FDA recall Z-2391-2021

Product

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.

Distribution

Distributed to one distributor within the US.

Key facts

Status

Terminated

Initiation date

2021-08-20

Report date

2021-09-15

Termination date

2023-02-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cincinnati, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2391-2021