Several lots of the company’s products were found to be contaminated with the bacteria Burkholderia cepacia complex. Eco-Med recalled the lots Aug. 4, but the FDA has determined that all of the company’s ultrasound gels and lotions are at risk for contamination with the bacteria.
The agency said Eco-Med didn’t complete its investigation of the issues surrounding the bacterial contamination and didn’t discover the root cause and extent of the contamination, therefore multiple products could have been affected.
The effects of contamination with the bacteria range from no symptoms to serious infection, including bloodstream infections that could cause sepsis or death. The ultrasound gel has been associated with at least 59 infections, including 48 bloodstream infections.
The gels and lotions are distributed by a number of companies under various product names, including MediChoice Ultrasound Gel distributed by Owens & Minor and Mac Medical Supply.
Eco-Med has shut down all operations and is no longer manufacturing or distributing any products, the FDA said.
Read the full warning here.
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