September 13, 2021 – Eco-Med Pharmaceuticals a Canadian pharmaceutical company that produces gels and lotions used in ultrasounds has issued a Class I Recall, the most serious type of recall.

Eco-Med products are marketed by a number of distributers, under different product name, which include but are not limited to the following:

What is the Reason for Recall of Ultrasound Gels?

According to a downloadable PDF file available on Eco-Med’s website (link below) is as follows:

Eco-Med has initiated this recall and quarantine due to bacterial contamination in the affected lots of ultrasound gel with Burkholderia cepacia complex (Bcc). The source(s) of the bacterial contamination is currently unknown. Eco-Med is conducting a comprehensive investigation to determine the root cause of this contamination and take all necessary corrective action. The effects of the bacteria, Burkholderia stabilis, a member of the Burkholderia cepacia complex (Bcc), vary widely, ranging 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. Additional infections have been identified that may also be associated with the use of this ultrasound gel and investigation is ongoing. Potential routes of transmission leading to bloodstream infections associated with a contaminated nonsterile gel may have included the use of the gel for visualization prior to, in preparation for, or during an invasive procedure or application of the gel inside the sterile ultrasound probe sleeve during an invasive procedure using ultrasound guidance.

What should I do if I was exposed to these recalled ultrasound gels and lotions?

The FDA has issued guidance on its MedWatch website and states the following:

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 (see Additional Resources).
• Contact the distributor that supplied these products to you if you have questions about the disposal of the products.
• Report any adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program.

Sources:

https://www.fda.gov/medical-devices/medical-device-recalls/all-ultrasound-gels-and-lotions-manufactured-eco-med-pharmaceutical-inc-recalled-due-risk-bacteria

https://eco-med.com/wp-content/uploads//2021/08/Eco-Med-Recall-Press-Release-08-04-21-4.pdf

Page: Ultrasound Gels by Eco-Med Recalled for Risk of Bacterial Contamination updated on September 13, 2021.