Z-0029-2022 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 13, 2021
- Initiation Date
- August 23, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23
Product Description
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
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
U.S. Nationwide distribution in the states of WA, TX, AK, AZ, CA.
Code Information
All lots with valid expiration dates