Federal health officials have expanded a recall of Eco-Med ultrasound gel products sold under more than 100 product names, due to the potential for bacterial contamination, which has been linked to dozens of severe blood stream infections.
The ultrasound gel recall expansion was announced by the U.S. Food and Drug Administration (FDA) on September 10, after finding approximately 115 brand names of ultrasound gel products and lotions manufactured by Eco-Med have the potential to be contaminated with Burkholderia cepacia complex (Bcc), which can lead to serious and life threatening health complications.
The gels and lotions are used for a variety of medical procedures including ultrasound imaging, in which the gel provides a medium which removes any air between the transducer and the skin, improving the quality of the image.
The Eco-Med ultrasound gel recall was first initiated on August 4, following several reports of patients suffering infections after using the gel, warning that potential routes of transmission resulting in infections may involve contaminated, nonsterile gel being used on patients before an invasive procedure, or when the gel is used inside a sterile ultrasound probe sleeve during an invasive procedure which relies upon ultrasound guidance.
The manufacturer initially recalled a series of brand names including EcoGel 200, Chattanooga Conductor USA, Conductor Australia, DJO Conductor, Liquasonic, Medico, Medline distributed throughout the United States, Canada, Honduras and Asia from March 26, 2021 to May 26, 2021, while an investigation was opened to determine the source of contamination.
Throughout the investigation, infection reports continued to rise, with a total of 66 infections, including 60 bloodstream infections associated with the gel products reported to officials as of August 31.
As a result of the growing number of infection reports, the FDA has determined that all ultrasound gels and lotions manufactured by Eco-Med are at risk for bacterial contamination.
Following the FDA determination, Eco-Lab, in conjunction with the agency, has issued a recall expansion of all Eco-Med ultrasound gels and lotions manufactured and distributed from 2018 until present, impacting approximately 115 brand names and distributors. A full list of product names and countries where they were sold is available in the updated recall expansion notice.
The FDA has given the recall Class I status, indicating it is the most serious of its kind, and that use of the product has a high probability of causing serious adverse health consequences or death.
In addition to the massive recall expansion and Class I designation, Eco-Med also announced it has shut down all operations and is no longer manufacturing or distributing any products until further notice.
Burkholderia cepacia complex is a group of bacteria found in soil and water. While sometimes harmless, the bacteria may also cause respiratory infections or serious bloodstream infections that can result in sepsis and even death.
The FDA is instructing healthcare providers and facilities to:
- Immediately stop using and discard any Eco-Med ultrasound gel and lotion products.
- Stop purchasing any ultrasound gels or lotions made by Eco-Med.
- Consult the U.S. Centers for Disease Control and Prevention and professional society guidelines to determine safe and appropriate use of ultrasound gels, as well as appropriate cleaning procedures
- Contact the distributor who supplied the affected ultrasound gels and lotions for answers to any questions
Adverse reactions, quality problems or infections can be reported to the FDA’s MedWatch Adverse Event Reporting program.