U.S. Marshals, acting at the request of the Food and Drug Administration, have seized Pharmaceutical Innovations' Other-Sonic Generic Ultrasound Transmission Gels after an FDA analysis found that product samples contained dangerous bacteria.
The ultrasound gels are used to improve the transmission of the ultrasound waves during ultrasound procedures.
The FDA received a report involving 16 surgical patients infected with Pseudomonas aeruginosa. The patients had transesophageal ultrasound procedures, while undergoing heart valve replacement, using Other-Sonic Generic Ultrasound Transmission Gel. An FDA analysis of product samples collected in February 2012 revealed the presence of the two bacterial strains: Pseudomonas aeruginosa and Klebsiella oxytoca.
The FDA warns healthcare professionals who perform ultrasound procedures to stop using Other-Sonic Generic Ultrasound Transmission Gel manufactured from June 2011 through December 2011, because of the risks posed by bacteria contamination.
The ultrasound gels are used to improve the transmission of the ultrasound waves during ultrasound procedures.
The FDA received a report involving 16 surgical patients infected with Pseudomonas aeruginosa. The patients had transesophageal ultrasound procedures, while undergoing heart valve replacement, using Other-Sonic Generic Ultrasound Transmission Gel. An FDA analysis of product samples collected in February 2012 revealed the presence of the two bacterial strains: Pseudomonas aeruginosa and Klebsiella oxytoca.
The FDA warns healthcare professionals who perform ultrasound procedures to stop using Other-Sonic Generic Ultrasound Transmission Gel manufactured from June 2011 through December 2011, because of the risks posed by bacteria contamination.
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