Stop Using All Eco-Med Ultrasound Gels and Lotions Due to Risk of Bacterial Contamination – Letter to Health Care Providers
August 18, 2021
The U.S. Food and Drug Administration (FDA) is informing health care providers, health care facility risk managers, and procurement staff to immediately stop using and discard all ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc., due to risk of bacterial contamination with Burkholderia cepacia complex (Bcc). Products manufactured by Eco-Med are distributed by a number of distributors under various product names, including MediChoice Ultrasound Gel distributed by both Owens & Minor and Mac Medical Supply Co., Inc. (See full list below).
Eco-Med initiated a voluntary recall on Aug. 4, 2021, to stop use of EcoGel 200 Ultrasound Gel due to risk of bacterial contamination. However, the FDA has determined that all ultrasound gels and lotions manufactured by Eco-Med are at risk for bacterial contamination.
The FDA’s determination is based on concerns that the company did not complete its investigation of the issues, the root cause and extent of bacterial contamination was not identified, and multiple products could be affected by manufacturing issues associated with the company’s ultrasound gel (such as inappropriate testing of finished product, inadequate testing of raw materials, and a lack of environmental controls).
Eco-Med has shut down all operations and is no longer manufacturing or distributing any products.
List of Eco-Med Ultrasound Gel Products and Lotions
Ultrasound gel products and lotions manufactured by Eco-Med are distributed by a number of distributors, under different product names, which include but are not limited to the following:
Product Name | Distributors |
---|---|
Action de Gala FuSion Conductive Gel | Aesthetics Systems (United States) |
Athena Liaison Ultrasound Gel | Mac Medical Supply Co Inc. (United States) |
Conductor Transmission Gel | Chattanooga Medical Supply (United States) |
Conductor Australia | DJO Australia (Australia) |
DJO Conductor | DJO Global (United States) |
EcoGel 100 | Amtec Sales, Inc. (dba Print Media) (United States) Eco-Med Pharmaceutical (Canada) Cardinal Health (Canada) Fujifilm Sonosite, Inc. (United States) Maranda Lauzon Inc (Canada) Medline Canada (Canada) NDC Inc. (United States) STAT Healthcare Corporation (Canada) The Stevens Company Limited (Canada) |
EcoGel 200 | Accelerated Care Plus (United States) Active Crystal Inc (Canada) Agencia Matamoros (Honduras) Amesys S.A. (Honduras) Amtec Sales, Inc. (dba Print Media) (United States) Anamed Corp. (United States) Best Medical Supply (United States) BP Medical (Dominican Republic) Cardinal Health (Canada) Cardinal Health, Inc. (United States) Choice Medical Systems, Inc. (United States) Christie Innomed Inc. (Canada) Clinomed, Inc. (United States) CMCC Supply Centre and Bookstore (Canada) Dada Dada & CIA (El Salvador) Dectro International (Canada) Dental & Medical Distributor (United States) DHG Specialties (United States) Dimesan USA (United States) Dolphin Med-Equipment & Supply (United States) Droredime (Honduras) Dunbar Medical (Canada) Dynamic Medical Supplies, Inc. (United States) Eastern Medical Supply Ltd (Canada) Eco-Med Pharmaceutical (Canada) Equimedic S.A. de C.V. (El Salvador) Eshus Merin, Inc (United States) Euro Essential Ltd. (Canada) Fernanada’s Beauty Products (Canada) Gadelius Medical (Japan) Global Medical Solution (NZ) LTD (New Zealand) Good-link Electronics Ltd. (Hong Kong) Grobartig Solution, LLC. (United States) Health & Global Enterprises (United States) Healthy You (United States) Henry Schein Arcona (Canada) Innovaciones Medicas (Guatemala) Intrasound Products, LLC (United States) Inversiones C.A. (Honduras) Luizapata Corp. (United States) Lumenis Ltd (Israel) Maranda Lauzon Inc (Canada) Medical Depot, S.A. (Panama) Medical Services, LLC. (United States) Medical Specialists Co., Inc. (United States) Medis Part Ltd. (Thailand) Medline Canada (Canada) Medplus Supply S.A. (Panama) MJM Distributing (Canada) Multiservicios Electromedicos, S.A. (Costa Rica) NDC Inc. (United States) North Coast Medical (United States) Nova Skin, Inc. (United States) Ortho Canada (Canada) Owens & Minor Distribution, Inc. (United States) Paramedicos del El Salvador (El Salvador) PTmart, Inc. (United States) Quantum Products, Inc. (United States) RAF, S.A. DE C.V. (El Salvador) Reserma, SA (Panama) So medico SDN BHD (Malaysia) Spavaro Inc. (Canada) STAT Healthcare Corporation (Canada) The Stevens Company Limited (Canada) Trimedic Supply Network Ltd. (Canada) Vitality Depot (Canada) Westside Surgical Corporation (United States) |
EcoGel 300 | Eco-Med Pharmaceutical (Canada) MJM Distributing (Canada) Vitality Depot (Canada) |
