Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA Orders Custom Ultrasonics To Recall All Endoscope Reprocessors

This article was originally published in The Gray Sheet

Executive Summary

The rare recall order comes as a result of a consent-decree violation by the company, which supplies endoscope reprocessors to almost 3,000 hospitals nationwide. FDA says Custom Ultrasonics has failed to validate its device designs, among other concerns.

You may also be interested in...



US FDA Says Custom Ultrasonics Device May Be Used To Disinfect Certain Duodenoscopes

Custom Ultrasonics' System 83 Plus automated endoscope reprocessors may now be used to disinfect specific models of Olympus and Pentax duodenoscopes, FDA says.

Facilities Must Stop Using Custom Ultrasonics' System To Reprocess Duodenoscopes, FDA Warns

The US agency issued a safety communication Aug. 17 advising all health care facilities to stop using Custom Ultrasonics' System 83 Plus automated endoscope reprocessors to reprocess duodenoscopes, although facilities may continue to use the AERs to clean and sterilize other flexible endoscopes.

Scope Firms, FDA Faulted In 300-Page Senate Report Seeking Device Reforms

Senate HELP Ranking Member Sen. Patty Murray in a staff report criticizes FDA and manufacturers for reacting slowly to duodenoscope contamination incidents in 2013. The report says FDA needs a more robust device surveillance system and calls for more attention to 510(k) modification policies. Murray is a key partner in ongoing Senate work to produce a so-called "medical innovation" bill.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT034397

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel