Recall of EcoGel 200 Ultrasound Gel - MediChoice (M500812) – Contamination with Burkholderia stabilis

Starting date:

August 13, 2021

Posting date:

August 13, 2021

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

Product Safety, Important Safety Information, Medical Devices

Audience:

Healthcare Professionals, Hospitals

Identification number:

RA-76233

Last updated:
2021-08-19

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  Issue
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  Who is affected
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  Report health or safety concerns

UPDATED INFORMATION – August 19, 2021

As a precautionary action, healthcare professionals are advised to immediately stop use and discard all ultrasound gel products manufactured by Eco-Med Pharmaceuticals, Inc. For more information on Eco-Med Pharmaceuticals, Inc. products, see the communication published on August 19, 2021.

At this time, the source of the bacterial contamination remains unknown and cannot be determined. As such, it is not known if other Eco-Med Pharmaceuticals, Inc. products are affected. Health Canada is expanding this recall as a precautionary measure.

Health Canada will continue to monitor available safety information involving ultrasound gel products manufactured by Eco-Med Pharmaceuticals, Inc., as it does for all health products on the Canadian market, to identify and assess potential harm. Health Canada will communicate any new safety information to healthcare professionals and consumers.

As of August 10th, 2021 Eco-Med Pharmaceuticals, Inc. ceased operations and filed for insolvency. Affected products should not be used by customers and should not be returned to Eco-Med Pharmaceuticals, Inc.

Audience

Implicated healthcare professionals including ultrasound technologists and physicians who perform ultrasounds in hospitals and clinics.

Key messages

• Eco-Med Pharmaceuticals, Inc. (Eco-Med) commenced a voluntary recall of certain lots of its EcoGel 200 Ultrasound Gel – MediChoice (M500812) due to bacterial contamination with Burkholderia stabilis, a member of the Burkholderia cepacia complex (Bcc). The product is also distributed under various brand names in other jurisdictions.
• Health Canada is communicating additional information as a follow-up to a Recall Notice posted on August 10, 2021.
• Healthcare professionals are advised to:
  • consult the Products affected section of this communication to identify affected lots and immediately destroy products from affected lots.
  • immediately stop use and quarantine all other lots of these products.
  • consider assessing patients who had a recent ultrasound and have an unusual or persistent infection, or are feeling unwell, for potential infection with Burkholderia stabilis.
• Health Canada will continue to monitor the situation, and will take appropriate and timely action should new information become available. Health Canada will also communicate any new safety information to healthcare professionals and consumers.

Issue

The manufacturer, Eco-Med Pharmaceuticals, Inc., has initiated a recall and quarantine of certain lots of EcoGel 200 Ultrasound Gel - MediChoice (M500812) due to bacterial contamination with Burkholderia stabilis.

Products affected

Healthcare facilities are instructed to identify affected lots and immediately destroy products from affected lots. Affected product lot numbers distributed in Canada are below:

Additionally, healthcare facilities are instructed to immediately stop use and quarantine all lots of the following ultrasound gels distributed under these brand names in these countries (and may be present in Canada):

