FDA Issues Class I Recall on Other-Sonic Ultrasound Gel
6/1/2012 8:16:24 AM
The Food and Drug Administration has issued a Class I recall on a non-sterile gel used in ultrasound procedures because it may have a microbial infection that could cause serious harm to people who have it applied to their bodies prior to having a scan. The agency issues Class I recalls when it considers use of a medical device to pose a risk of serious injury or death to the public. The recall includes certain Lots of Other-Sonic Generic Ultrasound Transmission Gel. The recall includes the following Lots: 060111, 080111, 090111, and 100811. FDA testing on samples taken from these Lots has detected the presence of Pseudomonas aeruginosa and Klebsiella oxytoca, two forms of microbial bacteria. Using this product alongside other Other-Sonic Generic Ultrasound Transmission Gel products could lead to serious complications and possibly death.