Important Safety Information on Ultrasound Gels and Lotions Manufactured by Eco-Med Pharmaceuticals, Inc. - Potential Contamination with Burkholderia stabilis

Starting date:
August 19, 2021
Posting date:
August 19, 2021
Type of communication:
Dear Healthcare Professional Letter
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Product Safety, Medical Devices, Important Safety Information
Audience:
Healthcare Professionals, Hospitals
Identification number:
RA-76279

Last updated:

Audience

Healthcare professionals including ultrasound technologists and physicians who perform ultrasounds in hospitals and clinics, physiotherapists, occupational therapists, massage therapists, physical medicine therapists and naturopathic doctors.

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).
  • Health Canada is communicating additional information as a follow-up to a Recall Notice posted on August 10, 2021, and a communication posted on August 13, 2021.
  • The source of the bacterial contamination is not known and cannot be determined at this time. As such, Health Canada is taking a precautionary approach to expand the recall to include all ultrasound gels and lotions manufactured by Eco-Med Pharmaceuticals, Inc.
  • Healthcare professionals are advised to:
    • immediately stop use and discard all lots of products mentioned in the Products affected section of this communication (including EcoGel, EcoLotion and various brand names).
    • consider assessing patients who had a recent ultrasound or other treatment using affected gels or lotions, 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., initiated a recall of certain lots of EcoGel 200 Ultrasound Gel - MediChoice (M500812) due to bacterial contamination with Burkholderia stabilis.

The source of the bacterial contamination is not known and cannot be determined at this time. As such, Health Canada is taking a precautionary approach to expand the recall to include all ultrasound gels and lotions manufactured by Eco-Med Pharmaceuticals, Inc.

Products affected

Healthcare facilities are instructed to immediately stop use and discard all ultrasound gels and lotions manufactured by Eco-Med Pharmaceuticals, Inc.

These products have been sold under the following brand names in Canada:

  • EcoGel 100
  • EcoGel 200
  • EcoGel 300
  • EcoLotion Transmission and Massage Lotion
  • Medelco EcoGel 200
  • Medelco Multi-Purpose Ultrasound Gel
  • Red Medical Ultrasound Gel

These products have been sold to the following distributors in Canada:

  • Active Crystal Inc.
  • Cardinal Health Canada
  • Christie Innomed Inc.
  • Dectro International
  • Medline Canada
  • Dunbar Medical
  • Eastern Medical Supply Ltd
  • Fernanda's Beauty Products
  • Spavaro Inc.
  • Henry Schein Arcona
  • Maranda Lauzon Inc
  • MJM Distributing
  • Ortho Canada
  • STAT Healthcare Corporation
  • The Stevens Company Limited
  • Strathroy Middlesex General Hospital
  • Trimedic Supply Network Ltd.
  • Vitality Depot
  • Medico Inc.
  • Red Medical Supplies Ltd.

These products have been sold internationally under the following brand names and may be present in Canada:

  • MediChoice Ultrasound Gel (Owens & Minor)
  • MediChoice Ultrasound Gel (Mac Medical Supply Co Inc.)
  • Chattanooga Conductor USA (DJO Global)
  • Conductor Australia (DJO Australia)
  • DJO Conductor (DJO Global)
  • Liquasonic (Athena Medical Products Inc.)
  • Medline (Medline Industries Inc.)
  • NDC Eco-Gel 200 Ultrasound Gel (NDC Inc.)
  • Omni (Accelerated Care Plus Leasing Inc.)
  • Smart 200 (Smart Technology and Product Co., Ltd)

Background Information

EcoGel is a series of non-sterile ultrasound gels designed for use in diagnostic imaging, therapeutic ultrasound, transcutaneous electrical nerve stimulation (TENS) treatment and/or other external procedures. EcoGel is not indicated for sterile ultrasound procedures.

EcoLotion is non-sterile and designed for use in therapeutic ultrasound and other external procedures such as shockwave therapy, when a lotion is preferred to a gel.

The manufacturer, Eco-Med Pharmaceuticals, Inc., initiated a voluntary recall in Canada and globally of certain lots due to bacterial contamination. On August 13, 2021, Health Canada communicated additional information as a follow-up to the recall. At this time, the source of the bacterial contamination is not known and cannot be determined. As such, it cannot be confirmed if other Eco-Med Pharmaceuticals, Inc. products are affected; however, based on the identified risk, all potentially impacted products are being recalled as a precautionary measure.

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 various 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 an 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 and EcoLotion are intended to be used for various low-risk ultrasound and other 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 the ultrasound gel or lotion was applied, or who are feeling unwell (e.g., fever and/or feeling tired) following an ultrasound, should seek immediate medical attention.

Information for healthcare professionals

Healthcare professionals are advised to:

  • immediately stop use and discard all lots of products mentioned in the Products affected section of this communication (including EcoGel, EcoLotion and various brand names).
  • consider assessing patients who had a recent ultrasound or other treatment using the affected gels or lotions, and have an unusual or persistent infection, or are feeling unwell, for potential infection with Burkholderia stabilis.

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.

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 gels and lotions 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, EcoLotion, or any other products manufactured by Eco-Med Pharmaceuticals, Inc., 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