Home / Recalls / Red Medical Supplies / Z-0089-2022

Z-0089-2022 Class I Ongoing

Recalled by Red Medical Supplies — Vancouver, N/A

Recall Details

Product Type: Devices
Report Date: October 20, 2021
Initiation Date: August 11, 2021
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2000

Product Description

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 Pattern

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

Code Information

All product manufactured by Eco-Med between 2020.09.23 - 2021.08.08