Device product
Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Z-2079-2021
Product summary
- Event
- Event 88112
- Status
- Terminated
- Classification
- Class II
- Quantity
- 680 units
- Official record key
device-enforcement:Z-2079-2021
Official wording
Reason: The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
Code information: Catalog: 504-657A Lot 17919780: Exp. Date 12/31/2022 and Lot 17988227: Exp. Date 10/31/2023
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of AR, AZ, FL, GA, IN, NC, NJ, and WV. The country of Canada.
Derived failure modes
-
Unknown
The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.