FDA-Device2021-09-15Class I

LiquaSonic Ultrasound Gel 5L, Model No. 001222

Athena Medical Products Inc
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
Distributed to one distributor within the US.
Affected count
480 cases of 4
Manufactured in
11270 Groome Rd St # B, N/A, Cincinnati, OH, United States
Products
LiquaSonic Ultrasound Gel 5L, Model No. 001222

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2392-2021

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