Aeris Balloon Dilation Catheter
This recall is currently active, issued July 17, 2023. It was issued by Bryan Medical Inc.
- Company
- Bryan Medical Inc
- Recall Initiated
- May 16, 2023
- Posted
- July 17, 2023
- Recall Number
- Z-2148-2023
- Quantity
- 5 units
- Firm Location
- Cincinnati, OH
- Official Source
- View on FDA website ↗
Reason for Recall
Devices were mislabeled.
Distribution
US Nationwide distribution in the states of GA, NY, & PA.
Lot / Code Info
Model No: KG0930; UDI: +B472KG09301; Lot No. 1402309E.
Root Cause
Error in labeling
Action Taken
Customers were emailed a recall notification dated 5/16/2023 requesting the return of affected devices. Customers were asked to quarantine all affected devices, complete the attached Recall Notification Confirmation Form, and return the form to the individuals identified in the notice.