FDA recall Z-0024-2025

Atrium Medical Corporation · Class II · device

Product

iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616

Reason for recall

There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.

Distribution

US Nationwide distribution in the states of FL, MA, MI, OH, WA.

Key facts

Status
Ongoing
Initiation date
2024-09-09
Report date
2024-10-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Merrimack, NH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0024-2025