Z-2079-2021 Class II Terminated
FDA device recall Z-2079-2021 was initiated by Cordis Corporation on June 9, 2021 and is designated Class II. Reason for recall: The product in the packaging is larger (both inner and outer diameter) than the labeling indicates. The recall status is terminated (terminated February 16, 2023). Affected quantity: 680 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 21, 2021
- Initiation Date
- June 9, 2021
- Termination Date
- February 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 680 units
Product Description
Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Reason for Recall
The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AR, AZ, FL, GA, IN, NC, NJ, and WV. The country of Canada.
Code Information
Catalog: 504-657A Lot 17919780: Exp. Date 12/31/2022 and Lot 17988227: Exp. Date 10/31/2023