FDA-Device2021-10-20Class I
EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
Red Medical Supplies
Hazard
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
Sold states
Firm sold product through Amazon.com. Domestic distribution nationwide.
Affected count
3000
Manufactured in
1037 Broadway W Unit 101, N/A, Vancouver, N/A, Canada
Products
EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0088-2022Don't want to check this manually?
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