Z-2148-2023 Class II Ongoing
FDA device recall Z-2148-2023 was initiated by Bryan Medical Inc on May 16, 2023 and is designated Class II. Reason for recall: Devices were mislabeled. The recall status is ongoing. Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 26, 2023
- Initiation Date
- May 16, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
Product Description
Aeris Balloon Dilation Catheter
Reason for Recall
Devices were mislabeled.
Distribution Pattern
US Nationwide distribution in the states of GA, NY, & PA.
Code Information
Model No: KG0930; UDI: +B472KG09301; Lot No. 1402309E.