PlainRecalls
FDA Devices Critical Class I Terminated

LiquaSonic Ultrasound Gel 250mL, Model No. 001205

Reported: September 15, 2021 Initiated: August 20, 2021 #Z-2391-2021

Product Description

LiquaSonic Ultrasound Gel 250mL, Model No. 001205

Reason for Recall

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.

Details

Units Affected
12,240 cases of 12
Distribution
Distributed to one distributor within the US.
Location
Cincinnati, OH

Frequently Asked Questions

What product was recalled?
LiquaSonic Ultrasound Gel 250mL, Model No. 001205. Recalled by Athena Medical Products Inc. Units affected: 12,240 cases of 12.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 15, 2021. Severity: Critical. Recall number: Z-2391-2021.