FDA-Device2021-10-06Class I
Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.
Accelerated Care Plus Corporation
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
US nationwide distribution.
Affected count
9436
Manufactured in
4999 Aircenter Cir Ste 103, N/A, Reno, NV, United States
Products
Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2518-2021Don't want to check this manually?
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