WASHINGTON (dpa-AFX) - Eco-Med Pharmaceuticals Inc. has commenced a voluntary recall of certain lots of its Eco-Gel 200 ultrasound gel after 15 people got sick due to bacterial contamination.
Eco-Med Pharmaceuticals said it doesn't know how its ultrasound gels got contaminated with the Burkholderia cepacia bacterial complex. These ultrasound gels are non-sterile and not indicated for sterile procedures, the company said in a statement. The Canadian company has recalled eight lots of EcoGel 200 and MediChoice M500812. The recalled EcoGel 200 and MediChoice M500812 lot Nos. are B029; B030; B031; B032; B040; B041; B048; and B055.
Eco-Med said it is conducting a comprehensive investigation to determine the root cause of this contamination and take all necessary corrective action. Eco-Med is instructing all health care facilities to identify the affected products by lot number and immediately destroy or return products from affected lots to Eco-Med.
The effects of the bacteria range 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.
The gel also was distributed in Canada, Honduras, New Zealand, Hong Kong, Thailand, Malaysia and Australia.
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