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.
A recall issued by Other-Sonic did not include one of the Lots included in the FDA warning, but the agency said its own testing discovered the presence of either bacterial contamination and included it in the recall.
â€śThis ultrasound gel presented serious health risks to patients, particularly vulnerable ones,â€ť said Dara A. Corrigan, the FDAâ€™s associate commissioner for regulatory affairs. â€śTherefore, FDA, with the assistance of our state partner, is taking aggressive enforcement action to protect the public health.â€ť
There is no indication as to whether this Other-Sonic transmission gel has caused any patients serious adverse reactions or illness. The product included in the recall is sold in 250-milliliter and 5-liter bottles and containers.