Eco-Med initiated a voluntary recall on August 4 of its EcoGel 200 ultrasound gel due to risk of bacterial contamination from Burkholderia cepacia complex bacteria. But the FDA subsequently determined that all ultrasound gels and lotions manufactured by Eco-Med are at risk for bacterial contamination, the agency said in a release.
The FDA found the company did not complete its investigation of the issues involved in the incident, did not identify the root cause and extent of bacterial contamination, and that multiple products could be affected by manufacturing issues associated with the company's ultrasound gel. These include inappropriate testing of finished product, inadequate testing of raw materials, and a lack of environmental controls, according to the release.
Products manufactured by Eco-Med are distributed by a number of distributors under various product names, including MediChoice Ultrasound Gel distributed by both Owens & Minor and Mac Medical Supply.
Eco-Med has shut down all operations and is no longer manufacturing or distributing any products. The FDA has provided a full list of Echo-Med ultrasound gel products and lotions.
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