Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
Reported: July 21, 2021 Initiated: June 9, 2021 #Z-2079-2021
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.
Details
- Recalling Firm
- Cordis Corporation
- Units Affected
- 680 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AR, AZ, FL, GA, IN, NC, NJ, and WV. The country of Canada.
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.. Recalled by Cordis Corporation. Units affected: 680 units.
Why was this product recalled? ▼
The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 21, 2021. Severity: Moderate. Recall number: Z-2079-2021.
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