Device product
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Z-0029-2022
Product summary
- Event
- Event 88624
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 23
- Official record key
device-enforcement:Z-0029-2022
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 lots with valid expiration dates
Distribution pattern: U.S. Nationwide distribution in the states of WA, TX, AK, AZ, CA.
Derived failure modes
-
Microbial contamination
bacterial contamination