The Food and Drug Administration has sent warning letters to manufacturers of a specialized medical scope that has been associated with outbreaks of a deadly “superbug” virus, saying the companies failed to adequately report problems with the devices and, in some instances, failed to ensure that they could be cleaned properly between uses.
The warnings come after the devices, known as duodenoscopes, have been linked in recent years to outbreaks of tough-to-fight bacterial infections involving carbapenem-resistant Enterobacteriaceae, or CRE.
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