FDA announces recall of ultrasound gel following at least 15 bacterial infections
The U.S. Food and Drug Administration announced Wednesday that Eco-Med Pharmaceuticals is recalling certain lots of its ultrasound gel due to contamination issues.
The Etobicoke, Ontario-based company recalled multiple lots of its Eco-Gel 200, used during ultrasound exams. To date, at least 15 people have been struck with a bacterial infection from the product and additional infections have been identified that may also be associated with the gel.
Eco-Med is telling healthcare facilities to “immediately destroy” or return affected lots, the FDA said in an announcement posted Aug. 4.
“Eco-Med has initiated this recall and quarantine due to bacterial contamination in the affected lots of ultrasound gel with Burkholderia cepacia complex (Bcc),” according to the notification. “The source(s) of the bacterial contamination is currently unknown. Eco-Med is conducting a comprehensive investigation to determine the root cause of this contamination and take all necessary corrective action.”
Bcc symptoms can range from nothing at all to serious infection. Bloodstream infections can lead to sepsis and potentially death, according to the news release.
The product recall applies to:
Eco-Gel 200 MediChoice M500812
- Lot number B029, distributed March 26, 2021.
- Lot number B030, distributed March 30, 2021.
- Lot number B031, distributed April 5, 2021.
- Lot number B032, distributed April 7, 2021.
- Lot number B040, distributed April 26, 2021.
- Lot number B041, distributed April 26, 2021.
- Lot number B048, distributed May 7, 2021.
- Lot number B055, distributed May 26, 2021.
In the U.S., the gel was distributed under the following brand names:
- MediChoice Ultrasound Gel, by Owens & Minor.
- MediChoice Ultrasound Gel, by Mac Medical Supply Co.
- Chattanooga Conductor USA, by DJO Global.
- DJO Conductor, by DJO Global.
- Liquasonic, by Athena Medical Products.
- Medline, by Medline Industries.
- NDC Eco-Gel 200 Ultrasound Gel, by NDC.
- Omni, by Accelerated Care Plus Leasing.
Read the full release here.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.