• EcoGel 200, by Eco-Med (Canada) 
• EcoGel 200, by Active Crystal Inc (Canada)
• EcoGel 200, by Cardinal Health Canada
• EcoGel 200, by CMCC Supply Centre and Bookstore (Canada)
• EcoGel 200 Blue, by Christie Innomed Inc. (Canada)
• EcoGel 200, by Dectro International (Canada)
• EcoGel 200, by Medline Canada
• EcoGel 200, by Dunbar Medical (Canada)
• EcoGel 200, by Eastern Medical Supply Ltd (Canada)
• EcoGel 200, by Henry Schein Arcona (Canada)
• EcoGel 200, by Maranda Lauzon Inc (Canada)
• EcoGel 200 Blue, by MJM Distributing (Canada)
• EcoGel 200, by Ortho Canada (Canada)
• EcoGel 200 and EcoGel 200 Blue, by STAT Healthcare Corporation (Canada)
• EcoGel 200 and EcoGel 200 Blue, by The Stevens Company Limited (Canada)
• EcoGel 200, by Strathroy Middlesex General Hospital (Canada)
• EcoGel 200, by Trimedic Supply Network Ltd. (Canada)
• EcoGel 200, by Vitality Depot (Canada)
• Medico, by Medico Inc. (Canada)
• Red Medical Ultrasound Gel Blue, by Red Medical Supplies Ltd. (Canada)
• MediChoice Ultrasound Gel, by Owens & Minor (United States)
• MediChoice Ultrasound Gel, by Mac Medical Supply Co Inc. (United States)
• EcoGel 200, by Agencia Matamoros (Honduras)
• EcoGel 200, by Global Medical Solution (NZ) LTD (New Zealand)
• EcoGel 200, by Good-link Electronics Ltd. (Hong Kong)
• EcoGel 200, by Medi’s Part Ltd. (Thailand)
• EcoGel 200, by So medico SDN BHD (Malaysia)
• Chattanooga Conductor USA, by DJO Global (United States)
• Conductor Australia, by DJO Australia
• DJO Conductor, by DJO Global (United States)
• Liquasonic, by Athena Medical Products Inc. (United States)
• Medline, by Medline Industries Inc. (United States)
• NDC Eco-Gel 200 Ultrasound Gel, by NDC Inc. (United States)
• Omni, by Accelerated Care Plus Leasing Inc. (United States)
• Smart 200, by Smart Technology and Product Co., Ltd (Thailand)

Background Information

EcoGel 200 Ultrasound Gel - MediChoice (M500812) is a non-sterile, medium viscosity, blue or clear ultrasound gel which is not indicated for sterile ultrasound procedures.

The manufacturer, Eco-Med Pharmaceuticals, Inc. initiated a voluntary recall in Canada and globally of certain lots due to bacterial contamination. The source(s) of the bacterial contamination is currently unknown. 

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. The use of ultrasound gels manufactured by Eco-Med have been associated with at least 15 infections to date, as indicated in the manufacturer’s voluntary recall letter, 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 non-sterile 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.

Who is affected

Information for consumers

EcoGel 200 Ultrasound Gel - MediChoice (M500812) is intended to be used for various low-risk ultrasound procedures on intact skin.

Patients, particularly those with compromised immune systems, experiencing an unusual or persistent infection on the skin or in the general area where an ultrasound gel was applied, or who are feeling unwell (e.g., having fever and/or feeling tired) following an ultrasound, should seek immediate medical attention.

Pregnant women who have had ultrasounds as part of medical care, are advised to follow up with the clinic where the ultrasound was performed if they have questions about the gel that was used in their ultrasound.

Information for healthcare professionals

Healthcare professionals are advised to:

• identify affected lots by lot number and immediately destroy products from affected lots (see Products affected section).
• immediately stop use and quarantine all other lots of these Eco-Med products.
• consider assessing patients who had a recent ultrasound and have an unusual or persistent infection, or are feeling unwell, for potential infection with Burkholderia stabilis.

Action taken by Health Canada

Health Canada is communicating this important safety information to Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians website.

Health Canada will continue to monitor available safety information involving the EcoGel 200 Ultrasound Gel - MediChoice (M500812), and any other ultrasound gels manufactured by Eco-Med Pharmaceuticals, Inc., as it does for all health products on the Canadian market, to identify and assess potential harm. Health Canada will take appropriate and timely action if and when any new health risks are identified. Health Canada will also communicate any new safety information to healthcare professionals and consumers.

Report health or safety concerns

Health Canada’s ability to monitor the safety of marketed health products depends on healthcare professionals and consumers reporting adverse reactions and medical device incidents. Any cases of infection with Burkholderia stabilis, or other serious or unexpected side effects in patients exposed to EcoGel 200 Ultrasound Gel - MediChoice (M500812), or other ultrasound gels should be reported to Health Canada.

The Health Product Complaint Form (FRM-0317) can be found on the Health Canada Web site.

For other health product inquiries related to this communication, contact Health Canada at:

Regulatory Operations and Enforcement Branch

E-mail: hc.hpce-cpsal.sc@canada.ca