Aeris Balloon Dilation Catheter
FDA device recall Z-2148-2023 · posted 2023-07-17 · Open, Classified
Recall details
- Recalling firm
- Bryan Medical Inc
- Reason for recall
- Devices were mislabeled.
- 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.
- Root cause
- Error in labeling
- Status
- Open, Classified
- Product code
- KTI
- Quantity affected
- 5 units
- Distribution
- US Nationwide distribution in the states of GA, NY, & PA.
- Date initiated
- 2023-05-16
- Date posted
- 2023-07-17
- Location
- Cincinnati, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| aeris Balloon Dialation Catheter (K150951) | Bryan Medical, Inc. | 2015-06-25 |