Many times consumers don’t hear about all of the recalls for various products. But in August 2021 the U.S. Food and Drug Administration (FDA) put out a serious recall for Eco-Med Ultrasound gels and lotions. Why is this so serious? The FDA received information from the CDC indicating that unopened bottles of nonsterile, multiuse ultrasound gel, manufactured by Eco-Med, tested positive for Bcc. (Burkholderia cepacia complex). While investigating this issue, the FDA independently confirmed that distributed product tested positive for bacterial contamination.
The effects of Bcc range from no symptoms to serious infections, including bloodstream infections that may result in sepsis or death. To date, the use of Eco-Med ultrasound gels has been associated with at least 66 infections, including 60 bloodstream infections. Additional possible infections may have been associated with the use of Eco-Med ultrasound gels.
Potential routes of transmission leading to bloodstream infections associated with a contaminated non-sterile ultrasound gel may include:
- Use of the gel for visualization prior to, in preparation for, or during an invasive procedure, where instruments are introduced into the patient’s body, or
- Application of the gel inside the sterile ultrasound probe sleeve during an invasive procedure using ultrasound guidance
Make sure that your healthcare provider follows the guidelines of the FDA recall. ALL ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical are ordered to be discarded due to the risk of bacterial contamination. Products manufactured by Eco-Med are distributed by a number of distributors under various product names.
For more information visit:
https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health