FDA-Device2021-07-21Class II

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

Cordis Corporation
Hazard

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

Sold states
Worldwide distribution - US Nationwide distribution in the states of AR, AZ, FL, GA, IN, NC, NJ, and WV. The country of Canada.
Affected count
680 units
Manufactured in
14201 NW 60th Ave, Miami Lakes, FL, United States
Products
Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2079-2021

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief