Eco-Med Pharmaceuticals, Inc. announced a voluntary recall of certain lots of its Eco-Gel 200 ultrasound gel due to bacterial contamination in a release from The U.S. Food and Drug Administration (FDA).
Eco-Med has initiated this recall and quarantine due to bacterial contamination in the affected lots of ultrasound gel with Burkholderia cepacia complex (Bcc). 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.
The product is also distributed as MediChoice Ultrasound Gel by Owens and Minor and Mac Medical Supply. These ultrasound gels are non-sterile and not indicated for sterile procedures.
Eco-Med is instructing all healthcare facilities to identify the affected products by lot number and immediately destroy or return products from affected lots to Eco-Med, Eco Gel 200, MediChoice M500812.
Additionally, Eco-Med is instructing all healthcare facilities to immediately stop use and quarantine all lots of the following ultrasound gels distributed under these brand names in the U.S.:
- MediChoice Ultrasound Gel, by Owens & Minor
- MediChoice Ultrasound Gel, by Mac Medical Supply Co Inc.
- Chattanooga Conductor USA, by DJO Global
- DJO Conductor, by DJO Global
- Liquasonic, by Athena Medical Products Inc.
- Medline, by Medline Industries Inc.
- NDC Eco-Gel 200 Ultrasound Gel, by NDC Inc.
- Omni, by Accelerated Care Plus Leasing Inc.
There are additional products internationally.
The effects of the bacteria, Burkholderia stabilis, a member of the Burkholderia cepacia complex (Bcc), vary widely, ranging from no symptoms at all to serious infections. Bcc bloodstream infections may result in sepsis and in certain cases, potentially death.
Use of ultrasound gels manufactured by Eco-Med have been associated with at least 15 infections to date, including bloodstream infections. Additional infections have been identified that may also be associated with the use of this ultrasound gel and investigation is ongoing. Potential routes of transmission leading to bloodstream infections associated with a contaminated nonsterile gel may have included the use of the gel for visualization prior to, in preparation for, or during an invasive procedure or application of the gel inside the sterile ultrasound probe sleeve during an invasive procedure using ultrasound guidance.
All healthcare facilities impacted by this recall should visit https://eco-med.com/recall/ and complete the form indicating the product and the lots/batch numbers identified and actions taken in the comment section.