Recall Z-2148-2023 ยท KTI Bronchoscope Accessory
Bryan Medical Inc
Aeris Balloon Dilation Catheter
| Date | Jul 17, 2023 (initiated May 16, 2023) |
| Status | Open, Classified |
| Reason | Devices were mislabeled. |
| Root cause | Error in labeling |
| Action | 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. |
| Quantity | 5 units |
| Distribution | US Nationwide distribution in the states of GA, NY, & PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150951 | aeris Balloon Dialation Catheter Bryan Medical, Inc., Jun 25, 2015 |