EcoLotion | Amtec Sales, Inc. (dba Print Media) (United States) Clinomed, Inc. (United States) Eco-Med Pharmaceutical (Canada) Eshus Merin, Inc (United States) Grobartig Solution, LLC. (United States) Healthy You (United States) Medical Services, LLC. (United States) Medical Specialists Co., Inc. (United States) NDC Inc. (United States) North Coast Medical (United States) PTmart, Inc. (United States) Quantum Products, Inc. (United States) The Stevens Company Limited (Canada) Vitality Depot (Canada) |
Intelect | DJO Global (United States) |
Liquasonic | Athena Medical Products Inc. (United States) Cardinal Health Inc. (United States) Concordance Healthcare Solutions (United States) Henry Shein Inc. (United States) Mckesson Medical Surgical Inc. (United States) Medline Industries, Inc. (United States) |
MAC Brand EcoGel | Mac Medical Supply Co Inc. (United States) |
Medelco | Medelco Inc. (Canada) |
MediChoice Ultrasound Gel | Mac Medical Supply Co Inc. (United States) North Coast Medical (United States) Owens & Minor (United States) |
Medline Ultrasound Gel | Medline Industries Inc. (United States) |
Myossage | DJO Global (United States) North Coast Medical (United States) |
Norco Ultrasound Gel North Coast Ultrasound Gel |
North Coast Medical (United States) |
Omnisound Ultrasound Gel | Accelerated Care Plus (United States) |
Pro Advantage Ultrasound Gel | NDC Inc. (United States) |
Red Medical Ultrasound Gel | Red Medical Supplies Ltd. (Canada) |
Scrip Crème All Purpose Lotion | Scrip Hessco (United States) |
Scrip Ultrasound Gel | Scrip Hessco (United States) |
Smart (EcoGel 200 Ultrasound Gel) | Smart Technology and Product Co., Ltd (Thailand) |
Ultra-Myossage | DJO Global (United States) |
Recommendations
The FDA recommends that 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.
Background
The FDA recently received information from the CDC indicating that unopened bottles of nonsterile, multiuse ultrasound gel, manufactured by Eco-Med, tested positive for Bcc. While investigating this issue, the FDA independently confirmed that distributed product tested positive for bacterial contamination.
The effects of Bcc range from no symptoms to serious infections, including bloodstream infections that may result in sepsis or death.
To date, the use of Eco-Med ultrasound gels has been associated with at least 66 infections, including 60 bloodstream infections. Additional possible infections may have been associated with the use of Eco-Med ultrasound gels.
Potential routes of transmission leading to bloodstream infections associated with a contaminated non-sterile ultrasound gel may include:
- Use of the gel for visualization prior to, in preparation for, or during an invasive procedure, where instruments are introduced into the patient’s body, or
- Application of the gel inside the sterile ultrasound probe sleeve during an invasive procedure using ultrasound guidance
FDA Actions
The FDA is working to ensure that health care providers, health care facility risk managers, and procurement staff are notified to immediately stop using and to discard all ultrasound gel and lotion products manufactured by Eco-Med, due to the risk of Bcc bacterial contamination in products other than those included in Eco-Med’s recall. Since the FDA understands Eco-Med has shut down operations, the FDA is working directly with distributors to follow through with the recall. Due to the high level of the risk posed by the contaminated product, FDA is classifying the recall as Class I. FDA laboratories are also testing product samples to determine the extent of the contamination.
The FDA is monitoring imports of ultrasound gels and lotions manufactured by Eco-Med to prevent contaminated product from entering into the United States.
The FDA is working with the CDC and state and local health departments to evaluate the extent of contaminated products from Eco-Med and will continue to keep facilities, health care providers, and the public informed as new or additional information becomes available.
Reporting Problems to the FDA
The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with Eco-Med ultrasound gels or lotions.
- Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
- Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
- Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
Additional Resources:
- CDC Outbreak and Patient Notification: Multistate Outbreak of Burkholderia cepacia Infections Associated with Contaminated Ultrasound Gel
- Guidelines for Cleaning and Preparing External- and Internal-Use Ultrasound Transducers and Equipment Between Patients as well as Safe Handling and Use of Ultrasound Coupling Gel. American Institute of Ultrasound in Medicine. AIUM; 05 March 2021.
- All Ultrasound Gels and Lotions Manufactured by Eco-Med Pharmaceutical, Inc. Recalled Due to Risk of Bacteria Contamination
Contact Information
If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).