Device product
EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU
Z-0089-2022
Product summary
- Event
- Event 88726
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 2000
- Official record key
device-enforcement:Z-0089-2022
Official wording
Reason: 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.
Code information: All product manufactured by Eco-Med between 2020.09.23 - 2021.08.08
Distribution pattern: Firm sold product through Amazon.com. Domestic distribution nationwide.
Derived failure modes
-
Microbial contamination
bacterial contamination