The U.S. Food and Drug Administration (FDA) said that Eco-Med Pharmaceuticals has issued a voluntary recall of certain lots of its Eco-Gel 200 ultrasound gel due to contamination from Burkholderia cepacia complex bacteria.
The bacteria causes bloodstream infections that may result in sepsis and, in certain cases, death. Use of ultrasound gels manufactured by Eco-Med have been associated with at least 15 infections to date, including bloodstream infections, the FDA statement says.
The product is also distributed as MediChoice Ultrasound Gel by Owens and Minor and Mac Medical Supply. These ultrasound gels are nonsterile and not indicated for sterile procedures, the company said.
Eco-Med is instructing all healthcare facilities to identify the affected products by lot number and immediately destroy or return products from affected lots to Eco-Med. The firm told the FDA that it's conducting a comprehensive investigation to determine the root cause of this contamination and take all necessary corrective action.
The full list of lot numbers can be found on the FDA's website.
