Other‐Sonic Generic Ultrasound Transmission Gel: Safety Communication - Risk of Bacterial Contamination
[UPDATED 05/30/2012] A Class I Recall was issued 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 Other-Sonic Generic Ultrasound Transmission Gel may cause serious adverse health consequences, including death.
Customers are instructed to STOP using Other-Sonic Generic Ultrasound Transmission Gel from lot numbers 060111, 080111, 090111, 100811, and 120111. Although lot 120111 was not voluntarily recalled by the firm, it has been added to the STOP using list because FDA testing revealed that this lot also contained Pseudomonas aeruginosa and Klebsiella oxytoca.
AUDIENCE: Risk Manager, OB/GYN, Radiology, Infectious Disease
ISSUE: FDA notified health care professionals and facilities to STOP using Other‐Sonic Generic Ultrasound Transmission Gel manufactured June though December 2011, because of bacterial contamination with the bacteria Pseudomonas aeruginosa and Klebsiella oxytoca. The contamination was found in lot numbers 060111, 090111, and 120111. These lots are 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.
BACKGROUND: 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 transducer to the body.
RECOMMENDATION: 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. Then, determine if further evaluation is needed. See the FDA Safety Communication for additional information.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
To help us learn as much as possible about the adverse events associated with Other‐Sonic Generic Ultrasound Transmission Gel, please include the following information in your reports, if available:
- Lot number
- Bottle size
- Date of adverse event
- Type of ultrasound procedure
- Details of the adverse event and medical intervention (if required)