Contaminated Ultrasound Gel
August 18, 2012
At FDA’s request, U.S. Marshals have seized Other-Sonic Generic Ultrasound Transmission Gel located at Pharmaceutical Innovations Inc. in Newark, N.J., after an FDA analysis found that product samples contained two dangerous bacterial strains: Pseudomonas aeruginosa and Klebsiella oxytoca. The seizure included all lots of the gel manufactured between June 2011 and December 2011. FDA has also notified health care professionals and facilities to stop using this gel manufactured between these dates.
The product is a non-sterile gel used to improve the transmission of ultrasound waves. Ultrasound is an imaging method that uses high-frequency sound waves to produce precise images of structures within the body.
Risk: People exposed to the bacteria Pseudomonas aeruginosa on the surface of their skin could develop itchy red skin with raised, weepy bumps (inflammatory dermatitis, also known as eczema). Klebsiella bacteria in the lungs or some other tissues may cause serious infections such as pneumonia, wound infection, or bloodstream infection.
Health care professionals have been advised to identify their patients who have been exposed to the contaminated gel to determine if further evaluation is needed. Be aware that the only ultrasound gel that is sterile is an unopened ultrasound gel container or packet labeled as sterile.