Other-Sonic Generic Ultrasound Transmission Gel Recalled due to Risk of Microbial Contamination

FDA informs healthcare professionals and consumers that Other-Sonic Generic Ultrasound Transmission Gel is recalled because it poses risk of microbial contamination that may cause serious adverse events, including death.

Background of Other-Sonic Generic Ultrasound Transmission Gel

Other-Sonic Generic Ultrasound Transmission Gel, by Pharmaceutical Innovations Inc., is a gel used by medical professionals in ultrasounds a procedure during which high-frequency sound waves are used to look at organs inside the body.

FDA Alert on Other-Sonic Generic Ultrasound Transmission Gel

Other-Sonic Generic Ultrasound Transmission Gel may contain organisms like Pseudomonas aeruginosa and Klebsiella oxytoca that can cause serious adverse events, including death.

The product is not sterile.

The affected lot numbers are 060111, 080111, 090111, 100811, and 120111, sold in 250 mL bottles and 5 liter dispensing containers.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

FDA Recommendation on Other-Sonic Generic Ultrasound Transmission Gel

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.

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