Recalls

Bacteria-contaminated ultrasound gel recalled

Potentially dangerous bacteria has been found in gel used in ultrasound transmission, according to a safety announcement issued by the Food and Drug Administration (FDA). A recall was issued on three lots of Other-Sonic Generic Ultrasound Transmission Gel, manufactured by Pharmaceutical Innovations Inc.

The recall was issued after the FDA received a report from a hospital that 16 patients had developed colonization or infection with the bacteria Pseudomonas aeruginosa. Each of the patients was examined with transesophageal ultrasound probes using Other-Sonic Ultrasound Transmission Gel. Upon investigation, the ultrasound gel was found contaminated with the bacteria Pseudomonas aeruginosa and Kiebsiella oxytoca.

Other-Sonic Generic Ultrasound Transmission Gel, manufactured by Pharmaceutical Innovations Inc., is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the tranducer to the body.

Pseudomonas aeruginosa is found most often in water and soil. Patients exposed to the bacteria on the surface of their skin could develop inflammatory dermatitis, even on intact skin. Pseudomonas aeruginosa is not usually found in places such as the upper airway, the lower GI tract or the female genital tract—if it is introduced to those places, it could colonize (the presence of bacteria at a site without signs of infection) or cause an infection.

Invasive biopsy procedures can carry bacteria into tissues, and could cause an abscess or sepsis. The bacteria can also move from one site to another. For example, if Pseudomonas aeruginosa is introduced into the upper airway through a transesophageal echocardiography procedure and begins to grow, it may cause no symptoms. However, if it is accidentally aspirated into the lower airway, it could cause tracheobronchitis or pneumonia.

Klebsiella bacteria is often found in the digestive tract where they do not often cause infection; however, when the lungs or other tissues are exposed to Klebsiella bacteria, either minor problems or more serious infections such as pneumonia, wound infection or bloodstream infections could occur.

Not every patient who is exposed to these bacteria in the transmission gel will develop colonization or infection, but the risk remains present. Thus, hospitals and health care professionals are urged to stop using the recalled lots of the gel immediately.

The affected lots were manufactured June 2011 through December 2011, and include the numbers 060111, 090111, and 120,111.

Any side effects or illnesses associated with the contaminated ultrasound gel should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA