FDA recall Z-2148-2023
Bryan Medical Inc · Class II · device
Product
Aeris Balloon Dilation Catheter
Reason for recall
Devices were mislabeled.
Distribution
US Nationwide distribution in the states of GA, NY, & PA.
Key facts
- Status
- Ongoing
- Initiation date
- 2023-05-16
- Report date
- 2023-07-26
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Cincinnati, OH, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2148-2023