Health care providers, health care facility risk managers, and procurement staff should immediately stop using and discard all ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical Inc. These products are distributed under various product names, including MediChoice Ultrasound Gel distributed by both Owens & Minor and Mac Medical Supply Co. Inc.
Due to a risk for bacterial contamination, Eco-Med initiated a voluntary recall to stop use of EcoGel 200 Ultrasound Gel on Aug. 4, 2021. However, all ultrasound gels and lotions manufactured by Eco-Med are at risk for bacterial contamination with Burkholderia cepacia complex according to a determination by the FDA. If you have questions about FDA regulations, make sure to contact an FDA regulatory consulting agency for a comprehensive suite of compliance services.
Health care providers and facilities are urged to immediately stop using and discard all ultrasound gel and lotion products manufactured by Eco-Med; not to purchase ultrasound gels or lotions manufactured by Eco-Med; to consult the U.S. Centers for Disease Control and Prevention and professional society guidelines regarding ultrasound gel use and ultrasound cleaning procedures; to contact distributers regarding disposal of these products; and to report any adverse reactions or quality problems experienced with use of these products.
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