Ultrasound Gel Recall: Bacterial Contamination Could Cause Sepsis or Death
All ultrasound gels and lotions made by an Ontario-based pharmaceutical company called Etobicoke could be contaminated with bacteria that can cause sepsis or even death. That’s the conclusion of a recent investigation conducted by the U.S. Food and Drug Administration (FDA). On August 18, 2021, the oversight agency issued an announcement urging medical practitioners to cease using those ultrasound gels immediately.
Class 1 Recall
The FDA’s directive comes even after Eco-Med Pharmaceuticals had issued a voluntary recall of many of its Eco-Gel 200 Ultrasound Gels on August 4, 2021, after about 15 individuals had suffered a bacterial infection associated with the product. The FDA directive stems from concerns that Eco-Med never conducted in-depth investigations on the full extent of bacterial contaminations on its products.
The August 18 directive also raised concerns regarding the possibility of the manufacturing problems associated with the company’s ultrasound gel affecting more products. The FDA classified the recall as a Class 1 because of the serious health risks posed by the contaminated ultrasound gel.
Risks Associated with Using the Contaminated Ultrasound Gel
Independent tests on Eco-Med ultrasound gel by FDA confirmed that the gel tested positive for Burkholderia cepacia complex (Bcc). According to CDC, the use of Bcc-contaminated Eco-Med gels has been linked to at least 66 serious infections, including 60 bloodstream infections. Bloodstream infections can lead to sepsis or even death.
FDA Recommendations to Medical Practitioners and Facilities
- Halting the use and purchase of all Eco-Med’s ultrasound gel and lotion products immediately
- Discarding the contaminated ultrasound products safely
- Directing all queries regarding the safest way to dispose of the contaminated products to the distributor that made the supplies
- Notifying the FDA’s MedWatch Adverse Event Reporting Program regarding any adverse side effects associated with the usage of Eco-Med products
- Consulting CDC as well as professional society procedures about using ultrasound gels and cleaning the ultrasound equipment correctly
Getting Legal Support
A person who has been diagnosed with a serious bacterial infection associated with the use of a contaminated ultrasound gel has the right to make a product liability claim or lawsuit against the liable party. A personal injury attorney can examine the case and identify the liable parties who can either be the manufacturer, distributor, or retailer of the product. The attorney can build a solid case that will force the liable party to reasonably compensate the victim for the financial impact of his or her infection or injury.