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Lookout for Ultrasound Gel Recall

United States Marshals, acting on the authority of the Food and Drug Administration (FDA), seized several lots of tainted ultrasound transmission gel from a Newark, New Jersey pharmaceutical company, Christian Nordqvist of Medical News Today reports. The gel is used during ultrasound 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 the Other-Sonic Generic Ultrasound Transmission Gel manufactured from June-Dec. 2011 (lot #s 060111, 090111, and 120111).

Tags: Practice Management