Eco-Med Pharmaceutical Recalls All Ultrasound Gels and Lotions

IPSIS Patient Safety Alert 09/29/2021: Eco-Med Pharmaceutical Recalls All Ultrasound Gels and Lotions Due to Bacterial Contamination. The FDA Has Identified This as a Class I Recall, the Most Serious Type of Recall. Use of These Products May Cause Serious Injuries or Death.

This is an important alert from the International Pain and Spine Intervention Society. IPSIS sends Patient Safety Alerts when it receives important information regarding products or services that can impact your patients' safety. When the U.S. Food and Drug Administration (FDA) issues a safety alert, or a company announces a recall or market withdrawal, the FDA posts the announcement as a public service. In such cases neither IPSIS nor the FDA endorse either the product or the company.

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 August 31, 2021, there have been at least 66 infections, including 60 bloodstream infections associated with these affected products, per the U.S. Centers for Disease Control and Prevention (CDC).

For more information about this recall click here.

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 August 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 Adverse Event Reporting Program:

• Complete and submit the report online; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178