Food and Drug Administration (FDA) has issued a medical device safety alert concerning all ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. due to risk of bacterial contamination [Manufacturing Years: 2018 until Present, Distribution Years: 2018 until as of date].
Ultrasound gel products and lotions are manufactured by Eco-med under different product names which include but not limited to the following: Action de Gala FuSion Conductive Gel, Athena Liaison Ultrasound Gel, Conductor Transmission Gel, Conductor Australia, DJO Conductor, EcoGel 100, EcoGel 200, EcoGel 300, EcoLotion, Intelect, Liquasonic, MAC Brand EcoGel, Medelco, MediChoice Ultrasound Gel, Medline Ultrasound Gel, Myossage, Norco Ultrasound Gel, North Coast Ultrasound Gel, Omnisound Ultrasound Gel, Pro Advantage Ultrasound Gel, Red Medical Ultrasound Gel, Scrip Crème All Purpose Lotion, Scrip Ultrasound Gel, Smart (EcoGel 200 Ultrasound Gel) and Ultra-Myossage.
All ultrasound gels and lotions manufactured by Eco-Med are being recalled due to risk of bacterial contamination with Burkholderia cepacia complex (Bcc). The FDA independently confirmed that distributed product tested positive for bacterial contamination. The use of affected ultrasound gels and lotions contaminated with Bcc may lead to serious infections, including bloodstream infections, which may result in sepsis or death.
The FDA recommends the following actions to healthcare providers and facilities:
Affected users should follow the actions listed on the customer letter, if any, to prevent the risks.
According to the local suppliers, the affected product is distributed in Hong Kong.
For more information, please refer to: https://www.fda.gov/medical-devices/medical-device-recalls/all-ultrasound-gels-and-lotions-manufactured-eco-med-pharmaceutical-inc-recalled-due-risk-bacteria
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 13 Sep 2021