Class 2 Device Recall Aeris Balloon Dilation Catheter

• Date Initiated by Firm: May 16, 2023
• Date Posted: July 17, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2148-2023
• Recall Event ID: 92558
• 510(K)Number: K150951
• Product Classification: Bronchoscope accessory - Product Code KTI
• Product: Aeris Balloon Dilation Catheter
• Code Information: Model No: KG0930; UDI: +B472KG09301; Lot No. 1402309E.
• FEI Number: 3005803389
• Recalling Firm/ Manufacturer: Bryan Medical Inc; 6100 Wooster Pike; Cincinnati OH 45227-4209
• For Additional Information Contact: Sales; 513-272-1600
• Manufacturer Reason for Recall: Devices were mislabeled.
• FDA Determined 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 in Commerce: 5 units
• Distribution: US Nationwide distribution in the states of GA, NY, & PA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KTI