FDA Reportedly Reverses Decision on Endoscope Recall

Washington, DC: Following a 2015 announcement of an endoscope recall, linked to an endoscope-cleaning device and a 2016 announcement confirming the recall, the US Food and Drug Administration (FDA) has now said a machine used to clean duodenoscopes can stay on the market. The product, known as the System 83 Plus machine, is made by Custom Ultrasonics. According to reports, the recall was initially announced to protect public health after improperly cleaned duodenoscopes were linked to several infection outbreaks in the United States


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