Aeris Balloon Dilation Catheter
Reported: July 26, 2023 Initiated: May 16, 2023 #Z-2148-2023
Product Description
Aeris Balloon Dilation Catheter
Reason for Recall
Devices were mislabeled.
Details
- Recalling Firm
- Bryan Medical Inc
- Units Affected
- 5 units
- Distribution
- US Nationwide distribution in the states of GA, NY, & PA.
- Location
- Cincinnati, OH
Frequently Asked Questions
What product was recalled? ▼
Aeris Balloon Dilation Catheter. Recalled by Bryan Medical Inc. Units affected: 5 units.
Why was this product recalled? ▼
Devices were mislabeled.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 26, 2023. Severity: Moderate. Recall number: Z-2148-2023.
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