Recall Z-0024-2025— Atrium Medical Corporation

Name: FDA recall Z-0024-2025
Creator: U.S. Food and Drug Administration
Published: 2024-09-09

Class II · Ongoing

Class II FDA medical device recall by Atrium Medical Corporation, initiated 2024-09-09. FDA's recall record names no specific 510(k) clearance for this event. Product: iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616. Reason: There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label..

Recalling firm: Atrium Medical Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-09-09
Firm location: Merrimack, NH, United States

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.