The U.S. Food and Drug Administration (FDA) told all healthcare facilities to stop using ultrasound gels and lotions from the now-defunct Eco-Med Pharmaceuticals over concerns that it may be contaminated with bacteria.
According to a news report, Eco-Med initiated the recall for its Eco-Gel 200 products after 15 people reported that they had been sickened with a bacterial infection.
The gels have been also been linked to dozens of additional infections and may cause serious side effects in some cases.
Potentially Fatal Infections
The FDA said that to date the gels have been linked to at least 59 infections including 48 bloodstream infections. The products may be contaminated with a type of bacteria known as Burkholderia cepacia complex (Bcc), officials said. The FDA said it recently received information from the Centers for Disease Control and Prevention indicating that unopened bottles of nonsterile, multiuse ultrasound gel manufactured by Eco-Med tested positive for Bcc.
While looking into this issue, the FDA independently confirmed that distributed products tested positive for the bacterial contamination. The effects of Bcc range from no symptoms to serious infections including bloodstream infections that could potentially result in death, the FDA said in its alert. The agency is taking action based on concerns that the company failed to complete its investigation into the root cause of this contamination. Eco-Med has shut down all operations and is no longer manufacturing or distributing any products, the FDA said.
Officials are advising healthcare providers and facilities to discard the ultrasound gel and lotions. The Eco-Med products are distributed under various names including MediChoice Ultrasound Gel distributed by Owens & Minor and Mac Medical Supply Co., Inc. The products were distributed not just in the United States, but also globally in Australia, Canada, the Honduras, New Zealand, China, Japan, Malaysia, and Israel.
Product Liability Issues
Product manufacturers have the responsibility to make products that are safe for consumers. Contamination of products could occur because of negligence or failure to adhere to safety and sanitation protocols. If you or a loved one has been affected because of a dangerous or defective product, you may be able to seek compensation for damages such as medical expenses, lost wages, hospitalization, permanent injuries, disabilities, and pain and suffering. An experienced product defect lawyer will be able to advise victims and their families regarding their legal rights and options.