The U.S. Food and Drug Administration is warning healthcare providers to “immediately” stop using a specific type of ultrasound gel due to growing contamination issues, the oversight group said Tuesday.
Eco-Med Pharmaceuticals first recalled multiple lots of its Eco-Gel 200 on Aug. 5 after at least 15 people were hit by a bacterial infection connected to the product.
But now, the FDA says all ultrasound gels and lotions manufactured by the Etobicoke, Ontario-based company may be tainted.
“The FDA’s determination is based on concerns that the company did not complete its investigation of the issues, the root cause and extent of bacterial contamination was not identified, and multiple products could be affected by manufacturing issues associated with the company’s ultrasound gel (such as inappropriate testing of finished product, inadequate testing of raw materials, and a lack of environmental controls),” according to the Aug. 18 announcement.
Eco-Med gels have now been associated with at least 59 Burkholderia cepacia complex (Bcc) infections, including 48 bloodstream infections. The latter can lead to sepsis and potentially death, according to the FDA.
Eco-Med has shut down all operations and is not currently manufacturing or distributing any products.
“The FDA is working with the CDC and state and local health departments to evaluate the extent of contaminated products from Eco-Med and will continue to keep facilities, healthcare providers, and the public informed as new or additional information becomes available,” the administration said in the statement.
For the full list of affected products click here.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.