Aeris Balloon Dilation Catheter recalled over labeling errors
- Recall date
- May 16, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Bryan Medical Inc recalls Aeris Balloon Dilation Catheter
- Recall number
- Z-2148-2023
- FDA classification
- Class II
- Brand / firm
- Bryan Medical Inc
- Sold / distributed
- US Nationwide distribution in the states of GA, NY, & PA.
Why it was recalled
Devices were mislabeled.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Aeris Balloon Dilation Catheter
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