Health product recall

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

  1. ECOGEL 200 ULTRASOUND GEL
  2. EcoLotion Transmission and Massage Lotion
  3. EcoGel 100 Ultrasound Gel
  4. 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