Cordis Corporation recalls Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring p…

Recall date

June 9, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2079-2021

FDA classification

Class II

Brand / firm

Cordis Corporation

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of AR, AZ, FL, GA, IN, NC, NJ, and WV. The country of Canada.

Why it was recalled

The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.