FDA orders recall of 2,800 scope-washing machines

About 2,800 automated endoscope reprocessors made by Custom Ultrasonics are used by hospitals and outpatient clinics in the U.S.


Federal regulators have ordered a Pennsylvania company to recall its scope-cleaning machines used at UCLA and more than 1,000 other hospitals and clinics, according to an article on the L.A. Times website.

The Food and Drug Administration said Custom Ultrasonics had continued to violate federal law and those lapses could result in an increased risk of infection for patients.

About 2,800 automated endoscope reprocessors made by Custom Ultrasonics are used by hospitals and outpatient clinics in the U.S.

In 2012, the FDA told the company to stop manufacturing and ordered a recall of devices. But the equipment was allowed to remain on the market after the company made changes.

Read the article.

 

 



November 20, 2015


Topic Area: Safety


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