Recall Z-2079-2021— Cordis Corporation
Class II · Terminated
Class II FDA medical device recall by Cordis Corporation, initiated 2021-06-09, terminated 2023-02-16. It names one FDA 510(k) clearance: K970392. Product: Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.. Reason: The product in the packaging is larger (both inner and outer diameter) than the labeling indicates..
- Recalling firm
- Cordis Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-06-09
- Terminated
- 2023-02-16
- Firm location
- Miami Lakes, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.