Z-0808-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 15, 2025
- Initiation Date
- November 12, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 479 units
Product Description
Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.
Reason for Recall
Some units in a single production lot were programmed incorrectly which will result in the VivAer Stylus being incorrectly recognized as RhinAer Stylus when connected to the Aerin Console.
Distribution Pattern
US Nationwide Distribution: AL, AZ, CA, CO, GA, ID, IL, IN, KY LA, MI, MN, NY, NE, NY, OH, OR PA, SC, TN, TX, UT, VA, WA, WI, and WV.
Code Information
Lot #10235, exp. 2026-05-01; UDI (01)08886479300269(17)260501(10)10235