FDA recall Z-0089-2022

Red Medical Supplies · Class I · device

Product

EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU

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

Firm sold product through Amazon.com. Domestic distribution nationwide.

Key facts

Status: Ongoing
Initiation date: 2021-08-11
Report date: 2021-10-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Vancouver, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0089-2022