FDA recall Z-2079-2021

Product

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

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

Key facts

Status

Terminated

Initiation date

2021-06-09

Report date

2021-07-21

Termination date

2023-02-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami Lakes, FL, United States

Primary source

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