Alerts and Notices (Medical Devices) > FDA Safety Communication: Bacteria Found in Other-Sonic Generic Ultrasound Transmission Gel Poses Risk of Infection

Alerts and Notices (Medical Devices) > FDA Safety Communication: Bacteria Found in Other-Sonic Generic Ultrasound Transmission Gel Poses Risk of Infection

Press Announcements > U.S. Marshals seize ultrasound gel product at a New Jersey company

 Safety Advisory: Bacteria Found in Ultrasound Transmissi​on Gel Poses Risk of Infection

This week the Food and Drug Administration (FDA) received a report from a hospital that 16 patients had developed colonization or infection with the bacteria Pseudomonas aeruginosa. Each of these patients were examined with transesophageal ultrasound probes* using Other-Sonic Generic Ultrasound Transmission Gel. Upon investigation, the ultrasound gel was found to be contaminated with the bacteria Pseudomonas aeruginosa and Klebsiella oxytoca. The product, Other-Sonic Generic Ultrasound Transmission Gel, is not labeled as sterile. It is NOT sterile.

 

At this time, the FDA is concerned about contamination of Other-Sonic Generic Ultrasound Transmission Gel lot numbers 060111 through 120111. These lots contain both 250 milliliter (mL) bottles and 5 liter (L) dispensing containers of gel. The lot number is printed on each bottle of gel. The lots were manufactured June through December 2011 by Pharmaceutical Innovations. You cannot identify contaminated products by looking at the gel. 

Not every patient exposed to Pseudomonas aeruginosa and Klebsiella oxytoca bacteria will develop colonization (the presence of bacteria at a site without any signs of infection) or infection, but the risk remains present. Pseudomonas aeruginosa is found 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 or cause an infection.

Recommendations for Health Care Professionals and Facilities Regarding Other-Sonic Generic Ultrasound Transmission Gel

• Do NOT use Other-Sonic Generic Ultrasound Transmission Gel from lot numbers 060111 through 120111.
• Identify patients who have been exposed to these lots of Other-Sonic Generic Ultrasound Transmission Gel. Review the procedures they underwent and the outcomes of those procedures to determine if further evaluation is needed.
•  To report adverse events associated with use of the contaminated gel, contact Pharmaceutical Innovations Inc. at 973-242-2900 (897 Frelinghuysen Avenue, Newark, NJ 07114). Refer to your facility’s infection control or other risk control procedures for appropriate disposal of Other-Sonic Generic Ultrasound Transmission Gel. 

FDA issued a safety communication and news release notifying the public about the seizure of remaining inventory of Other-Sonic Generic Ultrasound Transmission Gel located at Pharmaceutical Innovations, Inc. Newark, N.J. If you have questions, please contact the Division of Small Manufacturers, International, and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV, 800-638-2041 or 301-796-7100.

*These probes (flexible tubes) are used during diagnostic tests, such as a transesophageal echocardiography (TEE) procedure. During a TEE, doctors guide the probe with a transducer at its tip down a patient’s throat into the esophagus. Once in the esophagus, the transducer sends ultrasound waves to make detailed images of the heart chambers, valves, and surrounding areas.