The Food and Drug Administration (FDA), United States, has issued a safety communication on Other-Sonic Generic Ultrasound Transmission Gel manufactured by Pharmaceutical Innovations, Inc.
FDA alerted that health care professionals and facilities to stop using Other-Sonic Generic Ultrasound Transmission Gel manufactured June through December 2011 because of bacterial contamination. The contamination was found in 250 milliliter (mL) bottles and 5 liter (l) dispensing containers with lot numbers 060111, 090111 and 120111.
The FDA received a report from a hospital that 16 patients had developed colonization or infection with the bacteria Pseudomonas aeruginosa. Each of these patients was 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.
Regarding the captioned product, the FDA recommends healthcare professionals and Facilities to:
For details, please refer to FDA website
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm299409.htm
and
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm300873.htm
If you are in possession of the product, please contact your supplier for necessary actions.