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FDA Recalls Ultrasound Transmission Gel Due to Risk of Bacterial Contamination


The FDA issued a Class I Recall and notified health care professionals and facilities to stop using specific lots of Other-Sonic Generic Ultrasound Transmission Gel due to possible microbial contamination that included organisms such as Pseudomonas aeruginosa and Klebsiella oxytoca. Although this product is not labeled as either sterile or non-sterile, it is not sterile. The use of the gel may cause serious adverse health consequences, including death.

 

The gel is used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body. It is sold in 250 milliliter (mL) bottles and 5 liter (l) dispensing containers.

 

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. 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.

 

Health care professionals and consumers are warned to stop using Other-Sonic Generic Ultrasound Transmission Gel.

 

See the FDA Recall

 

 

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