Potential contamination of health products manufactured by Eco-Med Pharmaceuticals Inc. may pose health risks to Canadians
Summary
If you have purchased health products manufactured by Eco-Med Pharmaceuticals Inc., stop using them immediately and discard them. Consult a health care professional if you have used any of these products and have health concerns.
UPDATE - December 20, 2021: Expanded recall of medical devices manufactured by Eco-Med Pharmaceuticals due to potential contamination with Burkholderia stabilis
Medical devices manufactured by Eco-Med Pharmaceuticals, Inc. and being sold by DJO LLC and DJO France are being recalled voluntarily due to potential bacterial contamination with Burkholderia stabilis, a member of the Burkholderia cepacia complex (Bcc). See table of affected products below for a full list of recalled products.
Should any additional recalls be necessary, Health Canada will update the table of affected products and inform Canadians.
Affected products
All health products manufactured by Eco-Med Pharmaceuticals Inc. This includes ultrasound gels, transmission and massage lotions as well as hand sanitizers and first aid antiseptics.
Product description
| Product | Date added |
|---|---|
| Chattanooga Myossage 3.8L (sold by DJO LLC) | December 20, 2021 |
| Chattanooga Ultra Myossage 3.8L (sold by DJO LLC) | December 20, 2021 |
| Chattanooga Conductor Transmission Gel 5L (sold by DJO LLC) | December 20, 2021 |
| Chattanooga Conductor Transmission Gel 8.5oz (sold by DJO LLC) | December 20, 2021 |
| Intelect Ultrasound Gel 8.5oz (sold by DJO LLC) | December 20, 2021 |
| EcoGel 100 | August 25, 2021 |
| EcoGel 200 | August 25, 2021 |
| EcoGel 300 | August 25, 2021 |
| EcoLotion Transmission and Massage Lotion | August 25, 2021 |
| Medelco Multi Purpose Ultrasound Gel | August 25, 2021 |
| Red Medical Ultrasound Gel | August 25, 2021 |
| Product | Date added |
|---|---|
| Intelect Transport (sold by DJO LLC) | December 20, 2021 |
| Intelect Legend XT (sold by DJO LLC) | December 20, 2021 |
| INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUG (sold by DJO France) | December 20, 2021 |
| INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS (sold by DJO France) | December 20, 2021 |
| Intelect RPW (sold by DJO France) | December 20, 2021 |
| Intelect RPW 2 (sold by DJO France) | December 20, 2021 |
| INTELECT ADVANCED COLOR COMBO (sold by DJO France) | December 20, 2021 |
| Intelect Advanced 2CH Color Combo + EMG (sold by DJO France) | December 20, 2021 |
| Intelect Advanced Monochromatic Combo (sold by DJO France) | December 20, 2021 |
| Intelect Mobile (sold by DJO France) | December 20, 2021 |
| Intelect Mobile Combo (sold by DJO France) | December 20, 2021 |
| Product | Date added |
|---|---|
| Prevent+ (NPN 80097875) | August 25, 2021 |
| Prevent+ Foam Sanitizer (NPN 80102490) | August 25, 2021 |
| Prevent+ Rubbing Alcohol; Rubbing Alcohol 70%; (NPN 80103917) | August 25, 2021 |
| First Aid Antiseptic: Prevent+ Hydrogen Peroxide 3% USP; Hydrogen Peroxide 3% USP; (NPN 80107321) | August 25, 2021 |
Issue
As a precaution, Health Canada is advising Canadians to stop using and discard all products manufactured by Eco-Med Pharmaceuticals (ultrasound gels, transmission and massage lotions, hand sanitizers and first aid antiseptics) due to potential bacterial contamination with Burkholderia stabilis (B. stabilis).
Health Canada previously communicated the manufacturer's voluntary recall for certain lots of ultrasound gels as a result of this contamination. The Department is now expanding the list of impacted products to include all of the company's products because the source of the bacterial contamination is unknown and cannot be determined at this time. In addition, the Department is not able to determine if there are other potential risks or other bacterial contamination as Eco-Med has ceased all company operations.
B. stabilis is a member of a group of bacterial organisms called Burkholderia cepacia complex (Bcc) that are potentially highly virulent and multi-drug resistant. The effects of Bcc vary widely, ranging from no symptoms at all to serious infections. Bcc bloodstream infections may result in sepsis and death in some cases.
Patients - particularly those with compromised immune systems - experiencing an unusual or persistent infection on the skin or in the general area where the product was applied, or who are feeling unwell (e.g., have a fever and/or feel tired), should seek immediate medical attention.
What you should do
- If you have purchased any health product(s) listed above, stop using them and discard them appropriately:
- Follow municipal or regional guidelines on how to dispose of chemicals and other hazardous waste; or
- Return the product to your local pharmacy for proper disposal.
- If you have undergone procedures where the gel was applied to or introduced into the body, and you are feeling unwell (e.g., having a fever and/or feeling tired) following an ultrasound, seek immediate medical attention.
- Since Eco-Med Pharmaceuticals Inc. has ceased operations, you should report any side effects from these health products directly to Health Canada.
What industry professionals should do :
- Immediately stop using and discard all products listed (see above).
- Consider assessing patients who have recently had an 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 or other bacteria.
- Since Eco-Med Pharmaceuticals Inc. has ceased operations, you should report any side effects from these health products directly to Health Canada.
Additional information
Details
Media and public enquiries
Health Canada
613-957-2983
media@hc-sc.gc.ca
613-957-2991
1-866-225-0709
info@hc-sc.gc.ca
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