Eco-Med Pharmaceuticals issued a recall Aug. 4 of several lots of its ultrasound gel after finding they were contaminated with the bacteria Burkholderia cepacia, which has caused at least 15 infections.
The Canadian company is telling healthcare facilities to immediately destroy or return the gel, which is branded as both Eco-Gel 200 and MediChoice Ultrasound Gel and was distributed across the U.S.
The source of the contamination is unknown and Eco-Med said it's conducting an investigation to determine the root cause.
The effects of an infection with Burkholderia cepacia vary widely, from no symptoms to serious infections, the FDA said. Bloodstream infections could result in sepsis and death.
The recalled ultrasound gel from Eco-Med has been associated with at least 15 infections, including bloodstream infections. Additional infections are under investigation to see if they were caused by the gel, the company said.
Read the FDA's full news release here.