4 results

• FDA Clears Custom Ultrasonics Reprocessors For Cleaning Some Duodenoscopes

  April 11, 2018

  Irvin Jackson

  The FDA has cleared Custom Ultrasonics AERs for the cleaning of some duodenoscopes, which have been linked to hospital infection outbreaks.

• FDA Urges Doctors To Stop Using Custom Ultrasonics Reprocessors For Duodenoscopes

  August 18, 2016

  Irvin Jackson

  The FDA is urging hospitals not to use Custom Ultrasonics System 83 Plus AERs for cleaning duodenoscopes, but is allowing them to stay on the market for use on other types of endoscopes.

• FDA Quietly Backs Off Custom Ultrasonics AER Endoscope Washer Recall

  May 18, 2016

  Irvin Jackson

  Rolling back a recall on Custom Ultrasonics endoscope washers, it appears the FDA is allowing them to stay on the market if they are not used to clean duodenoscopes, which have been linked to a number of infection outbreaks.

• Custom Ultrasonics Endoscope Washer Recall Issued Under Consent Decree

  November 16, 2015

  Irvin Jackson

  The FDA has ordered a recall of endoscope cleaning devices by Custom Ultrasonics, saying the company has failed to prove that the devices clean and sterilize endoscopes enough to prevent infections.