used in a hemodialysis machine for patients with acute and chronical kidney failure. According to FDA, the Halomonas bacteria was found in the concentrate. Use of bacteria-contaminated concentrate could result in adverse events like bacteremia and sepsis. There have been reports of two injuries and one death that might be related to NaturaLyte, FDA notes.
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