FDA MedWatch - All Ultrasound Gels and Lotions by Eco-Med Pharmaceutical:

Class I Recall - Due to Risk of Bacteria Contamination

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: All Ultrasound Gels and Lotions by Eco-Med Pharmaceutical: Class I Recall - Due to Risk of Bacteria Contamination AUDIENCE: Patient, Health Professional, Risk Manager ISSUE: 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. As of Aug. 31, 2021, there have been at least 66 infections, including 60 bloodstream infections associated with these affected products, per the Centers for Disease Control and Prevention (CDC). For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: Eco-Med ultrasound gels and lotions are used during an ultrasound test to create images of organs and structures inside the body. RECOMMENDATIONS: On Aug. 4, 2021, Eco-Med Pharmaceutical, Inc. sent a recall classification notice for certain lots of EcoGel, MediChoice, and Mac Medical ultrasound gel. However, the FDA has determined that all ultrasound gels and lotions manufactured by Eco-Med are at risk for bacterial contamination. The FDA recommends health care providers and facilities: Immediately stop using and discard all ultrasound gel and lotion products manufactured by Eco-Med. Do not purchase ultrasound gels or lotions manufactured by Eco-Med. Consult Centers for Disease Control and Prevention (CDC) and professional society guidelines regarding use of ultrasound gel and appropriate ultrasound cleaning procedures. Contact the distributor that supplied these products to you if you have questions about the disposal of the products. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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