U.S. marshals seize contaminated ultrasound gel
Article Thumbnail ImageApril 18, 2012 -- Acting at the request of the U.S. Food and Drug Administration (FDA), U.S. marshals have seized Other-Sonic generic ultrasound transmission gel from manufacturer Pharmaceutical Innovations in Newark, NJ, after FDA analysis discovered dangerous bacteria in product samples.
Member Sign In:
  MemberID or E-mail Address:
  Password:
(?)

New AuntMinnie.com Members

Becoming a Member is FREE!

  • Real-time radiology-specific news
  • Case of the Day and Teaching Files
  • Focused topics digital communities
  • Lively, discussion groups
  • Medical imaging bookstore
  • SalaryScan
  • Job Boards
  • Online CME
  • Bookstore, market reports, more …
  • Conference Calendar
  • User-controlled eNewsletters
  • … registration is FREE and easy!
  • The seizure included all lots of the gel manufactured between June and December 2011, according to the FDA. Until they were seized, the products were being held under embargo by the New Jersey Department of Health and Senior Services at the FDA's request.

    Two strains of bacteria, Pseudomonas aeruginosa and Klebsiella oxytoca, were found in the samples and pose serious risks of infection to individuals exposed to the product, the FDA said. According to a complaint filed in the U.S. District Court for the District of New Jersey, FDA analysis of product samples collected in February 2012 revealed the presence of the two bacterial strains.

    The FDA said it had received a report involving 16 surgical patients infected with Pseudomonas aeruginosa, all of whom had transesophageal ultrasound procedures using the gel while undergoing heart valve replacement.

    Earlier today, the FDA issued a safety communication alerting healthcare professionals who perform ultrasound procedures to stop using Other-Sonic gel manufactured from June through December 2011 because of the risks posed by bacterial contamination.


    || About || Advertising || AuntMinnieCME.com || Bookstore || Breast MRI || Career Center || Case of the Day || Communities || Conferences || Contact Us || ECR News 2014 || Education || Equipment Classifieds || Europe || Facebook || Forums || Home || Links || Marketplace || Middle East || Mobile || Molecular Breast Imaging || New Installations || News in Brief || People in the News || Privacy Policy || RSNA News 2013 || Reference || Salary Survey Results || Trends in Radiology || Twitter || Vendor Connect || Webinars || XML/RSS ||

    Copyright © 2014 AuntMinnie.com. All Rights Reserved.