Ultrasound Gel Recall Issued Due To Bacterial Contamination Infection Reports
Eco-Med Pharmaceuticals indicates ultrasound gel sold under a number of different brand names may contain infectious, potentially deadly bacterial contamination, which has been linked to more than a dozen patient infections.
An ultrasound gel recall was announced on August 4, following reports of at least 15 Burkholderia stabilis bacterial infections among patients. The manufacturer, Eco-Med Pharmaceutical, says it suspects more infections are linked to the recalled ultrasound gel, and an investigation into the infections is ongoing.
Ultrasound imaging requires a device known as a transducer to project soundwaves into the body, creating an image based off the soundwaves which bounce back to the transducer when they hit an object. Ultrasound gel provides a medium that removes any air between the transducer and the skin, improving the quality of the image.
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Eco-Med initiated the recall following reports of infections, and after determining some lots were infected with Burkholder stabilis, a type of of Burkholderia cepacia bacteria. The source of the bacterial contamination is still unknown.
While sometimes harmless, Burkholder cepacian complex (Bcc) can cause serious bloodstream infections resulting in sepsis and can even cause death.
The manufacturer warns 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 recall affects Eco Gel 200 and MediChoice Ultrasound Gel M500812, sold under lot numbers B029, B030, B031, B032, B040, B041, B048, and B055. The nonsterile ultrasound gel was distributed from March 26, 2021 to May 26, 2021 under a variety of different brand names in the U.S., Canada, Honduras, and throughout Asia. Those brand names include EcoGel 200, Chatanooga Conductor USA, Conductor Australia, DJO Conductor, Liquasonic, Medico, Medline, Omni, Red Medical Ultrasound gel Blue and Smart 200. A full list of product names and countries where they were sold is available in the recall notice linked above.
The gel was distributed by Owens & Minor, Mac Medical Supply Co., DJO Global, Athena Medical Products, Medline Industries, NDC, and Accelerated Care Plus Leasing.
At this time, Eco-Med is asking distributors and healthcare providers to destroy or return the gel so that it can be properly disposed of without causing further contaminations. The company is calling on all health care facilities affected by the recall to visit https://eco-med.com/recall/ to complete a form indicating the product and lots or batch numbers identified.
Adverse reactions, quality problems or infections can be reported to the FDA’s MedWatch Adverse Event Reporting program.
PatriciaSeptember 16, 2021 at 5:18 am
I bough gel from Amazon, I was using till I got the email recall. I have not been feeling good since august now. I had a fever that lasted over two weeks. I have an infection in my belly button. Pus is coming out from it. I feel very nauseous and tired.
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