Ultrasound Gel manufactured by Eco-Gel (2021-08-04)
- Starting date:
- August 4, 2021
- Posting date:
- August 31, 2021
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-76349
Last updated:
2021-08-31
Affected Products
- ECOGEL 200 ULTRASOUND GEL
- EcoLotion Transmission and Massage Lotion
- EcoGel 100 Ultrasound Gel
- EcoGel 300 Ultrasound Gel
Reason
Bacterial contamination of Burkholderia Stabilus in Ultrasound Gel. Contamination source unknown, investigation is ongoing. Eco-Med has confirmed bacterial contamination from yet unidentified sources in certain lot numbers of these non-sterile, multi-use gel products.
Affected products
A. ECOGEL 200 ULTRASOUND GEL
Lot or serial number
- All lots.
Model or catalog number
- 40JB
- 40JBC
- 40JE
- 40JM
- 40JMC
- 40JS
- 40JSC
- 40JSP
- 40JSPC
- 40JT
- 50TM
- M500812
Companies
- Manufacturer
-
ECO-MED PHARMACEUTICALS INC
151 CARLINGVIEW DRIVE, Unit 14
Toronto
M9W 5S4
Ontario
CANADA
B. EcoLotion Transmission and Massage Lotion
Lot or serial number
- All lots.
Model or catalog number
- 85CB
- 85CJ
- 85CM
- 8BCS
Companies
- Manufacturer
-
ECO-MED PHARMACEUTICALS INC
151 CARLINGVIEW DRIVE, Unit 14
Toronto
M9W 5S4
Ontario
CANADA
C. EcoGel 100 Ultrasound Gel
Lot or serial number
- All lots.
Model or catalog number
- 30GB
- 30GB-12
- 30GE
- 30GM
- 30GS
Companies
- Manufacturer
-
ECO-MED PHARMACEUTICALS INC
151 CARLINGVIEW DRIVE, Unit 14
Toronto
M9W 5S4
Ontario
CANADA
D. EcoGel 300 Ultrasound Gel
Lot or serial number
- All lots.
Model or catalog number
- 30TB
- 30TB-12
- 30TM
- 30TS
Companies
- Manufacturer
-
ECO-MED PHARMACEUTICALS INC
151 CARLINGVIEW DRIVE, Unit 14
Toronto
M9W 5S4
Ontario
CANADA