Athena Medical Products Inc recalls LiquaSonic Ultrasound Gel 250mL, Model No. 001205

Recall date

August 20, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2391-2021

FDA classification

Class I

Brand / firm

Athena Medical Products Inc

Sold / distributed

Distributed to one distributor within the US.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

LiquaSonic Ultrasound Gel 250mL, Model No. 001205