Look Out for Ultrasound Gel Recall
U.S. marshals, acting on the authority of the Food and Drug Administration (FDA), seized several lots of tainted ultrasound transmission gel from a Newark, N.J. pharmaceutical company, Medical News Today reports. The gel is used to enhance the transmission of ultrasound waves.
The materials seized from Pharmaceutical Innovations, Inc. included all lots of Other-Sonic Generic Ultrasound Transmission Gel manufactured between June 2011 and December 2011. Laboratory analyses found samples of the transmission gel contained two strains of bacteria, Pseudomonas aeruginosa and Klebsiella oxytoca. The FDA has warned that the bacteria “pose serious risks of infection to individuals exposed to the product.” The agency has received reports of 16 surgical patients infected with Pseudomonas aeruginosa. Other-Sonic Generic Ultrasound Transmission Gel was used in every case.
The FDA has advised health care professionals who perform ultrasounds to stop using Other-Sonic Generic Ultrasound Transmission Gel manufactured between June and December 2011 (lot numbers: 060111, 090111, and 120111).