FDA recall Z-2533-2023
Advance Medical Designs, Inc. · Class II · device
Product
50-GEL20; Ultrasound gel
Reason for recall
Ultrasound gel mislabeled with inappropriate use.
Distribution
US, Canada, UK, Panama, Netherlands
Key facts
- Status
- Ongoing
- Initiation date
- 2023-07-07
- Report date
- 2023-09-20
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Marietta, GA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2533-2023