FDA Recalls 8 Lots of Ultrasound Gel for Contamination
Gel was sold under eight different brand names.
If you use ultrasound gel regularly, you’ll want to pay attention to a recent recall from the U.S. Food & Drug Administration (FDA).
In an Aug. 4 announcement, the FDA recalled eight lots of Eco-Med Pharmaceuticals ultrasound gel, citing contamination.
As of publication time 15 patients have contracted confirmed bacterial infections from the Eco-Gel 200 ultrasound gel. Additional cases are suspected but have not been confirmed.
Eco-Gel advised its customers to immediately discontinue use of the product and return it, if possible.
“Eco-Med has initiated this recall and quarantine due to bacterial contamination in the affected lots of ultrasound gel with Burkholderia cepacia complex (Bcc),” officials said in the FDA 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.”
Affected patients can be asymptomatic, or they could develop a serious infection, such as bloodstream infections that can cause sepsis or death.
Eight Eco-Med lots have been recalled:
- 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
The lots were sold under these brand names in the United States:
- 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
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