The contamination drama began in February 2012, when a Michigan hospital reported that 16 patients who underwent surgery were infected with Pseudomonas aeruginosa, a bacterial pathogen.

The hospital suspected the gel was the source.


A sample of that lot then tested positive for Pseudomonas aeruginosa. A second lot was shipped in April 2012 and was found to contain Pseudomonas aeruginosa and Klebsiella oxytoca.

At the time, Buchalter told the news site that the gel in question was non-sterile and not intended for internal use. According to the website, he alleged that the hospital had, in fact, used it internally.

"The gel was not made or recommended for that use,’’ Buchalter told NJ.com.

The FDA in 2012 explained that the patients who had been infected underwent an internal transesophageal ultrasound procedure during surgery for heart valve replacement, according the the news site.

"This ultrasound gel presented serious health risks to patients, particularly vulnerable ones," Dara Corrigan, the FDA’s associate commissioner for regulatory affairs stated at the time.

The company, in business since 1961, stressed at the time of the incident that "this is the only incident in the history of the company ... related to its sterile or non-sterile products.”

Back to HCB News

Business Affairs Homepage