Eco-Med Ultrasound Lotions Gels and Lotions Recalled Due to Burkholderia cepacia complex (Bcc) Bacteria Contamination Risk
Eco-Med Ultrasound Lotions Gel Recalls
On 09/28/2021, the U.S. Food and Drug Administration (“FDA”) and Eco-Med Pharmaceutical, Incorporated announced a Class I recall of all Eco-Med Ultrasound Lotions Gels and Lotions. An FDA Class I recall is the most severe type of product recall. Products categorized as a Class I recall may cause injury or death. Eco-Med’s ultrasound gels and lotions are rebranded and resold under several other companies and brands names, including and are not limited to:
| 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) |
Eco-Med’s affected ultrasound gels and lotions are applied to the skin and/or ultrasound device to create electronic images of fetuses, organs, and other structures located inside the patient’s body when conducting an ultrasound test. Ultrasound gels and lotions are transparent, water-based gels that help transmits sound waves resulting in an image.
The affected ultrasound gels and lotions that Eco-Med has manufactured are recalled due to potential Burkholderia cepacia complex (Bcc) bacterial contamination. The FDA has also independently verified that distributed products have tested positive for Burkholderia cepacia bacterial contamination. Using the recalled ultrasound lotions and gels that are contaminated with Burkholderia cepacia could cause serious infections. These infections may include bloodstream infections, resulting in sepsis or death.
There have been 60 bloodstream infections connected with the recalled Eco-Med ultrasound products, the Centers for Disease Control and Prevention (CDC) reported.
Eco-Med Pharmaceutical, Incorporated issued a recall classification notice for some lots of EcoGel, MediChoice, and the company’s Mac Medical ultrasound gel. The FDA has decided that all Eco-Med ultrasound gels and lotions must be recalled due to the Burkholderia cepacia complex (Bcc) risk.
The FDA also urges ultrasound patients, health care providers, and facilities to:
- Stop using and throw away all Eco-Med ultrasound gels and lotions.
- Stop buying Eco-Med ultrasound gels or lotions until further notice.
- Review the Consult Centers for Disease Control and Prevention (CDC) and professional society guidelines concerning the use and follow the appropriate ultrasound cleaning procedures.
- Speak with the retailer or distributor who sold the ultrasound products to you concerning questions or how to dispose of the products.
- Report all adverse events or quality problems to the FDA’s MedWatch Adverse Event Reporting program.
Eco-Med has closed down all of its operations and is not distributing or manufacturing any products.
Who Could Be Affected?
Ultrasound technicians and healthcare providers use ultrasound lotions and gel made by Eco-Med Pharmaceutical, Inc., and distributed by one of its several entities under various brand names.
Patients who receive an ultrasound that uses ultrasound lotions or gels manufactured by Eco-Med Pharmaceutical and distributed by one of the previously mentioned entities.
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