Ultrasound Gels by Eco-Med Recalled for Risk of Bacterial Contamination.

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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:

Product NameDistributors
Action de Gala FuSion Conductive GelAesthetics Systems (United States)
Athena Liaison Ultrasound GelMac Medical Supply Co Inc. (United States)
Conductor Transmission GelChattanooga Medical Supply (United States)
Conductor AustraliaDJO Australia (Australia)
DJO ConductorDJO Global (United States)
EcoGel 100Amtec 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 200Accelerated 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 300Eco-Med Pharmaceutical (Canada) 
MJM Distributing (Canada) 
Vitality Depot (Canada) 
EcoLotionAmtec 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)
IntelectDJO 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)
MedelcoMedelco Inc. (Canada)
MediChoice Ultrasound GelMac Medical Supply Co Inc. (United States) 
North Coast Medical (United States)
Owens & Minor (United States)
Medline Ultrasound GelMedline Industries Inc. (United States)
MyossageDJO 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 GelNDC Inc. (United States)
Red Medical Ultrasound GelRed Medical Supplies Ltd. (Canada)
Scrip Crème All Purpose LotionScrip Hessco (United States)
Scrip Ultrasound GelScrip Hessco (United States)
Smart (EcoGel 200 Ultrasound Gel)Smart Technology and Product Co., Ltd (Thailand)
Ultra-MyossageDJO Global (United States)

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.