FDA-Device2023-07-26Class II
Aeris Balloon Dilation Catheter
Bryan Medical Inc
Hazard
Devices were mislabeled.
Sold states
US Nationwide distribution in the states of GA, NY, & PA.
Affected count
5 units
Manufactured in
6100 Wooster Pike, N/A, Cincinnati, OH, United States
Products
Aeris Balloon Dilation Catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2148-2023Don't want to check this manually?
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