The U.S. Food & Drug Administration (FDA) has recalled eight lots of Eco-Med Pharmaceuticals ultrasound gel, with contamination being the culprit. Confirmed bacterial infections affected 15 patients who were in contact with the Eco-Gel 200 ultrasound gel. Unconfirmed cases are also suspected.
Eco-Gel instructed customers to immediately halt the use of the gel and return it to the manufacturer if possible.
FDA officials said, “Eco-Med has initiated this recall and quarantine due to bacterial contamination in the affected loss of ultrasound gel with Burkholderia cepacia complex (Bxx). 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.”
Patients who encountered the gel can be asymptomatic or develop severe toxicity, such as bloodstream infection, which can result in sepsis or death.
Eco-Med lot numbers included in the recall:
- Lot number B029 – distribution: March 26, 2021
- Lot number B030 – distribution: March 30, 2021
- Lot number B031 – distribution: April 5, 2021
- Lot number B032 – distribution: April 7, 2021
- Lot number B040 – distribution: April 26, 2021
- Lot number B041 – distribution April 26, 2021
- Lot number B048 – distribution: May 7, 2021
- Lot number B055 – distribution: May 26, 2021
These brand names were also tainted and are recalled:
- Chattanooga Conductor USA – DJO Global
- DJO Conductor – DJO Global
- Liquasonic – Athena Medical Products
- MediChoice Ultrasound Gel – Owens & Minor
- MediChoice Ultrasound Gel – Mac Medical Supply Co.
- Medline – Medline Industries
- NDC Eco-Gel 200 Ultrasound Gel – NDC
- Omni – Accelerated Care Plus Leasing
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Written by the digital marketing staff at Creative Programs & Systems: www.cpsmi.com.