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.
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